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

University Hospitals (UH)

Status

Completed

Conditions

Disorder of Abdomen (Disorder)

Gastric Foreign Body, Nos

Foreign Body in Esophagus

Disease of Small Intestine

Prostatic Diseases

Treatments

Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES)

Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Study type

Interventional

Funder types

Other

Identifiers

NCT00484783

08-06-13

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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