Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery
NCT ID: NCT00484783
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2006-08-31
2009-01-31
Brief Summary
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Detailed Description
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The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach, abdominal esophagus, prostate, bladder, proximal small intestine or who meet inclusion and exclusion criteria. The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut, prostate, or bladder and as determined by CPT coding.
The purpose of the study is to determine if NOTES access and abdominal exploration is feasible, safe, offers comparable visualization to laparoscopy in a controlled human setting.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prospective
Subjects scheduled to receive procedure
Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.
Historical
Chart review control group
Natural Orifice Translumenal Endoscopic Surgery (NOTES)
chart review of historical data from control group
Interventions
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Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.
Natural Orifice Translumenal Endoscopic Surgery (NOTES)
chart review of historical data from control group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing a prostatectomy or cystectomy with general anesthesia
* All patients will have a planned gastrotomy for exploration, foreign body removal, or removal of tissue, making it a contaminated case or a planned cystotomy or urethrotomy for exploration, foreign body removal or removal of tissue such as prostatectomy or bladder resection.
* No overwhelming medical co-morbidities
* Subject is 18 years of age or older
* Subject is his or her own medical decision maker
* Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
Exclusion Criteria
* Linitis Plastica
* Evidence of Active Bowel Obstruction
* Patients with history of oropharyngeal, esophageal, or gastric adenocarcinoma.
* Esophageal stricture prohibiting passage of an endoscope
* Urethral stricture prohibiting passage of an endoscope
* Emergent Surgery
* At any time during pre-operative or intra-operative periods, evidence of unresectability is demonstrated
* Any intra-operative condition prior to surgical resection that results in abortion of the surgical procedure
* Any contraindication to surgery
* Pregnancy or actively breastfeeding women
* Prisoners or Wards of State
18 Years
75 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Jeffrey Marks, MD
Prinicpal Investigator
Principal Investigators
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Jeffrey M. Marks, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Cleveland/ Institute for Surgical Innovation
Locations
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University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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08-06-13
Identifier Type: -
Identifier Source: org_study_id