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

NCT07056374 | Recruiting

• 1 other identifier: NL88846.018.25
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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 related patient experience, postoperative morbidity and readmissions, C-reactive protein (CRP) profile in the early postoperative period, functional outcomes, cost-effectiveness and surgical quality. Population: A total of 165 patients (age ≥ 18 years) with histologically proven cT1-4aN0-2M0 cancer of the sigmoid colon or proximal rectum, or premalignant lesions not amenable to endoscopic resection, that require elective AR will be enrolled throughout 10 European colorectal centers. Study procedures: The anastomosis will be created using the C-REX RectoAid Cath. The healing period will be approximately 10 days. The anastomotic ring detaches via necrosis and is evacuated with the feces. Patients will be asked to fill out questionnaires regarding Low Anterior Resection Syndrome (LARS) and use of healthcare and these will be gathered preoperatively, 90 days postoperative and 1 year after surgery. At 12 months a CT-scan and colonoscopy will be performed.

Conditions

Rectal Cancer; Sigmoid Cancer; Premalignant Lesion; Colorectal Cancer

Keywords

Anterior Resection; Adaptive anastomosis; Compression anastomosis; Anastomotic Leakage; Sigmoid resection; Partial Mesorectal Excision

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage rate

  The primary endpoint of clinical anastomotic leakage (AL) is defined, according to the International Study Group definition, as a confirmed defect of the intestinal wall at the ananstomotic site leading to a communication between the intra- and extraluminal compartments. Diagnosis of AL is made by either CT scan, flexible endoscopy or found at time of a reoperation. An abscess or collection of fluid in close proximity to the anastomosis will be deemed as an AL.

  30 days

Secondary Outcomes (10)

• Anastomotic leakage rate

  90 days

• Anastomotic leakage rate

  1 year

• Postoperative complications

  30 days

• Days until evacuation of the anastomotic ring

  14 days

• Number of readmissions

  90 days

Study Arms (1)

Intervention C-REX RectoAid Cath

Patients with cancer of the sigmoid colon or proximal rectum, or premalignant lesions not amenable to endoscopic resection, that require elective anterior resection as the procedure of choice. The anastomosis will be created using an adaptive anastomosis technique using the C-REX RectoAid Cath.

Device: C-REX RectoAid Cath

Interventions

C-REX RectoAid Cath DEVICE

Adaptive anastomotis

Intervention C-REX RectoAid Cath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

165 Patients (age ≥ 18 years) with histologically proven cT1-4aN0-2M0 cancer of the sigmoid colon or proximal rectum, or with premalignant lesions not amenable to endoscopic resection, that require AR as the procedure of choice

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Carponovum AB: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Sigmoid Neoplasms; Colorectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Neoplasms; Colonic Diseases; Sigmoid Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roel Hompes, MD, PhD, FASCRS(hon)

CONTACT

+31 (0)20 566 2714; r.hompes@amsterdamumc.nl

Lodi Grosheide, MD

CONTACT

+31 (0)20 566 2714; l.grosheide@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: July 9, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

NL (1)