Single Incision Laparoscopic Cholecystectomy | NCT00678873

Studies
Single Incision Laparoscopic Cholecystectomy

NCT00678873

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Dec 15, 2009Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Cholelithiasis

Interventions

Single Incision Laparoscopic Cholecystectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

May 14, 2008

First Submission Date that Met QC Criteria

May 15, 2008

First Posted Date

May 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2009

Last Update Posted Date

Dec 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical group	Experimental	Patients with ultrasound proven symptomatic cholelithiasis (gallstones).	Procedure: Single Incision Laparoscopic Cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single Incision Laparoscopic Cholecystectomy	Procedure	A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.

Measure	Description	Time Frame
Safety and feasibility		12 months

Measure	Description	Time Frame
Short-term clinical outcomes		12 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Homero Rivas, MD	UTSouthwestern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern		Dallas	Texas	75390	United States

Condition Browse Module

MeSH Terms

ID	Term
D002769	Cholelithiasis

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017081	Cholecystectomy, Laparoscopic
D002763	Cholecystectomy

Ancestor Terms

ID	Term
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D010535	Laparoscopy

Browse Leaves

Not provided

Browse Branches

Not provided