NCT03720262

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_2

Timeline
44mo left

Started Mar 2018

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Mar 2018Dec 2029

Study Start

First participant enrolled

March 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

8.8 years

First QC Date

October 24, 2018

Last Update Submit

August 14, 2025

Conditions

Loop Ileostomy

Outcome Measures

Primary Outcomes (1)

  • Hernia

    Hernia at the site of the stomal closure

    One year

Secondary Outcomes (5)

  • Operation time

    Three hours

  • Time for closing the stoma site

    One hour

  • Hospital stay

    Seven days

  • Postoperative pain

    Thirty days

  • Postoperative complications

    Thirty days

Study Arms (2)

Mesh reinforcement

EXPERIMENTAL

Retro muscular mesh at the stoma site.

Combination Product: Mesh reinforcement

No reinforcement

PLACEBO COMPARATOR

Standard closure of the abdominal wall

Other: No reinforcement

Interventions

Mesh reinforcementCOMBINATION_PRODUCT

Reinforcement of the abdominal wall with Ultrapro Advanced.

Mesh reinforcement
No reinforcementOTHER

Suturing the abdominal wall without mesh reinforcement

No reinforcement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Language barrier or cognitive disability
  • Recurrent cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Södertälje Hospital

Södertälje, Sweden

RECRUITING

Stockholm South General Hospital

Stockholm, 11883, Sweden

RECRUITING

Ersta Hospital

Stockholm, Sweden

RECRUITING

Västmanland Hospital

Västerås, Sweden

RECRUITING

Related Publications (1)

  • Eklov K, Bringman S, Lofgren J, Nygren J, Everhov AH. PHaLIR: prevent hernia after loop ileostomy reversal-a study protocol for a randomized controlled multicenter study. Trials. 2023 Sep 8;24(1):575. doi: 10.1186/s13063-023-07430-w.

    PMID: 37684648DERIVED

Study Officials

  • Åsa Hallqvist Everhov, MS, PhD

    Stockholm South General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Åsa Hallqvist Everhov, MD, PhD

CONTACT

+46702264127asa.hallqvist-everhov@sll.se

Jonas Nygren, MD, PhD

CONTACT

Jonas.Nygren@erstadiakoni.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the surgeon performing the follow-up are masked for the allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Study Start

March 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(4)