Perineal Wound Complications After ELAPE Clinical Trial
Official title:
Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision
NCT number | NCT04033484 |
Other study ID # | Bio-NEST 01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | July 31, 2021 |
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.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Zhen Jun. Wang | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Chao Yang Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | perineal wound complications | perineal wound complications after pelvic floor reconstruction following ELAPE | 6 months after operation |