Clinical trial · Interventional
Chimney Trial of Parastomal Hernia Prevention
Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention
NCT03799939CI-TRIAL-00073554unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominoperineal Resection | — | UNRESOLVED | — |
| Parastomal Hernia | — | UNRESOLVED | — |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention group
- description
- 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.
- interventionNames
- Device: Intervention group
- type
- NO_INTERVENTION
- label
- Control group
- description
- Participants in control group are operated with no preventive mesh.
Primary outcomes (1)
- measure
- Incidence of parastomal hernia
- timeFrame
- 12 months
- description
- Incidence of parastomal hernia at 12 months follow up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 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 Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDMakarainen E, Jarvinen J, Kossi J, Nikberg M, Wiik H, Carpelan-Holmstrom M, Pinta T, Lehto K, Nikki M, Ohtonen P, Rautio T. Prevention of Parastomal Hernia With Funnel-Shaped Intra-Abdominal Mesh vs No Mesh for Rectal Adenocarcinoma Surgery: 3-Year Follow-Up of a Randomized Clinical Trial. JAMA Surg. 2026 Jun 1;161(6):584-588. doi: 10.1001/jamasurg.2026.1036. PMID 42018309
- DERIVEDMakarainen 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 39196580
- DERIVEDMakarainen-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 31779699