Transvaginal Cholecystectomy Using Endoscopic Assistance

This study has been withdrawn prior to enrollment.
(unable to obtain funding)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00815438
First received: December 29, 2008
Last updated: October 9, 2009
Last verified: October 2009
  Purpose

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 trasvaginal assisted cholecystectomy.


Condition Intervention Phase
Cholelithiasis
Cholecystitis
Biliary Dyskinesia
Procedure: cholecystectomy.
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Cholecystectomy Using Transvaginal Endoscopic Assistance

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Reduction in the number of laparoscopic ports [ Time Frame: Time of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cost analysis comparison of surgical procedures. [ Time Frame: Cost analysis will be done at end of study. ] [ Designated as safety issue: No ]
  • Time of procedure [ Time Frame: Time recorded during surgical procedure. ] [ Designated as safety issue: No ]
  • Cosmesis and pain [ Time Frame: Prior to procedure, 1 to 3 days post op, 7 to 10 days post op, and at follow-up visit ~6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical Procedure
Laparoscopic transvaginal cholecystectomy with endoscopic assistance.
Procedure: cholecystectomy.
Patients enrolled in the study will have a flexible transvaginal endoscopy used during laparoscopic cholecystectomy.
Other Name: Gallbladder removal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815438

Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Brent Miedema, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Dr. Brent Miedema, University of Missouri
ClinicalTrials.gov Identifier: NCT00815438     History of Changes
Other Study ID Numbers: 1125518
Study First Received: December 29, 2008
Last Updated: October 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Transvaginal
Cholecstectomy
NOTES
Endoscopic

Additional relevant MeSH terms:
Dyskinesias
Cholecystitis
Acalculous Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases

ClinicalTrials.gov processed this record on September 18, 2014