anastomosis reconnection between intestine
Conditions
Interventions
In subjects who meet the inclusion/exclusion criteria the anastomosis will be
created using the ColonRing.
Sponsors
NiTi Surgical Solutions, Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is >= 18 years old. 2. BMI
Exclusion criteria
Exclusion criteria: 1. Subject has a known allergy to nickel. 2. Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis. 3. Subject has participated in another clinical study which may affect this study*s outcomes within the last 30 days. 4. Subject's ASA (American Society of Anesthesiology) score 4 or 5. 5. Subject has a concurrent or previous invasive pelvic malignancy. 6. Subject has a systemic or incapacitating disease. 7. Subject has extensive local disease in the pelvis. 8. Subject requires more than one anastomosis during the surgery. 9. Women who are known to be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is the rate of leaks. Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and * or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of other device related complications and other parameters during hospitalization and post procedure. The post operative parameters that will be measured during hospitalization period: 1. Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home 2. First day to first postoperative flatus 3. First day to first postoperative bowel movements 4. First day of first postoperative toleration of liquids and solids (time to *keeping them down*) Other device related complications during and post procedure - the following complications will be examined for relation to the device. 5. Intraoperative device failure (including cases of conversion to stapled or sutured anastomosis that are device related) 6. Bleeding 7. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Note - strictures are unlikely to occur within the study period 8. Septic complication (including wound infection, pelvic infection, peritonitis, abscess) 9. Readmission, re-operation, death within 30 days of the procedure. Note - a death will be considered related by physician discretion if it occurs as a result of peritonitis, colon obstruction or leak at the anastomosis site. 10. Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter) Length of time and ease of surgical procedure: The length of time and ease of the surgical procedure will be assessed by the performing surgeon. The length of time of the procedure will be defined as the time taken for creation of an anastomosis from the time of completion of two bowel ends to the beginning of the leak test. The ease of the surgical procedure as well as the extraction of the device will be | — |
Countries
Netherlands
Outcome results
None listed