Trial document




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  DRKS00015665

Trial Description

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Title

Usefulness of the abdominal binder as postoperative treatment following incisional hernia repair

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Trial Acronym

ABHIR-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Following incisional hernia repair in Western Europe an abdoiminal binder is often prescribed in order to reduce postoperative pain, the rate of seromas and relapses. Nevertheless these postoperative recommendations are not scientific investigated. The aim of the study is to investigate the usefullness of the abdominal binder.

One group of patients will carry the abdominal binder for two weeks and the other group wont carry the abdominal binder.

Two weeks and one year after surgery the patients will be examined in order to reveal the pain level, relapses and life quality.

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Brief Summary in Scientific Language

Frequently in Western Europe, surgical departments are prescribing an abdominal binder as postoperative treatment following an incisional hernia repair. The abdominal binder shall reduce pain, the rate of seroma formation, and prevent early postoperative damages, such as hernia recurrence or damage to the mesh sutures. However, there is a lack of evidence concerning clinical effects of an abdominal binder. Postoperative recommendations of surgical departments all over Germany seem to be random, as investigated by our workgroup [Paasch et al. 2018]. A shortened period of wearing an abdominal binder may have a social-economic impact by reducing the individual capacity for work and mobility. Therefore, further investigations are necessary.

Group II (n=30): Abdominal binder for two weeks
Group I (n=30): No Abdominal binder

1. Follow-up: 14. postoperative day
2. Follow-up: 365. postoperative day

Two weeks and one year after surgery the patients will be examined in order to reveal the pain level, relapses and life quality.

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Organizational Data

  •   DRKS00015665
  •   2019/05/16
  •   [---]*
  •   yes
  •   Approved
  •   Eth-05/19, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   K43 -  Ventral hernia
  •   R52 -  Pain, not elsewhere classified
  •   K40.91 -  [generalization K40.9: Unilateral or unspecified inguinal hernia, without obstruction or gangrene]
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Interventions/Observational Groups

  •   2 weeks carrying of an Abdominal binder following laparocopic incisional hernia repair (IPOM technique) (Intraperitoneal onlay mesh)
  •   No carrying of an Abdominal binder following incisional hernia repair (IPOM technique)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Pain after 2 weeks following incisional hernia repair in IPOM technique

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Secondary Outcome

Rate of seroma 1 day, 2 days and 2 weeks after surgery
Recurrence rate 1 year after surgery
Postoperative complications 2 weeks after surgery according to Clavien-Dindo-Classification
Quality of life 1 year after surgery (SF36 questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/07/01
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Patients suffering from an incisional hernia
Patients underwent laparoscopic IPOM hernia repair

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Exclusion Criteria

Pregnancy
Avoided closure of hernia gap

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Addresses

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    • Helios Forschungsförderung der Helios Kliniken
    • Friedrichstrasse 136
    • 10117   Berlin
    • Germany
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    • Universitätsklinikum Magdeburg
    • Mr.  Dr. med.  Eric  Lorenz 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Helios KlinikEmil von Behring Krankenhaus
    • Mr.  Dr. med.  Eric  Lelaona 
    • Walterhöferstraße 11
    • 14165  Berlin
    • Germany
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    • Helios Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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    • Helios Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Helios Forschungsförderung
    • Friedrichstrasse 136
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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