Trial document




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  DRKS00007800

Trial Description

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Title

Pilot trial on safety, feasibility and effectiveness of Osteopathic MANipulative Treatment following major abdominal surgery

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Trial Acronym

OMANT-Pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The term osteopathy describes a field of alternative medicine with different disease and treatment concepts. Its approach to healing is that life is reflected in the form of movement. Where movement is prevented, disease is spreading. Osteopathy therefore helps detecting and resolving movement restrictions.
The purpose of osteopathic manual-treatment after surgery is to improve the imbalance in the autonomic nervous system as well as the hormonal imbalance and thus to assist in the recovery.
This pilot study aims at verifying whether the use of osteopathic manual-treatment after abdominal surgery is safe and feasible and whether a benefit arises from this.

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Brief Summary in Scientific Language

Check of safety, feasibility and potential benefits of osteopathic manual-treatment after bowel resections.

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Organizational Data

  •   DRKS00007800
  •   2015/02/10
  •   [---]*
  •   yes
  •   Approved
  •   S-028/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Patients after open or laparoscopic elective bowel resection
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Interventions/Observational Groups

  •   Intervention group: daily treatment with three different techniques (each about 30 minutes) of osteopathy for 5 days.
  •   Control group: no-osteopathic manual treatment.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pilot study without primary endpoint.

General endpoints:
- Mortality and morbidity until discharge (to Clavien-Dindo)
- Complications caused by the intervention (quantitative and qualitative)
- Problems in the implementation of the intervention (quantitative and qualitative)
- Pain caused by intervention (NRS; before and after each treatment)
- Length of stay (in days in intensive care and general ward)
- Time to first bowel movement (hours postoperatively)
- Time to first flatus (hours postoperatively)
- Time to tolerance of solid food (postoperative day)
- Vomiting (events in the first five days)
- Pain (NRS; at each postoperative day until postoperative day 5)
- Pain medication use (in mg for each drug until postoperative day 5)
- Postoperative quality of life (PQL, pre-op, post-operative day 5, dismissal)

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Secondary Outcome

Pilot study without secondary endpoints, for objective criteria see previous item

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/02/15
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Open or laparoscopic elective bowel resection (with / without resection of other organs)
- Age 18 to 90 years

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Exclusion Criteria

- Diseases of the spine
- Metastatic cancer
- Preoperative medication with opiates
- Minors
- Inability to give informed consent

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Dr. med.  Pascal  Probst 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Dr. med.  Pascal  Probst 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Im Neuenheimer Feld 110
    • 69120   Heidelberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/29
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Trial Publications, Results and other Documents

  •   Probst P, Büchler E, Doerr-Harim C, Knebel P, Thiel B, Ulrich A, Diener MK. Randomized controlled pilot trial on feasibility, safety and effectiveness of Osteopathic MANipulative Treatment following major abdominal surgery (OMANT-Pilot trial). Int J Osteopath Med. 2016;20:31-40.
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* This entry means the parameter is not applicable or has not been set.