Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728281
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2023-02-04
Brief Title:
Impact of Time on Sexual Function FSFI Score After Hysterectomy
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Recommended Time to Resume Sexual Activity After Hysterectomy Impact on Sexual Function FSFI Score and Complication Rate ISHYS Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISHYS
Brief Summary:
In France more than 62 000 hysterectomies are performed each year Female sexual function is the result of multiple psychological social and physiological factors There is no information in the current literature about the optimum time between the surgery and the sexual relation resumption The primary outcome is to assess the impact of advising time between hysterectomy and sexual relation resumption by using FSFI score Secondaries outcomes are to describe and compare post-operative complications in the two groups of the study to describe the follow-up of the recommendation concerning time between surgery and sexual relation resumption and to describe why this recommendation was not followed This study is based on 4 questionnaires FSFI pre-operative and post-operative pre-operative questionnaire and post-operative questionnaire This is a monocentric comparative of superiority randomised and prospective study Patients are randomised into two groups sexual relation resumption advised 4 weeks after surgery or 8 weeks The inclusion criteria are more than 18 years francophone in sexual activity scheduled for a total hysterectomy for benign indication menometrorrhagia fibroma adenomyosis endometriosis pelvic floor disorders low-grade endometrial cancer considering vaginal laparoscopic and abdominal approach and a written consent Non-inclusion criteria are illiteracy cognitive disorders without social security deprived liberty by judicial or administrative decision psychiatric care patient with legal protection patient incapable of giving consent If our conclusions confirmed our hypothesis it can improve clinical practices by providing additional informations for surgeon and patient to undergo this surgery as serenely as possible
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None