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Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy

This study is currently recruiting participants.
Verified July 2012 by Baystate Medical Center
Sponsor:
Information provided by (Responsible Party):
John Romanelli, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00984100
First received: September 23, 2009
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multidisciplinary teams of surgeons and gastroenterologists collaborate to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions. Early studies have focused on transvaginal surgery as the access route to the abdomen as it sidesteps troubling questions about infection and closure of the organ. This study is a pilot study to test the feasibility to NOTES transvaginal cholecystectomy using conventional surgical and endoscopic tools.


Condition Intervention
Cholelithiasis
Biliary Dyskinesia
 Procedure: NOTES Transvaginal Cholecystectomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gallstones
U.S. FDA Resources

Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • Morbidity [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Postoperative pain [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3
Study Start Date: January 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Notes Transvaginal Cholecystectomy
Patients who undergo a NOTES Transvaginal cholescystectomy.
 Procedure: NOTES Transvaginal Cholecystectomy
An operation to remove the gallbladder, but instead of removing it via an incision in the abdominal wall, will be removed using an endoscope inserted through an opening in the posterior vagina (which then enters the abdominal cavity).

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult female (18 years old or over) patients who are able to provide informed consent for this surgical procedure
  2. Patients scheduled to undergo non-emergent surgical removal of the gallbladder

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Patients who have a history of prior pelvic surgery (excluding Caesarian sections, tubal ligations, or non-operative pelviscopy)
  3. Patients who have acute cholecystitis, gallstone pancreatitis, or who have had a percutaneous cholecystotomy tube placed
  4. Patients with a BMI > 40 kg/m2
  5. Pregnancy
  6. Male gender
  7. History of PID
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984100

Locations
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01085
Contact: Karen Christianson, RN, BSN     413-794-5174     karen.christianson@bhs.org    
Principal Investigator: John R Romanelli, MD, FACS            
Sub-Investigator: David J Desilets, MD, PhD            
Sub-Investigator: David B Earle, MD, FACS            
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: John Romanelli, MD Baystate Medical Center
  More Information

No publications provided

Responsible Party: John Romanelli, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00984100     History of Changes
Other Study ID Numbers: 08-086
Study First Received: September 23, 2009
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
Cholelithiasis
Biliary dyskinesia

Additional relevant MeSH terms:
Biliary Dyskinesia
Cholelithiasis
Cholecystolithiasis
Gallstones
Dyskinesias
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
 Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013