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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
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 21, 2013
Last Updated
March 31, 2013
Sponsor
National University Hospital, Singapore
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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

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

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