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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.
The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.
Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | Participants in control group are operated with no preventive mesh. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Device | Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of parastomal hernia | Incidence of parastomal hernia at 12 months follow up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of parastomal hernia at long term follow up | Incidence of parastomal hernia during 5 years of follow up | 5 years |
| Surgical site infection rate | Surgical site infections measured by Clavien-Dindo Classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisa Mäkäräinen-Uhlbäck, M.D. | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland | ||||
| Keski-Suomi Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42018309 | Derived | Makarainen 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. | |
| 39196580 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Chimney trial is a prospective randomized controlled multicenter trial.
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Participants are unaware of the randomization group.
| 30 days |
| Complications | Complications measured by Clavien-Dindo Classification | 30 days |
| Stoma related complications | Stoma related complications measured by Clavien-Dindo Classification | 5 years |
| Reoperation rate | Need for reoperations | 5 years |
| Operative time | Operative time | 1 day |
| Length of stay | Length of stay at the hospital | 30 days |
| Rand 36 quality of life | Quality of life measured by Rand-36 quality of life questionnaire | 5 years |
| Quality of life measured by Colostomy impact score | Quality of life measured by Colostomy impact score | 5 years |
| Medico-economic substudy | Medico-economic substudy including both short and long term costs included in both groups | 5 years |
| Radiological substudy of stoma distance | Distance of stoma from midline defined by umbilicus | 3 years |
| Radiological substudy of adipose tissue thickness | Thickness of adipose tissue on computer tomography scan on contralateral site of stoma | 3 years |
| Jyväskylä |
| Finland |
| Oulu University Hospital | Oulu | Finland |
| Seinäjoki Central Hospital | Seinäjoki | Finland |
| Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | Finland |
| Maziar Nikberg | Västerås | Sweden |
| 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. |
| 31779699 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |