Official Title: Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment
Further study details as provided by University Hospitals of Cleveland:
Primary Outcome Measures: * Feasibility and safety
[ Time Frame: 30 days post-op ] [ Designated as safety issue: Yes ]Estimated Enrollment: 20
Study Start Date: August 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008
(Final data collection date for primary outcome measure)Arms Assigned Interventions Prospective: Experimental
Subjects scheduled to receive procedure
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…This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal cavity access from natural orifice translumenal endoscopic surgery (NOTES) during combined laparoscopic-endoscopic foregut surgery. Post-operative course will be compared with a historical chart-review control group of patients undergoing standard laparoscopic foregut and urologic surgery.
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…
Inclusion Criteria:
* Patients undergoing an already combined laparoscopic and endoscopic foregut procedure with general anesthesia
* 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 formExclusion Criteria:
* Patients undergoing a non-palliative procedure in the face of resectable adenocarcinoma of the foregut or genitourinary tract
* 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…Contact: Jeffrey M. Marks, MD (216) 844-7874 jeffrey.marks@uhhospitals.org
Locations
United States, Ohio
University Hospitals of Cleveland Case Medical Center Recruiting
Cleveland, Ohio, United States, 44116
Contact: Jeffrey Marks, MD 216-844-7874 jeffrey.marks@uhhospitals.org
Contact: Bridget O’Brien-Ermlich, RN, BSN (216) 844-3602 bridget.ermlich@uhhospitals.org
Sub-Investigator: Raymond Onders, MD
Sub-Investigator: Jeffrey Ponsky, MD
Sub-Investigator: Michael Rosen, MD
Sub-Investigator: Amitabh Chak, MD
Sub-Investigator: Ashley Faulx, MD
Sub-Investigator: Michael McGee, MD…
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