Not provided
Not provided
Not provided
Not provided
Not provided
Planned recruitment of 630 patients was not possible to achieve within the given time frame
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.
Postoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints.
The question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monosyn | Construction of a gastrointestinal anastomoses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monosyn | Device | Monosyn will be used to perform the gastrointestinal anastomoses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of anastomosis leakage rate | Anastomotic leak is defined as radiographic demonstration of a fistula or non-absorbable material drainage from a wound after oral administration, or visible disruption of the suture line during re-exploration. | participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complication rate | As postoperative complications the following parameter will be documented: peritonitis, wound infection, bleeding, abscess, fistula, perforation, obstipation and stenosis. Wound infections, peritonitis and abscess are defined according to the Centres for Disease Control and Prevention (CDC, 17). | participants will be followed for the duration of hospital stay, an expected average of 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
adult patients
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia | |||
| Philippine General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29946452 | Result | Baumann P, Kim J, Ahn SH, Kim HH, Chong HY, Wente MN. Mid-term absorbable monofilament is safe and effective for gastrointestinal anastomosis - PROMEGAT - A single-arm prospective observational study. Ann Med Surg (Lond). 2018 Apr 6;30:1-6. doi: 10.1016/j.amsu.2018.04.003. eCollection 2018 Jun. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Reoperation rate | participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Length of hospital stay | Duration from day of operation until the day of discharge from the hospital. | participants will be followed for the duration of hospital stay, an expected average of 10 days |
| Stay in the intensive care unit | Duration from the first day in the ICU until the last day in the ICU. In the case of readmission to the ICU the sum of all days within the ICU. | participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Duration to perform the anastomosis | The time recorded for the construction of the anastomosis begins with the placement of the first stitch and ends with cutting the excess material from the last stitch. | intraoperatively |
| Cost | Calculation of the cost of material is based on the actual hospital costs for the suture material and the number of used threads by the surgeon. For the calculation of the operation costs, the time to perform the anastomosis will be multiplied with the cost of one operation minute (50-100 €). | duration of the intervention (approximately 18 months) |
| Handling of the device | Intra-operative handling of the suture material will be reported on a separate document one time per participating surgeon at the end of the study. The following criteria will be assessed: knot security, knot pull tensile strength, knot run-down, tissue drag, elasticity and feeling of the suture material. For the rating a 5-point scale is used | End of the Study (approximately 18 months) |
| Manila |
| Philippines |
| GangNam Severance Hospital | Gangnam-Gu, Seoul | 135-72 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 463-707 | South Korea |
| Veterans General Hospital-Taipei | Taipei | 112 Beitou District | Taiwan |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided