Colorectal Surgery
Conditions
Keywords
Colon Anastomosis, Rectum Anastomosis, Intestine, Colorectal Surgery, Colorectal Anastomosis
Brief summary
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
Detailed description
The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.
Interventions
DEVICEColonRing (Colorectal anastomosis)
Creation of a colorectal compression anastomosis
Sponsors
Atlanta Colon & Rectal Surgery, Atlanta, GA
FPMG Center for Colon & Rectal Surgery
Lester E. Cox Medical Centers
UCI Medical Center Irvine CA
Endeavor Health
St.Louis University hospital MO
University of Southern California
Bnai Zion Medical Center
Barmherzig Brueder
Catharina Ziekenhuis Eindhoven
Ziekenhuis Oost-Limburg
University Hospital, Gasthuisberg
Klinikum Neuperlach
novoGI
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years old. 2. BMI \< 34. 3. Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™. 4. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
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 | Description |
|---|---|---|
| To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month | Approx. 1 year | 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. |
| Device Related Leak Rate up to 30 Days Post op | 30 days post op | 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 | Description |
|---|---|---|
| Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure. | 30 days post op | 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) |
Countries
Austria, Belgium, Germany, Israel, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ColonRing TM ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis | 288 |
| Total | 288 |
Baseline characteristics
| Characteristic | ColonRing TM |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 111 Participants |
| Age, Categorical Between 18 and 65 years | 177 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 13.4 |
| Region of Enrollment Austria | 46 participants |
| Region of Enrollment Belgium | 83 participants |
| Region of Enrollment Germany | 9 participants |
| Region of Enrollment Israel | 13 participants |
| Region of Enrollment Netherlands | 10 participants |
| Region of Enrollment United States | 127 participants |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 279 |
| serious Total, serious adverse events | 26 / 279 |
Outcome results
Primary
Device Related Leak Rate up to 30 Days Post op
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.
Time frame: 30 days post op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ColonRing TM | Device Related Leak Rate up to 30 Days Post op | 4 participants |
Primary
To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month
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.
Time frame: Approx. 1 year
Secondary
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)
Time frame: 30 days post op