Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059217) titled 'A Prospective Study on the Safety and Efficacy of End-to End Delta-Shaped Anastomosis in Crohn's Disease Patients Undergoing Intestinal Resection' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine,

Condition: Condition - Crohn's disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In patients undergoing intestinal resection for Crohn's disease, this study aims to establish an "easy, safe, and universally applicable anastomotic technique" by adopting a stapled end-to-end delta shaped anastomosis. Specifically, the objective is to clarify the incidence of anastomotic leakage, the rate of endoscopic recurrence at the anastomotic site, and the reoperation rate associated with this simple and technically less operator-dependent procedure. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Delta shaped anastomosis

Eligibility: Age-lower limit - 16 years-old

Gender - Male and Female Key inclusion criteria - Patients aged 16 years or older at the time of informed consent Performance Status (ECOG) of 0-2 Patients diagnosed with Croh's disease who are scheduled to undergo intestinal resection and anastomosis, regardless of the number of prior surgeries, surgical approach (open/laparoscopic), or disease phenotype (stricturing/penetrating) Patients not scheduled for proximal stoma construction at the anastomotic site Patients who have provided written informed consent to participate in this study Key exclusion criteria - Malignant disease Patients in whom a discrepancy of more than twofold in bowel lumen diameter Patients in whom intraoperative findings indicated that bowel anastomosis was inappropriate or a proximal stoma was deemed necessary Emergency surgery for bleeding, perforation, or other acute conditions Malnutrition due to prolonged fasting Pregnant or lactating women, or women who are pregnant or intend to become pregnant Patients judged by the principal or sub-investigator to be inappropriate for inclusion in this study Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 01 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2033 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067723

Disclaimer: Curated by HT Syndication.