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NOTES Transvaginal Cholecystectomy and Appendectomy

Primary Purpose

Gallbladder Diseases, Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NOTES Transvaginal Cholecystectomy
NOTES Transvaginal Appendectomy
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Diseases

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical Center
  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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.

Outcomes

Primary Outcome Measures

TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES

Secondary Outcome Measures

TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH

Full Information

First Posted
October 31, 2007
Last Updated
July 28, 2020
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00552162
Brief Title
NOTES Transvaginal Cholecystectomy and Appendectomy
Official Title
NOTES Transvaginal Cholecystectomy and Appendectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases, Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.
Arm Title
2
Arm Type
Active Comparator
Arm Description
NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina.
Intervention Type
Procedure
Intervention Name(s)
NOTES Transvaginal Cholecystectomy
Intervention Description
The gallbladder will be dissected free and will be removed through an incision in the vagina.
Intervention Type
Procedure
Intervention Name(s)
NOTES Transvaginal Appendectomy
Intervention Description
The appendix will be dissected free and will be removed through an incision in the vagina.
Primary Outcome Measure Information:
Title
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES
Time Frame
continuous
Secondary Outcome Measure Information:
Title
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH
Time Frame
continuous

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Mintz, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
12000
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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NOTES Transvaginal Cholecystectomy and Appendectomy

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