Clinical trial NCT04166201: 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
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia of Midline of Upper Abdomen
Incisional Hernia of Midline of Lower Abdomen
Incisional Hernia of Midline of Abdomen
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-11-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: recurrence of the hernia
timeFrame: 2 years
measure: necrosis of the edges of the wound
timeFrame: 1 week
Secondary outcomes:
measure: seroma
timeFrame: 1 week
measure: hematoma
timeFrame: 1 week
measure: abdominal wall pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig Faculty of Medicine
state: Sharqya
Study officials:
References: