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

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 Overview

• Status: Completed
• Conditions: Ambulatory Surgery

• Study Type: Observational
• Enrollment (Actual): 991

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: Female

• Sampling Method: Non-Probability Sample

Study Population

Patient eligible for outpatient surgery, operated in gynecology at HPSJ in UCA from 01/05/2020 to 31/05/2021.

Description

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

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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Severine ALRAN, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

• La chirurgie du cancer du sein en ambulatoire est faisable et fiable de nos jours : étude portant sur 396 patientes
• Prise en charge ambulatoire de l'hystérectomie par voie mini-invasive : analyse des causes de résistances liées aux professionnels de santé

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): December 19, 2021
• Study Completion (Actual): October 10, 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: AMBUGYN

Drug and device information, study documents

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