NCT03720262 Prevention of Hernia After Loop Ileostomy Reversal
| NCT ID | NCT03720262 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Karolinska Institutet |
| Condition | Loop Ileostomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2018-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 208 participants in total. It began in 2018-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Patients operated for low anterior resection for rectal cancer with a diverting loop ileostomy and planned for stoma reversal Exclusion Criteria: * Language barrier or cognitive disability * Recurrent cancer
Contact & Investigator
Åsa Hallqvist Everhov, MS, PhD
PRINCIPAL INVESTIGATOR
Stockholm South General Hospital
Frequently Asked Questions
Who can join the NCT03720262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Loop Ileostomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03720262 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03720262 currently recruiting?
Yes, NCT03720262 is actively recruiting participants. Contact the research team at asa.hallqvist-everhov@sll.se for enrollment information.
Where is the NCT03720262 trial being conducted?
This trial is being conducted at Södertälje, Sweden, Stockholm, Sweden, Stockholm, Sweden, Västerås, Sweden.
Who is sponsoring the NCT03720262 clinical trial?
NCT03720262 is sponsored by Karolinska Institutet. The principal investigator is Åsa Hallqvist Everhov, MS, PhD at Stockholm South General Hospital. The trial plans to enroll 208 participants.