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

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 Overview

• Status: Unknown
• Conditions: Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.
• Intervention / Treatment: Other: questionnaires; Other: shorter hospitalization stay

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chérif YOUSSEF AZER AKLADIOS, Doctor; Phone Number: 0033 3 88 12 74 83; Email: Cherif.YOUSSEF.AZER@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67098
    • Hôptaux Universitaires de Strasbourg, Département de Gynécologie-Obstétrique
    • Contact: Chérif YOUSSEF AZER AKLADIOS, Doctor; Phone Number: 0033 3 88 12 74 83; Email: Cherif.YOUSSEF.AZER@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): July 4, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 5717