Transvaginal Cholecystectomy Using Endoscopic Assistance
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Reduction in the number of laparoscopic ports [ Time Frame: Time of surgery ] [ Designated as safety issue: Yes ]
- 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 |
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 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:
|
Biliary Dyskinesia Cholecystitis Acalculous Cholecystitis Cholelithiasis Cholecystolithiasis Gallstones Dyskinesias Common Bile Duct Diseases Bile Duct Diseases Biliary Tract Diseases |
Digestive System Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013