Perineal Wound Complications After ELAPE
Conditions
Keywords
extralevator abdominoperineal excision, Perineal wound healing, negative pressure wound therapy, biological mesh
Brief summary
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.
Interventions
PROCEDURENegative Pressure Wound Therapy
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
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Rectal cancer within 4 cm of the anal verge 2. T3 or T4, as determined by pre-operative MRI examination; patient did receive neoadjuvant chemoradiotherapy 3. Absence of distant metastases 4. Absence of intestinal obstruction
Exclusion criteria
1. T1-T2, as determined by pre-operative MRI before neoadjuvant chemoradiotherapy 2. Distant metastases 3. Intestinal obstruction 4. Pregnancy or lactating 5. Contraindications to surgery 6. A mental disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| perineal wound complications | 6 months after operation | perineal wound complications after pelvic floor reconstruction following ELAPE |
Countries
China
Contacts
Primary ContactJia Gang Han, MD
Outcome results
None listed