Rectal CancerADAPTNCT07056374
Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions
An observational study of Rectal Cancer and Sigmoid Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Sigmoid Cancer, Premalignant Lesion
- What is being tested?
- C-REX RectoAid Cath
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Mar 2025to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Roel Hompes, MD, PhD, FASCRS(hon), +31 (0)20 566 3355, r.hompes@amsterdamumc.nl
Lodi Grosheide, MD, +31 (0)20 566 3355, l.grosheide@amsterdamumc.nl
About this study
Official title: Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesion: a Multicentre Non-randomised Clinical Effectiveness Trial )ADAPT
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Rectal Cancer, Sigmoid Cancer, Premalignant Lesion, Colorectal Cancer
- Being tested
- C-REX RectoAid Cath
- Keywords
- Anterior Resection, Adaptive anastomosis, Compression anastomosis, Anastomotic Leakage, Sigmoid resection, Partial Mesorectal Excision
- Medical subject headings
- Rectal Neoplasms, Sigmoid Neoplasms, Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-REX RectoAid CathDevice
Adaptive anastomotis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: C-REX RectoAid Cath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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).
Measured: Intraoperative
Serial CRP
Measured C-reactive protein (mg/l) in the early postoperative period (day 2-4).
Measured: 2-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start25 Mar 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Carponovum AB
- Responsible party
- Principal investigator, Roel Hompes, MD, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056374
- Sponsor's protocol ID
- NL88846.018.25
- Acronym
- ADAPT
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesion: a Multicentre Non-randomised Clinical Effectiveness Trial )ADAPT
- ClinicalTrials.gov ID
- NCT07056374
- Acronym / sponsor ID
- ADAPT / NL88846.018.25
- Conditions
- Rectal Cancer, Sigmoid Cancer, Premalignant Lesion, Colorectal Cancer
- Keywords
- Anterior Resection, Adaptive anastomosis, Compression anastomosis, Anastomotic Leakage, Sigmoid resection, Partial Mesorectal Excision
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Carponovum AB
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention C-REX RectoAid Cath | – | Device: C-REX RectoAid CathPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-REX RectoAid CathAdaptive anastomotis | Device | Intervention C-REX RectoAid Cath |
Primary outcome
Anastomotic leakage rate
Time frame: 30 days
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.
10 secondary outcomes
Anastomotic leakage rate
Time frame: 90 days
Anastomotic leakage rate
Time frame: 1 year
Postoperative complications
Time frame: 30 days
Days until evacuation of the anastomotic ring
Time frame: 14 days
Number of readmissions
Time frame: 90 days
Economical evaluation
Time frame: 1 year
LARS score for functional outcomes
Time frame: 1 year
Surgeon satisfaction
Time frame: Intraoperative
NASA Task Load Index
Time frame: Intraoperative
Serial CRP
Time frame: 2-4 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Sigmoid Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roel Hompes, MD, PhD, FASCRS(hon) (+31 (0)20 566 2714, r.hompes@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.