Gastrointestinal Stromal TumorsGASTROMONCT04811833
Gastrointestinal Anastomosis Using MonoPlus® Suture
An observational study of Gastrointestinal Stromal Tumors and Gastrointestinal Neoplasms, run by Aesculap AG at 2 sites in Spain.
Trial summary
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasm
- How many people
- 0 participants
- Where
- 2 sitesSpain
- Study dates
- Jul 2022to Dec 2023
- 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 undergoing an elective, primary surgery within the gastrointestinal tract with the need for ananastomosis.
Who may be able to join
- Adult patients undergoing an elective open or laparoscopic primary tumor resection within GI tract (stomach, small intestine, large intestine , colon and rectum.
- Age ≥ 18 years
- ASA ≤ III
- Written informed consent
Who cannot join
- ASA ≥IV
- Emergency operations
- Peritonitis
- Surgical interventions in the pancreas, oesophagus
- Patients with traumatic perforations
- Pregnant and/or breast-feeding women
- Patients who had received chemotherapy within the last 4 weeks or radiotherapy on the treated region within the last 2 weeks
- Patients who were receiving immunosuppressant therapy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Servicio de Cirugía General y Digestiva, Sección cirugía
Madrid, 28007
Hospital Parc Taulí Sabadell
Sabadell, Catalonia, 08208
About this study
Official title: Assessment of MonoPlus® Suture Material for Anastomosis in the Gastrointestinal Tract. A Prospective, Multi-centric, International, Single-arm, Observational Study in Daily Practice
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction.
This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
- Conditions
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasm, Stomach Tumor, Small Intestine Tumor, Colon Tumor
- Keywords
- tumor disease, stomach tumor, small intestine tumor, colon tumor, rectum tumor, need for anastomosis
- Medical subject headings
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monoplus® | Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of anastomosis leakage rate at different timepoints in postoperative course
The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery
Measured: until 6 months after surgery
Secondary outcomes (18)
Comparison of dehiscence rate of the suture line at different timepoints in postoperative course
Comparison of the dehiscence rate of the suture line at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery.
Comparison of the Peritonitis rate at different timepoints in postoperative course
Comparison of the Peritonitis rate of the suture line at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of the Surgical Site infection rate at different timepoints in postoperative course
Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC) at different postoperative examinations.
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of bleeding at different timepoints in postoperative course
Comparison of postoperative Bleeding rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Abscess at different timepoints in postoperative course
Comparison of postoperative Abscess rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Fistula at different timepoints in postoperative course
Comparison of postoperative Fistula rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Perforation at different timepoints in postoperative course
Comparison of postoperative Perforation rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Obstipation at different timepoints in postoperative course
Comparison of postoperative Obstipation rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Stenosis at different timepoints in postoperative course
Comparison of postoperative Stenosis rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Reoperation rate due to an anastomosis leakage at different timepoints in postoperative course
Comparison of Reoperation rate due to an anastomosis leakage at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Mortality rate at different timepoints in postoperative course
Comparison of postoperative Mortality rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Stoma rate at different timepoints in postoperative course
Comparison of postoperative Stoma rate at different postoperative examinations
Measured: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Length of the overall postoperative hospital stay
Number of days between date of surgery and date of discharge
Measured: until discharge (approximately 10 days postoperative)
Length of the postoperative stay in intensive care unit
Number of days the patient has to stay in the intensive care unit after the intervention
Measured: until discharge (approximately 10 days postoperative)
Duration to perform the anastomosis
Time in Minutes the surgeon needs to perform the anastomosis
Measured: intraoperatively
Course of Health Status
EQ-5D-5L is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"
Measured: until 6 months postoperative
Satisfaction of the patient with the surgery
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain". The values are compared over postoperative period.
Measured: at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery
Assessment of suture material handling parameters
Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, stiffness) with 5 evaluation levels (excellent, very good, good, satisfied, poor).
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study startJul 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: The GASTROMO study has been stopped early before enrolling its first patient because the results of our primary endpoint would have been inconsistent. The variability of the leakage rate between all anastomosis included in the study was overly high.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Wenceslao Vasquez Jimenez, Dr., Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811833
- Sponsor's protocol ID
- AAG-O-H-2005
- Acronym
- GASTROMO
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of MonoPlus® Suture Material for Anastomosis in the Gastrointestinal Tract. A Prospective, Multi-centric, International, Single-arm, Observational Study in Daily Practice
- ClinicalTrials.gov ID
- NCT04811833
- Acronym / sponsor ID
- GASTROMO / AAG-O-H-2005
- Conditions
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasm, Stomach Tumor, Small Intestine Tumor, Colon Tumor
- Keywords
- tumor disease, stomach tumor, small intestine tumor, colon tumor, rectum tumor, need for anastomosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The GASTROMO study has been stopped early before enrolling its first patient because the results of our primary endpoint would have been inconsistent. The variability of the leakage rate between all anastomosis included in the study was overly high.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Mar 2021 (actual)
- 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 primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction.
This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monoplus® | – | –Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for ananastomosis.
Key inclusion criteria (4 listed)
- Adult patients undergoing an elective open or laparoscopic primary tumor resection within GI tract (stomach, small intestine, large intestine , colon and rectum.
- Age ≥ 18 years
- ASA ≤ III
- Written informed consent
Key exclusion criteria (8 listed)
- ASA ≥IV
- Emergency operations
- Peritonitis
- Surgical interventions in the pancreas, oesophagus
- Patients with traumatic perforations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of anastomosis leakage rate at different timepoints in postoperative course
Time frame: until 6 months after surgery
The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery
18 secondary outcomes
Comparison of dehiscence rate of the suture line at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery.
Comparison of the Peritonitis rate at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of the Surgical Site infection rate at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of bleeding at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Abscess at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Fistula at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Perforation at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Obstipation at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Stenosis at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Reoperation rate due to an anastomosis leakage at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Mortality rate at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Stoma rate at different timepoints in postoperative course
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Length of the overall postoperative hospital stay
Time frame: until discharge (approximately 10 days postoperative)
Length of the postoperative stay in intensive care unit
Time frame: until discharge (approximately 10 days postoperative)
Duration to perform the anastomosis
Time frame: intraoperatively
Course of Health Status
Time frame: until 6 months postoperative
Satisfaction of the patient with the surgery
Time frame: at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery
Assessment of suture material handling parameters
Time frame: intraoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Related trials for Gastrointestinal Stromal Tumors
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 1
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer
RecruitingPhase 2
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
Gastrointestinal Stromal Tumors
RecruitingPhase 3
A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)
Gastrointestinal Stromal Neoplasms
Active, not recruitingPhase 2
A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments
Unresectable Gastrointestinal Stromal Tumor (GIST), Locally Advanced Gastrointestinal Stromal Tumor (GIST)
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.
Wenceslao Vasquez Jimenez, Dr. principal investigator
Hospital General Universitario Gregorio Marañon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumors and Gastrointestinal Neoplasms, run by Aesculap AG at 2 sites in Spain.
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 8 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: withdrawn, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 withdrawn before enrolling participants, so there are no results.
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?
Comparison of anastomosis leakage rate at different timepoints in postoperative course (time frame: until 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2023.