NCT00691860

Brief Summary

Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
Last Updated

September 15, 2015

Status Verified

June 1, 2008

Enrollment Period

9 months

First QC Date

June 4, 2008

Last Update Submit

September 14, 2015

Conditions

Parastomal Hernia

Keywords

Parastomal herniasTolerance of lightweight meshesParacolostomy herniasPeristomal hernias

Outcome Measures

Primary Outcomes (1)

  • the reduction in the incidence of Parastomal Hernia after the mesh placement

    6 months

Study Arms (2)

1

EXPERIMENTAL

Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®

Device: Mesh (Ultrapro ®)Procedure: Conventional sigmoid end colostomy

2

OTHER

Patients receiving conventional sigmoid end colostomy, without mesh

Procedure: Conventional sigmoid end colostomy

Interventions

Mesh (Ultrapro ®)DEVICE

In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy

Also known as: Ultrapro ®
1
Conventional sigmoid end colostomyPROCEDURE

Patients receiving conventional sigmoid end colostomy, without mesh

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
  • Aged over 18,
  • Charlson comorbidity index below 7
  • Elective surgery
  • Radical surgery

You may not qualify if:

  • Loop colostomies,
  • Emergency surgery,
  • Body mass index above 35 kg/sq.m.,
  • Palliative surgery,
  • Hepatic cirrhosis,
  • Severe COPD (requiring home oxygen treatment),
  • Corticoid treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Salvador Navarro-Soto, MD

    Corporacio Sanitaria Parc Tauli

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

April 1, 2006

Primary Completion

January 1, 2007

Study Completion

February 1, 2008

Last Updated

September 15, 2015

Record last verified: 2008-06