Post-Op Complication Clinical Trial
— RAACHYSOfficial title:
Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.
Verified date | May 2023 |
Source | Centre Hospitalier Régional Metz-Thionville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHR Metz-Thionville | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
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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