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Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00984100
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
John Romanelli, Baystate Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Cholelithiasis Biliary Dyskinesia Procedure: NOTES Transvaginal Cholecystectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
Study Start Date : January 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Gallstones

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. Morbidity [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: One year ]
  2. Postoperative pain [ Time Frame: One year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00984100

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United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01085
Sponsors and Collaborators
Baystate Medical Center
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Principal Investigator: John Romanelli, MD Baystate Medical Center
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Responsible Party: John Romanelli, MD, Baystate Medical Center Identifier: NCT00984100    
Other Study ID Numbers: 08-086
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by John Romanelli, Baystate Medical Center:
Biliary dyskinesia
Additional relevant MeSH terms:
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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