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NOTES Transvaginal Cholecystectomy and Appendectomy

NCT00552162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-07-30

No results posted yet for this study

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.

Conditions

  • Gallbladder Diseases
  • Appendicitis

Interventions

PROCEDURE

NOTES Transvaginal Cholecystectomy

The gallbladder will be dissected free and will be removed through an incision in the vagina.

PROCEDURE

NOTES Transvaginal Appendectomy

The appendix will be dissected free and will be removed through an incision in the vagina.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Yoav Mintz, MD · Hadassah Medical Organization

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2018-01-01
Completion
2018-01-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00552162 on ClinicalTrials.gov