Appendicitis, Gallbladder Diseases
Conditions
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.
Interventions
PROCEDURENOTES Transvaginal Cholecystectomy
The gallbladder will be dissected free and will be removed through an incision in the vagina.
PROCEDURENOTES Transvaginal Appendectomy
The appendix will be dissected free and will be removed through an incision in the vagina.
Sponsors
Hadassah Medical Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES | continuous |
Secondary
| Measure | Time frame |
|---|---|
| TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH | continuous |
Countries
Israel
Outcome results
None listed