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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01824186
Other study ID # NHG DSRB 2009/00434
Secondary ID
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


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
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