Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair (Dangrip)

This study has been completed.
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00815698
First received: December 29, 2008
Last updated: February 22, 2016
Last verified: February 2016
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Inguinal Hernia
Interventions: Procedure: suture
Procedure: no suture

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
no Suture

self-adhesive mesh, i.e. no suture for mesh fixation

no suture: no suture for mesh fixation, because we use a self-adhesive mesh

Suture

Suture for mesh fixation

suture: suture for mesh fixation


Participant Flow:   Overall Study
    no Suture     Suture  
STARTED     163     171  
COMPLETED     163     171  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
no Suture

self-adhesive mesh, i.e. no suture for mesh fixation

no suture: no suture for mesh fixation, because we use a self-adhesive mesh

Suture

Suture for mesh fixation

suture: suture for mesh fixation

Total Total of all reporting groups

Baseline Measures
    no Suture     Suture     Total  
Number of Participants  
[units: participants]
  163     171     334  
Age  
[units: years]
Median (Inter-Quartile Range)
  56.8  
  (40.2 to 65.1)  
  59.9  
  (45.8 to 67.5)  
  58.0  
  (40.2 to 67.5)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     163     171     334  
Region of Enrollment  
[units: participants]
     
Denmark     163     171     334  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain, Numbness and Discomfort in the Groin   [ Time Frame: 12 months after surgery ]

2.  Secondary:   Recurrence   [ Time Frame: 12 months after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jacob Rosenberg
Organization: Herlev Hospital, dept. of Surgery
phone: +45 26237323
e-mail: jacob.rosenberg@regionh.dk


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00815698     History of Changes
Other Study ID Numbers: CPODenmark001
Study First Received: December 29, 2008
Results First Received: March 18, 2015
Last Updated: February 22, 2016
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics