NCT02150200

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

July 4, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

May 26, 2014

Last Update Submit

July 3, 2014

Conditions

Women Who Undergo a Laparoscopic Hysterectomy for Benign Disease.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

A group : Conventional hospitalization

OTHER

Patients discharged after 3 days hospital stay after laparoscopic hysterectomy

Other: questionnaires

B group : shorter stay

EXPERIMENTAL

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

Other: shorter hospitalization stayOther: questionnaires

Interventions

shorter hospitalization stayOTHER
B group : shorter stay
questionnairesOTHER
A group : Conventional hospitalizationB group : shorter stay

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • comorbidity which will automatically increase the period of hospital stay
  • contraindication in laparoscopy
  • difficulty to understand the protocol
  • no social security cover

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôptaux Universitaires de Strasbourg, Département de Gynécologie-Obstétrique

Strasbourg, 67098, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Chérif YOUSSEF AZER AKLADIOS, Doctor

CONTACT

3 88 12 74 83Cherif.YOUSSEF.AZER@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2015

Last Updated

July 4, 2014

Record last verified: 2014-07

Locations

FR(1)