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

University Hospital, Strasbourg, France44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.

Interventions

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: up to 30th days after the laparoscopic hysterectomy.

Secondary Outcomes

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.

Time frame: In pre-operative time and 30 days after the hysterectomy.

Patient satisfaction

Time frame: Patient satisfaction assessed one month after intervention

Evaluation of pain by Visual Analog Scale for Pain and by analgesic drugs consumption

Time frame: 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

Time frame: 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).

Time frame: 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

Time frame: each day from the date of intervention untill one month after intervention.

Perioperative morbidity

Time frame: from intervention untill one month after intervention

Number of rehospitalization

Time frame: one month after intervention