Pelvic Floor Reconstruction Using Biological Mesh With Ne... | NCT04033484

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

NCT04033484

Sponsor

Beijing Chao Yang Hospital

Status

Unknown status

Last Update Posted

Feb 8, 2021Actual

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Perineal Wound Complications After ELAPE

Interventions

Negative Pressure Wound Therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Jul 31, 2021Estimated

Completion Date

Jul 31, 2021Estimated

First Submitted Date

Jul 24, 2019

First Submission Date that Met QC Criteria

Jul 24, 2019

First Posted Date

Jul 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2021

Last Update Posted Date

Feb 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological Mesh	Active Comparator	Using biological mesh to recnostruct the pelvic floor following ELAPE	Procedure: Negative Pressure Wound Therapy
Biological Mesh With Negative Pressure Wound Therapy	Experimental	Using biological mesh compined with negative pressure wound therapy to recnostruct the pelvic floor following ELAPE	Procedure: Negative Pressure Wound Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Negative Pressure Wound Therapy	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
perineal wound complications	perineal wound complications after pelvic floor reconstruction following ELAPE	6 months after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jia Gang Han, MD	Contact	+86013522867841		hjg211@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhen Jun. Wang	Recruiting	Beijing		100020	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Types

Study Protocol

Time Frame

2019.07.1-2021.07.31

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

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054843	Negative-Pressure Wound Therapy

Ancestor Terms

ID	Term
D004322	Drainage
D013812	Therapeutics
D013514	Surgical Procedures, Operative
D058106	Wound Closure Techniques

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Browse Branches

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