NCT04088253

Brief Summary

local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

2.4 years

First QC Date

September 11, 2019

Last Update Submit

September 11, 2019

Conditions

Umbilical Hernia

Outcome Measures

Primary Outcomes (2)

  • early wound complications

    wound infection (with or without removal of the mesh) wound necrosis wound hematoma

    1 weak

  • late wound complications

    wound infection (with or without removal of the mesh) wound necrosis wound hematoma

    1 month

Study Arms (1)

cirrhotic patient

EXPERIMENTAL

cirrhotic patient with umbilical hernia to be operated

Procedure: umbilical herneal repair

Interventions

umbilical herneal repairPROCEDURE

reduction of the herneal content an repair of the defect with IPOM

cirrhotic patient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent patient age: ≥ 18 years elective surgery for umbilical hernia hernia diameter ≥ 1cm

You may not qualify if:

  • previous history of median laparotomy navel site infection pregnancy incarcerated hernia recurrent hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Soliman

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

hossam zaher

CONTACT

+201069369274hossamzaher3@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

October 1, 2019

Primary Completion

March 1, 2022

Study Completion

September 1, 2022

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

age, sex , clinical diagnosis

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 years
Access Criteria
age, sex , clinical diagnosis

Locations

EG(1)