Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty

NCT04430816 | Completed

• 1 other identifier: compared chevrel hazem
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between two groups of large midline incisional hernia, the first group managed by double mesh modification of chevrel's technique the second one managed by conventional onlay mesh repair

Conditions

Hernia Incisional Ventral

Keywords

midline incisional hernia chevrel

Outcome Measures

Primary Outcomes (3)

• incidence of skin flap ischemia

  impaired capillary filling of wound skin flaps , measured by clinical examination (capillary filling time \> 2 seconds)

  24 hours postoperative

• incidence of seroma formation

  presence of more than 20 ml serous fluid collected around the mesh prosthesis measured by superficial probe ultrasound

  24 hours after drain removal

• incidence of hernia recurrence

  presence of hernia defect of any size in the midline or near it detected by ultrasound or coputerized tomography scan of the anterior abdominal wall

  in the first 2 years post operative

Secondary Outcomes (1)

• difference between operative time of both groups

  1 day

Study Arms (2)

modified chevrel technique

ACTIVE COMPARATOR

22 participant with large midline incisional hernia underwent repair by double mesh modification of chevrel's technique

Procedure: double mesh modification of chevrel's technique

ON LAY mesh hernioplasty

ACTIVE COMPARATOR

21 participant with large midline incisional hernia underwent repair by online mesh hernioplasty

Procedure: on lay mesh hernioplasty

Interventions

double mesh modification of chevrel's technique PROCEDURE

repair of midline incisional hernia by double mesh modification of chevrel's technique

modified chevrel technique

on lay mesh hernioplasty PROCEDURE

repair of midline incisional hernia by online mesh hernioplasty

ON LAY mesh hernioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• above 18 years old suffering large midline incisional hernia.

You may not qualify if:

• complicated incisional hernia,
• advanced cardiac, respiratory, liver and renal diseases
• patients with abdominal and abdominal wall malignancy
• ASA III and IV

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

Location

Study Officials

• hazem nour, MD

  zag university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participants don't know the procedure they will undergo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: two groups of patients with incisional hernia group A underwent double mesh modification of chevrel's technique, group B underwent onlay mesh hernioplasty

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 12, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)