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Completed

NCT Number: NCT00981604

Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.

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Key information

Conditions

Cholelithiasis Bile Duct Diseases Biliary Dyskinesia Biliary Tract Diseases Common Bile Duct Diseases Digestive System Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Need for cholecystectomy

Exclusion criteria

  • Need for cholangiogram

Treatment and study plan

SILS

Procedure

Single Incision Laparoscopic Cholecystectomy

Standard Laparoscopic Cholecystectomy

Procedure

4 port technique

Other names: Laparoscopic Cholecystectomy

Primary outcomes

  1. Operative Time

    Time frame: 1 day

Secondary outcomes

  1. Operative complications

    Time frame: 2 weeks

  2. length of hospitalization

    Time frame: 1 week

  3. doses of analgesics

    Time frame: 1 week

  4. hospital/operation charges

    Time frame: 1 week

  5. surgeon perception of difficulty

    Time frame: 1 day

  6. cosmetic scores

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Single Incision Versus Laparoscopic Cholecystectomy

Acronym: SILS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2009
Registry last updated
Dec 13, 2011

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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