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

Capital Medical University

Status: Unknown

Conditions: Perineal Wound Complications After ELAPE

Treatments: Procedure: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04033484

Bio-NEST 01

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

Biological Mesh

Active Comparator group

Description:

Using biological mesh to recnostruct the pelvic floor following ELAPE

Treatment:

Procedure: Negative Pressure Wound Therapy

Biological Mesh With Negative Pressure Wound Therapy

Experimental group

Description:

Using biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE

Treatment:

Procedure: Negative Pressure Wound Therapy