NCT03445936

Brief Summary

This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not 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 Progress86%
Feb 2018Oct 2027

First Submitted

Initial submission to the registry

February 7, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4.7 years

First QC Date

February 7, 2018

Last Update Submit

January 31, 2024

Conditions

Rectum Cancer

Keywords

loop-ileostomy reversalhernia prevention

Outcome Measures

Primary Outcomes (2)

  • Surgical site infection

    The incidence of surgical site infections at 30 days follow up

    30 days

  • Incisional hernia

    Incidence of incisional hernia

    10 months

Secondary Outcomes (7)

  • Complications classified by Clavien-Dindo classification

    30 days

  • Re-operation rate

    5 years

  • Operative time

    30 days

  • Length of stay

    30 days

  • Quality of life measured by RAND-36 survey

    5 years

  • +2 more secondary outcomes

Study Arms (2)

Parietene Macro

ACTIVE COMPARATOR

Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.

Device: Parietene Macro

Permacol

ACTIVE COMPARATOR

Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.

Device: Permacol

Interventions

Parietene MacroDEVICE

Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Parietene Macro
PermacolDEVICE

Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Permacol

Eligibility Criteria

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

You may qualify if:

  • Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
  • years or older
  • Patient has a life expectancy of at least 12 months.
  • Patient signs the Informed consent and agrees to attend all study visits

You may not qualify if:

  • Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
  • Patients with concurrent or previous malignant tumors within 5 years before study enrollment
  • Patients with T4b tumors which imposed a multi-organ resection
  • Patient undergone emergency procedures
  • Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
  • Metastatic disease with life expectancy of less than 12 months
  • Pregnancy or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jyvaskyla Central Hospital

Jyväskylä, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Seinajoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Related Publications (1)

  • Makarainen EJ, Wiik HT, Kossi JAO, Pinta TM, Mantymaki LJ, Mattila AK, Nikki MJ, Jarvinen JE, Ohtonen PP, Rautio TT. Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial). Br J Surg. 2024 Jan 3;111(1):znad362. doi: 10.1093/bjs/znad362.

    PMID: 37944025DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Elisa Mäkäräinen-Uhlbäck

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a prospective randomized controlled multicenter trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 26, 2018

Study Start

February 13, 2018

Primary Completion

October 30, 2022

Study Completion (Estimated)

October 1, 2027

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(4)