Clinical trial NCT00484783: Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery
Official title: Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Foreign Body, Nos
Disorder of Abdomen (Disorder)
Foreign Body in Esophagus
Prostatic Diseases
Disease of Small Intestine
Keywords: Laparoscopic Surgical Procedures
Endoscopic Surgical Procedures
Laparoscopic & endoscopic procedures with a gastrotomy
or opening in bladder or urethra
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 30 day Post-op NOTES feasibility outcomes:
timeFrame: 30 days post-op
Secondary outcomes:
measure: 30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery
timeFrame: 30 Day Post-OP
measure: 30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration
timeFrame: 30 Day Post - Op
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals of Cleveland/ Institute for Surgical Innovation
name: Jeffrey M. Marks, MD
role: PRINCIPAL_INVESTIGATOR
References: