NCT04166201

Brief Summary

22 patients of incisional hernia underwent treatment by double mesh modification of the original Chevrel's technique the primary outcome was recurrence, skin necrosis secondery out come was pain hematoma seroma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

November 14, 2019

Last Update Submit

November 19, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • recurrence of the hernia

    the incisional hernia recurs back measured by clinical examination or abdominal CT

    2 years

  • necrosis of the edges of the wound

    gangrene of the medial edges of the midline incision after dissection of the skin and subcutaneous tissue off the rectus sheath measured by clinical examination

    1 week

Secondary Outcomes (3)

  • seroma

    1 week

  • hematoma

    1 week

  • abdominal wall pain

    1 year

Study Arms (1)

modified chevrel technique

OTHER

hernioplasty done with double mesh modification of chevrels technique

Procedure: double mesh hernioplasty with modified chevrel's technique

Interventions

hernioplasty done by modification of the chevrel's technique , no dissection further than 1 cm of the midline laterally, the medial flaps of the anterior rectus sheath is dissected of the anterior surface of the rectus abdominis muscle and sutured together reforming the posterior rectus sheath , one polypropylene mesh was fixed over the posterior rectus sheath and the other was tailored to raw area of the rectis abdominis muscle and sutured to the lateral free edges of the anterior rectus sheath

modified chevrel technique

Eligibility Criteria

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

You may qualify if:

  • adult with midline incisional hernia

You may not qualify if:

  • (ASA) 3, and 4,
  • inflammatory bowel disease,
  • urgent setting,
  • recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 22 patients with Incisional Hernia of Midline of the abdomen underwent hernioplasty by double mesh modification of Chevrel's technique follow up carried out for around 2 years for hernia recurrence pain early and late postoperative complications
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

January 1, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations