Evaluation of the Safety of Ambulatory Surgery in Senology and Gynecology Within the Paris Saint-Joseph Hospital Group
NCT ID: NCT05176990
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
991 participants
OBSERVATIONAL
2021-11-19
2022-10-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility of Ambulatory Hysterectomy
NCT03290339
Low Impact Laparoscopy Concept Versus Conventional Laparoscopy
NCT04165148
Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
NCT05031182
Evaluation of the Rate of Consultations in Gynecological Emergencies Under "Non-urgent" Management
NCT05325619
Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology
NCT03187327
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 deprived of liberty
* Patient under court protection
* Patient objecting to the use of her data for this research
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Severine ALRAN, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Groupe Hospitalier Paris Saint-Joseph
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AMBUGYN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.