Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.

Detailed Description
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As above

Official Title
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A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

Conditions
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Cholelithiasis, Choledocholithiasis, Cholecystolithiasis, Pancreatitis, Cholangitis

Intervention / Treatment
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* Procedure: SILC
* Procedure: LC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of symptomatic gallstones American Society of Anesthesiologists (ASA) score 1 or 2 informed consent Exclusion Criteria: active acute cholecystitis previous open upper abdominal surgery bleeding disorders

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SILC<br>Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision | Procedure: SILC<br>* Underwent single-incision laparoscopic cholecystectomy<br>* Other names: Single-incision laparoscopic cholecystectomy;|
| Active Comparator: LC<br>Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank | Procedure: LC<br>* Underwent conventional 4-port laparoscopic cholecystectomy<br>* Other names: Conventional laparoscopic cholecystectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain 4 hours | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 4 hours post-operative | 
| Post-operative pain 24 hours | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 24 hours post-operative | 
| Post-operative pain 14 days | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 14 days post-operative | 
| Post-operative pain 6 months | To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10. | 6 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural complications | To evaluate complications between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Conducted via telephone interview and review of hospital records in the intervening period | 6 months | 
| Operative duration | To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique | following skin closure | 
| Subject satisfaction | To evaluate subject satisfaction between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured on a Likert scale, from 1-5 (1 least satisfied, 5 most satisfied) | 14 days and 6 months | 
| Return to function | To evaluate post-operative return to function following surgery, between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured as days taken to independent toileting, and independently obtaining meals as a surrogate measure of function | 14 days |