Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.
- Conditions
- Post-Op Complication
- Registration Number
- NCT04268576
- Lead Sponsor
- Centre Hospitalier Régional Metz-Thionville
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 220
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the QoR-15 score D1 day 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.
- Secondary Outcome Measures
Name Time Method Overall duration of the hospital stay day of discharge from hospital Up to 30 days Overall duration of the hospital stay in days
Duration of fasting pre and post-operative Up to 30 days Duration of fasting pre and post-operative in hours
Overall duration of the hospital stay D-1 One day before surgery Overall duration of the hospital stay in days
Post-operative nausea / vomiting Day 0 Day of surgery Occurrence of nausea / vomiting postoperative (yes / no)
Post-operative nausea / vomiting day of hospital discharge Up to 30 days Occurrence of nausea / vomiting postoperative (yes / no)
Time to return gastrointestinal function Up to 30 days Transit recovery time in hours
Post-operative nausea / vomiting D+1 One day after surgery Occurrence of nausea / vomiting postoperative (yes / no)
Intraoperative maximum Visual Analog Scale (VAS) on day 0 day 0 Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)
Intraoperative maximum visual analog scale (VAS) on day 1 One day after surgery Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)
Intraoperative maximum visual analog scale (VAS) on day of discharge from hospital Up to 30 days Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)
Enhancement of gastrointestinal motility on day 1 One day after surgery whether or not chewing gum is taken (yes/no)
Time before first standing Up to 30 days Time before first standing in hours
Evaluation of the QoR-15 score D-1 Day -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.Rate of laparotomy day 0 percentage
Enhancement of gastrointestinal motility on Day 0 day 0 Whether or not chewing gum is taken (yes/no)
Evaluation of the QoR-15 score D0 Day 0 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.Enhancement of gastrointestinal motility on the day of discharge from the hospital Up to 30 days whether or not chewing gum is taken (yes/no)
Presence of a urinary catheter or drain in postoperative day 0 Presence of a urinary catheter or drain in postoperative (yes / no)
Mobility on day 1 One day after surgery The time between the end of surgery and the first time to get up in hours
Mobility on the day of discharge from the hospital Up to 30 days The time between the end of surgery and the first time to get up in hours
occurrence of postoperative complications day 30 occurrence of postoperative complications (resumption of surgery at 30 days)
Mobility on day 0 day 0 The time between the end of surgery and the first time to get up in hours,
Trial Locations
- Locations (1)
CHR Metz-Thionville
🇫🇷Metz, France