EVHA: Evaluation of Outpatient Hemorrhoidectomies at the Paris Saint Joseph Hospital Group

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05177016
Collaborator
(none)
397
1
14.3
27.7

Study Details

Study Description

Brief Summary

Hemorrhoidal disease is a frequent and disabling condition that is treated medically and surgically. Tri-pedicular hemorrhoidectomy is the most commonly used surgical technique in France. Due to the restrictive postoperative course (pain, secondary risk of bleeding, asthenia, local care several times a day, transit disorders, urinary disorders, nausea/vomiting), conventional hospitalization was preferred to outpatient surgery until 2015 in our department. The motivation to practice ambulatory surgery is in order to satisfy the patients on the one hand and to improve the economic cost of the management on the other hand. According to the HAS, this is a national priority in order to optimize the supply of care. However, situations such as the absence of an accompanying person, the presence of significant co-morbidities or the use of treatment modifying haemostasis do not allow such surgery to be performed on an outpatient basis. Thanks to the implementation of a dedicated care pathway, outpatient tri-pedicular hemorrhoidectomy at the Paris Saint-Joseph Hospital Group has increased from less than 5% in 2015 to more than 80% in 2021. Outpatient care remains a key criterion for the patient in the context of surgical management.

The objective of this work is to evaluate patient satisfaction with this type of care pathway and to identify the factors associated with dissatisfaction with outpatient care. The secondary objectives are to determine the associated factors of non-satisfaction, the profile of patients for whom outpatient care would not be desirable, to determine the actions to be taken to ensure that outpatient care is provided in the best possible way, to homogenize outpatient care within the department (oral information and written support before the operation, anticipation of postoperative measures (prescriptions and postoperative appointments given during the pre-operative consultation), postoperative liaison file given to the patient on discharge).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    397 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Outpatient Hemorrhoidectomies at the Paris Saint Joseph Hospital Group
    Actual Study Start Date :
    Oct 21, 2021
    Actual Primary Completion Date :
    Nov 21, 2021
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Patient satisfaction with their outpatient care [Day 1]

      This outcome corresponds to the satisfaction rate of patient.

    Secondary Outcome Measures

    1. Associated factors of non-satisfaction [Day 1]

      This outcome corresponds to the comparison of Satisfaction null or mediocre to good or excellent, No to Yes if it was to be done again in Ambulatory, No to Yes if it was to be advised a hemorrhoidectomy in ambulatory to a relative.

    2. Profile of patients for whom outpatient management would not be desirable [Day 1]

      This outcome corresponds to the conversion rate for conventional hospitalization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient whose age ≥ 18 years

    • Patient with an indication for tri-pedicular hemorrhoidectomy

    • Patient operated on between January 1, 2020 and December 31, 2020

    • French-speaking patient

    Exclusion Criteria:
    • Patient under guardianship or curatorship

    • Patient deprived of liberty

    • Patient under court protection

    • Patient who objects to the use of his or her data for this research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Vincent De Parades, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05177016
    Other Study ID Numbers:
    • EVHA
    First Posted:
    Jan 4, 2022
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 4, 2022