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

Perineal Wound Complications After ELAPE Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033484
• Other study ID #: Bio-NEST 01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2021
• Source: Beijing Chao Yang Hospital
• Contact: Jia Gang Han, MD
• Phone: +86013522867841
• Email: hjg211[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Perineal Wound Complications After ELAPE
• Wounds and Injuries

Intervention

Procedure:
• Negative 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

Locations

Country	Name	City	State
China	Zhen Jun. Wang	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perineal wound complications	perineal wound complications after pelvic floor reconstruction following ELAPE	6 months after operation