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Transvaginal Cholecystectomy Using Endoscopic Assistance

NCT00815438 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-09-30

No results posted yet for this study

Summary

Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall. Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The space in the abdominal cavity can then be seen on a video screen. Thin retractors and dissecting instruments are placed through the other cannula and the gallbladder is removed using the video screen for vision. The gallbladder duct and the artery are usually occluded with clips or stitches.

In this study we propose to do the procedure though a single 5 mm incision placed at the umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder will be retracted using strings (sutures) attached to the gallbladder. The dissection will be done using laparoscopic instruments (scissors, knives, dissectors) placed through the laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction. An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the abdomen through the vagina.

This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision and one vaginal incision. This will provide the basis for future studies evaluating decreased pain and costs with transvaginal assisted cholecystectomy.

Conditions

Interventions

PROCEDURE

cholecystectomy.

Patients enrolled in the study will have a flexible transvaginal endoscopy used during laparoscopic cholecystectomy.

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Brent Miedema, MD · University of Missouri-Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-05-31
Completion
2011-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815438 on ClinicalTrials.gov