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Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions

Recruitingn/aAges 18 Years - anyAllAmsterdam UMC, location VUmc
NCT07056374 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Anastomotic leakage (AL) after colorectal surgery remains a significant challenge, associated with increased morbidity, mortality, poor oncological outcomes, and reduced quality of life. Despite surgical advances, AL rates for colorectal procedures continue to range from 3% to 25%, especially in distal anastomoses. The commonly used cross-stapled circular anastomosis for anterior resections (AR) activates a foreign body response delaying gastrointestinal wound healing and potentially increasing the risk of AL. Additionally, crossed stapler lines further increase the risk of AL. An adaptive anastomosis technique eliminates permanent foreign body material, thereby reducing negative effects on wound healing and avoiding cross-stapling potentially lowering the incidence of AL. These areas have shown to have a lower burst pressure compared to a single stapled anastomosis. An ada

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📋 Eligibility rules (as published)
Inclusion Criteria: * Biopsy proven cancer of the sigmoid colon or proximal rectum (cT1-4aN0-2M0) that require AR as the procedure of choice or premalignant lesions not amenable to endoscopic resection, that require AR as the procedure of choice. * Suitable for curative AR * Suitable for elective laparoscopic or robotic surgery * Cognitive ability to take part in the study, to understand the information the patient receives about participating in the study, to provide informed consent and to agree to complete the questionnaires. Exclusion Criteria: * Pre-existing health conditions requiring emergency surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. * Cancer with distant metastases (TNM Stage IV). * Intestinal or anal stenosis or other obstructions distal to the planned anastomosis. * Prior pelvic radiation including neoadjuvant chemoradiotherapy. * Contraindications to general anaesthesia. * Need for defunctioning ileostomy (intention to treat). * Patients who have a contra-indication for or are unable to receive preoperative bowel preparation or at least two enemas prior to surgery. * Immunocompromised patients e.g. taking steroids or receiving immunotherapy. * Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection (e.g. diverticulitis) which may impair the use of C-REX RectoAid Cath
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What it tests

  • C-REX RectoAid Cath
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Where

1 site
Amsterdam UMC
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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