Mes données de santé

O site de informações destinado a pacientes tratados na rede Unicancer ou incluídos nos ensaios clínicos da rede Unicancer

Objetivos

In 2018 globally, the prevalence, incidence and mortality of gynaecological oncology cancers (cervix, endometrial, tubo-ovarian, vulval, vaginal) were 25.18 per 100 000 (954 439 cases), 29.35 per 100 000 (1 309 165 cases) and 13.03 per 100 000 (609 377 cases) respectively. Gynaecological cancers collectively after breast cancer account for the second greatest disease burden amongst all female cancers and by the year 2040, incidence is set to rise by 69%. 45% of all individuals diagnosed with cancer undergo surgery with curative intent. This amounts to 589 124 cases of gynaecological cancer surgery worldwide. Hence due to the current and growing disease burden of gynaecological malignancies, surgical care for gynaecological malignancies is an indispensable component of a functioning health system. However surgery has historically had a disproportionately low profile in global health priorities at the World Health Organization (WHO) due to the erroneous perception that it is a high cost intervention benefitting a small segment of society. The recent interest in surgical outcomes has been prompted by the recognition that conditions amenable to surgery such as gynaecological malignancies are important public health conditions, and that there are disparities in access to life saving and disability preventing surgeries particularly for rural and marginalised populations in lower and middle income countries (LMIC) representing unmet surgical needs. The WHO and the World Bank, have highlighted surgery as an important component for global health development.6 However, surgical care requires coordination of skilled human resources, specialised supplies and infrastructure including multicentre, international collaborations for the purpose of research to inform international policies. It is estimated that less than 25% of patients with cancer have access to safe, affordable, and timely surgery. Whilst death rates from cancer are decreasing in high income countries (HICs), the opposite is true in LMICs and up to 1.5% gross domestic product is lost because of cancer in some LMIC countries.

Despite 45% of women with gynaecological malignancies receiving surgical care with curative intent, safety and quality of care remain poorly measured and a low priority in many LMICs. In addition, there is a lack of standardised gynaecological oncology surgical data globally and a shortage of patient-level data. Gynaecological oncology surgical outcomes data, is not located or reported in any standardised way and requires information to be compiled from multiple agencies, ministries, health reports and published literature, as there is no central source for collecting or reporting. In addition, collected data does not take into account country specific epidemiological factors.

Detecting variations associated with outcomes following gynaecological oncology surgeries, and modifiable practices associated with these variations, are likely to act as surrogate markers for best performance of gynaecological oncology surgical units. Globally relevant risk factors for variations in outcomes relate to the training of the operating surgeon, availability of investigations, use of safety checklists, equipment and access to critical care facilities.

A prospective audit of surgical outcomes following gynaecological oncology surgery in the United Kingdom (UKGOSOC - United Kingdom Gynaecological Oncology Surgical Outcomes and Complications), a HIC, may lack relevance and comparability in LMICs or indeed other HICs which do not have a nationalised government funded health care system but private healthcare. Whilst the GlobalSurg collaborative has set up a consortium of general surgeons investigating surgical outcomes following general surgery, this has not included gynaecological oncology.

Objectif principal :

To evaluate international variation of post-operative morbidity and mortality following gynaecological oncology surgery between country groups defined by HDI.

Objectifs secondaires :

• To evaluate international variation between HDI country groups of intra-operative morbidity and mortality following gynaecological oncology surgery.

• To evaluate international variation between HDI country groups of histological clearance rates of gynaecological malignancies.

• To identify HDI group specific, modifiable surgical processes associated with best care taking into account resource availability/infrastructure.

• To develop best practices and standards for gynaecological oncology surgery.

• To establish an international gynaecological oncology surgical collaborative.

• To establish a prospective international database of gynaecological oncology surgical outcomes.

• To promote quality improvement and research in gynaecological oncology internationally.

• To describe variations in gynaecological oncology surgical training between HDI country groups.

Responsável pelo tratamento

Institut Claudius Regaud – IUCT-Oncopole

1 avenue Irène Joliot Curie

31059 Toulouse Cedex 9

France

Categorias de dados utilizados
Données de santé
Origine de données utilisées
Soins
Institut Claudius Regaud (Toulouse)
População sujeita à pesquisa ou ao tratamento de dados

Inclusion criteria:

1. Women aged >18 years undergoing curative, curative attempted but then abandoned (i.e. open/close laparotomy) or palliative surgery for primary tubo-ovarian/peritoneal, endometrial, cervical, vulval, vaginal, gestational trophoblastic malignancies.

2. Surgery for recurrent primary tubo-ovarian/peritoneal, endometrial, cervical, vulval, vaginal, gestational trophoblastic malignancies.

3. Open, minimal access (laparoscopic/robotic), minimal access converted to open or vaginal surgeries for tubo-ovarian/peritoneal, endometrial, cervical, vulval, vagina, gestational trophoblastic malignancies.

4. Elective and emergency surgeries.

5. Surgeries where pre-operative pathology thought to be benign but malignancy confirmed on histopathology post-operatively.

 

Exclusion criteria:

1. Surgeries where pre-operative pathology thought to be malignant but benign disease confirmed on histopathology post-operatively.

2. Non gynaecological disease as the primary malignancy.

3. Diagnostic procedures (e.g. staging laparoscopy, image guided biopsy).

4. Any procedure not requiring a skin incision under general/regional anaesthesia (e.g. chemotherapy, radiotherapy, hysteroscopy).

Base jurídica

Base juridique et exception permettant de traiter les données au sens des articles 6 et 9 du RGPD

Article 6 (Licéité du traitement) : exécution d’une mission d’intérêt public

Article 9 (Exception permettant de traiter des données de santé) : intérêt public dans le domaine de la santé publique

DROITS DES PERSONNES

L’ensemble de notre démarche est détaillée sur notre site internet, à la page suivante : https://www.iuct-oncopole.fr/recherches-necessitant-une-reutilisation-de-donnees

Conformément au Règlement Général sur la Protection des Données, les patients disposent à tout moment d'un droit d'accès, de rectification, d’opposition pour motif légitime sur leurs données (cf. cnil.fr pour plus d’informations sur les droits). Ils disposent en outre :

●         Du droit de solliciter une limitation du traitement de leurs données,

●         D’un droit à l’oubli et à l’effacement numérique,

●         D’un droit à la portabilité de leurs données,

●         Du droit d’introduire une réclamation auprès de la CNIL.

Pour exercer ces droits, ils peuvent s’adresser, en fournissant une copie d’un justificatif de leur identité, au délégué à la protection aux données de l’Institut pour leurs questions concernant leurs données à caractère personnel, aux coordonnées suivantes :

Mr Guillaume Jauffret - IUCT – Oncopole - 1 avenue Irène Joliot-Curie - 31059 TOULOUSE Cedex 9

DPO-ICR [at] iuct-oncopole.fr (DPO-ICR[at]iuct-oncopole[dot]fr) - Tél : 05 31 15 57 03

 

Destinatários internos e externos dos dados

Destinataire interne : Dr. Martina Angeles Fite, Chirurgie Oncologique, Institut Claudius Regaud, IUCT-Oncopole.

Destinataire externe : Global Gynaecological Oncology Surgical Outcomes Collaborative (GO SOAR), Foresterhill Health Campus, Aberdeen.

Data de início da pesquisa
19/01/2021
Período de retenção de dados

30 ans

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