Assessing Infectious Risk and Visceral Closure in Natural Orifice Translumenal Endoscopic Surgery (NOTES)

NCT01102725 | Completed DMC

• 1 other identifier: 02-09-39
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine:

1. 1.What quantity of bacteria is spilled into the abdomen during a colon resection
2. 2.If there is a correlation between the quantity and post-operative infection
3. 3.What intralumenal pressure is generated when testing the colonic anastomosis for air leak

Conditions

Colonic Diseases; Rectal Diseases

Keywords

Colon Surgery; Rectal Surgery; Colorectal Surgery

Study Arms (1)

Colorectal Surgery

Subject who are undergoing a colon or rectal resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our institution performed over 200 laparoscopic colon resections in the past year and should have no trouble accruing the number of patients required for the study. Subjects will be recruited until 90 patients have been enrolled. We will not specifically recruit or specifically exclude potential patients on the basis of their race or on the basis of our study demographics to date. No vulnerable subjects will be recruited into this study as this study will prolong the surgery by approximately 15 minutes which can be significant in the vulnerable population such as pregnant women and minors. Potential subjects who meet inclusion criteria will be approached for possible participation during a pre-operative clinic visit or on the day of surgery in the pre-operative area.

You may qualify if:

• Male and Female patients ≥18 years of age
• Subjects have a known preexisting condition that has been deemed treatable by totally laparoscopic or hand-assisted laparoscopic colorectal resection
• Any colon or rectal resection where ileocolonic, ileorectal, colocolonic, or colorectal anastomoses is created in the pelvis requiring a leak test. Air-leak test can be performed by an instrument of the surgeons discretion, such as a colonoscope, sigmoidoscope (rigid or flexible), or bulb syringe.

You may not qualify if:

• Surgical resection performed in an emergency setting
• Patients undergoing resection in a known contaminated field (i.e. entero-/colo-cutaneous fistula or acute diverticulitis) as this will bias the bacterial cultures collected intraoperatively

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Colonic Diseases; Rectal Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jeffrey M. Marks, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Surgical Endoscopy

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)