Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.

Conditions
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Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.

Intervention / Treatment
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* Other: shorter hospitalization stay
* Other: questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age between 35 and 70. affiliation to a social security system signed informed consent form disponibility of an responsible and valid accompanying person during 48 hours home situation, less than one hour to go to an adapted structure of care access to a phone Exclusion criteria: comorbidity which will automatically increase the period of hospital stay contraindication in laparoscopy difficulty to understand the protocol no social security cover

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A group : Conventional hospitalization<br>Patients discharged after 3 days hospital stay after laparoscopic hysterectomy | Other: questionnaires<br> <br> |
| Experimental: B group : shorter stay<br>Patients going home within 24 hours discharged the first day after laparoscopic hysterectomy. | Other: shorter hospitalization stay<br> <br> Other: questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessed by the Euroqol EQ-5D | 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. | up to 30th days after the laparoscopic hysterectomy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The assessment will take into account any case of rehospitalization | each day from the date of intervention untill one month after intervention. | 
| Perioperative morbidity |  | from intervention untill one month after intervention | 
| Number of rehospitalization |  | one month after intervention |