Clinical Trial: NOTES Transvaginal Cholecystectomy and Appendectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: NOTES Transvaginal Cholecystectomy and Appendectomy

Brief Summary:

Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma.

In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.

Detailed Summary:
Sponsor: Hadassah Medical Organization

Current Primary Outcome: TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: continuous ]

Original Primary Outcome: Same as current

Current Secondary Outcome: TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: continuous ]

Original Secondary Outcome: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: October 31, 2007
Date Started: June 2008
Date Completion: July 2020
Last Updated: April 13, 2016
Last Verified: April 2016