Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy. (RAACHYS)

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.

Study Overview

• Status: Completed
• Conditions: Post-Op Complication

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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

• Study Contact: Name: Antoine BECRET, MD; Phone Number: +33 387 18 64 19; Email: a.becret@chr-metz-thionville.fr
• Study Contact Backup: Name: Arpiné EL NAR, PhD; Phone Number: +33 3 87 55 77 66; Email: a.elnar@chr-metz-thionville.fr

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the QoR-15 score D1	The QoR score 15 is a self-questionnaire of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support. These 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions. A variation of 8 points is considered significant.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall duration of the hospital stay D-1	Overall duration of the hospital stay in days	One day before surgery
Overall duration of the hospital stay day of discharge from hospital	Overall duration of the hospital stay in days	Up to 30 days
Duration of fasting pre and post-operative	Duration of fasting pre and post-operative in hours	Up to 30 days
Post-operative nausea / vomiting Day 0	Occurrence of nausea / vomiting postoperative (yes / no)	Day of surgery
Post-operative nausea / vomiting D+1	Occurrence of nausea / vomiting postoperative (yes / no)	One day after surgery
Post-operative nausea / vomiting day of hospital discharge	Occurrence of nausea / vomiting postoperative (yes / no)	Up to 30 days
Intraoperative maximum Visual Analog Scale (VAS) on day 0	Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)	day 0
Intraoperative maximum visual analog scale (VAS) on day 1	Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)	One day after surgery
Intraoperative maximum visual analog scale (VAS) on day of discharge from hospital	Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)	Up to 30 days
Time to return gastrointestinal function	Transit recovery time in hours	Up to 30 days
Enhancement of gastrointestinal motility on Day 0	Whether or not chewing gum is taken (yes/no)	day 0
Enhancement of gastrointestinal motility on day 1	whether or not chewing gum is taken (yes/no)	One day after surgery
Enhancement of gastrointestinal motility on the day of discharge from the hospital	whether or not chewing gum is taken (yes/no)	Up to 30 days
Presence of a urinary catheter or drain in postoperative	Presence of a urinary catheter or drain in postoperative (yes / no)	day 0
Time before first standing	Time before first standing in hours	Up to 30 days
occurrence of postoperative complications	occurrence of postoperative complications (resumption of surgery at 30 days)	day 30
Evaluation of the QoR-15 score D0	The QoR score 15 is a self-questionnaire of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support. These 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions. A variation of 8 points is considered significant.	Day 0
Evaluation of the QoR-15 score D-1	The QoR score 15 is a self-questionnaire of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support. These 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions. A variation of 8 points is considered significant.	Day -1
Rate of laparotomy	percentage	day 0
Mobility on day 0	The time between the end of surgery and the first time to get up in hours,	day 0
Mobility on day 1	The time between the end of surgery and the first time to get up in hours	One day after surgery
Mobility on the day of discharge from the hospital	The time between the end of surgery and the first time to get up in hours	Up to 30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: hysterectomy; post operative
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2018-08-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No