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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Diseases; Gastric Foreign Body, Nos; Disorder of Abdomen (Disorder); Foreign Body in Esophagus; Disease of Small Intestine
• Intervention / Treatment: Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES); Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)

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: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: NOTES Surgery
Other: Historical; Chart review control group	Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES); chart review of historical data from control group; Other Names: NOTES Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day Post-op NOTES feasibility outcomes:	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	30 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery	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
30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration	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	30 Day Post - Op

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Jeffrey M. Marks, MD, University Hospitals of Cleveland/ Institute for Surgical Innovation

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: June 7, 2007
• First Submitted That Met QC Criteria: June 8, 2007
• First Posted (Estimate): June 11, 2007

Study Record Updates

• Last Update Posted (Estimate): December 16, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Laparoscopic Surgical Procedures; Endoscopic Surgical Procedures; Laparoscopic & endoscopic procedures with a gastrotomy; or opening in bladder or urethra
• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies; Prostatic Diseases
• Other Study ID Numbers: 08-06-13