Clinical Trial Verifying C-REX LapAid and C-REX DMH/DMHC

In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further. The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP (C-reactive protein)-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts quality of life negatively. Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure (C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters). The novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful preclinical study encourages a clinical verification in patients undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking Procedure by use of C-REX LapAid and C-REX DMH/DMHC.

Sex

All

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

1. Male or female age ≥ 18 years and ≤ 70 years.
2. Planned resection due to benign or malign disease in the left colon (descending colon and sigmoid) or the upper rectum (15 cm above the anal rim).
3. Cognitive ability to take part in the study and understand the information he/she receives about participating in the study.
4. Sign the informed consent form.

Exclusion Criteria:

1. Urgent medical condition requiring immediate care.
2. Current surgical conditions, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, intestinal ischemia or dissemination (metastases) of cancer.
3. Stenosis or other obstructions in the anal passage.
4. Previous major abdominal surgery, previous radiation therapy to organs in abdomen or pelvis.
5. Health condition classified as ASA (American Society of Anesthesiologists) score III - VI.
6. Albumin level less than 35 g/l.
7. Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease).
8. Disease that requires more than one anastomosis during the surgical procedure.
9. Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery.
10. Contraindications to general anesthesia.
11. Perioperative detection of extreme variants of intestinal diameters or wall thickness.
12. Cognitive ability that limits the patient's ability to take part in the study and understand the information he/she received about participating in the study, or the patient does not agree to join the study.
13. BMI \> 35.
14. Heart attack ≤ 6 months or sever heart disease.
15. Severe embolic disease.
16. Other conditions which surgeons think the patient should be excluded. -