Background: Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrants the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre RCT with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone Methods: P.E.L.I.O.N. is a multicentre, prospective, randomized, patient- and observer-blind trial. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomization into either abdominal wall closure with a continuous slowly absorbable suture in small stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ³ 1000 μm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. Primary endpoint will be the frequency of incisions hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas and enterocutaneous fistulas), postoperative pain, the number of revisions surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien Classification. Discussion: Depending on the results of the P.E.L.I.O.N. trial prophylactic mesh implantation could become the new standard for loop ileostomy reversal. Trial registration: DRKS00027921, U1111-1273-4657
Background Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre randomised-controlled trial (RCT) with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone. Methods P.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ≥ 1000 μm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1,014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. The primary endpoint will be the frequency of incision hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas, and enterocutaneous fistulas), postoperative pain, the number of revision surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien classification. Discussion Depending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal. Trial registration DRKS00027921, U1111-1273-4657
Ovarian-type mucinous tumours occur very rarely in the retroperitoneum. We present a case of primary retroperitoneal mucinous tumour of borderline malignancy in a 58-year-old woman, detected as an incidental finding. The patient presented with acute renal failure, investigation for which revealed a complex pelvic mass initially thought to be in the right adnexa and consistent with an ovarian neoplasm. Surgical findings revealed a 130-mm, right-sided non-communicating retroperitoneal pelvic mass, posterior to the appendix, which was completely resected. Both ovaries were normal. Macroscopically, it was a multiloculated cystic structure with a smooth external surface containing clear and mucinous fluid. Microscopic examination showed a mucinous tumour of borderline malignancy. The literature contains approximately nine other cases of primary mucinous retroperitoneal tumour of borderline malignancy. These cases have occurred in women aged 36-60 years. Most patients were asymptomatic and the mass was detected as an incidental finding. The patients have been followed up for up to 6 to 18 months and, to date, none have recurred. There are limitations to pre-operative radiological imaging. A definitive diagnosis can only be made after complete surgical excision and histological examination, having excluded retroperitoneal involvement by mucinous tumours from sites such the ovaries, bowel, appendix and pancreas.
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