Skip to main content
OpenTrials
Completed

NCT Number: NCT00552162

NOTES Transvaginal Cholecystectomy and Appendectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center, Jerusalem, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for group #1 Transvaginal cholecystectomy:

  • Females between the ages of 18 and 50
  • Diagnosis of gallstone disease which requires cholecystectomy
  • ASA class 1

Exclusion criteria

for group #1 Transvaginal cholecystectomy:

  • Pregnant women
  • Morbidly obese patients (BMI > 35)
  • Patients who are taking immunosuppressive medications and/or immunocompromised
  • Patients with severe medical comorbidities will be excluded.
  • Patients with a presumed gallbladder polyps, mass or tumor
  • Patients with a history of prior open abdominal or transvaginal surgery.
  • Patients with a prior history of peritoneal or vaginal trauma
  • Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
  • Patients with known common bile duct stones
  • Patients on blood thinners or aspirin or abnormal blood coagulation tests

Inclusion criteria

for group #2 Transvaginal appendectomy:

  • Clinical diagnosis of appendicitis
  • Emergency room evaluation within 36 hours of the onset of pain
  • ASA Classification

Exclusion criteria

for group #2 Transvaginal appendectomy:

  • pregnant women
  • Morbidly obese patients (BMI >35)
  • Patients who are taking immunosuppressive medications or are immunocompromised
  • Patients with evidence of an abdominal abscess or mass
  • Patients who present with a clinical diagnosis of sepsis or peritonitis
  • Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
  • Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
  • Patients with diffuse peritonitis on clinical exam
  • Previous trauma to the perineal area
  • Patients on blood thinners or aspirin or abnormal blood coagulation tests

Treatment and study plan

NOTES Transvaginal Cholecystectomy

Procedure

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

NOTES Transvaginal Appendectomy

Procedure

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

Primary outcomes

  1. TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES

    Time frame: continuous

Secondary outcomes

  1. TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH

    Time frame: continuous

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2007
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.