Pilot trial on safety, feasibility and effectiveness of Osteopathic MANipulative Treatment following major abdominal surgery
Not Applicable
- Conditions
- Patients after open or laparoscopic elective bowel resection
- Registration Number
- DRKS00007800
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Open or laparoscopic elective bowel resection (with / without resection of other organs)
- Age 18 to 90 years
Exclusion Criteria
- Diseases of the spine
- Metastatic cancer
- Preoperative medication with opiates
- Minors
- Inability to give informed consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pilot study without primary endpoint.<br><br>General endpoints:<br>- Mortality and morbidity until discharge (to Clavien-Dindo)<br>- Complications caused by the intervention (quantitative and qualitative)<br>- Problems in the implementation of the intervention (quantitative and qualitative)<br>- Pain caused by intervention (NRS; before and after each treatment)<br>- Length of stay (in days in intensive care and general ward)<br>- Time to first bowel movement (hours postoperatively)<br>- Time to first flatus (hours postoperatively)<br>- Time to tolerance of solid food (postoperative day)<br>- Vomiting (events in the first five days)<br>- Pain (NRS; at each postoperative day until postoperative day 5)<br>- Pain medication use (in mg for each drug until postoperative day 5)<br>- Postoperative quality of life (PQL, pre-op, post-operative day 5, dismissal)
- Secondary Outcome Measures
Name Time Method Pilot study without secondary endpoints, for objective criteria see previous item