Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

NCT ID: NCT04268576

Last Updated: 2023-05-06

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

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2023-04-15

Brief Summary

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It is an observational study, prospective in order to assess the impact of the implementation of an early rehabilitation program on post-operative recovery. this is measured by the qOR15 questionnaire in patients operated on for a programmed hysterectomy, it takes place in the gynecology department of the CHR Metz-Thionville hospital.

Detailed Description

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This program implemented will comply with HAS recommendations. The only change in management for patients participating in the study is the completion of the self-questionnaire QOR-15 on D-1 (the day before surgery), D0 (the day of the surgery) and D1 (the day after the surgery).

It is planned to include 74 patients before the implementation of the early rehabilitation protocol and 74 patients after the implementation of the early rehabilitation protocol. The total duration of inclusion is established at 18 months.

The measures applied should improve the patient's well-being and accelerate his return to normal life and therefore reduce the length of his stay.

Conditions

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Post-Op Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Indication of a scheduled hysterectomy
* Presence of a utero-ovarian affection, deemed resectable and requiring a regulated hysterectomy (outside the context of the emergency) associated or not with pelvic or lumbar-aortic dissection.
* classified ASA 1 to 3
* informed about the principles of improved rehabilitation by the surgeon and the anesthesiologist + written document (accessible on the site www.grace-asso.fr).
* able to return home after discharge from the hospital, having a telephone and being able to contact their doctor or the service if necessary or transferred to a convalescent home at their request.

Exclusion Criteria

* Patients included in another study
* Refusal to use data by the patient
* Inability to respond to self-questionnaires due to cognitive impairment, difficulties in reading or understanding the French language
* Patients included in another study
* Patients with severe or unbalanced associated conditions
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine BECRET, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz-Thionville

Locations

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CHR Metz-Thionville

Metz, , France

Site Status

Countries

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France

References

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Martin F, Vautrin N, Elnar AA, Goetz C, Becret A. Evaluation of the impact of an enhanced recovery after surgery (ERAS) programme on the quality of recovery in patients undergoing a scheduled hysterectomy: a prospective single-centre before-after study protocol (RAACHYS study). BMJ Open. 2022 Apr 7;12(4):e055822. doi: 10.1136/bmjopen-2021-055822.

Reference Type DERIVED
PMID: 35393312 (View on PubMed)

Other Identifiers

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2018-08-CHRMT

Identifier Type: -

Identifier Source: org_study_id

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