Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE
Primary Purpose
Perineal Wound Complications After ELAPE
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Perineal Wound Complications After ELAPE focused on measuring extralevator abdominoperineal excision, Perineal wound healing, negative pressure wound therapy, biological mesh
Eligibility Criteria
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
Sites / Locations
- Zhen Jun. WangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Biological Mesh
Biological Mesh With Negative Pressure Wound Therapy
Arm Description
Using biological mesh to recnostruct the pelvic floor following ELAPE
Using biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE
Outcomes
Primary Outcome Measures
perineal wound complications
perineal wound complications after pelvic floor reconstruction following ELAPE
Secondary Outcome Measures
Full Information
NCT ID
NCT04033484
First Posted
July 24, 2019
Last Updated
February 4, 2021
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04033484
Brief Title
Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE
Official Title
Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following Extralevator Abdominoperineal Excision
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineal Wound Complications After ELAPE
Keywords
extralevator abdominoperineal excision, Perineal wound healing, negative pressure wound therapy, biological mesh
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological Mesh
Arm Type
Active Comparator
Arm Description
Using biological mesh to recnostruct the pelvic floor following ELAPE
Arm Title
Biological Mesh With Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
Using biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE
Intervention Type
Procedure
Intervention Name(s)
Negative Pressure Wound Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
perineal wound complications
Description
perineal wound complications after pelvic floor reconstruction following ELAPE
Time Frame
6 months after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Gang Han, MD
Phone
+86013522867841
Email
hjg211@163.com
Facility Information:
Facility Name
Zhen Jun. Wang
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Jun Wang, Prof.
Phone
+86013601393711
Email
hjg211@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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. 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.
IPD Sharing Time Frame
2019.07.1-2021.07.31
IPD Sharing Access Criteria
Inclusion criteria
Tumor 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
Learn more about this trial
Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE
We'll reach out to this number within 24 hrs