Ischemic Conditioning (Delay Phenomenon) in Colorectal Surgery

NCT00887497 | Terminated Phase 4 DMC

• 1 other identifier: 2008-6618
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

One of the major complications of surgical excision of colorectal cancer includes improper healing of the anastomosis (reconnection of the remaining, cancer free intestine). This can result in anastomotic leak, abscess then abdominal and/or pelvic sepsis and mortality. Esophageal surgery has suffered from complications. Recently, an innovation in esophageal surgery has seen a relatively drastic decrease in complications during distal esophagectomies using a technique called "ischemic conditioning". This technique involves dividing the blood supply to the stomach that would be performed during a 1-stage esophagectomy but returning days later to complete the resection. Bench results have shown improved angiogenesis, vasodilation, less anastomotic collagen deposition and minimized ischemia at the time of surgery while clinical results have included improved stricture rates, leak rates and mortality in esophageal surgery. Hypothesis Ischemic conditioning is universal to the intestinal tract and a similar technique can be applied in colon and rectal surgery. The investigators plan evaluating this hypothesis by performing a pilot study comprised of the following: performing an endovascular embolization of the inferior mesenteric artery (IMA) followed by interval laparoscopic or open rectosigmoid resection. Methods Part 1 - Endovascular Procedure Patients will be admitted and undergo endovascular embolization of their IMA as an outpatient following diagnostic angiography. They will undergo sigmoidoscopy throughout the embolization and a laser probe will indirectly measure tissue oxygenation. The patient will be released home that day. Part 2 - Colorectal Procedure Patients will then return 2-4 days later for their definitive laparoscopic or open rectosigmoid resection. They will undergo sigmoidoscopy before and after surgery and a laser probe will indirectly measure tissue oxygenation. The patient will then be released home on average 3-5 days later.

Conditions

Colon Rectal Resection

Outcome Measures

Primary Outcomes (1)

• Any adverse even (safety study)

  6-12 months

Study Arms (1)

Catheterization

EXPERIMENTAL

Patients receive angioembolization prior to surgery

Procedure: Angioembolization

Interventions

Angioembolization PROCEDURE

Angioembolization

Catheterization

Eligibility Criteria

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

You may qualify if:

• Are at least 18 years of age, male or female
• Are scheduled for a non-emergent, resection of your colon
• Are able to give written informed consent to indicate an understanding of the study procedures.

You may not qualify if:

• Will be undergoing an emergency procedure or has a diagnosis of bowel complication(s) such as bowel obstruction, constriction, inflammation, infection, or have inflammatory bowel disease.
• Are currently participating in another clinical trial which may affect this study's outcomes.
• Have been taking regular steroid medication.
• Have a negative reaction to general anesthesia.
• Have severe arterial occlusive disease (disease of the blood vessels affecting blood flow to your legs).
• Have an abdominal aortic aneurysm (dilation of the large artery in your abdomen).

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Study Officials

• Steven D Mills, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 24, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 28, 2011

Record last verified: 2011-09

Locations

US (1)