Adaptive compression anastomosis for anterior resection in sigmoid and upper rectal cancer or premalignant lesions
Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesion: a Multicentre Non-randomised Clinical Effectiveness Trial )ADAPT
This study will test a removable silicone compression ring (C-REX RectoAid Cath) to create the bowel connection during elective anterior resection for people with sigmoid or proximal rectal cancer or premalignant lesions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07056374 on ClinicalTrials.gov |
What this trial studies
This observational study uses the CE-marked C-REX RectoAid Cath, a silicone snap-lock compression ring system, to create inverted serosa-to-serosa colorectal anastomoses during elective anterior resection for sigmoid or proximal rectal cancer or premalignant lesions. Trained colorectal surgeons size the lumen with a C-REX Test Device, place the proximal ring laparoscopically or open, and insert the distal component transanally to snap the bowel ends together without permanent metal staples. The study will track anastomotic leakage, wound healing, and postoperative complications and compare observed outcomes with historical benchmarks. As a single-center observational protocol, procedures follow local surgical standards and device training provided by the manufacturer rather than randomization.
Who should consider this trial
Good fit: Adults with biopsy-proven sigmoid colon or proximal rectal cancer (cT1-4aN0-2M0) or premalignant lesions not amenable to endoscopic removal who are scheduled for elective laparoscopic or robotic anterior resection and can give informed consent.
Not a fit: Patients with distant metastases, prior pelvic radiation, distal obstructions or stenosis, emergency surgical indications, or contraindications to general anaesthesia are excluded and unlikely to benefit from this device-based approach.
Why it matters
Potential benefit: If successful, this adaptive compression approach could lower anastomotic leakage rates and speed healing by avoiding permanent staples and eliminating cross-stapling.
How similar studies have performed: Compression or removable-ring anastomosis concepts have been tried before with mixed results, and the C-REX device is a newer CE-marked design with limited published clinical data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Roel Hompes, MD, PhD, FASCRS(hon)
- Email: r.hompes@amsterdamumc.nl
- Phone: +31 (0)20 566 2714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.