Clinical trial NCT00552162: NOTES Transvaginal Cholecystectomy and Appendectomy
Official title: NOTES Transvaginal Cholecystectomy and Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Appendicitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-11-01
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES
timeFrame: continuous
Secondary outcomes:
measure: TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH
timeFrame: continuous
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoav Mintz, MD
role: PRINCIPAL_INVESTIGATOR
References: