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

Launched by CARPONOVUM AB · Jun 6, 2017

Keywords

ClinConnect Summary

OVERALL DESIGN The study is a prospective, multicenter, single arm study Possible study candidates are patients requiring resection of the left colon (descending colon and sigmoid) or the upper rectum (15cm above the anal rim) due to malign or benign disease. After physical examination, checking of inclusion/exclusion criteria, and after informed consent has been achieved, potential subjects will be enrolled in the study, and the investigational surgery will be performed during hospitalization. The devices, i.e. C-REX LapAid and C-REX DMH/DMHC (dual male handle/dual male catheter handle), i...

Gender

ALL

Eligibility criteria

• 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. -