Genital Diseases, Female, Hysterectomy, Pain
Conditions
Keywords
Benign gynecological disease, Surgery, Postoperative follow-up strategy, Pain threshold, Chronic pelvic pain, [E04.950.300.399], [C13.351.500], [F02.463.593.710.560], [N02.421.585.722.700], Postoperative Care
Brief summary
The purpose of the study is to investigate the effect of four different follow-up strategies on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions. Furthermore the investigators aim to examine associations between preoperative thresholds for pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain after benign hysterectomy.
Detailed description
Contact sponsor if detailed information is requested.
Interventions
BEHAVIORALFollow-up strategy
Comparison of different follow-up strategies
BEHAVIORALNo contact after discharge
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Women between 18 and 60 years of age. * Women who are scheduled for vaginal or abdominal total or subtotal hysterectomy for benign gynecological diseases (including cervical dysplasia). * Women who understand and speak Swedish fluently. * Women who gives signed informed consent to participate in the study. * Women who have access to a telephone and/or internet.
Exclusion criteria
* Women where the hysterectomy is carried out in association with surgery for genital prolapse * Women with genital malignancies (does not include cervical dysplasia). * Women where the operation is planned or expected to comprise more than the hysterectomy with or without unilateral salpingooophorectomy and appendectomy en passant. * Women with previous bilateral salpingooophorectomy. * Women who are physically disabled to a degree so that mobilization postoperatively cannot be expected as for a normal individual. * Women who are mentally disabled to a degree so she cannot complete the forms in the study or understand the tenor of the participation or it is considered doubtful from an ethical point of view to participate. * Women with psychiatric disease or is on medication for severe psychiatric disease so that the physician consider participation in the study unsuitable. * Women with current drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life as measured by the EQ-5D health index | Six weeks | The Euroqol questionnaire form (EQ-5D) are used for assessing the quality of life. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks. |
| Quality of life as measured by the SF-36 sub scale scores | Six weeks | The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications related to operation | Six weeks | From surgery to six weeks postoperatively |
| Health economy | Up to 1 years | Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work |
| Postoperative symptoms | Six weeks | Selfreported symptoms in the Swedish Postoperative Symptom Questionnaire. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks. |
| Duration of sick-leave | Up to one year | Time from day of surgery to return to work at same level as preoperatively |
| Development of chronic pelvic pain | One year | Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively |
| Consumption of analgesic | Six weeks | Total amount of opioids and non-opioids from surgery to six weeks postoperatively |
Countries
Sweden
Outcome results
None listed