Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE

Study Overview
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Brief Summary
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Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown. And it was proved that neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer. Negative pressure therapy has proven benefits in open wounds, and recently a negative pressure system has been developed for use on closed wounds at high risk of breakdown. A systematic review suggested a significant decrease in perineal wound complications when using incisional negative pressure wound therapy was demonstrated, with surgical site infection rates as low as 9% (vs 41% in control groups). The review suggested that incisional negative pressure wound therapy decreases perineal wound complications after abdominoperineal resection. Prospective study also suggested that after ELAPE the application of a negative pressure system to the perineal wound closed with biologic mesh may reduce perineal wound complications. The aim of the present study was to determine whether negative pressure therapy combined with biological mesh compared with biological mesh alone after ELAPE could improve wound healing.

Official Title
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Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision

Conditions
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Perineal Wound Complications After ELAPE

Intervention / Treatment
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* Procedure: Negative Pressure Wound Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rectal cancer within 4 cm of the anal verge T3 or T4, as determined by pre-operative MRI examination; patient did receive neoadjuvant chemoradiotherapy Absence of distant metastases Absence of intestinal obstruction Exclusion Criteria: T1-T2, as determined by pre-operative MRI before neoadjuvant chemoradiotherapy Distant metastases Intestinal obstruction Pregnancy or lactating Contraindications to surgery A mental disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biological Mesh<br>Using biological mesh to recnostruct the pelvic floor following ELAPE | Procedure: Negative Pressure Wound Therapy<br>* The perineal wound was reconstructed with biologic mesh after ELAPE. The subcutaneous adipose layer was closed with 2/0 vicryl sutures, and a suction drain was left in the deep layer. The subcuticular layer and skin were closed with 3/0 vicryl mattress sutures and the negative pressure system applied at 80 mmHg<br>|
| Experimental: Biological Mesh With Negative Pressure Wound Therapy<br>Using biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE | Procedure: Negative Pressure Wound Therapy<br>* The perineal wound was reconstructed with biologic mesh after ELAPE. The subcutaneous adipose layer was closed with 2/0 vicryl sutures, and a suction drain was left in the deep layer. The subcuticular layer and skin were closed with 3/0 vicryl mattress sutures and the negative pressure system applied at 80 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perineal wound complications | perineal wound complications after pelvic floor reconstruction following ELAPE | 6 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extralevator abdominoperineal excision, Perineal wound healing, negative pressure wound therapy, biological mesh