Clinical trial NCT02150200: Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.
Official title: Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life assessed by the Euroqol EQ-5D
timeFrame: up to 30th days after the laparoscopic hysterectomy.
Secondary outcomes:
measure: 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.
timeFrame: In pre-operative time and 30 days after the hysterectomy.
measure: Patient satisfaction
timeFrame: Patient satisfaction assessed one month after intervention
measure: Evaluation of pain by Visual Analog Scale for Pain and by analgesic drugs consumption
timeFrame: the day of intervention, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days and 30 days after intervention
measure: Anxiety assessment by the State trait anxiety inventory forme Y-A
timeFrame: before intervention, the firt day, the second day, the third day after intervention, one week after intervention and one month after intervention.
measure: Patient recovery and discharge after intervention assessed by Post-Anaesthetic Discharge Scoring System (PADSS score).
timeFrame: 8 hours after laparoscopic surgery
measure: 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.
timeFrame: each day from the date of intervention untill one month after intervention.
measure: Perioperative morbidity
timeFrame: from intervention untill one month after intervention
measure: Number of rehospitalization
timeFrame: one month after intervention
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôptaux Universitaires de Strasbourg, Département de Gynécologie-Obstétrique
Study officials:
References: