|- candidate number||8971|
|- NTR Number||NTR2702|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jan-2011|
|- Secondary IDs||10-05-001 MEC Maastricht University|
|- Public Title||Herstel na een baarmoederoperatie: Onderzoek naar beïnvloedende factoren.|
|- Scientific Title||Recovery after hysterectomy: A study into influencing factors.|
|- hypothesis||Primary 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.
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) studied||Hysterectomy|
|- Inclusion criteria||1. 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 criteria||1. Cancer;|
3. Cognitive impairment (as indicated in the medical record).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||22-sep-2010|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||500|
|- Primary outcome||Chronic pain after surgery: Brief pain inventory – short form (BPI-SF) and DN4. |
|- Secondary outcome||1. 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).
|- Timepoints||1. 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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. H.M.S. Theunissen|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Madelon Peters|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University, NWO VICI grant|
|- Brief summary||The 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.
Physical and psychological recovery, sexual functioning.
500 woman (18-65 years) undergoing elective hysterectomy for benign
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)|
|- RECORD||19-jan-2011 - 25-sep-2011|