Laparoscopic Assisted Transvaginal Cholecystecomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholelithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Laparoscopic Assisted Transvaginal Cholecystectomy

Intervention Type PROCEDURE

Perform transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization

Interventions

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Laparoscopic Assisted Transvaginal Cholecystectomy

Perform transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization

Intervention Type PROCEDURE

Other Intervention Names

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Transvaginal (TV) NOTES scarless cholecystectomy cholecystectomy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No