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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
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.
UZA Antwerp
Antwerp, Belgium
Hopital Saint-Antoine
Paris, France
Ihu Strasbourg
Strasbourg, France
Rate of adverse events
occurence of intraoperative and postoperative complications
Time frame: up to 3 months
device introduction success rate
Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon
Time frame: During surgery
Device placement success rate
Measured by number of successful placement divided by overall placement number
Time frame: During surgery
Colovac procedure time
Procedure duration measured in minutes
Time frame: During surgery
Migration rate of the Colovac device
defined by the number of devices migrated over the anastomosis divided by the number of devices placed
Time frame: During surgical procedure and up to 15 days after placement
Device retrieval success rate
Retrieval success rate measured by number of successful retrieval without complication divided by overall number of retrieval performed
Time frame: At 14 days after device placement
rate of digestive disorders
Measured as number of patients presenting digestive disorders divided by overall number of patients
Time frame: up to 15 days after surgery
level of patient comfort measured using NIH's PROMIS health measurement questionnaires
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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)
Time frame: up to 15 days after surgery
occurence of anastomosis leakage
measured as mean number of anastomosis leakage episodes per patient
Time frame: up to 3 months after initial surgery
occurrence of anastomosis fistula
measured as mean number of anastomosis fisutal episodes per patient
Time frame: up to 3 months after initial surgery
occurrence of anastomotic abcesses
measured as mean number of anastomosis abcess episodes per patient
Time frame: up to 3 months after initial surgery