التفاصيل البيبلوغرافية
| العنوان: |
Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial). |
| المؤلفون: |
Mäkäräinen, Elisa J, Wiik, Heikki T, Kössi, Jyrki A O, Pinta, Tarja M, Mäntymäki, Leena-Mari J, Mattila, Anne K, Nikki, Marko J, Järvinen, Jyri E, Ohtonen, Pasi P, Rautio, Tero T |
| المصدر: |
British Journal of Surgery; Jan2024, Vol. 111 Issue 1, p1-5, 5p |
| مصطلحات موضوعية: |
ILEOSTOMY, HERNIA, HAZARDOUS waste sites, SURGICAL site, RECTAL cancer, ONCOLOGIC surgery |
| مستخلص: |
Background: The rate of incisional hernia after closure of a temporary loop ileostomy is significant. Synthetic meshes are still commonly avoided in contaminated wounds. The Preloop trial was a multicentre RCT designed to evaluate the benefits of synthetic mesh in incisional hernia prevention, and its safety for use in a contaminated surgical site compared with biological mesh. Methods: Study patients who underwent closure of a loop ileostomy after anterior resection for rectal cancer were assigned to receive either retrorectus synthetic or biological mesh to prevent incisional hernia. The primary outcomes were surgical-site infections within 30 days, and clinical or radiological incisional hernia incidence at 10 months. Secondary outcomes were reoperation rate, operating time, duration of hospital stay, other complications within 30 days of surgery, 5-year quality of life measured by RAND-36, and incisional hernia incidence within 5 years of follow-up. Results: Between November 2018 and September 2021, 102 patients were randomised, of whom 97 received the intended allocation. At 10-month follow-up, 90 patients had undergone clinical evaluation and 88 radiological evaluation. One patient in each group (2 per cent) had a clinical diagnosis of incisional hernia (P = 0.950) and one further patient in each group had a CT-confirmed incisional hernia (P = 0.949). The number of other complications, reoperation rate, operating time, and duration of hospital stay did not differ between the study groups. Conclusion: Synthetic mesh appeared comparable to biological mesh in efficacy and safety for incisional hernia prevention at the time of loop ileostomy closure. Registration number: NCT03445936 (http://www.clinicaltrials.gov). Preloop was a prospective, randomized, controlled, multicentre feasibility trial to show that synthetic mesh is non-inferior in incisional hernia prevention, safe for use in a contaminated surgical site, and a comparable alternative to biological mesh. One patient in each study group (2 per cent) had clinical suspicion of incisional hernia (P = 0.950). Two other patients, one in each group, had a CT-confirmed incisional hernia (P = 0.949). Synthetic mesh is equally effective and safe for incisional hernia prevention at contaminated surgical sites, and is comparable to biological mesh. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
