Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

Post-Op Complication Clinical Trial

— RAACHYS  

Official title:

Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268576
• Other study ID #: 2018-08-CHRMT
• Status: Completed
• Start date: November 18, 2019
• Est. completion date: April 15, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Op Complication
• Postoperative Complications

Locations

Country	Name	City	State
France	CHR Metz-Thionville	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall duration of the hospital stay D-1	Overall duration of the hospital stay in days	One day before surgery
Secondary	Overall duration of the hospital stay day of discharge from hospital	Overall duration of the hospital stay in days	Up to 30 days
Secondary	Duration of fasting pre and post-operative	Duration of fasting pre and post-operative in hours	Up to 30 days
Secondary	Post-operative nausea / vomiting Day 0	Occurrence of nausea / vomiting postoperative (yes / no)	Day of surgery
Secondary	Post-operative nausea / vomiting D+1	Occurrence of nausea / vomiting postoperative (yes / no)	One day after surgery
Secondary	Post-operative nausea / vomiting day of hospital discharge	Occurrence of nausea / vomiting postoperative (yes / no)	Up to 30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to return gastrointestinal function	Transit recovery time in hours	Up to 30 days
Secondary	Enhancement of gastrointestinal motility on Day 0	Whether or not chewing gum is taken (yes/no)	day 0
Secondary	Enhancement of gastrointestinal motility on day 1	whether or not chewing gum is taken (yes/no)	One day after surgery
Secondary	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
Secondary	Presence of a urinary catheter or drain in postoperative	Presence of a urinary catheter or drain in postoperative (yes / no)	day 0
Secondary	Time before first standing	Time before first standing in hours	Up to 30 days
Secondary	occurrence of postoperative complications	occurrence of postoperative complications (resumption of surgery at 30 days)	day 30
Secondary	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
Secondary	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
Secondary	Rate of laparotomy	percentage	day 0
Secondary	Mobility on day 0	The time between the end of surgery and the first time to get up in hours,	day 0
Secondary	Mobility on day 1	The time between the end of surgery and the first time to get up in hours	One day after surgery
Secondary	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