Evaluation of the Safety of Ambulatory Surgery in Senology and Gynecology Within the Paris Saint-Joseph Hospital Group

Ambulatory Surgery Clinical Trial

— AMBUGYN  

Official title:

Evaluation of the Safety of Ambulatory Surgery in Senology and Gynecology Within the Paris Saint-Joseph Hospital Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05176990
• Other study ID #: AMBUGYN
• Status: Completed
• Start date: November 19, 2021
• Est. completion date: October 10, 2022

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 991
• Est. completion date: October 10, 2022
• Est. primary completion date: December 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Patient under court protection

• Patient objecting to the use of her data for this research

Related Conditions & MeSH terms

• Ambulatory Surgery

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

Engbaek 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. — View Citation

Hejl 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. — View Citation

Marchal 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 30
Secondary	Conversion of stay to traditional hospitalization	This outcome corresponds to the number of ambulatory surgery conversion of stay to traditional hospitalization.	Day 30
Secondary	Revision of surgery	This outcome corresponds to the rate of revision of surgery within 30 days.	Day 30
Secondary	Re-hospitalization	This outcome corresponds to the rate of re-hospitalization within 30 days.	Day 30
Secondary	Emergency room visit	This outcome corresponds to the rate of emergency room visit within 30 days.	Day 30

External Links

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