Clinical trial NCT04268576: Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.
Official title: Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Op Complication
Keywords: hysterectomy
post operative
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected according to the inclusion and exclusion criteria when they go to the operating room. It is planned to include 74 patients for rehabilitation before the implementation of the protocol and 74 patients after the implementation of the protocol.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the QoR-15 score D1
timeFrame: day 1
Secondary outcomes:
measure: Overall duration of the hospital stay D-1
timeFrame: One day before surgery
measure: Overall duration of the hospital stay day of discharge from hospital
timeFrame: Up to 30 days
measure: Duration of fasting pre and post-operative
timeFrame: Up to 30 days
measure: Post-operative nausea / vomiting Day 0
timeFrame: Day of surgery
measure: Post-operative nausea / vomiting D+1
timeFrame: One day after surgery
measure: Post-operative nausea / vomiting day of hospital discharge
timeFrame: Up to 30 days
measure: Intraoperative maximum Visual Analog Scale (VAS) on day 0
timeFrame: day 0
measure: Intraoperative maximum visual analog scale (VAS) on day 1
timeFrame: One day after surgery
measure: Intraoperative maximum visual analog scale (VAS) on day of discharge from hospital
timeFrame: Up to 30 days
measure: Time to return gastrointestinal function
timeFrame: Up to 30 days
measure: Enhancement of gastrointestinal motility on Day 0
timeFrame: day 0
measure: Enhancement of gastrointestinal motility on day 1
timeFrame: One day after surgery
measure: Enhancement of gastrointestinal motility on the day of discharge from the hospital
timeFrame: Up to 30 days
measure: Presence of a urinary catheter or drain in postoperative
timeFrame: day 0
measure: Time before first standing
timeFrame: Up to 30 days
measure: occurrence of postoperative complications
timeFrame: day 30
measure: Evaluation of the QoR-15 score D0
timeFrame: Day 0
measure: Evaluation of the QoR-15 score D-1
timeFrame: Day -1
measure: Rate of laparotomy
timeFrame: day 0
measure: Mobility on day 0
timeFrame: day 0
measure: Mobility on day 1
timeFrame: One day after surgery
measure: Mobility on the day of discharge from the hospital
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville
Study officials:
affiliation: CHR Metz-Thionville
name: Antoine BECRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.