No registrations found.
ID
Source
Brief title
Health condition
Patients undergoing elective hysterectomy.
Baarmoederverwijdering
Sponsors and support
Maastricht University
Department of Clinical Psychological Science
P.O. Box 616
6200 MD Maastricht
The Netherlands
Phone: 0031-(0)433881603
Prof. Dr. Marco Marcus,
Anaesthesiology, Maastricht University Medical Center+ (MUMC+)
Phone 0031-(0)433875606
E-mail: m.marcus@mumc.nl
Address: P. Debyelaan 25, 6229 HX Maastricht
the Netherlands
Dep. of Clinical Psychological Science, Maastricht University. Phone 0031-(0)433881603
Dep. of Anaesthesiology, MUMC+. Phone 0031-(0)43-3875606
Intervention
Outcome measures
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).
Background 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.
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.
Study objective
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.
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.
Study design
1. Baseline: 1 week before surgery;
2. Day of surgery - Day 4 after surgery;
3. 3 Months after surgery;
4. 12 Months after surgery.
Intervention
N/A
Anaesthesiology
P. Debyelaan 25
H.M.S. Theunissen
Maastricht 6229 HX
The Netherlands
+31 (0)43 3876543
maurice.theunissen@mumc.nl
Anaesthesiology
P. Debyelaan 25
H.M.S. Theunissen
Maastricht 6229 HX
The Netherlands
+31 (0)43 3876543
maurice.theunissen@mumc.nl
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;
2. Illiteracy;
3. Cognitive impairment (as indicated in the medical record).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2576 |
| NTR-old | NTR2702 |
| Other | MEC Maastricht University : 10-05-001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |