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

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824186
• Other study ID #: NHG DSRB 2009/00434
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: March 31, 2013
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

Description:

As above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis
• Cholecystolithiasis
• Choledocholithiasis
• Cholelithiasis
• Gallstones
• Pancreatitis

Intervention

Procedure:
• SILC
Underwent single-incision laparoscopic cholecystectomy
• LC
Underwent conventional 4-port laparoscopic cholecystectomy

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	Operative duration	To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique	following skin closure	No
Secondary	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	No
Secondary	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	No