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

Terminated

• Conditions: Gastric Anastomosis (Site); C.Surgical Procedure; Digestive System; Gastrointestinal Neoplasms; Symptomatic Disorders of the Gastrointestinal Tract
• Interventions: Device: Monosyn

• Registration Number: NCT02080702
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Study Start: 2014-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monosyn	Monosyn	Construction of a gastrointestinal anastomoses

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Reoperation rate	participants will be followed for the duration of hospital stay, an expected average of 7 days
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.
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.
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 €).
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).
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.
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

Trial Locations

Locations (5)

Veterans General Hospital-Taipei; 🇨🇳 Taipei City, Taiwan

Philippine General Hospital; 🇵🇭 Manila, Philippines

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

GangNam Severance Hospital; 🇰🇷 Gangnam-Gu, Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of