An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract

Study Overview
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Brief Summary
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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.

Official Title
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An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.

Conditions
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C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms

Intervention / Treatment
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* Device: Monosyn


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Monosyn<br>Construction of a gastrointestinal anastomoses | Device: Monosyn<br>* Monosyn will be used to perform the gastrointestinal anastomoses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIT, Monosyn, anastomoses leakage