Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.

NCT ID: NCT04578561

Last Updated: 2020-10-08

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention of Incisional Hernia in Emergency Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prophylactic mesh

Patients who received a prophylactic mesh after emergency surgery due to high risk of incisional hernia.

Prophylactic mesh use

Intervention Type PROCEDURE

After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.

Suture

Patients who's laparotomies closure was using only suture without any abdominal wall reinforcement

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prophylactic mesh use

After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Incisional hernia prevention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing emergency midline laparotomy

Exclusion Criteria

* Those with need of concomitant hernia repair.
* Those who received incisions outside the midline.
* Those with delayed abdominal closure.
* Those who died in the immediate postoperative period.
* Those without a minimum 2 years of follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

José A. Pereira

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

José A. Pereira

Jose Antonio Pereira-Rodriguez; M.D; Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Bravo-Salva A, Argudo-Aguirre N, Gonzalez-Castillo AM, Membrilla-Fernandez E, Sancho-Insenser JJ, Grande-Posa L, Pera-Roman M, Pereira-Rodriguez JA. Long-term follow-up of prophylactic mesh reinforcement after emergency laparotomy. A retrospective controlled study. BMC Surg. 2021 May 18;21(1):243. doi: 10.1186/s12893-021-01243-x.

Reference Type DERIVED
PMID: 34006282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20198240I

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.