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NCT Number: NCT01824186

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

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.

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Key information

Conditions

Cholelithiasis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholecystolithiasis Choledocholithiasis Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases Pancreatic Diseases Pancreatitis

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SILC

Procedure

Underwent single-incision laparoscopic cholecystectomy

Other names: Single-incision laparoscopic cholecystectomy

LC

Procedure

Underwent conventional 4-port laparoscopic cholecystectomy

Other names: Conventional laparoscopic cholecystectomy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2013
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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