Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
NCT ID: NCT05939687
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
142 participants
INTERVENTIONAL
2023-06-05
2028-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery
NCT02576184
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation
NCT05546892
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
NCT02896686
Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
NCT04950140
PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection
NCT04357171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mesh
In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh.
mesh
We'll use mesh repair for prevention of stoma-site hernias in the study group.
non-mesh
In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation.
non-mesh
We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mesh
We'll use mesh repair for prevention of stoma-site hernias in the study group.
non-mesh
We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Blokhin's Russian Cancer Research Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sergey Gordeyev
Principal investigator, Department of Colorectal surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zaman Z Mamedli, PhD
Role: STUDY_DIRECTOR
N.N.Blokhin Russian Cancer Research Center
Nikolay L Matveev, PhD
Role: STUDY_CHAIR
Pirogov Russian National Research Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
N.N.Blokhin Russian Cancer Research Center
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ProMeLAR-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.