Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

NCT04268576 | Completed

• 1 other identifier: 2018-08-CHRMT
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Op Complication

Keywords

hysterectomy; post operative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Overall duration of the hospital stay D-1

  One day before surgery

• Overall duration of the hospital stay day of discharge from hospital

  Up to 30 days

• Duration of fasting pre and post-operative

  Up to 30 days

• Post-operative nausea / vomiting Day 0

  Day of surgery

• Post-operative nausea / vomiting D+1

  One day after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected according to the inclusion and exclusion criteria when they go to the operating room. It is planned to include 74 patients for rehabilitation before the implementation of the protocol and 74 patients after the implementation of the protocol.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville

Metz, 57085, France

Location

Related Publications (1)

• Martin F, Vautrin N, Elnar AA, Goetz C, Becret A. Evaluation of the impact of an enhanced recovery after surgery (ERAS) programme on the quality of recovery in patients undergoing a scheduled hysterectomy: a prospective single-centre before-after study protocol (RAACHYS study). BMJ Open. 2022 Apr 7;12(4):e055822. doi: 10.1136/bmjopen-2021-055822.

  PMID: 35393312 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine BECRET, MD

  CHR Metz-Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: November 18, 2019
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)