ArticleMedicine2020
Pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic extralevator abdominoperineal excision: A multi-center, prospective single-arm cohort study (IDEAL Phase 2A).
Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04177407 (Pelvic Peritoneum Reconstruction Using the Bladder Peritoneum Flap in Laparoscopic Extralevator Abdominoperineal Excision --- A Multi-center, Prospective Single-Arm Cohort Study), which is not on this map. Cited by 1 paper.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pelvic Peritoneum Reconstruction Using the Bladder Peritoneum Flap in Laparoscopic Extralevator Abdominoperineal Excision --- A Multi-center, Prospective Single-Arm Cohort Study (IDEAL Phase 2A)
Who cites it
1 citing paper in PubMed, 2 citations in OpenAlex.
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionExtralevator abdominoperineal excision (ELAPE) may cause various surgical complications including disruption of perineal wound, perineal hernia and adhesive small-bowel obstruction. Pelvic peritoneum reconstruction (PPR) could prevent those complications, but it may not always be achievable, especially in patients with severe pelvic fibrosis after neoadjuvant radiotherapy. Our previous study has reported the application of the PPR using the bladder peritoneum flap in laparoscopic ELAPE. The aim of the study is to evaluate the short-term clinical, technical and safety outcomes of PPR using the bladder peritoneum flap in laparoscopic ELAPE. METHODS AND ANALYSIS: This is a multi-center prospective single-arm cohort study and fulfill the IDEAL 2A stage principle. Rectal cancer patients undergoing laparoscopic ELAPE, suffering rigid pelvis or huge perineal peritoneum defect, and having difficulty in primary perineal wound closure will be considered eligible. Main exclusion criteria are being complicated with urgent complications, ASA grade >3 and accompanied with mental illness. After informed consent, 30 patients are planned to be included in the study. Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to be performed. The surgical safety is to be evaluated after one-year follow-up. Primary endpoints are the occurrence of intraoperative and postoperative complications of PPR using the bladder peritoneum flap. Second endpoints are overall complication rate within 30 days after surgery, extent of small intestine falling down to pelvic cavity, and other follow-up consequences within 1 year after surgery. ETHICS AND DISSEMINATION: This experiment was approved by the Biomedical Ethics Committee of West China Hospital of Sichuan University.
trial registrationNCT04177407.
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