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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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Inguinal Hernia
Interventions: Procedure: suture
Procedure: no suture

  Participant Flow
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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
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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
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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 
Overall Participants Analyzed 
[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
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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
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  More Information
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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