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Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04268576
Acronym
RAACHYS
Enrollment
220
Registered
2020-02-13
Start date
2019-11-18
Completion date
2023-04-15
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Op Complication

Keywords

hysterectomy, post operative

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.

Interventions

None listed

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the QoR-15 score D1day 1The 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

MeasureTime frameDescription
occurrence of postoperative complicationsday 30occurrence of postoperative complications (resumption of surgery at 30 days)
Overall duration of the hospital stay D-1One day before surgeryOverall duration of the hospital stay in days
Overall duration of the hospital stay day of discharge from hospitalUp to 30 daysOverall duration of the hospital stay in days
Duration of fasting pre and post-operativeUp to 30 daysDuration of fasting pre and post-operative in hours
Evaluation of the QoR-15 score D0Day 0The 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.
Post-operative nausea / vomiting Day 0Day of surgeryOccurrence of nausea / vomiting postoperative (yes / no)
Post-operative nausea / vomiting D+1One day after surgeryOccurrence of nausea / vomiting postoperative (yes / no)
Post-operative nausea / vomiting day of hospital dischargeUp to 30 daysOccurrence of nausea / vomiting postoperative (yes / no)
Intraoperative maximum Visual Analog Scale (VAS) on day 0day 0Maximum 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 1One day after surgeryMaximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)
Time before first standingUp to 30 daysTime before first standing in hours
Time to return gastrointestinal functionUp to 30 daysTransit recovery time in hours
Enhancement of gastrointestinal motility on Day 0day 0Whether or not chewing gum is taken (yes/no)
Enhancement of gastrointestinal motility on day 1One day after surgerywhether or not chewing gum is taken (yes/no)
Enhancement of gastrointestinal motility on the day of discharge from the hospitalUp to 30 dayswhether or not chewing gum is taken (yes/no)
Presence of a urinary catheter or drain in postoperativeday 0Presence of a urinary catheter or drain in postoperative (yes / no)
Evaluation of the QoR-15 score D-1Day -1The 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 laparotomyday 0percentage
Mobility on day 0day 0The time between the end of surgery and the first time to get up in hours,
Mobility on day 1One day after surgeryThe time between the end of surgery and the first time to get up in hours
Mobility on the day of discharge from the hospitalUp to 30 daysThe time between the end of surgery and the first time to get up in hours
Intraoperative maximum visual analog scale (VAS) on day of discharge from hospitalUp to 30 daysMaximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026