Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

NCT00484783 | Completed DMC

• 1 other identifier: 08-06-13
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery

  30 Day Post-OP

• 30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration

  30 Day Post - Op

Study Arms (2)

Prospective

EXPERIMENTAL

Subjects scheduled to receive procedure

Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES)

Historical

OTHER

Chart review control group

Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Interventions

Natural Orifice Transluminal Endoscopic Surgery (NOTES) PROCEDURE

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.

Also known as: NOTES Surgery

Prospective

Natural Orifice Translumenal Endoscopic Surgery (NOTES) PROCEDURE

chart review of historical data from control group

Also known as: NOTES Surgery

Historical

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44116, United States

Location

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic; Prostatic Diseases

Interventions

Natural Orifice Endoscopic Surgery

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jeffrey M. Marks, MD

  University Hospitals of Cleveland/ Institute for Surgical Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 11, 2007
• Study Start: August 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)