NCT02080702

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
4 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

March 5, 2014

Last Update Submit

June 29, 2018

Conditions

C.Surgical Procedure; Digestive SystemSymptomatic Disorders of the Gastrointestinal TractGastric Anastomosis (Site)Gastrointestinal Neoplasms

Keywords

GIT, Monosyn, anastomoses leakage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Postoperative complication rate

    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

    participants will be followed for the duration of hospital stay, an expected average of 10 days

  • Stay in the intensive care unit

    participants will be followed for the duration of hospital stay, an expected average of 7 days

  • Duration to perform the anastomosis

    intraoperatively

  • +2 more secondary outcomes

Study Arms (1)

Monosyn

Construction of a gastrointestinal anastomoses

Device: Monosyn

Interventions

MonosynDEVICE

Monosyn will be used to perform the gastrointestinal anastomoses

Monosyn

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Philippine General Hospital

Manila, Philippines

Location

GangNam Severance Hospital

Gangnam-Gu, Seoul, 135-72, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

Location

Veterans General Hospital-Taipei

Taipei, 112 Beitou District, Taiwan

Location

Related 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.amsu.2018.04.003. eCollection 2018 Jun.

    PMID: 29946452RESULT

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 6, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 2, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)TW(1)PH(1)KR(2)