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NOTES Transvaginal Cholecystectomy and Appendectomy

Not Applicable
Completed
Conditions
Gallbladder Diseases
Appendicitis
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

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
Primary Outcome Measures
NameTimeMethod
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUEScontinuous
Secondary Outcome Measures
NameTimeMethod
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACHcontinuous

Trial Locations

Locations (2)

Hadassah Medical Center

🇮🇱

Jerusalem, Israel

Hadassah Medical Organization

🇮🇱

Jerusalem, Israel

Hadassah Medical Center
🇮🇱Jerusalem, Israel

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