Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

this group will benefit from standard care including: one surgical consultation, one anesthesia consultation, surgery followed by 2-4 days of hospitalization and most of the time 3 post-operative consultations (M1, M6, M12) during the first operative year

Preoperative and postoperative protocols will be applied for optimizing same-day discharge. Gynaecologists, anaesthetists, and nursing staff will work as a team. A specific anesthesia consultation will focus on ambulatory surgery management. A geriatric evaluation will be offered to women over 70 years old with a score ≤14 according to G8 screening tool. A dietetic evaluation will be offered to women with BMI ≥ 35. A nursing consultation will be offered, as patient and their family preparation prior to ambulatory surgery is important.

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

ambulatory surgery

standard surgery

Geoffroy CANLORBE, MD

Lise ROCHAIX, MD PHD

To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

In developed countries, endometrial cancer is the fourth most common cancer in women. Women with stage I disease, representing almost 75% of cases, have an overall survival of 95%. According to the European guidelines, the standard surgical approach for stage I endometrial cancer consists of laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy. For patients undergoing laparoscopic surgery for gynecological malignancies, most studies report average hospital stays of 1 day after surgery. Patients are commonly kept in the hospital following surgery for pain and nausea control, prolonged bladder catheterization, and observation for surgical complications. However, some recent retrospective studies show that same-day discharge for patients undergoing laparoscopic staging for endometrial cancer is feasible and safe, despite associated comorbidities (i.e., obesity, hypertension, diabetes) related to endometrial cancer.

A short hospital stay decreases the risk of exposure to hospital infections, causes less disruption to the patient's personal life, results in potential cost savings for patients and relatives, as well as for hospitals, and there is positive feedback regarding the social environment of patients as they return rapidly to daily activities and work.

To date, safety, feasibility and cost-utility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low, intermediate- and high-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

Preoperative and postoperative protocols (including geriatric and dietetic evaluation, and anesthesia and nursing consultation) will be applied for optimizing same-day discharge of patients randomly assigned to ambulatory surgery.

Data will be collected in conjunction with usual care visit, 1 month after initial surgery.

The economic evaluation will closely follow the 2011 French National Authority for Health (HAS) economic evaluation guidelines and the evaluation proposal will have three complementary parts with a full cooperation between those involved in the evaluation:

First, the economic evaluation will focus on evaluating the cost-utility profile of ambulatory surgery in endometrial cancer in France. This economic evaluation will include a micro-costing study to estimate by direct observation the cost of resources used during the ambulatory pathway, and the total cost of patients' care in each group. The primary endpoint will be the incremental cost-utility ratio using the 30-day health related quality of life. It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights. QALYs will be computed at 30 days (primary analysis) using both mortality and HRQoL scores.

Second, the investigators will perform an analysis of patients' and professionals' preferences about ambulatory care pathways. These preferences will be analyzed in depth, using both surveys and recent tools developed in experimental economics. Health care professionals' views and preferences will be collected, using questionnaires and face-to-face interviews both at the beginning of the study (M0). Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Third, a thorough analysis of the ethical and inequality aspects tied to the development of ambulatory surgery in endometrial cancer will be developed, following the methodological guidance issued in 2013 by the HAS. Special emphasis will be laid on equity issues in the measurement of patients' benefits, using a capability approach (ICECAP-A questionnaire).

Finally, another secondary objective will be to assess the safety and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer, and to validate biomarkers of high risk of nodal involvement in a translational study (complementary budget will be asked for this part).

a multicentre, prospective and randomised study

Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)

Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights

QALYs will be computed using both mortality and HRQoL scores

Rate of women requiring overnight admission

Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Ecole d'econmie de Paris (PSE)-Hospinnomics

Université Montpellier

Université de Rennes 1 CREM CNRS UMR 6211

Assistance Publique - Hôpitaux de Paris

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Quality of Life

The AAT-based breast reconstruction surgery will include any of the following techniques: pedicled transverse rectus abdominis myocutaneous (TRAM) flap, Free TRAM, muscle-sparting TRAM flap, deep inferior epigastric perforator (DIEP) flap, superficial inferior epigastric artery (SIEA) flap, and Rubens flap.

The TE/I approach will include two-stage breast reconstruction surgery. In the initial stage, immediately after mastectomy and with or without sentinel node biopsy, an expander will be placed in the subpectoral plane and the defect closed. Two weeks after the surgery, the expansion of the TE will commence until the desired volume of the respective expander is achieved. The second stage will include removal of the TE and the placement of a permanent implant which may be either saline or gel. The delayed method will be similar to the immediate reconstruction with the exception of the incision, which will be relatively smaller as the mastectomy was performed previously with breast cavity being fully closed.

AAT-based orTE/I reconstruction in all patients undergoing breast reconstruction following mastectomy

Breast Reconstruction Surgery

Achilleas Thoma, MD MSc FRCSC

It is estimated that about 25% and 40% of health care expenditures in Canada and USA respectively are wasted because of inefficiencies and not practicing evidence-based medicine. As health care resources are scarce it behooves all of us to use these in a cost-effective manner. The term "cost-effective" is used in the health care literature often but erroneously. Investigators compare a "novel' intervention to a "prevailing" one and if the novel intervention is less costly it is labeled "cost-effective". In a methodologically correct cost-effectiveness study however, investigators need to integrate both the effectiveness and costs of the competing interventions and calculate an incremental cost-effective ratio. If this ratio falls within acceptability thresholds, the novel intervention is labeled cost-effective. There are many techniques of breast reconstruction. The two most common approaches are the Autologous Abdominal Tissue (AAT) and the Tissue Expansion / Implant reconstructions. In this study these two most common breast reconstruction approaches after mastectomy due to cancer performed in the Hamilton/Niagara/Haldimand/Brant and Waterloo/Wellington LHINs will be investigated with a cost-effectiveness analysis coupled with a methodologically robust observational study.

As a result of the recent advances in the treatment of breast cancer carried out by dedicated researchers and made possible through breast cancer research, its mortality has been gradually declining. Naturally, the quality of survivorship has taken an important role in the last 3 decades. Unfortunately, for most women with breast cancer, their concerns about survival are followed closely with concerns about body image, sexuality, self-esteem and social life. Mastectomy, a mainstay in the treatment of breast cancer, is the primary cause of these latter concerns. The investigators are therefore charged with looking at the disease and the respective treatment of breast cancer holistically. Providing a comprehensive management of breast cancer today requires attention to both oncologic principles and to the patient's quality of life. A large part of the patient's quality of life comes from improved reconstructive and aesthetic outcomes following mastectomy. In short, breast reconstruction after mastectomy for cancer aims to improve body image and quality of life by reducing the negative psychological impact of the deformity. Multiple techniques exist to accomplish this goal. They include breast implants, autologous tissues, or occasionally, a combination thereof. Although the ultimate goal is to recreate an aesthetically pleasing breast that attempts to match the missing one, the decision to use a particular technique is multi-factorial. It may be influenced by the surgeon's skills, the patient's preferences, inherent contraindications with a patient, or the resources available in a particular setting. Breast reconstructions can be costly to patients (indirect costs), third party payers and society, especially as new technologies are introduced in clinical practice. In the last 2 decades third party payers and governments in different jurisdictions have been advocating for production of evidence that shows "value for money" germane to these different procedures.Presently, the two most common approaches to breast reconstruction are the AAT method and the TE/I method. These two approaches to breast reconstruction have yet to be submitted to an economic evaluation using state-of-the-art cost-effectiveness analysis.

Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study

A Cost-Effectiveness Analysis Comparing Abdominal-based Autogenous Tissue (AAT) and Tissue Expander- Implant (TE/I) Reconstruction of the Breast After Mastectomy- A Feasibility Study

Identify and tabulate the costs for the two procedures under the purview of the patient, Ministry of Health and society. Costs will be further classified into two categories: surgery-related costs and costs incurred by the patient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)	NCT03580421	Endometrial Can... Endometrial Can...	ambulatory surg... standard surger...	18 Years -	Assistance Publique - Hôpitaux de Paris
Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study	NCT02438449	Breast Cancer	Breast Reconstr...	18 Years -	McMaster University
Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study	NCT02438449	Breast Cancer	Breast Reconstr...	18 Years -	McMaster University

Spots Global Cancer Trial Database for qaly

Every month we try and update this database with for qaly cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for qaly

Every month we try and update this database with for qaly cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for qaly cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.