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

Gastrointestinal Neoplasms Clinical Trial

— PROMEGAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02080702
• Other study ID #: AAG-O-H-1209
• Status: Terminated
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2018
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Monosyn
Monosyn will be used to perform the gastrointestinal anastomoses

Locations

Country	Name	City	State
Korea, Republic of	GangNam Severance Hospital	Gangnam-Gu, Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Philippines	Philippine General Hospital	Manila
Taiwan	Veterans General Hospital-Taipei	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Countries where clinical trial is conducted

Korea, Republic of,  Malaysia,  Philippines,  Taiwan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Reoperation rate		participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)