Changing Technique of Abdominal Wall Closure (PHACPA) (PHACPA)

October 8, 2019 updated by: José A. Pereira, Hospital del Mar

Changing Technique of Abdominal Wall Closure According to European Hernia Society (EHS) Guidelines in a General Hospital

Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgeons will receive instruction about new techniques of closure of the abdomen and will practice in models and receive a certification previously to implement in their surgical practice the new technique.

Results will be monitorised and compared with previous cohort of patients. A protocol of closure will be implemented. Patients without risk factors will receive a laparotomy closure with "short stitch" technique and patients with risk factor for developing incisional hernia or burst abdomen and aditional profilactic suprafascial mesh.

Study Type

Interventional

Enrollment (Actual)

1164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • José A. Pereira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients operated on by laparotomy

Exclusion Criteria:

  • Previous mesh
  • Concomitant hernia repair

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short stitch
Patients in which abdominal wall is closed by short stitch technique
Procedure: Short stitch
Surgeons will receive instructions to change the technique of abdominal wall closure
No Intervention: Large stitch
Patients who didn't receive properly closure according with the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incisional hernia and burst abdomen rate
Time Frame: One year
Analysis of the number of incisional hernia and burst abdomen after one year follow-up
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of fulfillment of the protocol
Time Frame: One year
Analysis of results related with the fulfillment of the protocol
One year
Complication rate
Time Frame: One month
Analysis of complications related with the closure technique
One month
Mesh complications rate
Time Frame: One year
Analysis of mesh related complications in patients with a prophylactic mesh
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Investigators

  • Principal Investigator: José A. Pereira, MD, Surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HMar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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