Changing Technique of Abdominal Wall Closure (PHACPA)

Closure of Abdominal Wall Clinical Trial

— PHACPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658955
• Other study ID #: HMar
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2018

Study information

• Verified date: October 2019
• Source: Hospital del Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1164
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients operated on by laparotomy

Exclusion Criteria:

• Previous mesh

• Concomitant hernia repair

Related Conditions & MeSH terms

• Closure of Abdominal Wall

Intervention

Procedure:
• Short stitch
Surgeons will receive instructions to change the technique of abdominal wall closure

Locations

Country	Name	City	State
Spain	José A. Pereira	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia and burst abdomen rate	Analysis of the number of incisional hernia and burst abdomen after one year follow-up	One year
Secondary	Rate of fulfillment of the protocol	Analysis of results related with the fulfillment of the protocol	One year
Secondary	Complication rate	Analysis of complications related with the closure technique	One month
Secondary	Mesh complications rate	Analysis of mesh related complications in patients with a prophylactic mesh	One year