Prospective Study of the Use of a Mesh to Prevent Parasto... | NCT01722565

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 4, 2012

First Submission Date that Met QC Criteria

Nov 6, 2012

First Posted Date

Nov 7, 2012Estimated

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

Sep 9, 2015

Last Update Posted Date

Sep 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xavier Serra-Aracil, Medical Doctor, Corporacion Parc TauliPrincipal Investigator

Lead Sponsor

Corporacion Parc TauliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. Since the introduction of laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia remains a surgical problem of considerable importance, requiring significant consumption of public health and economic resources, and representing a major alteration of the quality of life of these patients.

Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in elective surgery for laparoscopic abdominoperineal resection.

Methodology: prospective, multidisciplinary, multi-center randomized controlled study. Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of 65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal CT will be performed at 12 months along with another clinical evaluation.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesh Group	Experimental	Patients receiving conventional sigmoid end colostomy plus a preperitoneal lightweight mesh Physiomesh® by laparoscopic procedure	Procedure: laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)
Control Group	No Intervention	Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)	Procedure		Mesh Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The reduction in the incidence of Parastomal Hernia after the mesh placement		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of either sex intervened electively for colorectal surgery (rectal cancer) in whom definitive colostomy is indicated after laparoscopic abdominoperineal amputation.
Life expectancy above 12 months

Exclusion Criteria:

- Patients with allergy or intolerance of the compounds in the mesh
Carriers of prosthetic meshes in the area of the ostomy
Patients electively intervened for colorectal surgery (neo de reco) in whom definitive colostomy is indicated after abdominoperineal amputation but not via a laparoscopic approach.
Cirrhotic patients
Patients with life expectancy below 12 months due to underlying disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xavier Serra-Aracil, MD	Corporacion Sanitaria Universitaria Parc Tauli	Principal Investigator
Manuel Lopez-Cano, MD	Hospital Vall d'Hebron	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corporacion Sanitaria Universitaria Parc Tauli		Sabadell	Barcelona	08208	Spain

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D011126	Polypropylenes
C095495	glycolide E-caprolactone copolymer

Ancestor Terms

ID	Term
D011090	Polyenes
D000475	Alkenes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D010969	Plastics
D011108	Polymers
D046911	Macromolecular Substances
D001697	Biomedical and Dental Materials
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture