Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery (NOTES)
Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44116
- University Hospitals of Cleveland Case Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 form
Exclusion 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Prospective
Subjects scheduled to receive procedure
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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.
Other Names:
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Other: Historical
Chart review control group
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chart review of historical data from control group
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30 day Post-op NOTES feasibility outcomes:
Time Frame: 30 days post-op
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30 days post-op
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery
Time Frame: 30 Day Post-OP
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Description: Mortality Post-Op Mobidity repeat sugery Intra-Op or Post-Op RBC Transfusion Intra-Abdominal Abscess Superficial Surgical Site Infection Antibiotics>24th Post-Op Safety Issue?: Yes |
30 Day Post-OP
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30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration
Time Frame: 30 Day Post - Op
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Description: Identification of Specified Abdominal and Pelvic Organs Time to Adequately Visualize Specified Abdominal and Pelvic Organs Comparitive findings between standardaized abdominal exploration between laparoscopy and NOTES techniques
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30 Day Post - Op
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Collaborators and Investigators
Investigators
- Principal Investigator: Jeffrey M. Marks, MD, University Hospitals of Cleveland/ Institute for Surgical Innovation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-06-13
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