Feasibility of Transvaginal Cholecystectomy

NCT01232959 | Withdrawn DMC

• 1 other identifier: 09-001167
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. It is the current standard. It has replaced traditional open gallbladder surgery. Open gallbladder surgery is done with a large incision. A new way of removing the gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This study is being done to see if removing the gallbladder through the vagina will work for patients at Mayo Clinic Rochester. This is the first step of this research to test the procedure. In the future, other studies will examine the potential for less scarring and reduced pain. In this study the investigators will still make small incisions in the abdomen, they will be smaller than the standard procedure but you will still have some scars on your abdomen. Some very early research reports say that some patients may have less pain with the transvaginal approach; however, the investigators do not know if the transvaginal route will have any effect on your overall health and quality of life. This study will evaluate:

• Effectiveness of the surgery: ability to remove the gallbladder safely
• Effect of the operation on your body: change in pulse and blood pressure during the surgery, level of inflammation markers in your blood before and after the surgery
• Recovery from surgery in the hospital: how much pain you have, how much pain medication you need, how long you need to stay in the hospital, or nature of any surgical complications (problems)
• Overall recovery from surgery: general quality of life, abdominal symptoms What is the new type of surgery? The new type of surgery is called transvaginal cholecystectomy: A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.

Conditions

Gallstones

Keywords

Gallbladder removal

Outcome Measures

Primary Outcomes (1)

• Feasibility measured by successful transvaginal removal of gallbladder

  The procedure will be considered technically successful if at completion the cystic duct and artery have been clipped securely and the gallbladder has been removed through the transvaginal port. At the time of surgery, the procedure will be supervised with a laparoscope at all critical points. Conversion to a laparoscopic or open procedure is considered an incomplete transvaginal procedure.

  1 year

Secondary Outcomes (3)

• Safety and tolerability measured by individual and overall Adverse Events

  Following each surgery but overall at 1 year

• Pain Scores as measured on the Visual Analog Scale

  1 year

• Quality of Life measured through validated questionnaires

  1 year

Study Arms (1)

Transvaginal Surgery

EXPERIMENTAL

Gallbladder will be removed through the vagina

Device: Transvaginal Cholecystectomy

Interventions

Transvaginal Cholecystectomy DEVICE

A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.

Also known as: gallbladder removal

Transvaginal Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients undergoing elective cholecystectomy for cholelithiasis.

You may not qualify if:

• Male patients, patients \<18 years or \>65 years of age
• Pregnant patients
• Patients with prior pelvic surgery
• Patients with prior hepatobiliary surgery or other major abdominal surgery
• Patients with ASA class \>3
• Patients with BMI \>35
• Patients with risk factors for requiring an open cholecystectomy (e.g. possible gallbladder cancer, acute cholecystitis, jaundice)
• Patients who cannot provide consent for the study
• Patients not willing to participate in the study.
• Patients with common bile duct stones
• Patients with evidence of abdominal abscess or mass
• Patients with diffuse peritonitis
• Patients with a clinical diagnosis of sepsis
• Patients with coagulopathy or using anticoagulants or anti-platelet agents (aspirin up to 81mg/day acceptable)
• Patients with planned concurrent procedures

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Gallstones

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Juliane Bingener-Casey, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 13, 2016

Record last verified: 2016-01