NCT01824186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
Last Updated

April 4, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

March 21, 2013

Last Update Submit

March 31, 2013

Conditions

CholelithiasisCholedocholithiasisCholecystolithiasisPancreatitisCholangitis

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (4)

  • Procedural complications

    6 months

  • Operative duration

    following skin closure

  • Subject satisfaction

    14 days and 6 months

  • Return to function

    14 days

Study Arms (2)

SILC

EXPERIMENTAL

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

Procedure: SILC

LC

ACTIVE COMPARATOR

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

Procedure: LC

Interventions

SILCPROCEDURE

Underwent single-incision laparoscopic cholecystectomy

Also known as: Single-incision laparoscopic cholecystectomy
SILC
LCPROCEDURE

Underwent conventional 4-port laparoscopic cholecystectomy

Also known as: Conventional laparoscopic cholecystectomy
LC

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of symptomatic gallstones
  • American Society of Anesthesiologists (ASA) score 1 or 2
  • informed consent

You may not qualify if:

  • active acute cholecystitis
  • previous open upper abdominal surgery
  • bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 25446490DERIVED

MeSH Terms

Conditions

CholelithiasisCholedocholithiasisCholecystolithiasisPancreatitisCholangitis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesCommon Bile Duct DiseasesBile Duct DiseasesGallbladder DiseasesPancreatic Diseases

Study Officials

  • Stephen Kin Yong Chang, FRCS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

April 4, 2013

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 4, 2013

Record last verified: 2013-03

Locations

SG(1)