NOTES Transvaginal Cholecystectomy and Appendectomy

Study Overview
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Brief Summary
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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.

Official Title
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NOTES Transvaginal Cholecystectomy and Appendectomy

Conditions
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Gallbladder Diseases, Appendicitis

Intervention / Treatment
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* Procedure: NOTES Transvaginal Cholecystectomy
* Procedure: NOTES Transvaginal Appendectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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