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A preoperative diet to increase resistance of patients undergoing surgery.


- candidate number6013
- NTR NumberNTR1875
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2009
- Secondary IDsMETC-2007-1999 METC Erasmus MC
- Public TitleA preoperative diet to increase resistance of patients undergoing surgery.
- Scientific TitleBeneficial effects of fasting on postoperative recovery following living donor nephrectomy.
- ACRONYMDietary Restriction
- hypothesisMultiple studies have shown that dietary restriction extends lifespan in different animal species ranging from worms to rats. The beneficial effect of calorie restriction on life span may function in part through its ability to increase stress resistance.We hypothesize that the mechanisms involved in extended longevity may also be tapped for short-term clinical benefits against acute stress such as the acute phase response after surgery.
- Healt Condition(s) or Problem(s) studiedDiet, Preoperative nutrition, Acute phase response, Surgery
- Inclusion criteria1. Scheduled for laparoscopic donor nephrectomy;
2. 18 years age 80 years;
3. BMI 18.5.
- Exclusion criteria If inclusion criteria are not met.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-sep-2007
- planned closingdate11-sep-2009
- Target number of participants30
- InterventionsBased on reported calorie intake patients randomized to the dietary restriction group start a 30% calorie restricted diet three days pre-operatively. The day before surgery the donor is allowed to have a light breakfast followed by 12 hours of fasting. Until midnight preoperatively they are allowed to drink water ad libitum.
- Primary outcomePostoperative course of CRP, IL-6, IL-8 and IL-10.
This is an pilot study and therefore no samplesize calculation is performed.
- Secondary outcomePreoperatively and at days 1,2,3,7 and 14 the donors score pain and nausea on a visual analogue scale from 0 (none) to 10 (severe) and report the ability to perform daily tasks in the euroQol questionnaire.

Preoperatively and at 1,3,6 and 12 months postoperatively donors are asked to complete forms related to the quality of life and the ability to perform daily tasks and (if applicable) the time of regaining working activities.
- TimepointsPreoperatively and at days 1,2,3 and 4 the donors blood samples will be collected and analyzed.

Preoperatively and at 1,3,6 and 12 months postoperatively donors are asked to complete forms related to the quality of life and the ability to perform daily tasks and (if applicable) the time of regaining working activities.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. dr. J.N.M. IJzermans
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.N.M. IJzermans
- Sponsor/Initiator Erasmus Medical Center, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Netherlands Organization for Scientific Research (NWO), Lifespan
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD24-jun-2009 - 6-okt-2009


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