NOTES Transvaginal Cholecystectomy and Appendectomy

Hadassah Medical Center

Status: Completed

Conditions: Appendicitis; Gallbladder Diseases

Treatments: Procedure: NOTES Transvaginal Appendectomy; Procedure: NOTES Transvaginal Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00552162

21-2.11.07

NOTES HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Procedure: NOTES Transvaginal Cholecystectomy

2

Active Comparator group

Description:

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

Treatment:

Procedure: NOTES Transvaginal Appendectomy