Double Mesh Modification of Incisional Hernia Can be Effective Without Severe Local Complications
Primary Purpose
Incisional Hernia of Midline of Upper Abdomen, Incisional Hernia of Midline of Lower Abdomen, Incisional Hernia of Midline of Abdomen
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
double mesh hernioplasty with modified chevrel's technique
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia of Midline of Upper Abdomen
Eligibility Criteria
Inclusion Criteria:
• adult with midline incisional hernia
Exclusion Criteria:
- (ASA) 3, and 4,
- inflammatory bowel disease,
- urgent setting,
- recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer).
Sites / Locations
- Zagazig Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
modified chevrel technique
Arm Description
hernioplasty done with double mesh modification of chevrels technique
Outcomes
Primary Outcome Measures
recurrence of the hernia
the incisional hernia recurs back measured by clinical examination or abdominal CT
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
Secondary Outcome Measures
seroma
presence of serous fluid collection in the subcutaneous space measured by superficial probe ultrasound examination
hematoma
blood collection around the mesh prosthesis measured by superficial probe ultrasound examination
abdominal wall pain
pain related to the surgical wound or the mesh prosthesis fixation sutures , measured by visual analogue scale
Full Information
NCT ID
NCT04166201
First Posted
November 14, 2019
Last Updated
November 19, 2019
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT04166201
Brief Title
Double Mesh Modification of Incisional Hernia Can be Effective Without Severe Local Complications
Official Title
Evaluation of Double Mesh Modification of Chevrel's Technique in Management of Midline Incisional Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
This study is a clinical trial carried out on 22 patients with midline incisional hernia, using the double mesh modification of Chevrel's technique, all the procedures were performed by the same group of surgeons.
The exclusion criteria were American Society of Anesthesiologists (ASA) 3, and 4, inflammatory bowel disease, urgent setting, recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer). All patients were informed and consented before recruitment in the study All patients received an intravenous antibiotic prophylaxis with subcutaneous administration of fractionated heparin before surgery when indicated.
Surgical technique All patients were operated on with the double mesh modification of Chevrel's technique. The previous scar was excised then, dissection of the subcutaneous space was performed deep to the neck of the hernia, not wider than 1cm from the edges of the defect, then the sac was opened and resected, the defect size was measured, the skin and subcutaneous tissue was dissected off the anterior rectus sheath only allowing dissection of an anterior rectus sheath flap just sufficient to close the defect without tension After that a bilateral longitudinal incisions was done on the anterior surface of the anterior rectus sheath and a medial anterior rectus sheath flap was dissected off the rectus abdominis muscle, both recti muscles was dissected off the posterior rectus sheath opening the retrorectus space, each of the medial anterior rectus sheath flaps was sutured to that of the other side with slowly absorbed sutures closing the defect without any tension and reforming the posterior rectus sheath
A sizable prolene mesh was fixed with prolene sutures in the retrorectus space spreading between lateral ends of the space and tunneled up 4 cm in the retrorectus space far from vertical edges of the defect,Then the anterior rectus sheath was closed using a prolene mesh tailored to the size of the space between the lateral flaps of both sides and sutured to the edges of the lateral flaps with interrupted non absorbable sutures.
suction drain is left in site, subcutaneous tissue was closed with Vicryl (3\0) , skin was closed with prolene (3\0), drain was removed when the amount of drainage is below 30 ml \ day .
Data of the patients as demographic data, preoperative investigations, operative findings as defect size, operative time, early postoperative data as viability of skin flaps, wound infection, seroma and early hernia recurrence, late postoperative data as hernia recurrence. All data were collected, properly presented and analyzed using the SPSS package 22.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia of Midline of Upper Abdomen, Incisional Hernia of Midline of Lower Abdomen, Incisional Hernia of Midline of Abdomen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modified chevrel technique
Arm Type
Other
Arm Description
hernioplasty done with double mesh modification of chevrels technique
Intervention Type
Procedure
Intervention Name(s)
double mesh hernioplasty with modified chevrel's technique
Intervention Description
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
Primary Outcome Measure Information:
Title
recurrence of the hernia
Description
the incisional hernia recurs back measured by clinical examination or abdominal CT
Time Frame
2 years
Title
necrosis of the edges of the wound
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
seroma
Description
presence of serous fluid collection in the subcutaneous space measured by superficial probe ultrasound examination
Time Frame
1 week
Title
hematoma
Description
blood collection around the mesh prosthesis measured by superficial probe ultrasound examination
Time Frame
1 week
Title
abdominal wall pain
Description
pain related to the surgical wound or the mesh prosthesis fixation sutures , measured by visual analogue scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• adult with midline incisional hernia
Exclusion Criteria:
(ASA) 3, and 4,
inflammatory bowel disease,
urgent setting,
recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer).
Facility Information:
Facility Name
Zagazig Faculty of Medicine
City
Zagazig
State/Province
Sharqya
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Double Mesh Modification of Incisional Hernia Can be Effective Without Severe Local Complications
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