NOTES Transvaginal Cholecystectomy and Appendectomy

Not Applicable

Completed

• Conditions: Gallbladder Diseases; Appendicitis
• Interventions: Procedure: NOTES Transvaginal Appendectomy; Procedure: NOTES Transvaginal Cholecystectomy

• Registration Number: NCT00552162
• Lead Sponsor: Hadassah Medical Organization

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 Description

Not available

Study Timeline

• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-01
• Study Start: 2008-06
• Status Verified: 2016-04
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	NOTES Transvaginal Appendectomy	NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina.
1	NOTES Transvaginal Cholecystectomy	NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.

Primary Outcome Measures

Name	Time	Method
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES	continuous

Secondary Outcome Measures

Name	Time	Method
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH	continuous

Trial Locations

Locations (2)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel