Prevention of Hernia After Loop Ileostomy Reversal
Who is this study for? Patients who underwent low anterior resection for rectal cancer with a diverting loop ileostomy and planned for stoma reversal
What treatments are being studied? Mesh reinforcement
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Patients operated for low anterior resection for rectal cancer with a diverting loop ileostomy and planned for stoma reversal
Locations
Other Locations
Sweden
Södertälje Hospital
RECRUITING
Södertälje
Ersta Hospital
RECRUITING
Stockholm
Stockholm South General Hospital
RECRUITING
Stockholm
Västmanland Hospital
RECRUITING
Västerås
Contact Information
Primary
Åsa Hallqvist Everhov, MD, PhD
asa.hallqvist-everhov@sll.se
+46702264127
Backup
Jonas Nygren, MD, PhD
Jonas.Nygren@erstadiakoni.se
Time Frame
Start Date: 2018-03-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 208
Treatments
Experimental: Mesh reinforcement
Retro muscular mesh at the stoma site.
Placebo_comparator: No reinforcement
Standard closure of the abdominal wall
Related Therapeutic Areas
Sponsors
Collaborators: Stockholm South General Hospital
Leads: Karolinska Institutet