Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Primary Purpose
Cholelithiasis, Choledocholithiasis, Cholecystolithiasis
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
SILC
LC
Sponsored by
About this trial
This is an interventional treatment trial for Cholelithiasis
Eligibility Criteria
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
Sites / Locations
- National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SILC
LC
Arm Description
Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision
Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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
Operative duration
To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique
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)
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
Full Information
NCT ID
NCT01824186
First Posted
March 21, 2013
Last Updated
March 31, 2013
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT01824186
Brief Title
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Official Title
A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
As above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Choledocholithiasis, Cholecystolithiasis, Pancreatitis, Cholangitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SILC
Arm Type
Experimental
Arm Description
Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision
Arm Title
LC
Arm Type
Active Comparator
Arm Description
Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank
Intervention Type
Procedure
Intervention Name(s)
SILC
Other Intervention Name(s)
Single-incision laparoscopic cholecystectomy
Intervention Description
Underwent single-incision laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
LC
Other Intervention Name(s)
Conventional laparoscopic cholecystectomy
Intervention Description
Underwent conventional 4-port laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Post-operative pain 4 hours
Description
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.
Time Frame
4 hours post-operative
Title
Post-operative pain 24 hours
Description
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.
Time Frame
24 hours post-operative
Title
Post-operative pain 14 days
Description
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.
Time Frame
14 days post-operative
Title
Post-operative pain 6 months
Description
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.
Time Frame
6 months post-operative
Secondary Outcome Measure Information:
Title
Procedural complications
Description
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
Time Frame
6 months
Title
Operative duration
Description
To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique
Time Frame
following skin closure
Title
Subject satisfaction
Description
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)
Time Frame
14 days and 6 months
Title
Return to function
Description
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
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Kin Yong Chang, FRCS
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
25446490
Citation
Chang SK, Wang YL, Shen L, Iyer SG, Madhavan K. A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. World J Surg. 2015 Apr;39(4):897-904. doi: 10.1007/s00268-014-2903-6.
Results Reference
derived
Learn more about this trial
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
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