Status:
TERMINATED
Clinical Study Verifying C-REX LapAid in Clinical Practice
Lead Sponsor:
Carponovum AB
Collaborating Sponsors:
Fudan University
Conditions:
Cancer Colonic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Male or female age ≥18 years and ≤80 years.
- 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).
- Cognitive ability to take part in the study and understand the information he/she receives about participating in the study.
- The patient has signed a written informed consent.
Exclusion
- Urgent medical condition requiring immediate care.
- Current surgical conditions, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, intestinal ischemia or severe dissemination (metastases) of cancer.
- Stenosis or other obstructions in the anal passage.
- Previous major abdominal surgery, previous radiation therapy to organs in abdomen or pelvis.
- Health condition classified as ASA III - VI .
- Albumin level less than 35 g/l.
- Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease).
- Disease that requires more than one anastomosis during the surgical procedure.
- Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery.
- Contraindications to general anaesthesia.
- Perioperative detection of extreme variants of intestinal diameters or wall thickness.
- 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.
- BMI \> 35.
- Myocardial infarct ≤ 6 months or sever heart disease.
- Severe embolic disease.
- Other conditions which surgeons think the patient should be excluded.
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03404934
Start Date
January 3 2018
End Date
May 10 2019
Last Update
April 30 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 2000032