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.
Study Type
OBSERVATIONAL
Enrollment
106
Monosyn will be used to perform the gastrointestinal anastomoses
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Philippine General Hospital
Manila, Philippines
GangNam Severance Hospital
Gangnam-Gu, Seoul, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Veterans General Hospital-Taipei
Taipei, Taiwan
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.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
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).
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Reoperation rate
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 €).
Time frame: 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
Time frame: End of the Study (approximately 18 months)
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