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Study identifier: NCT07056374 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Rectal Cancer · Sigmoid Cancer · Premalignant Lesion  ·  Sponsor: Amsterdam UMC, location VUmc

PhaseN/A
Planned participants165
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 adaptive anastomotic technique eliminates cross-stapling and permanent foreign body material in the anastomosis reducing the negative effects on wound healing potentially lowering the incidence of AL. Design: This is a prospective, international, non-randomized, multicentre study. Endpoints: The Primary objective of this trial is to assess the incidence of AL within 30 days after surgery. Secondary objectives are to assess anastomotic integrity at 90 days and 1 year, intraoperative efficacy and efficiency of the C-REX device, time to evacuation of the anastomotic ring, mode of evacuation and re…

This description comes directly from the study's public registry record.

Talk to the study team

Roel Hompes, MD, PhD, FASCRS(hon)  ·  +31 (0)20 566 2714  ·  r.hompes@amsterdamumc.nl

Lodi Grosheide, MD  ·  +31 (0)20 566 2714  ·  l.grosheide@amsterdamumc.nl

Always discuss trial participation with your own doctor first.

Locations (1)

Amsterdam UMCAmsterdam, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT07056374