Gastrointestinal Anastomotic Complication
Conditions
Keywords
anastomotic leakage, fistula
Brief summary
The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
Interventions
DEVICECOLOVAC
The intervention consists in the placement of the Colovac device, during the colorectal surgery, Once the colorectal anastomosis has been completed as per standard care and the water-thightness of the anastomosis has been verified.
Sponsors
Safeheal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must be \>= 18 and \<= 65 years old 2. Indicated for colorectal resection 3. Patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy 4. Willing to comply with protocol-specified follow-up evaluations 5. Signed Informed Consent
Exclusion criteria
1. Patient with inflammatory bowel disease 2. Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating) 3. Known allergy to nickel or other components of the Colovac kit 4. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including: 1. immunodeficiency 2. steroid therapy 3. infections at the time of intervention 4. major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study 5. diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis 6. preexisting sphincter problems or evidence of extensive local disease in the pelvis 7. blood loss (\> 500 cc) 8. non amended peroperative anastomosis failure 9. intra-operative adverse events 10. malnourishment 11. obesity (BMI \> 35) 12. history of excessive smoking and alcohol use 5. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study 6. Patient unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | up to 3 months | occurence of intraoperative and postoperative complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colovac procedure time | During surgery | Procedure duration measured in minutes |
| occurence of anastomosis leakage | up to 3 months after initial surgery | measured as mean number of anastomosis leakage episodes per patient |
| Migration rate of the Colovac device | During surgical procedure and up to 15 days after placement | defined by the number of devices migrated over the anastomosis divided by the number of devices placed |
| Device retrieval success rate | At 14 days after device placement | Retrieval success rate measured by number of successful retrieval without complication divided by overall number of retrieval performed |
| Device placement success rate | During surgery | Measured by number of successful placement divided by overall placement number |
| level of patient comfort measured using NIH's PROMIS health measurement questionnaires | up to 15 days after surgery | measures using health measurement questionnaires to assess parameters like pain (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no incontinence - 10 : uncontrollable incontinence), diarrhea (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no diarrhea - 10 : more than 3 episodes of diarrhea per day) |
| device introduction success rate | During surgery | Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon |
| occurrence of anastomosis fistula | up to 3 months after initial surgery | measured as mean number of anastomosis fisutal episodes per patient |
| occurrence of anastomotic abcesses | up to 3 months after initial surgery | measured as mean number of anastomosis abcess episodes per patient |
| rate of digestive disorders | up to 15 days after surgery | Measured as number of patients presenting digestive disorders divided by overall number of patients |
Countries
Belgium, France
Outcome results
None listed