Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

Completed · Not applicable

Conditions studied: Gastric Foreign Body, Nos, Disorder of Abdomen (Disorder), Foreign Body in Esophagus, Prostatic Diseases, Disease of Small Intestine

In brief

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.

Key facts

Study ID

NCT00484783

Run by

University Hospitals Cleveland Medical Center

People needed

11

Starts

2006-08-01

Expected to finish

2009-01-01

Last updated by the study team

2014-12-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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