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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01722565
Other study ID # LAP-APR-2012-028
Secondary ID
Status Completed
Phase Phase 4
First received November 4, 2012
Last updated September 9, 2015
Start date January 2012
Est. completion date December 2014

Study information

Verified date September 2015
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)


Locations

Country Name City State
Spain Corporacion Sanitaria Universitaria Parc Tauli Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary The reduction in the incidence of Parastomal Hernia after the mesh placement 12 months Yes
See also
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Recruiting NCT04311333 - Endostomal Three-dimensional Ultrasonography for Parastomal Hernia N/A
Not yet recruiting NCT06077318 - Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia
Completed NCT01380860 - Primary Prevention of Peristomial Hernias Via Parietal Prostheses N/A
Completed NCT00908661 - Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia N/A
Recruiting NCT04282473 - Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Completed NCT03792243 - Outcomes After Parastomal Hernia Repair
Recruiting NCT01955278 - Role of Prosthetic Mesh in Preventing Parastomal Hernias Phase 3
Terminated NCT00641342 - Prevention of Parastomal Hernia by Primary Mesh Insertion Phase 2/Phase 3
Terminated NCT04966065 - Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
Recruiting NCT04440514 - Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)
Not yet recruiting NCT04950140 - Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient N/A
Terminated NCT02489175 - Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia N/A
Recruiting NCT03667287 - Stoma Hernia Intraperitoneal Full-Thickness Skin N/A
Completed NCT02368873 - the Use of a IPOM Mesh for Prevention of Parastomal Hernia N/A
Completed NCT02233465 - Treating Parastomal Hernia With a Mesh Phase 1/Phase 2
Completed NCT00917995 - Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh Phase 2/Phase 3
Completed NCT01484743 - Risk Factors for Morbidity After Parastomal Hernia Repair
Completed NCT00509054 - Prevention of Parastomal Hernia With a Mesh Phase 4
Completed NCT04187235 - Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia