Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery (NOTES)

Study Description

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Brief Summary:

NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.

Condition or disease	Intervention/treatment	Phase
Gastric Foreign Body, Nos; Disorder of Abdomen (Disorder); Foreign Body in Esophagus; Prostatic Diseases; Disease of Small Intestine	Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES); Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	11 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
Study Start Date :	August 2006
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Prospective; 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.; Other Name: NOTES Surgery
Historical; Chart review control group	Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES); chart review of historical data from control group; Other Name: NOTES Surgery

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 30 day Post-op NOTES feasibility outcomes: [ Time Frame: 30 days post-op ]
   • Number of successful NOTES access attempts
   • Number of failed NOTES access attempts
   • Injury to collateral organs or structures
   • Time to gain access to peritoneal cavity
   • Necessary balloon dilator size required for translumenal passage of endoscope

Secondary Outcome Measures :

1. 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 ]

   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

2. 30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration [ Time Frame: 30 Day Post - Op ]
   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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44116

Sponsors and Collaborators

University Hospitals Cleveland Medical Center

Investigators

Principal Investigator:	Jeffrey M. Marks, MD	University Hospitals of Cleveland/ Institute for Surgical Innovation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jeffrey Marks, MD, Prinicpal Investigator, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:	NCT00484783 History of Changes
Other Study ID Numbers:	08-06-13
First Posted:	June 11, 2007
Last Update Posted:	December 16, 2014
Last Verified:	December 2014

Keywords provided by Jeffrey Marks, MD, University Hospital Case Medical Center:

Laparoscopic Surgical Procedures; Endoscopic Surgical Procedures; Laparoscopic & endoscopic procedures with a gastrotomy; or opening in bladder or urethra

Additional relevant MeSH terms:

Prostatic Diseases; Foreign Bodies; Gastrointestinal Diseases	Genital Diseases, Male; Wounds and Injuries; Digestive System Diseases