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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04268576
Other study ID # 2018-08-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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