Stoma Closure and Reinforcement Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-02-01

Brief Summary

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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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Detailed Description

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Conditions

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Colon Cancer Rectal Cancer Ileostomy - Stoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall

Group Type EXPERIMENTAL

Mesh Implantation

Intervention Type DEVICE

Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation

Interventions

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Mesh Implantation

Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No