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Pain with sexual activity at 1 and 3 years: Comparing total extraperitoneal with Lichtenstein inguinal hernia repair in a randomized setting (TEPLICH trial)

Open AccessPublished:August 27, 2022DOI:https://doi.org/10.1016/j.surg.2022.07.013

      Abstract

      Background

      Pain at sexual activity induced by an inguinal hernia or as a cause of its repair is not thoroughly studied. Reported frequencies are between 25% and 30% preoperatively and 10% and 15% postoperatively. The primary aim was to analyze pain at sexual activity at 1 year comparing total extraperitoneal with Lichtenstein repair in a randomized setting.

      Methods

      Men, 30 to 60 years old, with a primary inguinal hernia were randomized to total extraperitoneal without mesh fixation or Lichtenstein repair. A questionnaire on pain prevalence, frequency, intensity, and impairment of sexual functions caused by pain at sexual activity was introduced. Clinical examination, a questionnaire on sexual function, and the 36-Item Short Form Survey were performed preoperatively and at 1 and 3 years postoperatively. A risk factor analysis for pain at sexual activity as performed.

      Results

      A total of 243 patients (111 total extraperitoneal and 132 Lichtenstein) were included between 2008 and 2014; 97% remained for 1-year and 90% for 3-year analysis. Preoperative pain at sexual activity was reported in 35%, with a reduction to 5.9% in total extraperitoneal and 12.5% in Lichtenstein (P = .098) at 1 year and 7.0% in total extraperitoneal and 9.3% in Lichtenstein (P = .566) at 3 years. Quality of life preoperatively was markedly reduced in patients with pain at sexual activity but restored almost to norm levels at 1 and 3 years. New pain at sexual activity (harm) was seen in 8 patients (3.6%) at 1 year. Risk factors for having postoperative pain at sexual activity were preoperative pain and Lichtenstein technique.

      Conclusion

      Pain at sexual activity in inguinal hernia patients is more common than suspected and reduces quality of life. Repair will markedly reduce pain at sexual activity and restore quality of life in most patients without difference between techniques. Patients should be informed on a potential relation between having an inguinal hernia and sexual impairment.

      Introduction

      Improved surgical techniques have lowered the recurrence rates after inguinal hernia repair. Chronic pain has come into focus. Pain at sexual activity (SEX-P) caused by an existing inguinal hernia, or as a remaining or a new problem after inguinal hernia repair, has been less extensively explored. Only a few studies exist reporting SEX-P in relation to an inguinal hernia or its repair.
      • Zieren J.
      • Menenakos C.
      • Paul M.
      • Muller J.M.
      Sexual function before and after mesh repair of inguinal hernia.
      • Aasvang E.K.
      • Mohl B.
      • Bay-Nielsen M.
      • Kehlet H.
      Pain related sexual dysfunction after inguinal herniorrhaphy.
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      • Bansal V.K.
      • Krishna A.
      • Manek P.
      • et al.
      A prospective randomized comparison of testicular functions, sexual functions and quality of life following laparoscopic totally extra-peritoneal (TEP) and trans-abdominal pre-peritoneal (TAPP) inguinal hernia repairs.
      The preoperative incidence of SEX-P in hernia patients varies between 10% and 32% in studies.
      • Zieren J.
      • Menenakos C.
      • Paul M.
      • Muller J.M.
      Sexual function before and after mesh repair of inguinal hernia.
      ,
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      ,
      • Bittner R.
      • Gmahle E.
      • Gmahle B.
      • Schwarz J.
      • Aasvang E.
      • Kehlet H.
      Lightweight mesh and noninvasive fixation: an effective concept for prevention of chronic pain with laparoscopic hernia repair (TAPP).
      • Tolver M.A.
      • Rosenberg J.
      Pain during sexual activity before and after laparoscopic inguinal hernia repair.
      • Andresen K.
      • Burcharth J.
      • Fonnes S.
      • et al.
      Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial.
      Studies have reported diminished SEX-P after surgery, with incidence varying between 4.5% and 27%. Both transabdominal preperitoneal (TAPP) repair and total extraperitoneal (TEP) repair seemed to have lower incidence compared with Lichtenstein and the plug and patch techniques.
      • Zieren J.
      • Menenakos C.
      • Paul M.
      • Muller J.M.
      Sexual function before and after mesh repair of inguinal hernia.
      ,
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      ,
      • Bittner R.
      • Gmahle E.
      • Gmahle B.
      • Schwarz J.
      • Aasvang E.
      • Kehlet H.
      Lightweight mesh and noninvasive fixation: an effective concept for prevention of chronic pain with laparoscopic hernia repair (TAPP).
      • Tolver M.A.
      • Rosenberg J.
      Pain during sexual activity before and after laparoscopic inguinal hernia repair.
      • Andresen K.
      • Burcharth J.
      • Fonnes S.
      • et al.
      Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial.
      Despite this, postoperative incidence also is surprisingly high for minimally invasive techniques. The large variation in reported preoperative and postoperative incidence of SEX-P could be partly explained by differences in patient population, the definition of pain, or the instruments used for assessment.
      One large study from the Danish Hernia Database reported long-term SEX-P in 11% of >1,300 patients having had a TAPP repair,
      • Pommergaard H.C.
      • Burcharth J.
      • Andresen K.
      • Fenger A.Q.
      • Rosenberg J.
      No difference in sexual dysfunction after transabdominal preperitoneal (TAPP) approach for inguinal hernia with fibrin sealant or tacks for mesh fixation.
      with young age as a risk factor for pain. In a study of >800 TAPP-operated patients, long-term SEX-P was reported in 10.9% (2.4% being moderate or severe pain).
      • Bischoff J.M.
      • Linderoth G.
      • Aasvang E.K.
      • Werner M.U.
      • Kehlet H.
      Dysejaculation after laparoscopic inguinal herniorrhaphy: a nationwide questionnaire study.
      The occurrence of SEX-P before operation that is not relieved by hernia repair is not thoroughly investigated nor is the risk of developing SEX-P as a result of hernia repair. Furthermore, the influence of SEX-P due to a hernia or a hernia operation on quality of life (QOL) is sparsely reported.
      The aim of this study was to compare TEP with Lichtenstein regarding the occurrence of SEX-P in a randomized setting at 1 and 3 years after surgery. The operations were performed by board-certified hernia specialists following a strict protocol. Secondary aims were SEX-P at 3 years, QOL in relation to SEX-P over time, and a risk factor analysis for SEX-P.

      Methods

      This is a single-center randomized controlled trial (RCT), conducted at a specialist university hernia center by surgeons trained according to a standardized curriculum aligning to agreed technical details, comparing TEP with Lichtenstein concerning hernia-related SEX-P.
      Men 30 to 60 years old referred for assessment of inguinal hernia symptoms were included in the current study. They constituted a subgroup of the cohort of 30 to 75-year-old men included in the larger overall TEPLICH trial.
      • Gutlic N.
      • Gutlic A.
      • Petersson U.
      • Rogmark P.
      • Montgomery A.
      Randomized clinical trial comparing total extraperitoneal with Lichtenstein inguinal hernia repair (TEPLICH trial).
      The overall TEPLICH trial compared TEP with Lichtenstein repair for treatment of a unilateral primary inguinal hernia with chronic pain as the primary outcome.
      The Consolidated Standards of Reporting Trials checklist was used, and reasons for exclusions are listed in Figure 1. The Regional Ethical Review Board in Lund, Sweden, approved the study (DNR 596/2007). Informed consent was signed by all of the patients. The trial was registered at www.clinicaltrial.gov (NCT00803985).
      Figure thumbnail gr1
      Figure 1Flowchart showing inclusion and randomization of patients. ASA, American Society of Anesthesiologists; CONSORT, Consolidated Standards of Reporting Trials; TEP, total extraperitoneal.

      End points

      The primary end point was SEX-P at 1 year, defined as pain/discomfort (yes/no) in the operated groin during sexual activity. Secondary end points were SEX-P at 3 years; QOL; surgical harm (defined as SEX-P 1 year after operation that did not exist preoperatively); and SEX-P before the operation that remained unchanged at 1 year (interpreted as pain not caused by the hernia or the operation). A risk factor analysis for SEX-P was performed for preoperative pain, operative technique, and age over 45 years.

      Surgical techniques

      General anesthesia was administered in all patients. Antibiotic prophylaxis was not routinely administrated. Operating surgeons were all hernia specialists, locally board certified for participation in the study according to a specific protocol for each technique. Adherence to the operative protocol was checked regularly at unannounced visits by main investigators.
      TEP operations were performed using a subumbilical entrance for preperitoneal insufflation of carbon dioxide. Two 5-mm working ports were positioned in the lower midline. Peritoneum was mobilized ≥5 cm retroperitoneally to expose the triangle of doom and laterally up to the iliac spine.
      • Ploneda-Valencia C.P.
      • Bautista-López C.A.
      • Navarro-Montes C.A.
      • Verdugo-Tapia J.C.
      The Art and Science of Abdominal Hernia Minimally invasive surgery of the groin: inguinal hernia repair, The Art and Science of Abdominal Hernia.
      The inguinal and femoral area was covered with an unfixed mesh (heavyweight 3DMax, large, 12 × 17 cm; Bard, Chelmsford, MA).
      The Lichtenstein repair was performed through a groin incision. Special care was taken to identify, without mobilizing, the 3 inguinal nerves (nervus ilioinguinalis, nervus iliohypogastricus, and nervus ienitofemoralis) and leave the cremaster muscle undivided. An indirect sac was dissected to the internal ring and opened, and the femoral canal was palpated for a potential femoral hernia. The sac was ligated and excised. In direct hernias, the femoral canal was palpated through a transverse fascia incision that was later closed using a running monofilament absorbable suture (PDS II, 2-0; Ethicon, Somerville, NJ). A macroporous lightweight polypropylene mesh (Parietene Lightweight Mesh, 10 × 15 cm; Medtronic, Minneapolis, MN) was shaped and placed with a 2-cm overlap of the pubic tubercle and fixated with a running nonabsorbable monofilament polypropylene 2-0 suture to the inguinal ligament. The slit of the mesh was closed laterally to the internal ring using the same suture. The mesh was medially fixated at 2 points with an absorbable monofilament polydioxanone 2-0 suture, avoiding capture of the iliohypogastric nerve.

      Protocol, clinical data, and examinations

      A standardized protocol was used for registration of data from preoperative, 1- year, and 3-year assessments. Data registrations were performed at scheduled outpatient clinic follow-up. The patients not attending follow-up received the questionnaire by mail. The standardized protocol included a study-specific protocol for symptoms, clinical examination, sexual questionnaire and the 36-Item Short Form Survey (SF-36) QOL instrument. The patients were seen 4 weeks postoperatively to report on complaints and complications (eg, significant hematoma [with or without reoperation], seroma [with or without aspiration], infection requiring antibiotic treatment or operative drainage, severe groin pain [treated with analgesics or by reoperation], testicular pain, and urinary retention). Any reoperation performed was registered. Recurrence was diagnosed by clinical examination. A herniography was performed in cases of doubt.

      Questionnaires

      Sexual questionnaire

      A specific questionnaire for SEX-P and sexual dysfunction due to pain was used (Figure 2). It included questions in the following order: prevalence of pain, impairment of sexual function due to pain, pain frequency, and intensity of pain (visual analog scale [VAS]). In the first question, expressions of pain and discomfort were combined: “Do you have pain/discomfort in your groin during sexual activity?” An affirmative answer was interpreted as pain at analysis. Only patients reporting pain/discomfort were requested to answer the subsequent questions. The SEX-P status at each given follow-up time is reported in Figure 3, and only patients participating at all times points were included.
      Figure thumbnail gr2
      Figure 2Specific questionnaire on sexual dysfunction.
      Figure thumbnail gr3
      Figure 3Assessment of pain at sexual activity over time. Patients are included as long as an unbroken suite is recorded. Relief represents relating to patients relived of pain after surgery. Harm represents relating to patients who developed pain after surgery. Blue boxes represent pain at sexual activity. White boxes represent no pain at sexual activity. Lich, Lichtenstein repair; TEP, total extraperitoneal.
      New, remaining, and relief of SEX-P were calculated based on all responding patients at each given follow-up time.

      SF-36

      The SF-36 for measurement of health-related QOL (HRQL), licensed by the RAND Corporation (www.rand.org) was used. The 8 subscales and the composite scores for physical and mental health were calculated according to a manual.
      • Sullivan M.
      • Karlsson J.
      • Taft C.
      • Ware J.E.
      SF-36 Hälsoenkät: Svensk Manual och Tolkningsguide, 2:a upplagan.
      ,
      • Taft C.
      • Karlsson J.
      • Sullivan M.
      Performance of the Swedish SF-36 version 2.0.
      Norm-based scores were calculated using the Swedish age- and sex-specific means and SDs. The norm data have a mean of 50 (SD 10). A 5-point difference corresponds to an effect size of 0.5 SD, which is regarded as a medium-sized clinical difference.
      • Cohen J.
      Statistical Power Analysis for the Behavioral Sciences.

      Risk factor analysis

      The factors selected for SEX-P risk factor analysis at 1 year after hernia repair were SEX-P before surgery, age >45 years, operative technique, and postoperative complications within 4 weeks after surgery. Factors were selected in consensus by the researchers after reviewing the literature.
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      ,
      • Pommergaard H.C.
      • Burcharth J.
      • Andresen K.
      • Fenger A.Q.
      • Rosenberg J.
      No difference in sexual dysfunction after transabdominal preperitoneal (TAPP) approach for inguinal hernia with fibrin sealant or tacks for mesh fixation.

      Sample size and randomization

      A sample size calculation was performed on the subgroup of patients (men ages 30–60 years) based on the TEPLICH trial.
      • Gutlic N.
      • Gutlic A.
      • Petersson U.
      • Rogmark P.
      • Montgomery A.
      Randomized clinical trial comparing total extraperitoneal with Lichtenstein inguinal hernia repair (TEPLICH trial).
      Dichotomous measures for pain/no SEX-P were used. The hypothesis was that 8% of TEP- and 20% of Lichtenstein-operated patients had SEX-P after 1 year. A total of 131 patients in each group were required to distinguish a difference of 12% (α = 0.05) with a power of 80%.
      • Aasvang E.K.
      • Mohl B.
      • Bay-Nielsen M.
      • Kehlet H.
      Pain related sexual dysfunction after inguinal herniorrhaphy.
      ,
      • Tolver M.A.
      • Rosenberg J.
      Pain during sexual activity before and after laparoscopic inguinal hernia repair.
      • Andresen K.
      • Burcharth J.
      • Fonnes S.
      • et al.
      Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial.
      • Pommergaard H.C.
      • Burcharth J.
      • Andresen K.
      • Fenger A.Q.
      • Rosenberg J.
      No difference in sexual dysfunction after transabdominal preperitoneal (TAPP) approach for inguinal hernia with fibrin sealant or tacks for mesh fixation.
      • Bischoff J.M.
      • Linderoth G.
      • Aasvang E.K.
      • Werner M.U.
      • Kehlet H.
      Dysejaculation after laparoscopic inguinal herniorrhaphy: a nationwide questionnaire study.
      Allocation ratio was 1:1.
      The randomization sequence was created using Microsoft Excel. Allocation was performed using a computer-generated list of random numbers, and the allocated group was written on cards contained in sequentially numbered opaque sealed envelopes. They were kept in a locked office in the outpatient clinic by the trial coordinator. Random blocks of 8 to 18 were used. The method was blinded to the recruiting surgeon, and randomization was performed when an operation was scheduled. The patient was informed on the allocated procedure on the day of operation. A trial coordinator kept track of patients who met the inclusion criteria. The nature of the procedures precludes masking both patients and staff. The patients remained in the allocated group on an intention-to-treat basis.

      Statistical methods

      Statistical calculations were performed using SPSS Statistics, version 25 (IBM Corp, Armonk, NY). Mean (SD) or median and IQR were used appropriately. The χ2 analysis or Fisher exact test (2-sided) was used for analysis of the categorical variables and Student’s t test for the continuous variables. The categorical variables were dichotomized when using the χ2 analysis or Fisher exact test. The odds ratios were calculated using logistic regression. Multivariable binary logistic regression was performed to estimate odds ratios for risk factors. All of the factors were entered simultaneously.

      Results

      Between April 2008 and February 2014, 1,318 men were assessed for inclusion. A total of 587 (52%) met the inclusion criteria and 304 remained for randomization (Figure 1). The allocated operation was performed on 243 patients; 111 received a TEP and 132 a Lichtenstein operation. A total of 107 (96%) in TEP and 129 (98%) in the Lichtenstein group remained for analysis at 1 year and 101 (91%) in TEP and 118 (89%) in Lichtenstein at 3 years.
      A total of 10 surgeons participated (8 performed both TEP and Lichtenstein, 1 performed TEP, and 1 Lichtenstein only). No conversions of TEP to Lichtenstein repair were required. The patients’ mean age was 46 (SD 8.2) years. Preoperative, operative, and short-term postoperative data are reported in Table I. Reoperations within the first week were performed in 2 patients in the Lichtenstein group: 1 on the day of operation due to severe pain and 1 due to testicular ischemia, where orchiectomy was performed on day 7. In total, 1 recurrence was seen at 1 year in a TEP patient. No additional recurrences were found at 3 years. No herniography for a suspected hernia was performed.
      Table IBaseline, preoperative, and postoperative data
      TEP

      n = 111
      Lichtenstein

      n = 132
      P value
      Age, mean, y (SD)46 (8.1)46 (8.3)
      BMI, mean, kg/m2 (SD)25 (2.4)25 (2.5)
      ASA
      ASA I93 (84%)119 (90%)
      ASA II17 (15%)13 (10%)
      Missing1 (1%)0 (0%)
      Hernia type
      Direct26 (23%)34 (26%)
      Indirect68 (61%)82 (62%)
      Combined4 (4%)8 (6%)
      Missing13 (12%)8 (6%)
      Profession
      Light30 (27%)36 (27%)
      Heavy80 (73%)94 (71%)
      Missing1 (1%)2 (2%)
      Outpatient61 (55%)71 (54%)0.625
      Outpatient versus inpatient.
      Inpatient1 (1%)3 (2%)
      Missing49 (44%)58 (44%)
      Complications within 4 wk2 (2%)8 (6%)0.112
      Any postoperative complications versus no complications.
      Hematoma/seroma03
      Infection02
      Neuralgia01
      Testicular pain22
      ASA, American Society of Anesthesiologists; BMI, body mass index; TAPP, transabdominal preperitoneal.
      Outpatient versus inpatient.
      Any postoperative complications versus no complications.

      Pain at sexual activity

      The results of the sexual questionnaire are displayed in Table II. The total numbers of patients answering the questionnaire after operation were 221/236 (93.6%) at 1 year and 194/219 (88.6%) at 3 years. A total of 35.0% of patients experienced SEX-P before operation without difference between groups. One year after surgery, a total of 9.5% of the patients, 5.9% in TEP and 12.5% in the Lichtenstein group, experienced SEX-P (P = .098). At 3 years, the corresponding figures were 8.2%, 7.0%, and 9.3%, respectively (P = .566). Impairment of sexual function to a moderate/severe degree was seen in 40.2% of patients reporting SEX-P preoperatively. One year after surgery, a total of 9.5% of the patients with SEX-P, 0 in TEP and 33.3% in the Lichtenstein group, experienced moderate/severe degree of impairment (P = .262). At 3 years, the corresponding figures were 28.6%, 20.0%, and 33.3%, respectively (P = 1.000). The SEX-P frequency reported as often/always was seen in 63.4% preoperatively. One year after surgery, the corresponding figures were 38.1% of patients with SEX-P, 0 in TEP, and 53.3% in the Lichtenstein group (P = .046), and at 3 years 46.7%, 33.3%, and 55.6% (P = .608), respectively. Pain intensity (VAS ≥3) was reported by 70.0% of patients with SEX-P preoperatively. One year after surgery, the corresponding figures were 33.3% of the patients with SEX-P, 0 in TEP and 46.2% in the Lichtenstein group (P = .114), and at 3 years, 66.7%, 60.0%, and 71.4% (P = 1.000), respectively.
      Table IIPatients with pain and their associated functional impairments at sexual activity preoperatively and at 1 and 3 years
      PreoperativelyTEPLichtensteinP value
      N = 111/111N = 132/132
      Pain at sexual activity
      Patients reporting pain were requested to answer subsequent questions.
       Yes33520.116
       No7880
       Missing00
      Impairment of sexual function
      Impairment of sexual function due to pain.
       No, not at all620.295
      No, not at all/yes, little versus yes, moderate/yes, a lot.
       Yes, little1625
       Yes, moderate813
       Yes, a lot39
       Missing03
      Pain frequency
       Rarely13170.665
      Rarely versus often/always.
       Often923
       Always119
       Missing03
      Pain (VAS, cm)
       <39120.630
      VAS <3 versus VAS 3 to 7/VAS ≥7.
       3–71325
       ≥756
       Missing69
      One yearTEPLichtensteinP value
      N = 101/107N = 120/129
      Pain at sexual activity
      Patients reporting pain were requested to answer subsequent questions.
       Yes615
       No951050.098
       Missing69
      Impairment of sexual function
      Impairment of sexual function due to pain.
       No, not at all330.262
      No, not at all/yes, little versus yes, moderate/yes, a lot.
       Yes, little37
       Yes, moderate02
       Yes, a lot03
       Missing00
      Pain frequency
       Rarely67
       Often030.046
      Rarely versus often/always.
       Always05
       Missing00
      Pain (VAS, cm)
       <357
       3–7050.114
      VAS <3 versus VAS 3 to 7/VAS ≥7.
       ≥701
       Missing12
      Three yearsTEPLichtensteinP value
      N = 86/101N = 108/118
      Pain at sexual activity
      Patients reporting pain were requested to answer subsequent questions.
       Yes6100.56
       No8098
       Missing15106
      Impairment of sexual function
      Impairment of sexual function due to pain.
       No, not at all211.000
      No, not at all/yes, little versus yes, moderate/yes, a lot.
       Yes, little25
       Yes, moderate02
       Yes, a lot11
       Missing11
      Pain frequency
       Rarely440.608
      Rarely versus often/always.
       Often12
       Always13
       Missing61
      Pain (VAS, cm)
       <3221.000
      VAS <3 versus VAS 3 to 7/VAS ≥7.
       3–724
       ≥711
       Missing13
      TEP, total extraperitoneal; VAS, visual analog scale.
      Patients reporting pain were requested to answer subsequent questions.
      Impairment of sexual function due to pain.
      No, not at all/yes, little versus yes, moderate/yes, a lot.
      § Rarely versus often/always.
      VAS <3 versus VAS 3 to 7/VAS ≥7.
      The SEX-P pattern and changes over time are displayed in Figure 3. In TEP patients with preoperative SEX-P, 3.0% had remaining SEX-P at 1 year and the corresponding figure was 8.3% in the Lichtenstein group (P < .149). The percentages of patients being relieved at 1 year from SEX-P by surgery were thereby 28% in the TEP and 30% in the Lichtenstein group. New postoperative SEX-P (ie, surgery-induced harm) was seen in a total of 3.6% after 1 year, 3.0% in the TEP and 4.2% in the Lichtenstein group. New pain (harm) was seen as a total in 5.2% patients at 3 years, 4.7% in TEP and 5.6% in the Lichtenstein group.

      Risk factor analysis

      Two independent risk factors for postoperative SEX-P were identified in the multivariable risk factor analysis: the Lichtenstein repair and SEX-P before surgery (Figure 4). Age was not a risk factor. No postoperative complications were recorded in the group suffering from SEX-P; thus, no odds ratios could be computed.
      Figure thumbnail gr4
      Figure 4A multivariate risk factor analysis, including preop pain status, operative technique, and age for inguinal hernia–related pain at sexual activity. Lich, Lichtenstein repair; TEP, total extraperitoneal.

      SF-36

      The results for SF-36 are reported in Figure 5. The preoperative measurements were below the norm, especially in the physical dimensions, but markedly lower in the patients with SEX-P. The patients without SEX-P preoperatively returned to (or slightly exceeded) norm-based values after the hernia repair; whereas the patients with SEX-P preoperatively seemed to have an increase in QOL after operation in general, especially in the physical domains. No changes in mental scores were observed for the patients with SEX-P compared with the patients with no SEX-P for either TEP and Lichtenstein at 1 and 3 years.
      Figure thumbnail gr5
      Figure 5The 8 subscales and 2 composite scores of SF-36 at baseline, 1 year, and 3 years for the TEP and Lichtenstein groups. SF-36 norm-based score (mean 50 [SD 10]). BP, bodily pain; GH, general health; MCS, mental composite score; MH, mental health; PCS, physical composite score; PF, physical function; RE, role emotional; RP, role physical; SF-36, 36-Item Short Form Survey; TEP, total extraperitoneal; VT, vitality.

      Discussion

      This single-center RCT reports on SEX-P in relation to groin hernia and surgical treatment by TEP or Lichtenstein repair; 35.0% of the patients experienced SEX-P preoperatively, 5.9% had continued SEX-P, and 3.6% had new SEX-P 1 year after surgery without significant differences between techniques. Both techniques relieve most patients from SEX-P related to their groin hernia with a minor risk of inducing new SEX-P.
      The primary aim of the study was to compare the effect of hernia surgery on SEX-P after 1 year. The incidence decreased from 30% preoperatively to 5.9% at 1 year after TEP repair and from 39% to 12.5% after Lichtenstein repair, with no difference between the groups. The SEX-P incidence for TEP operated in this study was in the lower range of what other studies using laparoscopic techniques have reported.
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      ,
      • Tolver M.A.
      • Rosenberg J.
      Pain during sexual activity before and after laparoscopic inguinal hernia repair.
      ,
      • Pommergaard H.C.
      • Burcharth J.
      • Andresen K.
      • Fenger A.Q.
      • Rosenberg J.
      No difference in sexual dysfunction after transabdominal preperitoneal (TAPP) approach for inguinal hernia with fibrin sealant or tacks for mesh fixation.
      The studies by Tolver et al
      • Tolver M.A.
      • Rosenberg J.
      Pain during sexual activity before and after laparoscopic inguinal hernia repair.
      (TAPP) reported 10% pain, Schouten et al
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      (TEP) 9.1%, and Pommergaard et al
      • Pommergaard H.C.
      • Burcharth J.
      • Andresen K.
      • Fenger A.Q.
      • Rosenberg J.
      No difference in sexual dysfunction after transabdominal preperitoneal (TAPP) approach for inguinal hernia with fibrin sealant or tacks for mesh fixation.
      (TAPP) 11.3%. The 12.5% found in the Lichtenstein group in our study was possibly somewhat lower compared with the Lichtenstein group in the study by Andresen et al,
      • Andresen K.
      • Burcharth J.
      • Fonnes S.
      • et al.
      Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial.
      23% at 6 months, but in line with the incidence for the open new simplified totally extraperitoneal (ONSTEP) repair in the same study. We found no changes in incidence of SEX-P after 3 years, suggesting that SEX-P is a long-lasting condition.
      When analyzing the frequency, intensity, and sexual impairment effect of SEX-P, the TEP group had better outcome at 1 year. No TEP patient reported SEX-P more frequent than “rarely,” none had pain intensity of VAS >3, and none had SEX-P–induced impairment of sexual function to a moderate or severe degree. In the Lichtenstein group, the corresponding numbers of patients reporting frequency, intensity, and sexual impairment to a moderate/severe degree were 44%, 46%, and 26% respectively. The frequency of moderate or severe impairment is in accordance with reports by others.
      • Aasvang E.K.
      • Mohl B.
      • Bay-Nielsen M.
      • Kehlet H.
      Pain related sexual dysfunction after inguinal herniorrhaphy.
      ,
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      The SEX-P frequency, intensity, and SEX-P–related impairment diminished over time in the Lichtenstein group, and the differences seen at 1 year disappeared at 3 years. In contrast to our results, a recent meta-analysis comparing minimally invasive techniques with open hernia repair reported nonsignificant but somewhat lower rates of sexual impairment for Lichtenstein.
      • Ssentongo A.E.
      • Kwon E.G.
      • Zhou S.
      • Ssentongo P.
      • Soybel D.I.
      Pain and dysfunction with sexual activity after inguinal hernia repair: systematic review and meta-analysis.
      The definition in the study by Ssentongo et al
      • Ssentongo A.E.
      • Kwon E.G.
      • Zhou S.
      • Ssentongo P.
      • Soybel D.I.
      Pain and dysfunction with sexual activity after inguinal hernia repair: systematic review and meta-analysis.
      for sexual impairment was “inability to complete sexual intercourse.” The included studies were prospective studies, retrospective studies, and RCTs. The adherence to standardized operative protocols and having board-certified surgeons is a potential explanation for our results that found no difference between techniques regarding postoperative sexual impairment.
      This study did not include erectile and ejaculatory impairment in relation to SEX-P. This study was ongoing at the time the Sexual Inguinal Hernia Questionnaire (SexIHQ) was launched. The SexIHQ measures SEX-P and includes 2 questions on ejaculatory and erectile impairment graded on a VAS scale.
      • Gutlic N.
      • Petersson U.
      • Rogmark P.
      • Montgomery A.
      The relevance of sexual dysfunction related to groin pain after inguinal hernia repair – the SexIHQ Short Form questionnaire assessment.
      The SexIHQ was initially used in a registry-based retrospective study, including patients with a primary inguinal hernia operated with TEP; 29% of SEX-P patients had erectile impairment (VAS ≥3) and 27% had ejaculatory dysfunction (VAS ≥3).
      The SEX-P in our study was analyzed over time for individual patients in order to be able to describe to what extent surgery may cause postoperative SEX-P. Among patients without SEX-P preoperatively, 3.6% (TEP 3.0% and Lichtenstein 4.2%) developed SEX-P postoperatively at 1 year. For comparison, the equally large RCT by Andresen et al
      • Andresen K.
      • Burcharth J.
      • Fonnes S.
      • et al.
      Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial.
      detected new pain after 6 months in 9% of ONSTEP patients and 20% of Lichtenstein patients. New pain after TAPP operations was found in 7.4% by Bittner et al.
      • Bittner R.
      • Gmahle E.
      • Gmahle B.
      • Schwarz J.
      • Aasvang E.
      • Kehlet H.
      Lightweight mesh and noninvasive fixation: an effective concept for prevention of chronic pain with laparoscopic hernia repair (TAPP).
      Pain appearing after hernia repair may be interpreted as surgery-induced harm. However, it is harder to explain why 2% to 3% of patients who had been without SEX-P preoperatively and at 1 year after operation developed SEX-P at 3-year follow-up. Even if hernia surgery relives most of the SEX-P experienced by one third of patients preoperatively, there is a small risk of having surgery-induced SEX-P.
      The QOL, measured with SF-36, was found to be below the norm preoperatively, both for patients without and especially for patients with SEX-P. The postoperative improvement of QOL to levels higher than the norm for patients without SEX-P and levels still lower than the norm, especially for the mental subscales, for patients with SEX-P at 1 year indicate the extent of the negative impact that SEX-P has on QOL.
      The Lichtenstein operation and SEX-P before surgery were independent risk factors for SEX-P at 1 year. Preoperative SEX-P being a risk factor has formerly been reported by Tolver and Rosenberg.
      • Tolver M.A.
      • Rosenberg J.
      Pain during sexual activity before and after laparoscopic inguinal hernia repair.
      Contrary to the results of Pommergaard et al,
      • Pommergaard H.C.
      • Burcharth J.
      • Andresen K.
      • Fenger A.Q.
      • Rosenberg J.
      No difference in sexual dysfunction after transabdominal preperitoneal (TAPP) approach for inguinal hernia with fibrin sealant or tacks for mesh fixation.
      we did not find younger age to be a risk factor for pain during sexual activity. One explanation for this might be that we only included patients <60 years of age.
      A strength of this study was the uniform surgical training and technique exercised by the 10 participating surgeons, all educated according to the same curriculum. The experience among the surgeons was well past learning curves for the techniques, and the results reflected what was achieved in a specialized hernia center. The strict operative protocol and educative curriculum might’ve explained the low rates of SEX-P achieved after laparoscopic repair compared with the other mentioned studies.
      • Schouten N.
      • van Dalen T.
      • Smakman N.
      • et al.
      Impairment of sexual activity before and after endoscopic totally extraperitoneal (TEP) hernia repair.
      ,
      • Tolver M.A.
      • Rosenberg J.
      Pain during sexual activity before and after laparoscopic inguinal hernia repair.
      ,
      • Pommergaard H.C.
      • Burcharth J.
      • Andresen K.
      • Fenger A.Q.
      • Rosenberg J.
      No difference in sexual dysfunction after transabdominal preperitoneal (TAPP) approach for inguinal hernia with fibrin sealant or tacks for mesh fixation.
      A 1-year follow-up rate exceeding 90% added reliability to the findings. The detailed analyses of SEX-P development and alterations over time, from preoperative to 3 years postoperative, will provide new information that might be of importance for understanding hernia- and hernia surgery–related SEX-P.
      A lack of generalizability might be considered a weakness of this study. The RCT setup with defined inclusion criteria, which resulted in a 52% inclusion rate during the study period, and that only hernia-specialized surgeons performed the operations are 2 circumstances that might contribute to less generalizability of the findings. A potential weakness of this study was not including patients ≥60 years. The chosen cutoff age was based on a large multicountry survey reporting on the prevalence of men’s erectile difficulties based on age. It reported that there is an increased risk of erectile problems after the age of 60.
      • Laumann E.O.
      • Nicolosi A.
      • Glasser D.B.
      • et al.
      Sexual problems among women and men aged 40-80 y: prevalence and correlates identified in the Global Study of Sexual Attitudes and Behaviors.
      Younger patients are in general more sexually active and have fewer concomitant diseases that could cause sexual impairment.
      In conclusion, overall SEX-P 1 year after hernia repair did not differ between TEP- and Lichtenstein-operated patients. However, TEP patients experienced less severe SEX-P and had less impairment of sexual functions. Furthermore, Lichtenstein repair was 1 of 2 independent risk factors for 1-year postoperative SEX-P. The ongoing increase in TEP repairs at our department was encouraged by these results. The TEP technique is also possible to standardize to a high extent, resulting in uniformly good results. The patients should be informed preoperatively on the relations between hernia pain and SEX-P and what result to expect after operation.

      Funding/Support

      The authors are grateful to the Department of Clinical Sciences, Lund University, Region Skåne Research and Development Funds, for nonrestricted educational grants.

      Conflict of interest/Disclosure

      The authors have no conflicts of interests or disclosures to report.

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