Ambulatory SurgeryAMBUGYNNCT05176990
Evaluation of the Safety of Ambulatory Surgery in Senology and Gynecology Within the Paris Saint-Joseph Hospital Group
An observational study of Ambulatory Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Ambulatory surgery is defined as "surgical procedures scheduled and performed under technical conditions that imperatively require the safety of an operating room, under an anesthesia of variable mode and followed by a postoperative monitoring allowing, without increased risk, the discharge of the patient on the same… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ambulatory Surgery
- How many people
- 991 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2021to 10 Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient eligible for outpatient surgery, operated in gynecology at HPSJ in UCA from 01/05/2020 to 31/05/2021.
Who may be able to join
- Patient whose age ≥ 18 years
- Patient eligible for outpatient surgery
- Patient operated in gynecology at HPSJ in UCA from 01/05/2020 to 31/05/2021
- French-speaking patient
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of her data for this research
Trial locations and contacts
1 site in 1 country.
About this study
Ambulatory surgery is defined as "surgical procedures scheduled and performed under technical conditions that imperatively require the safety of an operating room, under an anesthesia of variable mode and followed by a postoperative monitoring allowing, without increased risk, the discharge of the patient on the same day of his intervention.
It therefore does not include hospital accommodation and represents an alternative to traditional hospitalization.
Read more
Ambulatory surgery is of interest in a growing number of situations. Its interest lies on the one hand in the obvious economic interest and in the fact that this model corresponds to the expectations of patients in 2021, allowing them to return to their usual living environment as soon as possible. It also reduces the risk of infections associated with care, due to the short duration of the stay and the minimally invasive surgical techniques, without compromising safety conditions.
It therefore requires a well-designed circuit, ensuring the quality and safety of care at all stages, to allow an early return home without risk.
Since 2011, the French National Authority for Health has defined outpatient surgery as a priority objective in France, setting a target of 70% of surgeries performed as outpatient procedures by 2022.
Currently, less than 50% of surgery in France is performed on an outpatient basis, compared to 65% in Belgium, in Northern European countries and even 85% in the United States.
As early as 2001, the Assurance Maladie identified gynecological surgery as a surgery with a high potential for development in ambulatory care, particularly breast surgery and gynecological laparoscopy.
Many gynecological surgeries benefit from this type of management, in particular because of the low level of patient comorbidity, but the risks of failure are difficult to predict because of the small amount of data available in the literature, particularly in gynecology.
Paris Saint-Joseph Hospital inaugurated the Ambulatory Surgery Unit (ASU) in 2018, with a well-defined patient pathway, and outpatient surgical activity in gynecology represents 15% of activity among the 9 surgical disciplines.
The aim of this study is therefore to evaluate the safety of ambulatory management of patients operated on at the GHPSJ in the ambulatory surgery unit, in the context of breast surgery or gynaecological surgery, by assessing complications and their risk factors.
- Conditions
- Ambulatory Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate of ambulatory surgery
This outcome corresponds to a composite criterion corresponding to the Conversion of stay to traditional hospitalization Or revision of surgery within 30 days Or re-hospitalization within 30 days Or emergency room visit within 30 days.
Measured: Day 30
Secondary outcomes (4)
Conversion of stay to traditional hospitalization
This outcome corresponds to the number of ambulatory surgery conversion of stay to traditional hospitalization.
Measured: Day 30
Revision of surgery
This outcome corresponds to the rate of revision of surgery within 30 days.
Measured: Day 30
Re-hospitalization
This outcome corresponds to the rate of re-hospitalization within 30 days.
Measured: Day 30
Emergency room visit
This outcome corresponds to the rate of emergency room visit within 30 days.
Measured: Day 30
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 start19 Nov 2021
- Primary completion19 Dec 2021
- Study completion10 Oct 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 Ambulatory SurgeryStudies 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
- 991 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Severine ALRAN, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176990
- Sponsor's protocol ID
- AMBUGYN
- Acronym
- AMBUGYN
- 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
Bredart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S, Chie WC, Hammerlid E, Arraras JI, Efficace F, Rodary C, Schraub S, Costantini M, Costantini A, Joly F, Sezer O, Razavi D, Mehlitz M, Bielska-Lasota M, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group and Quality of Life Unit. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005 Sep;41(14):2120-31. doi: 10.1016/j.ejca.2005.04.041.
PubMed 16182120Marchal F, Dravet F, Classe JM, Campion L, Francois T, Labbe D, Robard S, Theard JL, Pioud R. Post-operative care and patient satisfaction after ambulatory surgery for breast cancer patients. Eur J Surg Oncol. 2005 Jun;31(5):495-9. doi: 10.1016/j.ejso.2005.01.014.
PubMed 15922885Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.
PubMed 32407900Engbaek J, Bartholdy J, Hjortso NC. Return hospital visits and morbidity within 60 days after day surgery: a retrospective study of 18,736 day surgical procedures. Acta Anaesthesiol Scand. 2006 Sep;50(8):911-9. doi: 10.1111/j.1399-6576.2006.01090.x.
PubMed 16923084
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 the Safety of Ambulatory Surgery in Senology and Gynecology Within the Paris Saint-Joseph Hospital Group
- ClinicalTrials.gov ID
- NCT05176990
- Acronym / sponsor ID
- AMBUGYN / AMBUGYN
- Conditions
- Ambulatory Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 991 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 10 Oct 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.
Ambulatory surgery is defined as "surgical procedures scheduled and performed under technical conditions that imperatively require the safety of an operating room, under an anesthesia of variable mode and followed by a postoperative monitoring allowing, without increased risk, the discharge of the patient on the same day of his intervention.
It therefore does not include hospital accommodation and represents an alternative to traditional hospitalization.
Ambulatory surgery is of interest in a growing number of situations. Its interest lies on the one hand in the obvious economic interest and in the fact that this model corresponds to the expectations of patients in 2021, allowing them to return to their usual living environment as soon as possible. It also reduces the risk of infections associated with care, due to the short duration of the stay and the minimally invasive surgical techniques, without compromising safety conditions.
It therefore requires a well-designed circuit, ensuring the quality and safety of care at all stages, to allow an early return home without risk.
Since 2011, the French National Authority for Health has defined outpatient surgery as a priority objective in France, setting a target of 70% of surgeries performed as outpatient procedures by 2022.
Currently, less than 50% of surgery in France is performed on an outpatient basis, compared to 65% in Belgium, in Northern European countries and even 85% in the United States.
As early as 2001, the Assurance Maladie identified gynecological surgery as a surgery with a high potential for development in ambulatory care, particularly breast surgery and gynecological laparoscopy.
Many gynecological surgeries benefit from this type of management, in particular because of the low level of patient comorbidity, but the risks of failure are difficult to predict because of the small amount of data available in the literature, particularly in gynecology.
Paris Saint-Joseph Hospital inaugurated the Ambulatory Surgery Unit (ASU) in 2018, with a well-defined patient pathway, and outpatient surgical activity in gynecology represents 15% of activity among the 9 surgical disciplines.
The aim of this study is therefore to evaluate the safety of ambulatory management of patients operated on at the GHPSJ in the ambulatory surgery unit, in the context of breast surgery or gynaecological surgery, by assessing complications and their risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient eligible for outpatient surgery, operated in gynecology at HPSJ in UCA from 01/05/2020 to 31/05/2021.
Key inclusion criteria (4 listed)
- Patient whose age ≥ 18 years
- Patient eligible for outpatient surgery
- Patient operated in gynecology at HPSJ in UCA from 01/05/2020 to 31/05/2021
- French-speaking patient
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of 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
Complication rate of ambulatory surgery
Time frame: Day 30
This outcome corresponds to a composite criterion corresponding to the Conversion of stay to traditional hospitalization Or revision of surgery within 30 days Or re-hospitalization within 30 days Or emergency room visit within 30 days.
4 secondary outcomes
Conversion of stay to traditional hospitalization
Time frame: Day 30
Revision of surgery
Time frame: Day 30
Re-hospitalization
Time frame: Day 30
Emergency room visit
Time frame: Day 30
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 16182120Bredart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S, Chie WC, Hammerlid E, Arraras JI, Efficace F, Rodary C, Schraub S, Costantini M, Costantini A, Joly F, Sezer O, Razavi D, Mehlitz M, Bielska-Lasota M, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group and Quality of Life Unit. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005 Sep;41(14):2120-31. doi: 10.1016/j.ejca.2005.04.041.
- Background: PubMed 15922885Marchal F, Dravet F, Classe JM, Campion L, Francois T, Labbe D, Robard S, Theard JL, Pioud R. Post-operative care and patient satisfaction after ambulatory surgery for breast cancer patients. Eur J Surg Oncol. 2005 Jun;31(5):495-9. doi: 10.1016/j.ejso.2005.01.014.
- Background: PubMed 32407900Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.
- Background: PubMed 16923084Engbaek J, Bartholdy J, Hjortso NC. Return hospital visits and morbidity within 60 days after day surgery: a retrospective study of 18,736 day surgical procedures. Acta Anaesthesiol Scand. 2006 Sep;50(8):911-9. doi: 10.1111/j.1399-6576.2006.01090.x.
- La chirurgie du cancer du sein en ambulatoire est faisable et fiable de nos jours : étude portant sur 396 patientesLink provided by the sponsor.
- Prise en charge ambulatoire de l'hystérectomie par voie mini-invasive : analyse des causes de résistances liées aux professionnels de santéLink provided by the sponsor.
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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.
Severine ALRAN, 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 Ambulatory Surgery, 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?
Complication rate of ambulatory surgery (time frame: Day 30). 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 NCT05176990, 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.