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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00552162
Other study ID # NOTES HMO-CTIL
Secondary ID 21-2.11.07
Status Completed
Phase N/A
First received
Last updated
Start date June 2008
Est. completion date January 1, 2018

Study information

Verified date April 2016
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Hadassah Medical Center Jerusalem
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES continuous
Secondary TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH continuous
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