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

NCT ID: NCT02150200

Last Updated: 2014-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

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.

Detailed Description

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Conditions

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Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A group : Conventional hospitalization

Patients discharged after 3 days hospital stay after laparoscopic hysterectomy

Group Type OTHER

questionnaires

Intervention Type OTHER

B group : shorter stay

Patients going home within 24 hours discharged the first day after laparoscopic hysterectomy.

Group Type EXPERIMENTAL

shorter hospitalization stay

Intervention Type OTHER

questionnaires

Intervention Type OTHER

Interventions

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shorter hospitalization stay

Intervention Type OTHER

questionnaires

Intervention Type OTHER

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôptaux Universitaires de Strasbourg, Département de Gynécologie-Obstétrique

Strasbourg, , France

Site Status

Countries

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France

Central Contacts

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Chérif YOUSSEF AZER AKLADIOS, Doctor

Role: CONTACT

3 88 12 74 83 ext. 0033

Facility Contacts

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Chérif YOUSSEF AZER AKLADIOS, Doctor

Role: primary

3 88 12 74 83 ext. 0033

Other Identifiers

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5717

Identifier Type: -

Identifier Source: org_study_id

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