Colon Cancer Clinical Trial

Stoma Closure and Reinforcement Trial

Summary

Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of large pore monofilament polypropylene mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.

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Eligibility Criteria

Inclusion Criteria:

Age > 18years
Patient is undergoing closure of loop ileostomy
Patient has a diagnosis of left sided colon or rectal cancer treated with resection and diverting loop ileostomy
Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery

Exclusion Criteria:

Pre-existing systemic infection at the time of ileostomy takedown
Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone >10mg/day)
Previous abdominal hernia repair with mesh placement
Concurrent procedures in addition to closure of diverting loop ileostomy
Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)

Study is for people with:

Colon Cancer

Estimated Enrollment:

20

Study ID:

NCT03750461

Recruitment Status:

Completed

Sponsor:

Dartmouth-Hitchcock Medical Center

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There is 1 Location for this study

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Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

20

Study ID:

NCT03750461

Recruitment Status:

Completed

Sponsor:


Dartmouth-Hitchcock Medical Center

How clear is this clinincal trial information?

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