NCT03799939

Brief Summary

Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

7 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 Progress98%
Feb 2019Jul 2026

First Submitted

Initial submission to the registry

January 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

February 5, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

January 6, 2019

Last Update Submit

January 31, 2024

Conditions

Parastomal HerniaRectal AdenocarcinomaAbdominoperineal Resection

Outcome Measures

Primary Outcomes (1)

  • Incidence of parastomal hernia

    Incidence of parastomal hernia at 12 months follow up

    12 months

Secondary Outcomes (12)

  • Incidence of parastomal hernia at long term follow up

    5 years

  • Surgical site infection rate

    30 days

  • Complications

    30 days

  • Stoma related complications

    5 years

  • Reoperation rate

    5 years

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia.

Device: Intervention group

Control group

NO INTERVENTION

Participants in control group are operated with no preventive mesh.

Interventions

Intervention groupDEVICE

Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
  • Patient has a life expectancy of at least 12 months.
  • Patient must sign Informed consent before any study procedures and agrees to attend all study visits

You may not qualify if:

  • Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
  • Complication requiring laparotomy during post surgery treatment at surgical ward after APR
  • Patient with a comorbid illness or condition that would preclude 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 impose a multi-organ resection
  • Rectal malignancy other than adenocarcinoma
  • Patient undergoing emergency procedures
  • Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
  • Metastatic disease with no possibility of curative surgery
  • Pregnant or suspected pregnancy
  • Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
  • Active abdominal infection at the time of surgery
  • Previous surgery at the colostomy site
  • Language barrier or other reasons why informed consent is not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Helsinki University Hospital

Helsinki, Finland

Location

Keski-Suomi Central Hospital

Jyväskylä, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Maziar Nikberg

Västerås, Sweden

Location

Related Publications (2)

  • Makarainen E, Wiik H, Nikberg M, Kossi J, Carpelan-Holmstrom M, Pinta T, Lehto K, Nikki M, Jarvinen J, Ohtonen P, Rautio T. Parastomal Hernia Prevention Using Funnel-Shaped Intra-Abdominal Mesh Compared to No Mesh: The Chimney Randomized Clinical Trial. JAMA Surg. 2024 Nov 1;159(11):1244-1250. doi: 10.1001/jamasurg.2024.3260.

    PMID: 39196580DERIVED

  • Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):652. doi: 10.1186/s13063-019-3764-y.

    PMID: 31779699DERIVED

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, M.D.

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are unaware of the randomization group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Chimney trial is a prospective randomized controlled multicenter trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 10, 2019

Study Start

February 5, 2019

Primary Completion

August 30, 2022

Study Completion (Estimated)

July 1, 2026

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(6)SE(1)