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NCT00887497 · ClinicalTrials.gov registry record · Phase 4
Ischemic Conditioning (Delay Phenomenon) in Colorectal Surgery
A Phase 4 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT00887497 is a Phase 4 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 10 participants.
The verdict
NCT00887497, a Phase 4 study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Angioembolization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-04 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00887497
The ClinicalTrials.gov registry entry for NCT00887497 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Angioembolization is the first listed.
NCT00887497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00887497 about?
NCT00887497 is a clinical study titled "Ischemic Conditioning (Delay Phenomenon) in Colorectal Surgery". 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 suffer...
What is the current status of trial NCT00887497?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2009-04. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00887497?
The interventions under investigation include: Angioembolization (PROCEDURE).
Who is sponsoring clinical trial NCT00887497?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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