Transvaginal Cholecystectomy Using Endoscopic Assistance

NCT00815438 | Withdrawn Phase 1

• 1 other identifier: 1125518
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Cholelithiasis; Cholecystitis; Biliary Dyskinesia

Keywords

Transvaginal; Cholecystectomy; NOTES; Endoscopic

Outcome Measures

Primary Outcomes (1)

• Reduction in the number of laparoscopic ports

  Time of surgery

Secondary Outcomes (3)

• Cost analysis comparison of surgical procedures.

  Cost analysis will be done at end of study.

• Time of procedure

  Time recorded during surgical procedure.

• Cosmesis and pain

  Prior to procedure, 1 to 3 days post op, 7 to 10 days post op, and at follow-up visit ~6 weeks

Study Arms (1)

Surgical Procedure

EXPERIMENTAL

Laparoscopic transvaginal cholecystectomy with endoscopic assistance.

Procedure: cholecystectomy.

Interventions

cholecystectomy. PROCEDURE

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

Also known as: Gallbladder removal

Surgical Procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female age ≥ 18 yrs
• Diagnosis of cholelithiasis, cholecystectomy, choledocholithiasis or biliary dyskinesia and scheduled for laparoscopic cholecystectomy
• Have an indication for a standard laparoscopic procedure cholecystectomy
• Not pregnant

You may not qualify if:

• Any significant co-morbidities, including significant cardiac disease, history of stroke, severe pulmonary disease, hypertension with a diastolic greater than 100, pancreatitis.
• Patients that are immunosuppressed or on immunosuppression therapy.
• An unacceptable psychological or medical risk as determined by the primary investigators.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

MeSH Terms

Conditions

Cholelithiasis; Cholecystitis; Biliary Dyskinesia

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Common Bile Duct Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Brent Miedema, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share