The aim of this trial is to investigate the safety and efficacy of an adaptive anastomosis using the C-REX RectoAid Cath following elective anterior resection for sigmoid or proximal rectal cancer, or premalignant lesions not amenable tot endoscopic…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the anastomotic leak rate within 30 days after surgery
Secondary outcome
Secondary outcome measures are: anastomotic leak rate at 90 days and 1 year
postoperatively, intra- and postoperative complications, readmissions, the
intra-operative effectiveness and efficiency of the C-REX device, surgeon
satisfaction with the C-REX RectoAid Cath, time to evacuation of the
anastomotic ring, quality of life, cost-effectiveness, and stoma-free survival.
Background summary
Anastomotic leakage (AL) after colorectal surgery remains a significant
challenge in current day to day practice. Anastomotic leaks are associated with
increased morbidity and mortality, poorer oncological outcomes, a reduction in
quality of life and poses a significant socio-economic financial burden.
Despite advances in surgical procedures and improvements to surgical stapling
devices, AL rates for colorectal procedures still range from 3% up to 25%, with
higher rates for more distal anastomosis. Multiple risk factors such as male
gender, diabetes, smoking, low preoperative haemoglobin levels, epidural
analgesia, neo-adjuvant radiotherapy and technical aspects related to the
formation of the anastomosis have been identified.
The routine method for construction of the anastomosis after an anterior
resection (AR) is a cross stapled circular anastomosis. The inflammatory immune
response in combination with a collagenase activating foreign body reaction to
the staplers delays gastrointestinal wound healing and increases the risk of
AL. Furthermore, the crossing of staples lines is a known risk factor for AL,
particularly for a circular and linear stapler line that create *dog ears*.
An adaptive anastomotic technique using a compression device eliminates foreign
body material in the anastomosis reducing the negative effects on wound healing
and could therefore potentially lower the incidence of AL. The compression
anastomotic device also avoids cross stapling and the formation of *dog ears*.
A novel adaptive compression anastomosis device, the C-REX RectoAid Cath has
been shown to be feasible and safe for anastomosis after colorectal resections
in small single institution cohorts. A multicentre trial is needed to assess
the true efficacy of the C-REX RectoAid Cath in a larger cohort of patients
undergoing AR for colorectal cancer or premalignant lesions.
Study objective
The aim of this trial is to investigate the safety and efficacy of an adaptive
anastomosis using the C-REX RectoAid Cath following elective anterior resection
for sigmoid or proximal rectal cancer, or premalignant lesions not amenable tot
endoscopic resection.
Study design
The ADAPT trial is a prospective, non-randomised, multicentre clinical
effectiveness trial.
Study burden and risks
Patients will receive standard post-operative follow-up according to local
protocol after elective AR. Additionally, patients are asked to fill in
questionnaires pre-operative, 90 days and 1 year after the operation to assess
functional outcomes/quality of life and to perform a health economic analysis.
Some of these questionnaires are already standard practice for many of the
participating sites. Furthermore, the use of the adaptive anastomosis
technique, requiring the patient to expell the anastomotic ring with the feces
and participation in medical research can be experienced as a burden by the
participant.
Different to standard AR with cross stapling anastomosis will be that patients
need to expel the anastomotic ring after approximately 10 days. When the
anastomotic ring is not be expelled within 14 days after surgery, the ring will
be removed manually. According to the guideline synopsis of non-metastatic
colorectal cancer, a routine CT-scan and endoscopy at one year will be
performed for follow-up and will allow for assessment of long-term anastomotic
integrity and patency.
The expected benefit to patients will be a lower anastomotic leak rate compared
to the standard treatment.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1. Male or female age >= 18 years old.
2. Biopsy proven cancer of the sigmoid colon or proximal rectum (cT1-4aN0-2M0)
that require AR as the procedure of choice.
3. premalignant lesions not amenable to endoscopic resection, that require AR
as the procedure of choice.
4. Suitable for curative AR
5. Suitable for elective laparoscopic or robotic surgery
6. 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
1. Pre-existing health conditions requiring emergency surgery, such as
intestinal obstruction or perforation, local or systemic infections,
peritonitis, or intestinal ischemia.
2. Cancer with distant metastases (TNM Stage IV).
3. Intestinal or anal stenosis or other obstructions distal to the planned
anastomosis.
4. Prior pelvic radiation including neoadjuvant chemoradiotherapy.
5. Contraindications to general anaesthesia.
6. Need for defunctioning ileostomy (intention to treat).
7. Patients who have a contra-indication for or are unable to receive
preoperative bowel preparation or at least two enemas prior to surgery.
8. Immunocompromised patients e.g. taking steroids or receiving immunotherapy.
9. 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88846.018.25 |