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Chronic Complaints After Small Umbilical Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741740
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Thue Bisgaard, Hvidovre University Hospital

Tracking Information
First Submitted Date December 3, 2012
First Posted Date December 5, 2012
Last Update Posted Date December 24, 2012
Study Start Date January 2000
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2012)
pain at rest at the hernia repair site [ Time Frame: chronic complaints 5 years after hernia repair ]
a verbal rating scale for pain is used (none, little, moderate or severe
Original Primary Outcome Measures
 (submitted: December 4, 2012)
pain at rest at the hernia repair site [ Time Frame: chronic complaints 5 years after hernia repair ]
Change History
Current Secondary Outcome Measures
 (submitted: December 13, 2012)
discomfort at rest at the hernia site [ Time Frame: 5 years ]
a verbal rating scale for pain is used (none, little, moderate or severea
Original Secondary Outcome Measures
 (submitted: December 4, 2012)
discomfort at rest at the hernia site [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures
 (submitted: December 13, 2012)
recurrence [ Time Frame: five years ]
reoperation for recurrence combined with clinical examination for non reoperated recurrences
Original Other Pre-specified Outcome Measures
 (submitted: December 4, 2012)
recurrence [ Time Frame: five years ]
 
Descriptive Information
Brief Title Chronic Complaints After Small Umbilical Hernia Repair
Official Title High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair
Brief Summary There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Consecutive patients undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repair during a five years period
Condition
  • Chronic Pain
  • Ventral Hernia
Intervention Not Provided
Study Groups/Cohorts retrospective surgical patients
consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2012)
295
Original Actual Enrollment Same as current
Actual Study Completion Date January 2009
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • primary elective open non-mesh sutured umbilical or epigastric hernia repair

Exclusion Criteria:

  • mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age < 18 years, pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01741740
Other Study ID Numbers SMALLUMBI123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thue Bisgaard, Hvidovre University Hospital
Study Sponsor Hvidovre University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Thue Bisgaard, DMSc Hvidovre and Glostrup University Hospitals
PRS Account Hvidovre University Hospital
Verification Date December 2012