Tripedicular HemorrhoidectomyEVHANCT05177016
Evaluation of Outpatient Hemorrhoidectomies at the Paris Saint Joseph Hospital Group
An observational study of Tripedicular Hemorrhoidectomy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tripedicular Hemorrhoidectomy
- How many people
- 397 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an indication for tri-pedicular hemorrhoidectomy, operated on between January 1, 2020 and December 31, 2020.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Tripedicular Hemorrhoidectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with their outpatient care
This outcome corresponds to the satisfaction rate of patient.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
Profile of patients for whom outpatient management would not be desirable
This outcome corresponds to the conversion rate for conventional hospitalization.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start21 Oct 2021
- Primary completion21 Nov 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tripedicular HemorrhoidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent De Parades, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177016
- Sponsor's protocol ID
- EVHA
- Acronym
- EVHA
- Status last verified
- Mar 2023
- First submitted
- 31 Dec 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26547481Soudan 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.
PubMed 28919275Moult 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.
PubMed 25311960Vinson-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.
PubMed 25427629
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Outpatient Hemorrhoidectomies at the Paris Saint Joseph Hospital Group
- ClinicalTrials.gov ID
- NCT05177016
- Acronym / sponsor ID
- EVHA / EVHA
- Conditions
- Tripedicular Hemorrhoidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an indication for tri-pedicular hemorrhoidectomy, operated on between January 1, 2020 and December 31, 2020.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction with their outpatient care
Time frame: Day 1
This outcome corresponds to the satisfaction rate of patient.
2 secondary outcomes
Associated factors of non-satisfaction
Time frame: Day 1
Profile of patients for whom outpatient management would not be desirable
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 26547481Vinson 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.
- Background: PubMed 28919275Soudan 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.
- Background: PubMed 25311960Moult 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.
- Background: PubMed 25427629Vinson-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent De Parades, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tripedicular Hemorrhoidectomy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with their outpatient care (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177016, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.