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Herstel na een baarmoederoperatie: Onderzoek naar beïnvloedende factoren.


- candidate number8971
- NTR NumberNTR2702
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2011
- Secondary IDs10-05-001 MEC Maastricht University
- Public TitleHerstel na een baarmoederoperatie: Onderzoek naar beïnvloedende factoren.
- Scientific TitleRecovery after hysterectomy: A study into influencing factors.
- ACRONYMHysterectomy&CPSP
- hypothesisPrimary Objective:
The identification of (somatic and psychological) risk and protective factors for postoperative recovery, including the development of chronic post operative pain (CPSP), defined as persistent pain 3 and 12 months after the intervention.

Secondary Objective(s):
1. Determination of the prevalence of CPSP after hysterectomy;
2. Determination of the prevalence of sexual dysfunctions after hysterectomy;
3. The identification of risk and protective factors for sexual dysfunctions after hysterectomy;
4. Exploration of the mechanisms (behavioural, cognitive, biological) of CPSP.
- Healt Condition(s) or Problem(s) studiedHysterectomy
- Inclusion criteria1. Age 18 – 60 years;
2. Good command of Dutch language;
3. Elective surgery (in azM Maastricht; CzE Eindhoven; MMC Veldhoven/Eindhoven);
4. Total or subtotal hysterectomy, with or without oophorectomy;
5. Vaginal or abdominal hysterectomy;
6. Laparotomy and laparoscopy;
7. Informed consent.
- Exclusion criteria1. Cancer;
2. Illiteracy;
3. Cognitive impairment (as indicated in the medical record).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-sep-2010
- planned closingdate1-mrt-2013
- Target number of participants500
- InterventionsN/A
- Primary outcomeChronic pain after surgery: Brief pain inventory – short form (BPI-SF) and DN4.
- Secondary outcome1. Physical functioning (SF-36);
2. Global Surgical Recovery (GSR);
3. Depression (CES-D);
4. Optimism (LOTr);
5. General well-being (W-BQ12);
6. Sexual functioning (FSFI).
- Timepoints1. Baseline: 1 week before surgery;
2. Day of surgery - Day 4 after surgery;
3. 3 Months after surgery;
4. 12 Months after surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. H.M.S. Theunissen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Madelon Peters
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University, NWO VICI grant
- PublicationsN/A
- Brief summaryThe prevalence of chronic postoperative pain (CPSP) after hysterectomy ranges from 5 up to 32%.
Etiologic/prognostic research on postoperative recovery traditionally focussed on surgical and anesthesiological factors.

This prospective, observational, multicenter study aims to assess influencing factors for postoperative recovery in a wider perspective.
Apart from somatic factors the interaction between genotype and psychological factors like optimism and resilience will be assessed. Whether surgical intervention leads to epigenetic changes will be studied as well. Finally, the effect of the immunologic response on recovery will be studied.

Primary outcome measure:
Chronic postsurgical pain.

Secondary outcome:
Physical and psychological recovery, sexual functioning.

Population:
500 woman (18-65 years) undergoing elective hysterectomy for benign indication.
Baseline data 1 week before surgery, data during hospital stay day 0-4.
Follow-up at 3 and 12 months postoperative.
- Main changes (audit trail)
- RECORD19-jan-2011 - 25-sep-2011


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