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

NCT ID: NCT01824186

Last Updated: 2013-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-10-31

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

Conditions

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Cholelithiasis Choledocholithiasis Cholecystolithiasis Pancreatitis Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SILC

Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision

Group Type EXPERIMENTAL

SILC

Intervention Type PROCEDURE

Underwent single-incision laparoscopic cholecystectomy

LC

Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank

Group Type ACTIVE_COMPARATOR

LC

Intervention Type PROCEDURE

Underwent conventional 4-port laparoscopic cholecystectomy

Interventions

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SILC

Underwent single-incision laparoscopic cholecystectomy

Intervention Type PROCEDURE

LC

Underwent conventional 4-port laparoscopic cholecystectomy

Intervention Type PROCEDURE

Other Intervention Names

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Single-incision laparoscopic cholecystectomy Conventional laparoscopic cholecystectomy

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Kin Yong Chang, FRCS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type DERIVED
PMID: 25446490 (View on PubMed)

Other Identifiers

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NHG DSRB 2009/00434

Identifier Type: -

Identifier Source: org_study_id

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