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

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ClinicalTrials.gov Identifier: NCT01824186
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Choledocholithiasis Cholecystolithiasis Pancreatitis Cholangitis Procedure: SILC Procedure: LC Not Applicable

Detailed Description:
As above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SILC
Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision
Procedure: SILC
Underwent single-incision laparoscopic cholecystectomy
Other Name: Single-incision laparoscopic cholecystectomy

Active Comparator: LC
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
Underwent conventional 4-port laparoscopic cholecystectomy
Other Name: Conventional laparoscopic cholecystectomy




Primary Outcome Measures :
  1. Post-operative pain 4 hours [ Time Frame: 4 hours post-operative ]
    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.

  2. Post-operative pain 24 hours [ Time Frame: 24 hours post-operative ]
    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.

  3. Post-operative pain 14 days [ Time Frame: 14 days post-operative ]
    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. Post-operative pain 6 months [ Time Frame: 6 months post-operative ]
    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 :
  1. Procedural complications [ Time Frame: 6 months ]
    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

  2. Operative duration [ Time Frame: following skin closure ]
    To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique

  3. Subject satisfaction [ Time Frame: 14 days and 6 months ]
    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)

  4. Return to function [ Time Frame: 14 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824186


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Stephen Kin Yong Chang, FRCS National University Hospital, Singapore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01824186     History of Changes
Other Study ID Numbers: NHG DSRB 2009/00434
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
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Pancreatitis
Cholangitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Choledocholithiasis
Pancreatic Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases