C.Surgical Procedure; Digestive SystemPROMEGATNCT02080702
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
An observational study of C.Surgical Procedure; Digestive System and Symptomatic Disorders of the Gastrointestinal Tract, run by Aesculap AG at 5 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site)
- What is being tested?
- Monosyn
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Aug 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
South Korea2 sites
GangNam Severance Hospital
Gangnam-Gu, Seoul, 135-72
Seoul National University Bundang Hospital
Gyeonggi-do, 463-707
About this study
Official title: 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.
- Conditions
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms
- Being tested
- Monosyn
- Keywords
- GIT, Monosyn, anastomoses leakage
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonosynDevice
Monosyn will be used to perform the gastrointestinal anastomoses
| Study group | Role | What they receive |
|---|---|---|
| Monosyn | Construction of a gastrointestinal anastomoses Receives: Device: Monosyn |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes (7)
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).
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Reoperation rate
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 €).
Measured: 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
Measured: End of the Study (approximately 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Planned recruitment of 630 patients was not possible to achieve within the given time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for C.Surgical Procedure; Digestive SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080702
- Sponsor's protocol ID
- AAG-O-H-1209
- Acronym
- PROMEGAT
- Status last verified
- Jun 2018
- First submitted
- 5 Mar 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29946452
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.
- ClinicalTrials.gov ID
- NCT02080702
- Acronym / sponsor ID
- PROMEGAT / AAG-O-H-1209
- Conditions
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms
- Keywords
- GIT, Monosyn, anastomoses leakage
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Planned recruitment of 630 patients was not possible to achieve within the given time frame
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monosyn | – | Device: MonosynConstruction of a gastrointestinal anastomoses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Emergency surgery
- Peritonitis
- Patients undergoing an operation due to a tumour within the pancreas, rectum, esophagus
- Pregnant women and breast-feeding women
- Chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonosynMonosyn will be used to perform the gastrointestinal anastomoses | Device | Monosyn |
Primary outcome
Frequency of anastomosis leakage rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
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.
7 secondary outcomes
Postoperative complication rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Reoperation rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Stay in the intensive care unit
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Duration to perform the anastomosis
Time frame: intraoperatively
Cost
Time frame: duration of the intervention (approximately 18 months)
Handling of the device
Time frame: End of the Study (approximately 18 months)
Results and safety
The study was stopped early (reason given: Planned recruitment of 630 patients was not possible to achieve within the given time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Results publication: PubMed 29946452Baumann 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.
- Individual participant dataSharing planned: No
Related trials for C.Surgical Procedure; Digestive System
Recruiting
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
C.Surgical Procedure; Disruption of Wound, Suture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C.Surgical Procedure; Digestive System and Symptomatic Disorders of the Gastrointestinal Tract, run by Aesculap AG at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea, Malaysia, Philippines, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Planned recruitment of 630 patients was not possible to achieve within the given time frame). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of anastomosis leakage rate (time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.