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

Aesculap

Status: Terminated

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

Treatments: Device: Monosyn

Study type: Observational

Funder types: Industry

Identifiers

NCT02080702

AAG-O-H-1209

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

106 participants in 1 patient group

Monosyn

Description:

Construction of a gastrointestinal anastomoses

Treatment:

Device: Monosyn