Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658955
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
José A. Pereira, Hospital del Mar

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.

Condition or disease Intervention/treatment Phase
Closure of Abdominal Wall Procedure: Short stitch Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1164 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changing Technique of Abdominal Wall Closure According to European Hernia Society (EHS) Guidelines in a General Hospital
Actual Study Start Date : June 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rate of fulfillment of the protocol [ Time Frame: One year ]
    Analysis of results related with the fulfillment of the protocol

  2. Complication rate [ Time Frame: One month ]
    Analysis of complications related with the closure technique

  3. Mesh complications rate [ Time Frame: One year ]
    Analysis of mesh related complications in patients with a prophylactic mesh


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients operated on by laparotomy

Exclusion Criteria:

  • Previous mesh
  • Concomitant hernia repair
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658955


Locations
Layout table for location information
Spain
José A. Pereira
Barcelona, Spain, 08003
Sponsors and Collaborators
Hospital del Mar
Investigators
Layout table for investigator information
Principal Investigator: José A. Pereira, MD Surgeon
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: José A. Pereira, MD, Hospital del Mar
ClinicalTrials.gov Identifier: NCT02658955    
Other Study ID Numbers: HMar
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by José A. Pereira, Hospital del Mar:
Abdominal wall closure