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Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 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: August 12, 2013
Last verified: August 2013
  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:


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 2015
Estimated Primary Completion Date: January 2015 (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).

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
Cholelithiasis
Biliary dyskinesia

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

ClinicalTrials.gov processed this record on November 27, 2014