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OpenTrials
Completed

NCT Number: NCT02658955

Changing Technique of Abdominal Wall Closure (PHACPA)

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

Completed

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Key information

Conditions

Closure of Abdominal Wall

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José A. Pereira

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients operated on by laparotomy

Exclusion criteria

  • Previous mesh
  • Concomitant hernia repair

Treatment and study plan

Short stitch

Procedure

Surgeons will receive instructions to change the technique of abdominal wall closure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital del Mar

Other

Registry information

Official study title

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

Acronym: PHACPA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2016
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.