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Corresponding author: Department of Surgery, Hepato-Biliary-Pancreatic Surgery and Breast Surgery, Ehime University Graduate School of Medicine, Shitsukawa, Toon City, Ehime 791-0295, Japan.
Controversy continues as to whether single-incision laparoscopic cholecystectomy, with the somewhat larger incision at the umbilicus, may lead to a worse postoperative quality of life and more pain compared with the more classic 4-port laparoscopic cholecystectomy. The aim of this study was to compare single-incision and 4-port laparoscopic cholecystectomy from the perspective of quality of life.
Methods
This study was a multicenter, parallel-group, open-label, randomized clinical trial. A total of 120 patients who were scheduled to undergo elective cholecystectomy were randomly assigned 1:1 into the single-incision laparoscopic cholecystectomy or the 4-port laparoscopic cholecystectomy group and then assessed continuously for 2 weeks during the postoperative period. The primary outcome was quality of life, defined as the time to resume normal daily activities. Postoperative pain was also assessed. To explore the heterogeneity of treatment effects, we assessed the interactions of sex, age, and working status on recovery time.
Results
A total of 58 patients in the single-incision group and 53 in the 4-port group (n = 111, 47 male, mean age 57 years) were analyzed. The mean time to resume daily activities was 10.2 days and 8.8 days, respectively, for single-incision and 4-port laparoscopic cholecystectomy (95% confidence interval –0.4 to 3.2, P = .12). Similarly, the time to relief from postoperative pain did not differ significantly between the groups. Statistically insignificant but qualitative interactions were noted; in the subgroups of women, full-time workers, and patients younger than 60 years, recovery tended to be slower after single-incision laparoscopic cholecystectomy.
Conclusion
Postoperative quality of life did not differ substantially between single-incision laparoscopic cholecystectomy and 4-port laparoscopic cholecystectomy. Patients younger than 60 years, women, and full-time workers tended to have a somewhat slower recovery after single-incision laparoscopic cholecystectomy.
Introduction
The classic 4-port laparoscopic cholecystectomy (4PLC) has been the gold standard in the treatment of benign gallbladder diseases such as symptomatic cholecystolithiasis.
This new technique allows the procedure to be performed using a special access device to simultaneously insert instruments and the laparoscope through just 1 small incision. With the scar largely concealed in the concave aspect of the umbilicus, SILC offers a virtually invisible scar to patients. This technique, along with the expectation of less pain and quicker recovery, has gained some acceptance and currently accounts for 16% of laparoscopic cholecystectomies performed in Japan.
In contrast, SILC requires some specific skills to ensure triangulation under the interference between instruments, which leads to a somewhat increased workload on surgeons and prolonged operative time.
Impact of single-incision laparoscopic cholecystectomy (SILC) versus conventional laparoscopic cholecystectomy (CLC) procedures on surgeon stress and workload: a randomized controlled trial.
Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial.
Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data.
Evaluation of pain scores after single-incision and conventional laparoscopic cholecystectomy: a randomized control trial in a rural Indian population.
A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy.
Cosmesis and body image in patients undergoing single-port versus conventional laparoscopic cholecystectomy: a multicenter double-blinded randomized controlled trial (SPOCC-trial).
These trials were designed to focus on cosmesis, pain, or quality of life (QOL), with patient-reported outcomes to evaluate subjectively the degree of patient suffering. In particular, QOL is drawing attention as a key measure to understand how patients evaluate their physical, mental, or social health status.
Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data.
In contrast, controversy persists regarding pain; some studies have reported that SILC has an advantage regarding pain because of the decreased number of ports,
Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial.
A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy.
Not much literature is available on QOL after SILC, and, furthermore, published results seem to lack agreement and reproducibility.
The aim of this study was to compare QOL between the SILC and conventional 4PLC by continuous QOL assessment in the postoperative period. Based on our clinical experience, patients who undergo SILC seem to have increased postoperative pain. Thus we hypothesized that SILC delays the resumption of normal daily activities compared with 4PLC.
Methods
Study design
This was a multicenter, 2-arm parallel group, open-label, randomized clinical trial involving 3 investigational sites in Japan. This study was approved by the Ethics Committee of Ehime University Hospital (approval number: 1304001) and by the other sites. The study team was organized by members from Ehime University, Kyoto University, and NPO iHOPE International. Before trial commencement, the protocol was registered in the University Hospital Medical Information Network Clinical Trial Registry (registration number: UMIN000010583 http://www.umin.ac.jp/english/). Written informed consent was obtained from all participants. This study was conducted in accordance with the Declaration of Helsinki, and this report is based on the CONSORT (Consolidated Standards of Reporting Trials) statement (http://www.consort-statement.org).
Participants
Participants were recruited at 3 teaching hospitals, where both SILC and 4PLC procedures were performed as routine medical care: Ehime University Hospital, Uwajima City Hospital, and Ehime Prefectural Central Hospital.
Patients were eligible if they were 20 years or older and were scheduled to undergo elective laparoscopic cholecystectomy for symptomatic cholelithiasis, gallbladder polyp, or adenomyomatosis. Exclusion criteria were history of acute cholecystitis, severe cirrhosis, suspected cases of gallbladder cancer, when other operations were combined with cholecystectomy, body mass index greater than 35 kg/m2, pregnancy, and mental disorder or dementia.
Randomization
After obtaining written consent, the surgeon sent the registration form via fax to the coordinating center (Clinical Research Support Center of Ehime University Hospital) by the day before the operation. Then a dynamically allocated, 1:1 random sequence stratified by institution, sex, age (<70 years or not), and working status (yes or no, including domestic duties) was computer generated in the coordinating center. The patient allocation was sent back to the surgeon via fax, and the surgeon informed patients of the assigned procedure before the operation.
Surgical procedures
All laparoscopic cholecystectomies were performed in the same way as routine practice by members in the study sites ranging from specialist to resident, including those having performed fewer than 5 SILCs. Bile ducts were evaluated with preoperative magnetic resonance cholangiopancreatography. Perioperative management in both groups was the same using the clinical pathway of each site. Prophylactic cefazolin 1.0 g was administered intravenously within 30 minutes before skin incision and postoperatively on that day.
SILC procedure
A 25-mm incision was made in the umbilicus. After a small-size wound protector was installed through the incision, an access device (EZ ACCESS, HAKKO, Nagano, Japan) or a surgical glove (glove technique)
with 3 5-mm trocars was attached to the wound protector. Additionally, a 3-mm or smaller instrument was inserted in the right epigastrium to retract the fundus of the gallbladder. The operator performed cholecystectomy in the standard fashion for conventional 4PLC.
4PLC procedure
A 15-mm incision was made in the umbilicus. A 12-mm trocar was inserted by an open method, and 3 5-mm trocars were placed in the right upper quadrant.
After operation, analgesics were administered intravenously (flurbiprofen 50 mg, a nonsteroidal anti-inflammatory agent) as necessary during the fasting period and then orally (loxoprofen 60 mg, also an oral nonsteroidal anti-inflammatory agent) for 3 days or more if necessary. No opioids were administered throughout the study. Discharge from the hospital was on the second to fifth postoperative day.
Outcomes
The primary outcome was the time to resume normal daily activities (work or other daily activities) postoperatively. This outcome was selected as the most relevant one to assess the QOL of patients who underwent laparoscopic cholecystectomy. Difficulties in daily activities were measured by the Role Physical subscale (RP) of the 36-Item Short Form Health Survey (SF-36),
which asks patients 4 questions concerning problems with work or other activities as a result of physical health. Patients answered the questions once the day before operation and every day from postoperative day 1 (the first day postoperatively) to the first outpatient visit (typically days 14–20). The time to resume normal daily activities was defined as the number of days postoperatively when the RP score first returned to the preoperative level or the norm-based scoring 50 (standardized value of a general population in Japan, mean = 50, SD = 10), whichever came first after discharge.
The secondary outcomes were the following: time to relief of postoperative pain, time to resume working, operative time, bleeding, duration of hospital stay, inflammatory responses, and clinical complications. Postoperative pain was assessed by the following 3 instruments: the Bodily Pain subscale of the SF-36, a numeric rating scale of 0 to 10, and a modified Surgical Pain Scale
including degrees at rest, with daily activities, with hard work/exercise, and contrasted with what had been expected.
Data collection
To collect reports from participants, a health diary that comprised a series of questions including RP, pain, and working status was used. It took approximately 5 minutes to complete the questionnaire per day. Each participant was asked to complete the questionnaire once before and every day postoperatively until the first outpatient visit after discharge. Demographic data, operative findings, and complications were recorded in each patient data sheet by the surgeons. These data were sent to the coordinating center and entered in a computer file by coordinators.
Sample size
The time course of the change in QOL was unknown for the early recovery phase after laparoscopic cholecystectomy. A pilot survey was therefore performed to estimate the time to recovery of RP, which was found to be 12 days with a standard deviation of 3.3 to 4.8 days. Assuming a clinically relevant difference between SILC and 4PLC of 2 days, 50 patients per group were required to detect this difference with a 2-sided α error of .05 and a power of 0.8. Considering dropouts, the sample size was determined to be 60 per group.
Statistical methods
Data were analyzed according to the principle of intention to treat (ITT). Numeric data are summarized by means and standard deviation. Categorical data are presented as raw counts. The size of treatment effects (difference between 2 groups) on the time to recovery is expressed as an absolute difference in days and the 95% confidence interval (95% CI). For patients who did not reach complete recovery during the observation period (ie, were censored), the time to recovery was replaced by the day of last observation. The t test and Fisher exact test (or χ2 test if appropriate) were used for numeric and categorical data, respectively.
For the primary outcome, in addition to the previously stated outcomes, differences between groups were identified by Kaplan-Meier curves, and sensitivity analyses
of sex, age (<60 years or not), and working status (full-time [5 or more days per week] worker or not) were assessed using general linear models, although they were not specified in advance in the protocol.
All analyses were carried out using SAS 9.4 or JMP 9.0 (SAS Institute, Inc, Cary, NC).
Results
Patients
From May 2013 to October 2015, 392 adult patients underwent elective laparoscopic cholecystectomy, of whom 123 patients were enrolled in this study (Fig 1). A total of 63 patients were assigned to SILC and 60 to 4PLC. In the SILC group, 1 patient required the addition of a port and 1 required conversion to 4PLC, both because of adhesions. One patient in the 4PLC group underwent the SILC procedure because of the surgeon's error in confirming the assignment. No patient in the 4PLC group was converted to open cholecystectomy. After random allocation, 5 patients withdrew their consent to change their allocated procedure to the other one. In 1 patient allocated to 4PLC, the operation was cancelled because of asthma after induction of anesthesia. During follow-up, the questionnaires of 5 patients were not able to be collected, and 1 patient in the SILC group withdrew from the study because of dissatisfaction with a staff member. Consequently, a total of 111 patients were available for ITT analyses: 58 for SILC and 53 for 4PLC. For per-protocol set analyses, 3 patients who underwent the opposite procedure for any reasons were excluded and 108 patients were available (56 for SILC and 52 for 4PLC).
Fig. 1The CONSORT flow diagram for this study. *Excluded from per-protocol set analyses. 4PLC, 4-port laparoscopic cholecystectomy; SILC, single-incision laparoscopic cholecystectomy.
The characteristics of the patients are shown in Table 1. Their mean age was 57.4 years (range: 28–79 years), with women accounting for two thirds of the patients. The 2 groups were well balanced except for working days and hours, which tended to be less in the SILC group than in the 4PLC group.
Kaplan-Meier curves indicated the proportions of patients who resumed normal daily activities in the 2 treatment groups (Fig 2). These data include censored cases: 11 patients in the SILC group and 9 in the 4PLC group who did not resume daily activities within the observation period. The mean time to resume daily activities was 10.2 ± 4.6 days in the SILC group and 8.8 ± 4.6 days in the 4PLC group (95% CI: –0.4 to 3.2; P = .12; Table 2). The sensitivity analyses also gave results that were not statistically significant: a difference of 1.4 days (95% CI: –0.5 to 3.1, P = .15) on the PPS analysis and 1.3 days (95% CI: –0.1 to 2.6, P = .07) by excluding censored patients.
Fig. 2Kaplan-Meier curves showing time to resume daily activities after laparoscopic cholecystectomy. 4PLC, 4-port laparoscopic cholecystectomy; SILC, single-incision laparoscopic cholecystectomy.
Table 3 summarizes the results for postoperative pain in the 2 treatment groups. No significant differences were noted in relief from postoperative pain between the SILC group and the 4PLC group.
Table 3Time for relief from postoperative pain in the 2 treatment groups.
Table 4 summarizes other clinical outcomes. The mean operative time of SILC was similar to that of 4PLC (99 vs 92 minutes; P = nonsignificant). Duration of postoperative hospital stay (4.3 vs 4.2 days) and time to resume working (9.9 vs 9.4 days) were also similar. As for the postoperative inflammatory response, that of SILC was similar (white blood cell counts: 8179 vs 7743/μL, C-reactive protein: 2.5 vs 1.7 mg/dL). Operative complications (wound infection, incisional hernia, abdominal hematoma, and choledocholithiasis) did not differ between the groups. One patient in the SILC group developed an incisional hernia with omental incarceration on postoperative day 4 and required operative repair. One patient in the SILC group was found to have a perihepatic hematoma and was treated conservatively. Two patients in the 4PLC group developed choledocholithiasis and required endoscopic lithotomy. None of the patients had operative bleeding greater than 50 mL or bile duct injury.
The heterogeneity of treatment effects on the primary outcome is summarized in Fig 3. Statistically nonsignificant but qualitative interactions were noted; the recovery tended to be slower in the SILC group than in the 4PLC group in the subgroups of women (a difference of 2.3 days, 95% CI: –0.3 to 4.9), full-time workers (2.4, 0.5–4.2), and especially patients younger than 60 years (2.1, 0.0–4.3), whereas there were almost no differences in other subgroups. Interactions of age and treatment effects on postoperative pain are shown in Supplementary Fig 1. Again, although not statistically significant, relief from pain tended to be slower in the SILC group than in the 4PLC group in the subgroup of patients younger than 60 years, whereas there were almost no significant differences in the subgroup of patients aged 60 years or older.
Fig. 3Interactions of sex, age, and working status on the time to resume daily activities. 4PLC, 4-port laparoscopic cholecystectomy; CI, confidence interval; SILC, single-incision laparoscopic cholecystectomy.
In this study the time to resume normal daily activities (QOL) was not significantly greater in the SILC group than in the 4PLC group. For subgroups of patients younger than 60 years, women, and full-time workers, the results suggested that SILC may delay recovery of QOL compared with 4PLC, but no significant interactions were identified.
This is the first randomized clinical trial conducted in Japan in which the population included patients who were older and whose body mass index was low compared with previous studies from other regions. To the best of our knowledge, the study is the second randomized clinical trial designed to assess the QOL as a primary endpoint of patients undergoing SILC and 4PLC. The present results are not in line with those of the first study by Abd Ellatif et al,
who reported that SILC patients had better QOL (mobility, self-care, activity, and pain or discomfort on the EuroQoL EQ-5D) at 1 week postoperatively and an improved pain profile. Six other published randomized trials explored QOL as a secondary endpoint
Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data.
Cosmesis and body image in patients undergoing single-port versus conventional laparoscopic cholecystectomy: a multicenter double-blinded randomized controlled trial (SPOCC-trial).
Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data.
Cosmesis and body image in patients undergoing single-port versus conventional laparoscopic cholecystectomy: a multicenter double-blinded randomized controlled trial (SPOCC-trial).
also reported better QOL at 1 year after SILC in several domains of SF-36 (emotional well-being, physical pain, physical health, and mental health), whereas Bingener et al,
using the Linear Analog Self-Assessment tool, reported that fatigue was greater in the SILC group at 1 week.
QOL is a broad, multidimensional subjective concept that includes physical, mental, and social health status, and it can be elusive, even though its measurement has become common in medical research today. In addition, there is a lack of standardized methodology, and considerable heterogeneity is found among studies, including those mentioned earlier. Validated measurement tools of global QOL such as the SF-36 are available, whereas a cholecystectomy-specific one is yet to be developed. One potential problem of using a single global QOL measurement tool is the low ability to perceive meaningful differences in specific dimensions of QOL.
Before this study, a pilot survey was performed to test the SF-36 with 16 patients who underwent laparoscopic cholecystectomy, including 5 SILCs and 11 4PLCs. Through the results of the pilot survey and with reference to an earlier study,
it was evident that the RP subscale of the SF-36 detected a greater difference in QOL than the other subscales; patients experienced difficulty in daily activities or a return to work as a result of laparoscopic cholecystectomy. As for the schedule of assessments, most earlier studies measured outcomes sporadically in the perioperative period or a long time after the operation. In minimally invasive surgery, however, most patients return to normal activities quickly. Saad et al
reported that patients were largely relieved from pain by day 7 after laparoscopic cholecystectomy. Therefore in the present study patients were assessed at multiple time points
during the perioperative period, and the number of days to recovery was compared instead of the scores obtained at certain points.
Our study set out to verify our hypothesis that SILC impedes recovery of patients QOL (normal daily activities). A possible explanation for this was our belief that SILC would lead to more pain at the umbilicus. Although SILC is characterized by fewer access ports than 4PLC, it requires a somewhat larger incision at the umbilicus to place 3 ports, a location with maximum pain sensation among other port sites in the abdominal wall.
To date, however, the amount and importance of postoperative pain of SILC has been controversial, possibly attributable to disparities in incision size among studies. Many of the earlier studies limited the operators to certain experienced surgeons, whereas this study allowed residents to participate as surgeons. Considering the tradeoff between incision size at the umbilicus and the interference of instruments in performing SILC, an adequate incision is required to decrease intraoperative stress for surgeons.
The results indicated that SILC tends to impede recovery of QOL in the subgroups of patients younger than 60 years, women, and full-time workers. One of the possible causes may be the increased need for physical activity during convalescence. Various physical activities in this period contract the rectus abdominis, causing pain at the umbilicus. Patients younger than 60 years or those performing full-time work restart daily life earlier than other population groups, which may have accentuated the intensity of the pain of SILC. Notably, the present study had some imbalances in patient characteristics; in the SILC group, the mean age was older, and the proportion of patients with full-time work was less. Except for these imbalances, SILC might have had a worse QOL and pain than obtained in this study. With respect to a sex difference in pain perception, several studies reported that women are more susceptible to pain than men.
The report also noted that the sex-related difference disappeared in elderly patients. Although sex hormones or psychologic factors are thought to affect pain sensitivity, the underlying mechanism of this difference according to patient sex has not yet been fully determined.
Single-incision laparoscopic cholecystectomy: is it a plausible alternative to the traditional four-port laparoscopic approach?.
Minim Invasive Surg.2012;
The technical steps of SILC are basically the same as for 4PLC and not necessarily complicated for surgeons skilled in 4PLC. Nevertheless, some surgeons have difficulty in the manipulation of SILC with the instruments because the degrees of freedom are restricted for experienced surgeons.
Impact of single-incision laparoscopic cholecystectomy (SILC) versus conventional laparoscopic cholecystectomy (CLC) procedures on surgeon stress and workload: a randomized controlled trial.
Our present study has several limitations. First, the participation rate was low; only 123 of 392 eligible patients (31%) participated in this study. Therefore this group may have been a potentially nonrepresentative population, which might have led to selection bias. Second, this was an open-label study. The possibility of the placebo effect and bias in an open-label study cannot be completely excluded. In theory, patients could have obtained information and reconsidered their allocation beforehand; 5 patients in fact revoked their participation in the study after knowing their allocation. Third, the subgroup analysis in this study was post hoc. It involved a multiplicity problem that can lead to false-positive results and a risk of reporting bias. Therefore the result should be interpreted with caution. To confirm the conclusion in this study, further studies with larger sample sizes and subgroup analyses prespecified in the protocol would be needed. Fourth, although analgesic use affects patient perception of pain, this study lacked a strict protocol to monitor administration of analgesics. Fifth, surgeon technique differed by years of experience or institutions in this study. It is possible that, through a learning curve effect, operating time and the complication rate of the SILC procedure might differ between the early and late periods.
In conclusion, the time to resume normal daily activities (QOL) or to be free of pain were not substantially greater after SILC than after 4PLC. There might be some delay of recovery after SILC in patients younger than 60 years, women, and full-time workers. These findings indicate that SILC can be a feasible option in clinical practice, but 4PLC might be more favorable than SILC specifically for these subgroups. Further modeling work is required to establish a more clinically relevant and reproducible QOL assessment for minimally invasive surgery.
Disclosures
This study was an investigator-initiated clinical trial, and no financial support was received.
Acknowledgments
We wish to thank Dr. Shinsuke Kajiwara and Dr. Kenzo Okada (Uwajima City Hospital) for patient recruitment.
Impact of single-incision laparoscopic cholecystectomy (SILC) versus conventional laparoscopic cholecystectomy (CLC) procedures on surgeon stress and workload: a randomized controlled trial.
Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial.
Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data.
Evaluation of pain scores after single-incision and conventional laparoscopic cholecystectomy: a randomized control trial in a rural Indian population.
A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy.
Cosmesis and body image in patients undergoing single-port versus conventional laparoscopic cholecystectomy: a multicenter double-blinded randomized controlled trial (SPOCC-trial).
Values are means (standard deviation).
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