Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

Prostatic Diseases Clinical Trial

— NOTES  

Official title:

Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484783
• Other study ID #: 08-06-13
• Status: Completed
• Phase: N/A
• First received: June 7, 2007
• Last updated: December 12, 2014
• Start date: August 2006
• Est. completion date: January 2009

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease of Small Intestine
• Disorder of Abdomen (Disorder)
• Foreign Bodies
• Foreign Body in Esophagus
• Gastric Foreign Body, Nos
• Gastrointestinal Diseases
• Prostatic Diseases

Intervention

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.
• Natural Orifice Translumenal Endoscopic Surgery (NOTES)
chart review of historical data from control group

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes