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

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).

Study Overview

• Status: Completed
• Conditions: Tripedicular Hemorrhoidectomy

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with an indication for tri-pedicular hemorrhoidectomy, operated on between January 1, 2020 and December 31, 2020.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with their outpatient care	This outcome corresponds to the satisfaction rate of patient.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associated factors of non-satisfaction	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.	Day 1
Profile of patients for whom outpatient management would not be desirable	This outcome corresponds to the conversion rate for conventional hospitalization.	Day 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

General Publications

• Vinson Bonnet B, Juguet F; French National Coloproctology Society. Ambulatory proctologic surgery: Recommendations of the French National Coloproctology Society (SNFCP). J Visc Surg. 2015 Dec;152(6):369-72. doi: 10.1016/j.jviscsurg.2015.10.001. Epub 2015 Nov 5. No abstract available.
• Soudan D, Fathallah N, de Parades V. [Open haemorrhoidectomy as an ambulatory procedure, is it reasonable?]. Presse Med. 2017 Nov;46(11):1106-1107. doi: 10.1016/j.lpm.2017.08.003. Epub 2017 Sep 14. No abstract available. French.
• Moult HP, Aubert M, De Parades V. Classical treatment of hemorrhoids. J Visc Surg. 2015 Apr;152(2 Suppl):S3-9. doi: 10.1016/j.jviscsurg.2014.09.012. Epub 2014 Oct 11.
• Vinson-Bonnet B, Higuero T, Faucheron JL, Senejoux A, Pigot F, Siproudhis L. Ambulatory haemorrhoidal surgery: systematic literature review and qualitative analysis. Int J Colorectal Dis. 2015 Apr;30(4):437-45. doi: 10.1007/s00384-014-2073-x. Epub 2014 Nov 28.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): November 21, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EVHA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No