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Completed

NCT Number: NCT04268576

Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

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.

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Key information

Conditions

Post-Op Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHR Metz-Thionville

Metz, 57085, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of the QoR-15 score D1

    Time frame: 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 outcomes

  1. Overall duration of the hospital stay D-1

    Time frame: One day before surgery

    Overall duration of the hospital stay in days

  2. Overall duration of the hospital stay day of discharge from hospital

    Time frame: Up to 30 days

    Overall duration of the hospital stay in days

  3. Duration of fasting pre and post-operative

    Time frame: Up to 30 days

    Duration of fasting pre and post-operative in hours

  4. Post-operative nausea / vomiting Day 0

    Time frame: Day of surgery

    Occurrence of nausea / vomiting postoperative (yes / no)

  5. Post-operative nausea / vomiting D+1

    Time frame: One day after surgery

    Occurrence of nausea / vomiting postoperative (yes / no)

  6. Post-operative nausea / vomiting day of hospital discharge

    Time frame: Up to 30 days

    Occurrence of nausea / vomiting postoperative (yes / no)

  7. Intraoperative maximum Visual Analog Scale (VAS) on day 0

    Time frame: day 0

    Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)

  8. Intraoperative maximum visual analog scale (VAS) on day 1

    Time frame: One day after surgery

    Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)

  9. Intraoperative maximum visual analog scale (VAS) on day of discharge from hospital

    Time frame: Up to 30 days

    Maximum Visual Analog Scale (VAS) (from 0 to 100mm), 0 mm (minimum, none) 100 mm (maximum, worst pain possible)

  10. Time to return gastrointestinal function

    Time frame: Up to 30 days

    Transit recovery time in hours

  11. Enhancement of gastrointestinal motility on Day 0

    Time frame: day 0

    Whether or not chewing gum is taken (yes/no)

  12. Enhancement of gastrointestinal motility on day 1

    Time frame: One day after surgery

    whether or not chewing gum is taken (yes/no)

  13. Enhancement of gastrointestinal motility on the day of discharge from the hospital

    Time frame: Up to 30 days

    whether or not chewing gum is taken (yes/no)

  14. Presence of a urinary catheter or drain in postoperative

    Time frame: day 0

    Presence of a urinary catheter or drain in postoperative (yes / no)

  15. Time before first standing

    Time frame: Up to 30 days

    Time before first standing in hours

  16. occurrence of postoperative complications

    Time frame: day 30

    occurrence of postoperative complications (resumption of surgery at 30 days)

  17. Evaluation of the QoR-15 score D0

    Time frame: 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.

  18. Evaluation of the QoR-15 score D-1

    Time frame: 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.

  19. Rate of laparotomy

    Time frame: day 0

    percentage

  20. Mobility on day 0

    Time frame: day 0

    The time between the end of surgery and the first time to get up in hours,

  21. Mobility on day 1

    Time frame: One day after surgery

    The time between the end of surgery and the first time to get up in hours

  22. Mobility on the day of discharge from the hospital

    Time frame: Up to 30 days

    The time between the end of surgery and the first time to get up in hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Acronym: RAACHYS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2020
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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