Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.

Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.

Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol

Prehabilitation Program + Enhanced Recovery After Surgery

Enhanced Recovery After Surgery

Andre Lopes, MD

Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to the multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or suspicious gynaecological cancer, who will undergo gynaecological surgery.

The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, the protocol and specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

Single-Blind (surgeons and anesthesiologists)

Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery

Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery

Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs

Postoperative Intensive Care Unit admission and stay

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Compliance to ERAS® protocol and implementation of the program

Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.

Patients will perform a 6-Minute Walk Test

Muscle strength is measured by using an dynamometer

Body mass is measured by using a bioelectrical impedance analysis

Days from surgical procedure to hospital discharge

Instituto Brasileiro de Controle do Cancer

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Endometriosis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Cellvizio®

Gautier CHENE, MD

Gery LAMBLIN, MD

Philippe Chabert, MD

Karine Lebail-Carval, MD

Erdogan Nohuz, MD

Philippe CHABERT, MD

Géry LAMBLIN, MD

Optical biopsy is a new technology that generates a real-time, cell-based, high-resolution view and analysis of tissues. Observation is instantaneous and non-invasive. This allows reliable and fast diagnosis which facilitates decision making as well as patient management.

The investigator have already conducted a feasibility study on the use of this new technology to evaluate ovarian and tubal pre-cancerous lesions in laparoscopy. In this new study, he wants to continue investigations, expand its use to other gynecological pathologies, and demonstrate the benefit of such a non-invasive technology in gynecology on the one hand in the diagnosis of lesions but also to appreciate the margins as accurately as possible surgical excision of tumors and / or endometriosis lesions.

The investigator have set up a prospective monocentric descriptive study. The hypothesis is that optical biopsy by Cellvizio® allows to observe in real time microscopically tissues and to characterize them in the field of gynecological surgery

Optical Biopsy in Gynecological Surgery

Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery

The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient.

Hospices Civils de Lyon

Genital Neoplasms, Female

Urogenital Neoplasms

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

Analgesics

Anti-Inflammatory Agents

Antirheumatic Agents

Ropivacaine

Morphine

Parecoxib

Cyclooxygenase Inhibitors

Cyclooxygenase 2 Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Before incision, patients in controlled Group received NS

Before incision, parecoxib patients received 40mg of parecoxib IV

Before incision, patients in Group P (n = 120) receive 40mg of parecoxib IV. Thereafter, parecoxib patients receive 40mg of parecoxib IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.

Parecoxib Sodium

Before incision, patients in Group C (n = 120) receive 2 mL of normal saline IV. Thereafter, they receive 2 mL of normal saline IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.

Normal saline

Wenqi Huang, postgraduate

The purpose of this study is to determine the effects of parecoxib in combination with epidural morphine in providing analgesia for patients undergoing gynecological surgery.

Researches have showed that the use of epidural and spinal block resulted in significant reduction in morbidity and mortality after surgery. Moreover, appropriate pain management results in better outcomes. Opioids therapy is recommended as the first choice medication for the management of postoperative pain but is associated with a number of undesirable adverse effects. A multimodal therapy for providing postoperative analgesia has advantages over the use of opioids alone. The use of NSAIDs and opioids together often improves analgesia and reduces the need for opioids in the postoperative period. Often, the combination of COX-2 inhibitors with epidural analgesia is preferred. With epidural analgesia, addition of COX-2 inhibitors may improve the analgesia and decrease the undesirable side effects.

Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery

A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of Intravenous Parecoxib Sodium on Morphine Patient-controlled Epidural Analgesia After Gynecologic Surgery

The primary end-point of this study was to quantify the morphine-sparing effect of a multimodal approach containing parecoxib compared with the standard PCEA approach in patients undergoing abdominal hysterectomy.

The secondary outcome included pain intensity, the patients' global evaluation, and side effects accompanied with PCEA and parecoxib, such as nausea, vomiting, pruritus, sedation, motor block in the lower extremities, and the time to passage of flatus and first bowel movement.Blood loss, length of hospitalization, and postoperative cardiovascular (CV) events were also recorded.

Guangdong Provincial People's Hospital

Second Affiliated Hospital, Sun Yat-Sen University

Nanfang Hospital, Southern Medical University

Liu Weifeng

attending doctor

Symptoms and General Pathology

Musculoskeletal Diseases

Wounds and Injuries

Digestive System Diseases

Infections

Pain, Postoperative

Syndrome

Shoulder Impingement Syndrome

Pain

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
Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery	NCT04505111	Gynecologic Sur... Enhanced Recove...	Prehabilitation... Enhanced Recove...	18 Years - 80 Years	Instituto Brasileiro de Controle do Cancer
Optical Biopsy in Gynecological Surgery	NCT04154683	Gynecologic Sur...	Cellvizio®	18 Years -	Hospices Civils de Lyon
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery	NCT01566669	Benign Female R...	Parecoxib Sodiu... Normal saline	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery	NCT01566669	Benign Female R...	Parecoxib Sodiu... Normal saline	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen 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
Optical Biopsy in Gynecological Surgery	NCT04154683	Gynecologic Sur...	Cellvizio®	18 Years -	Hospices Civils de Lyon
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

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