Clinical trial NCT01171027: Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy
Official title: Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gall Bladder Diseases
Keywords: Cholecystectomy
NOTES
Transvaginal
Transgastric
Natural orifice
Gallbladder removal
Lead sponsor: Natural Orifice Surgery Consortium for Assessment and Research
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
First posted: 2010-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to be a United States multicenter prospective randomized controlled non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative outcomes will be measured.

Detailed description: Primary To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.

To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.

Secondary To assess cosmesis associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.

To assess objective operative cost and logistical comparisons between transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.

To identify unforeseen barriers to transgastric or transvaginal surgery adoption.

Eligibility criteria: Inclusion Criteria:

* Competent male or female subjects, between the ages of 18-75 and who present for elective cholecystectomy will be offered participation in this study.
* Male subjects must be willing to have the cholecystectomy by either the laparoscopic or transgastric NOTES approach.
* Female subjects must be willing to have the cholecystectomy by either the laparoscopic or either the NOTES approaches (transgastric and/or transvaginal) being performed at the site.
* Patients offered participation in this study must provide written, informed consent and meet the following criteria prior to randomization.
* Diagnosis of benign gallstone disease which requires cholecystectomy.
* ASA Class 1 or 2.
* Willingness to have laparoscopic cholecystectomy performed and have research data collected for control group.
* Willingness to have abdomen photographed (for cosmesis assessment).
* For sites performing transgastric NOTES approach

  * Willingness to have cholecystectomy performed via NOTES transgastric approach.
  * Willingness to have NOTES procedure videotaped.
* For sites performing transvaginal NOTES approach - Female subjects only

  * Willingness to have cholecystectomy performed via NOTES transvaginal approach.
  * Willingness to have intra-abdominal procedure digitally recorded.
  * Pelvic examination in the past 12 months without significant pathology.

Exclusion Criteria:

* Pregnant women.
* Obese patients (BMI \> 35).
* Patients with severe medical comorbidities (ie, NOT ASA Class 1 or 2) will be excluded such as:
* Chronic renal failure
* Chronic liver disease
* Congestive heart failure
* Patients with a presumed gallbladder malignancy.
* Patients with a history of prior open abdominal or laparoscopic or transvaginal surgery. However patients with prior appendectomy, tubal ligation or Cesarean section will be included.
* Patients who are taking immunosuppressive medications and/or immunocompromised.
* Patients with a prior history of perineal trauma leading to significant alteration of vaginal anatomy.
* Patients with a history of ectopic pregnancy, pelvic inflammatory disease, large fibroids or severe endometriosis.
* Patients with known common bile duct stones. (ie, not cleared prior to surgery). Patients with common bile duct stones discovered intra-operatively will remain in the study.
* Patients on anticoagulation drugs other than once daily aspirin. Abnormal blood coagulation tests. Minimal abnormalities may be allowed at the discretion of site principal investigator.
* Gallstones\> 2.5cm in diameter.
* Presence of untreated esophageal stricture.
* Surgically altered gastric anatomy or severe uncorrected paraesophageal types 2, 3 or 4.
* Unwillingness to consent to NOTES procedure(s).
* Acute cholecystitis or cholangitis
* For sites performing transgastric NOTES approach

  * Contraindicated for esophagogastroduodenoscopy (EGD).
  * Patients with hypersecretory states.

Primary outcomes:
measure: To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
timeFrame: 4 weeks post surgery
Secondary outcomes:
measure: To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
timeFrame: 4 weeks post surgery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Clinic
state: Oregon
Study officials:
affiliation: Cambridge Health Alliance
name: Steven Schwaitzberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Michael L. Kochman, MD
role: PRINCIPAL_INVESTIGATOR
References: