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OpenTrials
Completed

NCT Number: NCT00678873

Single Incision Laparoscopic Cholecystectomy

The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.

The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UT Southwestern

Dallas, Texas, 75390, United States

About this study

Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction.

In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults male and female(>18 years old)
  • Capable of giving informed consent
  • Ultrasound proven cholelithiasis
  • Symptomatic cholelithiasis
  • Elective cholecystectomy

Exclusion criteria

  • Pregnancy
  • Contraindications for general anesthesia
  • Morbid obesity
  • Multiple previous abdominal surgeries
  • Uncontrolled medical conditions
  • Acute cholecystitis

Treatment and study plan

Single Incision Laparoscopic Cholecystectomy

Procedure

A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.

Other names: Single incision surgery, Single access surgery, Single incision laparoscopy, Single access laparoscopy, Laparoscopic cholecystectomy, Single access laparoscopic cholecystectomy, Cholecystectomy

Primary outcomes

  1. Safety and feasibility

    Time frame: 12 months

Secondary outcomes

  1. Short-term clinical outcomes

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: SILC

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 16, 2008
Registry last updated
Dec 15, 2009

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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