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

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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu, Seoul, Korea, Republic of, 135-72
    • Gangnam Severance Hospital
  • Gyeonggi-do, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
• Philippines
  • Manila, Philippines
    • Philippine General Hospital
• Taiwan
  • Taipei City, Taiwan, 112 Beitou District
    • Veterans General Hospital-Taipei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Monosyn; Construction of a gastrointestinal anastomoses	Device: Monosyn; Monosyn will be used to perform the gastrointestinal anastomoses

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA

Publications and helpful links

General Publications

• Baumann P, Kim J, Ahn SH, Kim HH, Chong HY, Wente MN. Mid-term absorbable monofilament is safe and effective for gastrointestinal anastomosis - PROMEGAT - A single-arm prospective observational study. Ann Med Surg (Lond). 2018 Apr 6;30:1-6. doi: 10.1016/j.amsu.2018.04.003. eCollection 2018 Jun.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (ESTIMATE): March 6, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: GIT, Monosyn, anastomoses leakage
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: AAG-O-H-1209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO