Adaptive compression anastomosis for anterior resection in sigmoid and upper rectal cancer or premalignant lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Quality of life after colorectal cancer treatment

  This project will test whether late side effects at 6, 12, and 24 months affect quality of life in people aged 25–65 who completed initial treatment for colorectal cancer at the Institute of Oncology Ljubljana.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT07427901

• Botensilimab plus balstilimab followed by balstilimab for colorectal cancer with detectable ctDNA after surgery and chemotherapy

  This trial tests whether giving botensilimab with balstilimab, then continuing balstilimab alone, helps people with microsatellite-stable colorectal cancer or colorectal liver metastases who still have detectable ctDNA after surgery and chemotherapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07227636

• Fruquintinib plus FOLFIRI for second-line metastatic colorectal cancer

  This study will test whether adding fruquintinib to FOLFIRI helps people with metastatic colorectal cancer who progressed after first-line FOLFOX plus bevacizumab.

  Recruiting at 14 sites Phase 2 SCRI Development Innovations, LLC · Denver, Colorado and 13 other locations · NCT07011576

• Evaluating a new CAR T-cell therapy for solid tumors expressing EGFR

  This study is testing a new CAR T-cell therapy to see if it can safely help adults with certain solid tumors, like colorectal and lung cancer, that have specific markers.

  Recruiting at 10 sites Phase 1/2 A2 Biotherapeutics Inc. · Gilbert, Arizona and 9 other locations · NCT06682793

• Prehabilitation program for patients with rectal cancer

  This study is testing a prehabilitation program to see if it helps people with rectal cancer feel better before surgery compared to standard care.

  Recruiting at 2 sites Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT06565052

• Evaluating a new CAR T-cell therapy for solid tumors expressing MSLN

  This study is testing a new CAR T-cell therapy to see if it can safely treat adults with solid tumors like colorectal and lung cancer that express a specific protein.

  Recruiting at 12 sites Phase 1/2 A2 Biotherapeutics Inc. · Gilbert, Arizona and 11 other locations · NCT06051695

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.