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Umbilical Hernial Repair Using IPOM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04088253
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 13, 2019
Information provided by (Responsible Party):
Hossam mohamed, Assiut University

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

Condition or disease Intervention/treatment Phase
Umbilical Hernia Procedure: umbilical herneal repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Repair of Umbilical Hernia in Cirrhotic Patient Using Intraperitoneal Onlay Mesh Technique
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: cirrhotic patient
cirrhotic patient with umbilical hernia to be operated
Procedure: umbilical herneal repair
reduction of the herneal content an repair of the defect with IPOM

Primary Outcome Measures :
  1. early wound complications [ Time Frame: 1 weak ]
    wound infection (with or without removal of the mesh) wound necrosis wound hematoma

  2. late wound complications [ Time Frame: 1 month ]
    wound infection (with or without removal of the mesh) wound necrosis wound hematoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04088253

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Contact: hossam zaher +201069369274

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Assiut university Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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Study Director: Ahmed Soliman Assiut University
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Responsible Party: Hossam mohamed, Assistant Lecturer, Assiut University Identifier: NCT04088253    
Other Study ID Numbers: IPOM hernioplasty
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: age, sex , clinical diagnosis
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 3 years
Access Criteria: age, sex , clinical diagnosis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal