Laparoscopic Assisted Transvaginal Cholecystecomy

Not Applicable

Withdrawn

• Conditions: Cholelithiasis
• Interventions: Procedure: Laparoscopic Assisted Transvaginal Cholecystectomy

• Registration Number: NCT04113590
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-07-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Study First Posted: 2019-10-03
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvaginal cholecystectomy under laparoscopic guidance	Laparoscopic Assisted Transvaginal Cholecystectomy	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).

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Visual Analog Scale	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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] using a Quality of Life scale	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.