Comparision of Air Versus CO2 for Distention During Sigmoidoscopy

NCT00771290 | Terminated

• 1 other identifier: AAAB6097
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Intra-operative colonoscopy (inserting a flexible endoscope with a camera at its tip through the anus and up into the rectum and colon) is most often indicated to locate or verify the location of small cancer, polyp, bleeding site, or simply to inspect the bowel after the two ends have been rejoined together. Usually colonoscopy utilizes ambient air to expand and inflate the colon and, as a result, leaves the colon bloated or distended until the gas is either expelled or absorbed. This endoscopy related bowel distension is problematic in the setting of both traditional open (big incision) colorectal surgery and after minimally invasive (laparoscopic assisted) procedures. In the case of the former, it may prove difficult to close a traditional laparotomy incision if the bowel is distended and may hinder respiration with the abdomen closed. In the setting of a laparoscopic procedure, the bowel distension limits the working space available to the surgeon. Since the laparoscopic domain is limited, a distended colon following intra-operative colonoscopy can prevent the minimally invasive completion of a case (meaning that a conversion to traditional "open" methods would be necessary) that otherwise was going well with good prospects of laparoscopic completion. Colonic distension also causes abdominal pain and lengthens the recovery time from the procedure. The investigators believe that the use of CO2 during intra-operative colonoscopy or sigmoidoscopy (exam of only the last 2 to 2 ½ feet of the colon) will not cause long lasting bloating or distension of the colon as opposed to air. Carbon dioxide is absorbed 250 times faster than ambient air and may decrease after procedure colonic distension. This prospective, randomized study will compare the two gases in terms of colonic distension. Patients undergoing open or minimally invasive colorectal resection will be randomized to undergo intra-operative colonoscopy using one of the two gases. Direct measurements of colon diameter will be taken at specific time intervals after the colonoscopy.

Conditions

Colorectal Surgery

Keywords

Rectal sparing; Colon cancer

Outcome Measures

Primary Outcomes (1)

• diameter of colon/rectal wall at surgery

  at surgery

Interventions

Air insufflation with standard endoscopy unit, CO2 insufflation for colonoscopy (special CO2 insufflation unit) PROCEDURE

comparison of Air insufflation to CO2 insufflation during intraoperative endoscopy

Eligibility Criteria

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

You may qualify if:

• All patients, over age 18, undergoing elective, open or minimally invasive (laparoscopicassistedor handassisted) left sided colorectal resection, for any indication, in whom it is anticipated that a transanal circular,stapled colorectal anastomosis will be constructed will be eligible for enrollment in this study, provided they are able to understand and sign the Informed Consent Form. Patients will be identified preoperatively in anticipation of undergoing the operation detailed above.

You may not qualify if:

• Patients undergoing right sided, transverse, or descending colectomy are not eligible since their anastomosis would not be carried out with a transanally placed circular stapler. Patients undergoing abdominoperineal resection (which includes no anastomosis) are also not eligible. Patients with severe COPD or emphysema would not be eligible for entry into this study. Further, patients who are undergoing emergent surgery or elective patients who are ASA Class 3 or 4 will not be eligible for this study.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Richard L Whelan, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

US (1)