NCT04145908

Brief Summary

comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Status
completed

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

July 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

3.1 years

First QC Date

October 25, 2019

Last Update Submit

October 28, 2019

Conditions

Midline IncisionsHigh Risk PatientsMesh ReinforcementIncisional Hernia

Keywords

midline reinforcementincisional herniamesh

Outcome Measures

Primary Outcomes (1)

  • midline incisional hernia ,

    clinical and ultrasound examination of the abdomen for incisional hernia development

    weekly for one month , then monthly for 6 months then every 3 months later on till one year

Secondary Outcomes (1)

  • post operative complications

    (1st month post operative

Study Arms (2)

preperitoneal mesh

ACTIVE COMPARATOR

patients underwent preperitoneal mesh mesh placement

Procedure: midline mesh reinforcement

onlay mesh

ACTIVE COMPARATOR

patients underwent preperitoneal mesh mesh placement

Procedure: midline mesh reinforcement

Interventions

midline mesh reinforcementPROCEDURE

augmentation of midline closure by nonabsorbsble mesh

onlay meshpreperitoneal mesh

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obesity
  • Diabetes mellitus (DM),
  • Steroid therapy,
  • Liver diseases,
  • Renal diseases,
  • Cardiac diseases, Chest diseases ,
  • Malignancy,
  • Nutritional deficiency
  • Old age

You may not qualify if:

  • non risk factor
  • previous incisional hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
patient don't know the procedure
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: two groups one group for onlay mesh position the other for preperitoneal position
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 31, 2019

Study Start

July 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

October 31, 2019

Record last verified: 2019-10