Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.
Overview
- Phase
- Not Applicable
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Quality of life assessed by the Euroqol EQ-5D
Overview
Brief Summary
Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000 hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The percentage of hysterectomies performed laparoscopically is increasing. The advantage of laparoscopy include fewer infections, less operative pain, faster recovery time and shorter hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy reduced to 3-4 days.
The study hypothesis is that a shorter postoperative stay does not decrease the quality of life of the patients.
This study will compare the evolution of quality of life (with a questionnaire concerning measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3 days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Quality of life assessed by the Euroqol EQ-5D
Time Frame: up to 30th days after the laparoscopic hysterectomy.
Measure of quality of life with a questionnaire concerning health related quality of life (the Euroqol EQ-5D).The patients will complete the questionnaire at up to 30th days after the laparoscopic hysterectomy.
Secondary Outcomes
- Perioperative morbidity(from intervention untill one month after intervention)
- Number of rehospitalization(one month after intervention)
- Quality of life with assessed by the short SF-36 score (the 36 items Short Form Health Survey). in pre-operative time and 30 days after the hysterectomy.(In pre-operative time and 30 days after the hysterectomy.)
- Patient satisfaction(Patient satisfaction assessed one month after intervention)
- Evaluation of pain by Visual Analog Scale for Pain and by analgesic drugs consumption(the day of intervention, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days and 30 days after intervention)
- Anxiety assessment by the State trait anxiety inventory forme Y-A(before intervention, the firt day, the second day, the third day after intervention, one week after intervention and one month after intervention.)
- Patient recovery and discharge after intervention assessed by Post-Anaesthetic Discharge Scoring System (PADSS score).(8 hours after laparoscopic surgery)
- Comparison between a hospital stay of 3-4 days after laparoscopic hysterectomy costs and hospital stay of 1day after laparoscopic hysterectomy costs from the day of intervention until one month after intervention.(each day from the date of intervention untill one month after intervention.)