RecruitingPhase 2Phase 3NCT03720262

Prevention of Hernia After Loop Ileostomy Reversal

Sponsor

Karolinska Institutet

Enrollment

208 participants

Start Date

Mar 1, 2018

Study Type

INTERVENTIONAL

Conditions

Loop Ileostomy

Summary

PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery are randomized between retro muscular mesh Ultrapro Advanced or standard treatment without mesh.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria1

Patients operated for low anterior resection for rectal cancer with a diverting loop ileostomy and planned for stoma reversal

Exclusion Criteria2

Language barrier or cognitive disability
Recurrent cancer

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Interventions

COMBINATION_PRODUCTMesh reinforcement

Reinforcement of the abdominal wall with Ultrapro Advanced.

OTHERNo reinforcement

Suturing the abdominal wall without mesh reinforcement

Locations(4)

Södertälje Hospital

Södertälje, Sweden

Stockholm South General Hospital

Stockholm, Sweden

Ersta Hospital

Stockholm, Sweden

Västmanland Hospital

Västerås, Sweden

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NCT03720262