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Stoma Closure and Reinforcement Trial (SCAR)

Dartmouth Health logo

Dartmouth Health

Status

Completed

Conditions

Ileostomy - Stoma
Colon Cancer
Rectal Cancer

Treatments

Device: Mesh Implantation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Intervention
Experimental group
Description:
Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall
Treatment:
Device: Mesh Implantation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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