Parastomal Hernia Prevention Using Funnel-Shaped Intra-Abdominal Mesh Compared to No Mesh: The Chimney Randomized Clinical Trial

Elisa Mäkäräinen, Heikki Wiik, Maziar Nikberg, Jyrki Kössi, Monika Carpelan-Holmström, Tarja Pinta, Kirsi Lehto, Marko Nikki, Jyri Järvinen, Pasi Ohtonen, Tero Rautio

Tutkimustuotos: ArtikkelijulkaisuArtikkeliTieteellinenvertaisarvioitu

Abstrakti

IMPORTANCE Prophylactic placement of a mesh has been suggested to prevent parastomal hernia. Evidence to support this practice is contradictory. OBJECTIVE To determine whether funnel-shaped permanent synthetic parastomal mesh is effective and safe in parastomal hernia prevention. DESIGN, SETTING, AND PARTICIPANTS The Chimney Trial was a randomized single-blinded multicenter trial conducted in 4 hospitals in Finland and 1 in Sweden from February 2019 and September 2021. Of 439 patients with rectal adenocarcinoma undergoing either laparoscopic or robotic-assisted abdominoperineal resection or the Hartmann procedure, 143 were enrolled in the trial, 135 received their allocated intervention, and 121 were analyzed at 12-month follow-up. Data were analyzed from December 2023 to May 2024. INTERVENTION In the intervention group, a permanent colostomy was created with a funnel-shaped intraperitoneal mesh and compared to a control group with a stoma without the mesh. MAIN OUTCOME AND MEASURE The primary end point was the incidence of computed tomography (CT)–confirmed parastomal hernia 12 months after surgery. RESULTS There were 68 patients (mean [SD] age, 68.7 [11.6] years; 36 [53% male and 32 [47%] female) who received the intended allocation in the mesh group and 67 (mean [SD] age, 66.4 [11.7] years; 48 [72%] male and 19 [28%] female) who received the intended allocation in the control group. CT scans were available for 58 patients in the mesh group and 59 patients in the control group at the 12-month follow-up. CT scans confirmed parastomal hernia in 6 of 58 patients (10%) in the mesh group compared to 22 of 59 patients (37%) in the control group (difference, 27%; 95% CI, 12-41; P < .001). Clinical parastomal hernia as a secondary outcome was recorded in 1 of 60 patients (2%) in the mesh group compared to 27 of 61 (43%) in the control group (difference, 41%; 95% CI, 29-55; P < .001). The number of patients with Clavien-Dindo class II ileus was 23 (35%) in the mesh group compared to 11 (17%) in the control group (difference, 18%; 95% CI, 3-32; P = .006). Only slight differences between the groups were detected in other stoma-related complications, readmissions, operative time, surgical site infections, reoperations, and quality of life. CONCLUSIONS AND RELEVANCE In this study, funnel-shaped parastomal mesh prevented a significant number of parastomal hernias without predisposing patients to mesh- or stoma-related complications during 12-month follow-up. The results of this study suggest the funnel-shaped mesh is a feasible option to prevent parastomal hernia.

Alkuperäiskielienglanti
LehtiJAMA surgery
Vuosikerta159
Numero11
Sivut1244-1250
Sivumäärä7
ISSN2168-6254
DOI - pysyväislinkit
TilaJulkaistu - marrask. 2024
OKM-julkaisutyyppiA1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä, vertaisarvioitu

Lisätietoja

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© 2024 American Medical Association. All rights reserved.

Tieteenalat

  • 3126 Kirurgia, anestesiologia, tehohoito, radiologia

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