Neoplasms MalignantPhase 3ProMeLARNCT05939687
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
A Phase 3 study testing mesh and non-mesh in people with Neoplasms Malignant and Rectal Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neoplasms Malignant, Rectal Cancer, Hernia Incisional
- What is being tested?
- mesh and non-mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteRussia
- Study dates
- 5 Jun 2023to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Absence of distant metastases (M0)
- ECOG (Eastern Cooperative Oncology Group) status 0-2
- completed course of adjuvant treatment
- Absence of acute inflammatory parastomal complications
- Integrity of colorectal anastomosis
Who cannot join
- Inability to obtain consent to participate
- Synchronous and metachronous malignant neoplasms
- Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system
- Parastomal inflammation and other conditions that increase the risk of postoperative complications
- Pregnancy
- HIV infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
N.N.Blokhin Russian Cancer Research Center
Moscow, 115478
Sergey S Gordeyev, PhD, 9104501213 ext. 007, ss.netoncology@gmail.com
About this study
Official title: Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study.
Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.
Read the detailed description
This clinical trial is prospective randomized phase III study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. We will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. In these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. Our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. Stratification will be used for patients with >5 cm vs <5 cm stoma-site hernia.
The control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation.
Additional endpoints are the wound infection rate, the complication rate (Clavien-Dindo), the rate of the repeated surgery for hernia at the site of stoma closure. We'll assess the quality of life by HerQLes (Hernia-Related Quality of Life Survey) scale.
- Conditions
- Neoplasms Malignant, Rectal Cancer, Hernia Incisional, Surgery
- Being tested
- mesh, non-mesh
- Keywords
- Rectal cancer, mesh, stoma-site hernia, prevention, surgery
- Medical subject headings
- Neoplasms, Rectal Neoplasms, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meshProcedure or surgery
Also called polypropylene mesh
We'll use mesh repair for prevention of stoma-site hernias in the study group.
non-meshProcedure or surgery
We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.
| Study group | Role | What they receive |
|---|---|---|
| mesh | Experimental | In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh. Receives: Procedure: mesh |
| non-mesh | Active comparator | In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation. Receives: Procedure: non-mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
hernia rate
The rate of parastomal hernias after stoma closure for 2 years.
Measured: 2 years
Secondary outcomes (2)
90 day surgical morbidity
Complications after stoma closure including hernias
Measured: 90 days
Quality of life indicators by HerQLes scale
Quality of life as assessed by Hernia-Related Quality of Life Survey scale (HerQLes) at 30 days, 1 year and 2 years after stoma closure (higher scores are worse)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start5 Jun 2023
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms MalignantStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 electronic randomisation
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Gordeyev, Blokhin's Russian Cancer Research Center
- Investigators
- Zaman Z Mamedli, PhD, Study director, N.N.Blokhin Russian Cancer Research CenterNikolay L Matveev, PhD, Study chair, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939687
- Sponsor's protocol ID
- ProMeLAR-01
- Acronym
- ProMeLAR
- Status last verified
- Aug 2024
- First submitted
- 3 Jul 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT05939687
- Acronym / sponsor ID
- ProMeLAR / ProMeLAR-01
- Conditions
- Neoplasms Malignant, Rectal Cancer, Hernia Incisional, Surgery
- Keywords
- Rectal cancer, mesh, stoma-site hernia, prevention, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 11 Jul 2023 (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 goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study.
Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.
Detailed description
This clinical trial is prospective randomized phase III study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. We will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. In these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. Our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. Stratification will be used for patients with >5 cm vs <5 cm stoma-site hernia.
The control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation.
Additional endpoints are the wound infection rate, the complication rate (Clavien-Dindo), the rate of the repeated surgery for hernia at the site of stoma closure. We'll assess the quality of life by HerQLes (Hernia-Related Quality of Life Survey) scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 electronic randomisation
| Arm | Type | Receives |
|---|---|---|
| mesh | Experimental | Procedure: meshIn these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh. |
| non-mesh | Active comparator | Procedure: non-meshIn these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Absence of distant metastases (M0)
- ECOG (Eastern Cooperative Oncology Group) status 0-2
- completed course of adjuvant treatment
- Absence of acute inflammatory parastomal complications
Key exclusion criteria (6 listed)
- Inability to obtain consent to participate
- Synchronous and metachronous malignant neoplasms
- Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system
- Parastomal inflammation and other conditions that increase the risk of postoperative complications
- Pregnancy
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 |
|---|---|---|
| meshAlso: polypropylene meshWe'll use mesh repair for prevention of stoma-site hernias in the study group. | Procedure or surgery | mesh |
| non-meshWe'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group. | Procedure or surgery | non-mesh |
Primary outcome
hernia rate
Time frame: 2 years
The rate of parastomal hernias after stoma closure for 2 years.
2 secondary outcomes
90 day surgical morbidity
Time frame: 90 days
Quality of life indicators by HerQLes scale
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Zaman Z Mamedli, PhD study director
N.N.Blokhin Russian Cancer Research Center
Nikolay L Matveev, PhD study chair
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mesh and non-mesh in people with Neoplasms Malignant and Rectal Cancer, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey Gordeyev, D.Sc. (9104501213 ext. 007, ss.netoncology@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hernia rate (time frame: 2 years). 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 7 Aug 2024.