A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hysterectomy
- Sponsor
- University Hospital, Linkoeping
- Enrollment
- 525
- Locations
- 5
- Primary Endpoint
- Quality of life as measured by the EQ-5D health index
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Preben Kjolhede, MD, professor
Professor
University Hospital, Linkoeping
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Quality of life as measured by the EQ-5D health index
Time Frame: 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
Time Frame: Six weeks
The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks
Secondary Outcomes
- Complications related to operation(Six weeks)
- Health economy(Up to 1 years)
- Consumption of analgesic(Six weeks)
- Duration of sick-leave(Up to one year)
- Postoperative symptoms(Six weeks)
- Development of chronic pelvic pain(One year)