Full Text View
Tabular View
No Study Results Posted
Related Studies
NOTES Transvaginal Cholecystectomy and Appendectomy
This study is not yet open for participant recruitment.
Study NCT00552162   Information provided by Hadassah Medical Organization
First Received: October 31, 2007   Last Updated: May 12, 2008   History of Changes

October 31, 2007
May 12, 2008
June 2008
 
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: continuous ]
Complete list of historical versions of study NCT00552162 on ClinicalTrials.gov Archive Site
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: continuous ] [ Designated as safety issue: No ]
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: continuous ]
 
NOTES Transvaginal Cholecystectomy and Appendectomy
NOTES Transvaginal Cholecystectomy and Appendectomy

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.

 
 
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
  • Gallbladder Diseases
  • Appendectomy
  • Procedure: NOTES Transvaginal Cholecystectomy
  • Procedure: NOTES Transvaginal Appendectomy
  • Active Comparator: NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.
  • Active Comparator: NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
40
July 2009
 

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
Female
18 Years to 50 Years
No
Contact: Yoav Mintz, MD 972-2-6777111 ymintz@hadassah.org.il
Israel
 
NCT00552162
Yoav Mintz MD, Hadassah Medical Organization
NOTES HMO-CTIL, 21-2.11.07
Hadassah Medical Organization
 
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization, Jerusalem, Israel
Hadassah Medical Organization
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP