Clinical trial NCT02080702: An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
Official title: An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: C.Surgical Procedure; Digestive System
Symptomatic Disorders of the Gastrointestinal Tract
Gastric Anastomosis (Site)
Gastrointestinal Neoplasms
Keywords: GIT, Monosyn, anastomoses leakage
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2014-03-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of anastomosis leakage rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes:
measure: Postoperative complication rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Reoperation rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Stay in the intensive care unit
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Duration to perform the anastomosis
timeFrame: intraoperatively
measure: Cost
timeFrame: duration of the intervention (approximately 18 months)
measure: Handling of the device
timeFrame: End of the Study (approximately 18 months)
Other outcomes:
Locations:
city: Gangnam-Gu, Seoul
country: Korea, Republic of
facility: GangNam Severance Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Taipei City
country: Taiwan
facility: Veterans General Hospital-Taipei
Study officials:
References:
citation: 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.