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

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group.

Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.

Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.

Ambulatory surgery

Jaana H Vironen, MD, PhD

The aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only.

The patients with small breast tumours (\<2 cm)and clinically node negative disease, were randomized to receive breast conserving surgery and sentinel node biopsy as ambulatory surgery or inpatient-surgery.Complication rate, patient satisfaction and psychosocial outcomes were compared. The psychosocial effects of the treatment mode on their spouses were recorded as well.

Feasibility of Ambulatory Surgery for Early Breast Cancer

Same Day Discharge After Surgery for Early Breast Cancer - a Feasible Option

Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare

The difference in the number of complications or return to the hospital rate between the groups

Helsinki University Central Hospital

Associate chief surgeon

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Syndrome

Recurrence

Pain, Postoperative

Nausea

Vomiting

Postoperative Nausea and Vomiting

Pain

Hyperalgesia

Postoperative Complications

Neurologic Manifestations

Signs and Symptoms, Digestive

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Adjuvants, Anesthesia

Analgesics

Anti-Arrhythmia Agents

Antihypertensive Agents

Fentanyl

Analgesics, Opioid

Esmolol

Metoprolol

Adrenergic beta-Antagonists

Narcotics

Adrenergic Agents

Anesthetics, Intravenous

Anesthetics, General

Adrenergic Antagonists

Neurotransmitter Agents

Adrenergic beta-1 Receptor Antagonists

Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control

Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.

fentanyl

esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.

beta-blocker (esmolol, metropolol)

Etienne de Medicis, MD MSc

The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).

Finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.

Postoperative Analgesia Impact of Narcotic Free Anesthesia

The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy

Université de Sherbrooke

Doctor

Urinary Bladder Neoplasms

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Patients in the usual care arm of the trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.

The ERAS protocol for ambulatory TURBT has been designed based on patient and provider input, a needs assessment of 150 patients in the hours after TURBT, a review of the literature, and experience with other ambulatory ERAS protocols already implemented at Johns Hopkins Hospital. The ERAS protocol for ambulatory TURBT aims to optimize care delivered in the pre, intra and postoperative settings.

ERAS Protocol

Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.

Standard of Care

Michael E Rezaee, MD, MPH

Rana Harb

This is a single-center, randomized-controlled trial to investigate the effectiveness of an ERAS protocol compared to usual care in patients with bladder cancer undergoing ambulatory TURBT. The ERAS protocol is comprised of pre, intra and postoperative components designed to optimize each phase of perioperative care.

Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol

The QoR-15 score is a validated 15-item questionnaire that assesses quality of recovery in five dimensions: pain, physical comfort, functional autonomy, emotions, and psychological support. Each item is scored 0 to 10 with higher scores representing superior quality of recovery. The QoR-15 score is patient-reported outcome measure and has been extensively used to evaluate ERAS for both inpatient and ambulatory surgeries. It is a shorter and more patient-friendly version of the QoR-40 with equivalent psychometric properties.

The UTI-SIQ-8 is a validated questionnaire of voiding symptom severity and bother, with higher scores representing worse symptoms (8-40).

Bladder Utility Symptom Scale - a validated 10-question instrument designed specifically for patients with bladder cancer, will be used to measure health-related quality of life (0-100), with higher scores representing higher quality of life.

Dysuria, Suprapubic/Bladder, Urethral, Penis or Vulvar Pain Rated from 0 (No pain) to 10 (Unbearable pain)

Self-reported on a scale of 1 (lowest satisfaction) to 10 (highest satisfaction).

None, Pink, Red, Red with Clots as self-reported by patients

Change in incontinence will be assessed by the average number of pads used per day

Change in opioid consumption (Morphine milligram equivalents) obtained from medical record

Number of unplanned post-procedural ambulatory visits, emergency department visits, phone calls, and electronic messages assessed individually.

Surgical complications as classified by Clavien-Dindo category.

Johns Hopkins University

Musculoskeletal Diseases

Wounds and Injuries

Digestive System Diseases

Gland and Hormone Related Diseases

Infections

Shoulder Impingement Syndrome

Gallstones

Cholelithiasis

Cholecystolithiasis

Cysts

Ovarian Cysts

Appendicitis

Communicable Diseases

Intraabdominal Infections

Gastroenteritis

Gastrointestinal Diseases

Cecal Diseases

Intestinal Diseases

Joint Diseases

Shoulder Injuries

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Biliary Tract Diseases

Gallbladder Diseases

Calculi

Pathological Conditions, Anatomical

Oxycodone

Adult patients who were treated in 23 h surgical unit

Patients were treated in 23 surgical unit

23 h surgery

Ulla-Maija Ruohoaho, MD

Extended day surgery or 23 h surgery (23-hour surgery) is a surgical model where patients arrive to the hospital from home at the day of surgery, are operated and recover in a 23 h surgery unit. 23H surgery units are usually situated near postoperative recovery unit. THe 23 H surgical model was implemented in Kuopio University Hospital 2015 and between May 2017-May 2018 patients were recruited in the present prospective follow up cohort study. Patients were informed and they gave their informed consent. The patients were contacted two weeks after the study and details of their recovery were asked.

Extended day surgery or 23 h surgery is a surgical model where patients arrive to the hospital from home at the day of surgery, are operated and recover in a 23 h surgery unit. 23H surgery units are usually situated near postoperative recovery unit. THe 23 H surgical model was implemented in Kuopio University Hospital 2015 and between May 2017-May 2018 patients were recruited in the present prospective follow up cohort study. Patients were informed and they gave their informed consent. The patients were contacted two weeks after the study and details of their recovery were asked. Satisfaction to the care in 23 h unit and surgical process, were asked. Amount of readmissions, reoperations, contacts to health care professionals and adverse events are recorded.

Detailed information about intensity of pain, analgesic need and use in the hospital was recorded and pain interference in daily life for short term recovery period was asked.

Implementation of 23 Hour Surgery Model in a Tertiary Hospital

23 Hour Surgical Model in a Tertiary Hospital: Evaluation From Patient and Organisational Perspective

Adverse events after 23 h surgical procedure

The amount of patients discharged from hospital by the first postoperative day 10 am

Pain intensity after surgery for the first 24 hours

Amount of different analgesics consumed during the 24 h period postoperatively

How many patients are admitted to hospital within 30 postoperative days

How many patients are reoperated within 30 postoperative days

Amount of adverse events after surgery within 14 postoperative days

Number of contacts to health care within 14 postoperative days

Scale 0-7 (0= not satisfied, 7 =very satisfied), the higher score the better result

Amount of patients who had pain still two weeks after surgery

Patient assessed pain interference in daily activities up to 2 weeks after surgery

amount of patients using analgesics two weeks after surgery

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
Feasibility of Ambulatory Surgery for Early Breast Cancer	NCT01613352	Early Breast Ca... Psychosocial We... Ambulatory Surg...	Ambulatory surg...	18 Years - 90 Years	Helsinki University Central Hospital
Postoperative Analgesia Impact of Narcotic Free Anesthesia	NCT01544959	Pain, Postopera... Breast Cancer Postoperative N...	fentanyl beta-blocker (e...	18 Years - 65 Years	Université de Sherbrooke
Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT	NCT05905276	Bladder Cancer	ERAS Protocol Standard of Car...	18 Years -	Johns Hopkins University
Implementation of 23 Hour Surgery Model in a Tertiary Hospital	NCT04142203	Ambulatory Surg... Laparoscopy Shoulder Imping... Ovarian Cysts Cholecystolithi... Appendicitis Gynecologic Sur... Ambulatory Surg... Neurosurgery	23 h surgery	18 Years - 100 Years	Kuopio University Hospital
Implementation of 23 Hour Surgery Model in a Tertiary Hospital	NCT04142203	Ambulatory Surg... Laparoscopy Shoulder Imping... Ovarian Cysts Cholecystolithi... Appendicitis Gynecologic Sur... Ambulatory Surg... Neurosurgery	23 h surgery	18 Years - 100 Years	Kuopio University Hospital

Spots Global Cancer Trial Database for ambulatory surgery