Clinical Trial: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
Brief Summary: Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multidisciplinary teams of surgeons and gastroenterologists collaborate to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions. Early studies have focused on transvaginal surgery as the access route to the abdomen as it sidesteps troubling questions about infection and closure of the organ. This study is a pilot study to test the feasibility to NOTES transvaginal cholecystectomy using conventional surgical and endoscopic tools.
Detailed Summary:
Introduction: Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multiple animal studies utilizing similar techniques are ongoing at several institutions, including Baystate Medical Center. These multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions.
The NOTES team at Baystate began animal studies in May, 2006. Multiple procedures, including but not limited to uterine horn resection (simulating appendectomy), cholecystectomy, nephrectomy, splenectomy, distal pancreatectomy, small bowel resection, mediastinal exploration, and sleeve gastrectomy have been completed successfully by the team. This work has led to a separate, IRB-approved protocol to perform NOTES pancreatic pseudocystgastrostomy in human patients. To date, 2 patients have successfully undergone entirely transluminal, endoscopic cystgastrostomy with a third case upcoming. The focus of much of our research (as well as that of many other investigators), is to develop a secure closure method for the stomach. Unfortunately, key scientific questions remain regarding this technique and thus have limited human trials to date. Given this, we have begun to explore other access techniques.
Gynecologists have long considered transvaginal access to the peritoneum as a safe route of entry into the abdomen. Transvaginal hysterectomy and transvaginal tubal ligation have indeed become a regular part of the gynecologic armamentarium. NOTES surgeons have learned from this access approach and have begun to employ it
Sponsor: Baystate Medical Center
Current Primary Outcome: Morbidity [ Time Frame: One year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mortality [ Time Frame: One year ]
- Postoperative pain [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: Baystate Medical Center
Dates:
Date Received: September 23, 2009
Date Started: January 2009
Date Completion:
Last Updated: November 17, 2015
Last Verified: November 2015
