An observational study in Rectal Cancer, Sigmoid Cancer and Premalignant Lesion, sponsored by Amsterdam UMC, location VUmc. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Amsterdam UMC, location VUmc · Observational
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.
Detailed description of device and surgical procedure:
During the surgical procedure, the colorectal anastomosis will be created using the C-REX RectoAid Cath (Carpo Novum AB, Halmstad, Sweden). The C-REX devices are CE-marked and used in its intended purpose in this trial. The C-REX RectoAid Cath is a refined anastomotic device that facilitates the construction of an inverted serosa-to-serosa adaptive colorectal anastomosis where the bowel ends are held together by snap-locking a proximal and distal silicone anastomotic ring. The C-REX devices can be used in both open and minimally invasive procedures. The proximal limit for C-REX RectoAid Cath is 25 cm above the anal verge and the distal limit is formed by the anal ring.
The anterior resection using the C-REX RectoAid Cath is performed by experienced colorectal surgeons who received training to use the C-REX device from an experienced Clinical Field Trainer from Carpo Novum AB. After bowel resection and measuring of the lumen using the C-REX Test Device, the proximal ring is placed using the C-REX LapAid. This device ensures that the colonic wall is folded around the anastomotic ring. Once this colonic ring is in position, the anvil is connected whereby catheters are placed into the colonic lumen. Subsequently, the C-REX RectoAid can be inserted transanal. In similarity to ordinary stapler devices, a concealed trocar becomes visible by rotating the knob on the base of the handle of the C-REX RectoAid. When possible, the stapler line of the transected proximal rectal stump is invaginated into the distal anastomotic C-REX ring and thus removed at firing of the RectoAid instrument. The trocar and proximal anvil are connected and by turning the knob clockwise, the gap between the anvil and the head of the instrument is closed. After firing the device, the two anastomotic rings are connected and the anastomosis is created. The four integrated catheters will be extracted simultaneous with the RectoAid instrument and can be used to measure the Anastomotic contact pressure (ACP) to validate the anastomosis. These catheters are in direct contact with the anastomotic healing site. When the anastomotic rings detach during the healing process by necrosis, after approximately 10 days, the anastomotic ring loosens from of the intestinal wall and is expelled with the feces.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 165 is close to the median of 161 across 498 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Adaptive anastomotis
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 days
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 days
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 year
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 days
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 days
Number of readmissions
Any unplanned readmission within 90 days after surgery will be registered. Data will be derived from the electronic patient dossier.
Time frame: 90 days
Economical evaluation
An economical evaluation of the adaptive anastomosis technique will be performed. To ensure a broad evaluation of costst both direct costs will be collected using the iMTA Medical Consumption Questionnaire (iMCQ) as well as indirect costs such as production losses using the iMTA Productivity Cost Questionnaire (iPCQ). A combination of these two questionnaires combined with data from the patient file such as hospital stay and complications to determine direct medical costs will ensure a complete economical evaluation.
Time frame: 1 year
LARS score for functional outcomes
Measured by the internationally validated Low Anterior Resection Syndrome (LARS) score questionnaire. The questionnaire is composed of 5 questions that centre on the symptoms experienced by patients; the sum of all the items varies from 0 to 42 points, for classification into 3 groups: non-LARS (0-20 points), minor LARS (21-29 points) and major LARS (30-42 points). Patients will fill in the questionnaires before surgery, 90 days after surgery and 1 year after surgery
Time frame: 1 year
Surgeon satisfaction
Satisfaction with the performance and usability of the C-REX device is measured using the following questions: Overall satisfaction: (Very unsatisfied/unsatisfied/neutral/satisfied/very satisfied) Satisfaction with method of creation proximal anvil: (Very unsatisfied/unsatisfied/neutral/satisfied/very satisfied) Satisfaction with ring connection 'Stapling': (Very unsatisfied/unsatisfied/neutral/satisfied/very satisfied)
Time frame: Intraoperative
NASA Task Load Index
Though not mandatory, all surgeons are asked to fill out the NASA Task Load Index after surgery. Hart and Staveland's NASA Task Load Index method assesses work load on seven (Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, Frustration) scales ranging from low (1) to high (20).
Time frame: Intraoperative
Serial CRP
Measured C-reactive protein (mg/l) in the early postoperative period (day 2-4).
Time frame: 2-4 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Oct 2026, 18 months after the start.
Of 213 non-industry observational studies under Rectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 18 months is below that.
Counting every sponsor, half of 228 studies reached it within 45 months; a quarter within 24 and three quarters within 116.
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Amsterdam UMC, location VUmc →