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.

Study Overview

• Status: Completed
• Conditions: Gallbladder Diseases; Appendicitis
• Intervention / Treatment: Procedure: NOTES Transvaginal Cholecystectomy; Procedure: NOTES Transvaginal Appendectomy

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization
  • Jerusalem, Israel, 12000
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria for group #1 Transvaginal cholecystectomy:

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

Exclusion Criteria for group #1 Transvaginal cholecystectomy:

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

Inclusion Criteria for group #2 Transvaginal appendectomy:

1. Clinical diagnosis of appendicitis
2. Emergency room evaluation within 36 hours of the onset of pain
3. ASA Classification

Exclusion Criteria for group #2 Transvaginal appendectomy:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.	Procedure: NOTES Transvaginal Cholecystectomy; The gallbladder will be dissected free and will be removed through an incision in the vagina.
Active Comparator: 2; NOTES Transvaginal Appendectomy. The appendix 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES	continuous

Secondary Outcome Measures

Outcome Measure	Time Frame
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH	continuous

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Yoav Mintz, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 31, 2007
• First Submitted That Met QC Criteria: October 31, 2007
• First Posted (Estimate): November 1, 2007

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Biliary Tract Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Gallbladder Diseases
• Other Study ID Numbers: NOTES HMO-CTIL; 21-2.11.07