NCT04808063

Brief Summary

Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

March 15, 2021

Last Update Submit

March 18, 2021

Conditions

Incisional Hernia of Midline of Abdomen

Outcome Measures

Primary Outcomes (1)

  • Incisional hernia

    Diagnosis by clinical or image control of incicionsal hernia during follow up.

    Durign first and second year of follow up

Secondary Outcomes (2)

  • Incidence os surgical site ocurrence complications

    During first postoperative month.

  • Long term mesh related complications: chronic pain and mesh infection.

    During first year of follow-up.

Other Outcomes (3)

  • Global rate of complication.

    Durign first month of postoperative follow up.

  • Reintervention

    During first postoperative month follow up.

  • Hospital readmission

    During first postoperative month follow up.

Study Arms (1)

Algorithm use for prphylactic mesh after emergency laparotomy

EXPERIMENTAL

Patients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not.

Procedure: Prophylactic mesh implantation

Interventions

Prophylactic mesh implantationPROCEDURE

Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.

Algorithm use for prphylactic mesh after emergency laparotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency midline laparotomy.

You may not qualify if:

  • Surgical infection present at the moment of surgery.
  • Ventrla or incisional hernia present at the moment of laparotomy .
  • Open abdomen.
  • Preoperative American Society of Anesthesiologist score (ASA) of V.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, Catalonia, 08911, Spain

RECRUITING

Central Study Contacts

Alejandro Bravo-Salva, M.D.

CONTACT

+34932483204abravo@psmar.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Patients with emergency surgery using midline laparotomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant doctor

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 19, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)