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CompletedNCT04578561Updated Oct 8, 2020

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

An observational study in Prevention of Incisional Hernia in Emergency Surgery, sponsored by José A. Pereira. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by José A. Pereira · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
187
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Prevention of Incisional Hernia in Emergency Surgery
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In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 187 is below the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

This is the only study on the registry with José A. Pereira as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who underwent emergency midline laparotomies in the period between January 2009 and July 2010 in our University Hospital. We included all consecutive patients. with at least 2 years of follow-up.

Inclusion criteria

  • Patients undergoing emergency midline laparotomy

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
187 participants (actual)
Patient registry
No

Groups and cohorts

  • Prophylactic mesh

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

    Procedure: Prophylactic mesh use

  • Suture

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

Interventions

  • ProcedureProphylactic mesh use

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

    Also known as: Incisional hernia prevention

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What researchers measure

Primary outcomes

  1. Incisional hernia

    Detection of clinical or subclinical incisional hernia during postoperative longterm followup

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 34006282 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04578561
Lead sponsor
José A. Pereira
Responsible party
José A. Pereira (Jose Antonio Pereira-Rodriguez; M.D; Ph.D., Hospital del Mar) — Sponsor-investigator
First posted
Oct 8, 2020
Start date
Jan 2010
Primary completion
Jan 2019
Completion
Jan 2020
Last update
Oct 8, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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