Laparoscopic Assisted Transvaginal Cholecystecomy

October 1, 2019 updated by: University of Texas Southwestern Medical Center
Laparoscopic cholecystectomy is currently the standard procedure for removing the gallbladder. This procedure usually requires the insertion of four trocars into the abdomen for passage of laparoscopic instruments; each trocar requires a small incision, which results in postoperative pain and scarring. There has recently been a tremendous surge in interest within the surgical community to further reduce the pain, invasiveness, and cosmesis of laparoscopic surgery. To achieve this goal, surgeons are either reducing the number of trocars placed through the abdominal wall or eliminating them completely The goal of this project is to evaluate the feasibility of performing transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. This has the potential to decrease postoperative pain, improve cosmesis, and lead to a shorter recovery following cholecystectomy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

20 female patients will be enrolled. Patients who are scheduled to undergo elective laparoscopic cholecystectomy will be invited to participate in this study. The laparoscopic instrumentation will be sterilized using standard methods. Conventional and new laparoscopic and endoscopic equipment will be used for this project; all equipment is commercially available and is FDA-approved for laparoscopic procedures. Access will be obtained into the peritoneal cavity at the umbilicus in a standard fashion, either by use of a Veress needle technique or by insertion of a trocar using the open technique. Through a single umbilical incision, a 5mm trocar will be placed into the peritoneal cavity. A 5mm laparoscope will then be inserted into the peritoneal cavity. This will be used to monitor safe peritoneal entry of a dilating12mm transvaginal trocar. Subsequent operative visualization will be by use of a flexible endoscope which will be placed through the transvaginal port. The gallbladder will be retracted using sutures as well as endoscopic and / or laparoscopic graspers. In order to obtain the critical view of safety [5] the cystic duct and artery will be dissected, ligated and divided by use of conventional laparoscopic and new articulating instruments. The dissected gallbladder will be retrieved transvaginally. If for any reason suitable retraction or dissection cannot be performed using the transvaginal strategy, the case will be promptly converted to a standard laparoscopic approach by the insertion of additional transabdominal trocars.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Scheduled to undergo elective laparoscopic cholecystectomy
  • Women 18-75 years of age
  • English or Spanish speaking

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification of ≥ 3
  • Morbid obesity (BMI ≥35)
  • Pregnant women
  • Acute cholecystitis
  • Any ongoing intra-abdominal infection
  • Prior upper abdominal or pelvic surgery and/or adhesions
  • Virgins
  • Women with an active sexually transmitted disease or any vaginal infection
  • History of dyspareunia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transvaginal cholecystectomy under laparoscopic guidance
The removal of the gallbladder through several small incisions using a camera to see is called laparoscopic cholecystectomy. This study is being done to evaluate whether cholecystectomy can be performed through a natural orifice (the vagina) with minimal laparoscopic assistance (only one abdominal trocar versus four in the routine laparoscopic cholecystectomy).
Procedure: Laparoscopic Assisted Transvaginal Cholecystectomy
Perform transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization
Other Names:
  • cholecystectomy
  • Transvaginal (TV) NOTES
  • scarless cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Quality of Life scale
Time Frame: 23 hours post op
The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A postoperative Quality of Life questionnaire will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.
23 hours post op
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Visual Analog Scale
Time Frame: 23 hours post op
The primary outcome of this study will be to evaluate the feasibility of performing a transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. A Visual Analog Scale for pain will be given to the patient to access pain. We will also address whether cosmesis was a factor for their decision. Operative time will be tracked as well as standard operative outcomes including any complications. Patients will be kept for 23 hours observation postoperatively and will follow up in the clinic.The Visual Analog Scale is a scale from 0-10, with 10 being a better outcome.
23 hours post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Daniel Scott, MD, UT Southwestern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 122010-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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