Changing Technique of Abdominal Wall Closure (PHACPA) | NCT02658955

Studies
Changing Technique of Abdominal Wall Closure (PHACPA)

NCT02658955

Sponsor

Hospital del Mar

Status

Completed

Last Update Posted

Oct 10, 2019Actual

Enrollment

1,164Actual

Phase

Not Applicable

Conditions

Closure of Abdominal Wall

Interventions

Short stitch

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

Jan 14, 2016

First Submission Date that Met QC Criteria

Jan 15, 2016

First Posted Date

Jan 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2019

Last Update Posted Date

Oct 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Short stitch	Experimental	Patients in which abdominal wall is closed by short stitch technique	Procedure: Short stitch
Large stitch	No Intervention	Patients who didn't receive properly closure according with the protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Short stitch	Procedure	Surgeons will receive instructions to change the technique of abdominal wall closure	Short stitch

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Rate of fulfillment of the protocol	Analysis of results related with the fulfillment of the protocol	One year
Complication rate	Analysis of complications related with the closure technique

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients operated on by laparotomy

Exclusion Criteria:

Previous mesh
Concomitant hernia repair

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
José A. Pereira, MD	Surgeon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
José A. Pereira		Barcelona		08003	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided