Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 23, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedNovember 18, 2015
November 1, 2015
6 years
September 23, 2009
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morbidity
One year
Secondary Outcomes (2)
Mortality
One year
Postoperative pain
One year
Study Arms (1)
Notes Transvaginal Cholecystectomy
EXPERIMENTALPatients who undergo a NOTES Transvaginal cholescystectomy.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Adult female (18 years old or over) patients who are able to provide informed consent for this surgical procedure
- Patients scheduled to undergo non-emergent surgical removal of the gallbladder
You may not qualify if:
- Inability to provide informed consent
- Patients who have a history of prior pelvic surgery (excluding Caesarian sections, tubal ligations, or non-operative pelviscopy)
- Patients who have acute cholecystitis, gallstone pancreatitis, or who have had a percutaneous cholecystotomy tube placed
- Patients with a BMI \> 40 kg/m2
- Pregnancy
- Male gender
- History of PID
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baystate Medical Center
Springfield, Massachusetts, 01085, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Romanelli, MD
Baystate Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 23, 2009
First Posted
September 25, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
November 18, 2015
Record last verified: 2015-11