This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy

This study has been completed.
Information provided by (Responsible Party):
John Romanelli, Baystate Medical Center Identifier:
First received: September 23, 2009
Last updated: November 17, 2015
Last verified: November 2015
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: Intervention Model: Single Group Assignment
Masking: None (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 John Romanelli, Baystate Medical Center:

Primary Outcome Measures:
  • Morbidity [ Time Frame: One year ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: One year ]
  • Postoperative pain [ Time Frame: One year ]

Enrollment: 8
Study Start Date: January 2009
Study Completion Date: January 2015
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00984100

United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01085
Sponsors and Collaborators
Baystate Medical Center
Principal Investigator: John Romanelli, MD Baystate Medical Center
  More Information

Responsible Party: John Romanelli, MD, Baystate Medical Center Identifier: NCT00984100     History of Changes
Other Study ID Numbers: 08-086
Study First Received: September 23, 2009
Last Updated: November 17, 2015

Keywords provided by John Romanelli, Baystate Medical Center:
Biliary dyskinesia

Additional relevant MeSH terms:
Biliary Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases processed this record on September 21, 2017