C.Surgical Procedure; Digestive System, Gastric Anastomosis (Site), Gastrointestinal Neoplasms, Symptomatic Disorders of the Gastrointestinal Tract
Conditions
Keywords
GIT, Monosyn, anastomoses leakage
Brief summary
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.
Interventions
DEVICEMonosyn
Monosyn will be used to perform the gastrointestinal anastomoses
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * ASA I-III * Indication for an elective tumor surgery within the GI tract (stomach, small intestine, large intestine) * Written informed consent
Exclusion criteria
* Emergency surgery * Peritonitis * Patients undergoing an operation due to a tumour within the pancreas, rectum, esophagus * Pregnant women and breast-feeding women * Chemotherapy * Current immunosuppressive therapy * Radiotherapy on the treated region within the last 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of anastomosis leakage rate | participants will be followed for the duration of hospital stay, an expected average of 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | participants will be followed for the duration of hospital stay, an expected average of 7 days | — |
| Length of hospital stay | participants will be followed for the duration of hospital stay, an expected average of 10 days | Duration from day of operation until the day of discharge from the hospital. |
| Stay in the intensive care unit | participants will be followed for the duration of hospital stay, an expected average of 7 days | 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. |
| Postoperative complication rate | participants will be followed for the duration of hospital stay, an expected average of 7 days | 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). |
| Cost | duration of the intervention (approximately 18 months) | 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 €). |
| Handling of the device | End of the Study (approximately 18 months) | 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 |
| Duration to perform the anastomosis | intraoperatively | 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. |
Countries
Malaysia, Philippines, South Korea, Taiwan
Outcome results
None listed