Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
C-REX RectoAid Cath
DeviceAdaptive anastomotis
Treatment groups
165 Participants
are divided into 1 treatment groupGroup A: Intervention C-REX RectoAid Cath1 intervention
Trial outcomes
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.
Time frame
30 daysSecondary outcomes
1
Anastomotic leakage rate
Clinical anastomotic leakage 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, within 90 days after surgery. 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.
Time frame
90 days2
Anastomotic leakage rate
Clinical anastomotic leakage 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, within 1 year after surgery. 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.
Time frame
1 year3
Postoperative complications
Postoperative complications will be classified according to the Clavien-Dindo scale. The Clavien Dindo Classification is used to rank the severity of a surgical complication. It is based on the type of therapy needed to correct the complication. The scale consists of several grades (Grade I, II, IIIa, IIIb, IVa, IVb and V). A grade I complication is any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions whilst a Grade IV complication is a life-threatening complication requiring ICU-management.
Time frame
30 days4
Days until evacuation of the anastomotic ring
An anastomotic ring remains at the site of the anastomosis for approximately 10 days. The ring detaches via necrosis on the inner part of the intestinal surface and is evacuated with the feces. When the patient has not evacuated the ring after 14 days, the ring will be manually removed.
Time frame
14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
Carponovum AB
Collaborator
Source ClinicalTrials.gov