Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Antipyretics

Analgesics

Gastrointestinal Agents

Antiemetics

Herbal and Botanical

Ethanol

Anesthetics

Acetaminophen

Morphine

Analgesics, Opioid

Laxatives

Cathartics

Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling

Changes in preoperative care

Blended anesthesia is mostly carried out using Total Intra Venous Anesthesia (TIVA) with loco regional analgesia, in particular Thoracic Epidural Anesthesia (TEA) in open surgery and spinal morphine or Transversus Abdominis Plane (TAP) block or quadratus lumborum block for laparoscopic surgical approach, associated to NSAIDs or acetaminophen; control of deep neuromuscular blocking with Train-of-four (TOF) stimulation avoiding residual paralysis. Multimodal prevention of PONV (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.

Changes in intraoperative care

Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. According to the type of surgery TEA, TAP block , quadratus lumborum block or IT morphine is preferred. Patient is proposed to start drinking clear fluid 4 hours after surgery and to start eating the evening of the surgery, with the introduction of a normal free diet within 24 hours after surgery. It is proposed to chew gum three times daily for at least 15 minutes and eventually to use laxatives to promote a faster bowel function. Early mobilization is started from the evening of surgery.

Changes in postoperative care

Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.

Validation of an ERAS Protocol in Gynecological Surgery

Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial

NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Wounds and Injuries

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

COVID-19

Fractures, Bone

Communicable Diseases

Liver Neoplasms

Postoperative Complications

Intestinal Neoplasms

Lung Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Intestinal Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

no intervention

Diansan Su, MD,PHD

To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.

A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection

Main Postoperative Complications After SARS-CoV-2 Infection: A Retrospective Cohort Study

All-cause mortality at 30 days after operation

a composite of postoperative pneumonia, acute respiratory distress syndrome (ARDS) and unexpected ventilation

a composite of cardiogenic death, myocardial infarction, new-onset heart failure or cardiogenic shock, and cerebrovascular accident (CVA)

The First Affiliated Hospital of Anhui Medical University

First Affiliated Hospital of Chongqing Medical University

Sichuan Academy of Medical Sciences

Second Hospital of Shanxi Medical University

RenJi Hospital

preoperative / intraoperative/ postoperative management

preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling

intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.

postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.

It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.

ERAS protocol

Beihua Kong, MD.PhD.

Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery

Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain.

Time to Foley catheter removal postoperative

Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)

Shandong University

Clinical Professor

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Uterine Cervical Neoplasms

Endometriosis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Leiomyoma

Myofibroma

Uterine Neoplasms

Cysts

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Clinically symptomatic females with one or more of the following gynecological pathology:

* Endometriosis,
* Adenomyosis,
* Ovarian cysts,
* Fibroids,
* Ovarian cancer,
* Cervical cancer
* Uterine cancer.

Asymptomatic females with:

* Cervical dysplasia or cancer
* A normal pap-smear (control)

Saliva sample

Sofiane Bendifallah, MD

GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva.

The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females.

The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the local recommendations.

Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology

Identify a diagnostic signature for each pathology (Endometriosis / Adenomyosis / Ovarian cysts / Fibroids / Cervical Displasia / Ovarian cancer / Cervical cancer /Uterine cancer) by analyzing of coding and non-coding RNA contained in the saliva.

Monitoring Force Group

ZIWIG

Nutritional and Metabolic Diseases

Blood and Lymph Conditions

Prostatic Neoplasms

Obesity

Hernia

Prolapse

Pelvic Organ Prolapse

Obesity, Morbid

Mediastinal Neoplasms

Hernia, Inguinal

Hernia, Ventral

Thymoma

Thymus Neoplasms

Prostatic Diseases

Genital Diseases, Male

Male Urogenital Diseases

Pathological Conditions, Anatomical

Hernia, Abdominal

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Neoplasms by Histologic Type

Lymphatic Diseases

Mediastinal Diseases

Thoracic Diseases

Subjects scheduled to undergo robotic-assisted surgery

Robotic-assisted Surgery

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Clinical Investigation of the da Vinci Surgical System

A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System

Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.

Intuitive Surgical

Zhenmin Lei, MD

This proposal seeks to retain "discard" pieces of human gynecologic tissues and "discard" ascites fluid collected during normal surgical procedures, along with corresponding blood samples and urine, for research involving prognostic markers of disease/cancer. The specific aims of the proposal include:

1. To collect "discard" pieces of benign, pre-malignant and malignant gynecologic tissues, "discard" ascites fluid and, when possible, corresponding blood and urine specimens from patients undergoing:

   1. hysterectomy
   2. excisions of cervical dysplasia and/or venereal warts, and
   3. therapeutic excisional surgeries to remove gynecologic disease/cancer (uterine, ovarian and lower female genital tract).
   4. paracentesis for the symptomatic relief of ascites fluid accumulation (distention).
2. To collect pre-operative blood and urine from patients along with pre- operative blood work drawn for clinical evaluation.
3. De-identify the patients from their donated tissue, blood and urine specimens by assigning a laboratory identification number.
4. Rapidly process and store the collected specimens to preserve biological integrity. (RNA, DNA and proteins)
5. Collect and record the patient's demographic and medical information into a research database under the assigned lab number only.
6. Assess the specimens for prognostic markers of gynecologic disease/cancer by molecular techniques such as DNA arrays,immunohistochemistry and ELISA.

During the last two decades, cancer research has shifted from using cell lines and animal models to directly using human tissue. This is especially true for research focused on premalignancies for which there are few good animal models. Research utilizing human tissues and sera not only addresses many issues/questions of medical research that cannot be evaluated in cell lines and/or in animal models of human disease, but it also provides a system to test the relevance of these findings to human diseases. Various biologic and genetic changes that occur in the developmental stages of human neoplasia can be identified and analyzed using human tissues.

Research using human tissues and sera is making great strides in the effort to define possible markers of developing neoplasia and will promote the design of targeted cancer treatments and possible prevention. It is important to link research findings in tissue and blood specimens to the clinical outcome of patients with malignancy so we can pinpoint when and where, during the course of cancer development, molecular changes occur.

Many malignancies of the female genital tract may arise in more than one location, either synchronously or metachronously, giving rise to the concept of a "field" effect of carcinogenesis. By collecting tissue from multiple epithelial sites (sampled by the physician) it is possible to compare the molecular changes seen in preinvasive to those that occur in invasive neoplasia for differential expression profiles of potential markers. If protein markers are identified in cells present in the diseased tissue we can check the patient's serum and urine to see if the proteins can be detected. This information will enable us to screen and possibly identify these protein markers in patient serum and urine to correlate with the presence of a premalignant or malignant state.

Malignant ascites is excess fluid that accumulates in the space between the membranes lining the abdomen and abdominal organs, otherwise known as the peritoneal, or abdominal cavity. Malignant ascites typically occurs because of a disease, infection, or cancer in the peritoneal cavity that produces excessive fluid. Ascites fluid accumulation is very common in gynecologic cancers, especially ovarian. If protein markers are identified in the cells present in the diseased ascites fluid we may be able to correlate these markers with metastasis of the disease/cancer and possibly help prevent the spread of several gynecologic cancers.

Prognostic Markers of Gynecologic Cancers

James Graham Brown Cancer Center

University of Louisville

Professor

Myoma

Choriocarcinoma

Endometrial Neoplasms

Trophoblastic Neoplasms

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Pregnancy Complications, Neoplastic

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Connective Tissue Diseases

Ma Ding, M.D.

The database and biobank establishment started in 1997 in our institute. However, the sample size was too small with respect to our clinical and fundamental scientific research's requirement. Thus the Chinese gynecological oncology study (GOS) group was established to create a large multicentre database and biobank of patients with gynecologic diseases.

The database contains clinical and epidemiologic information about patients with gynecologic neoplasms, such as cervical carcinoma, ovarian carcinoma, etc. With the data gathered from this database, the investigators could further demonstrate the etiology, risk factor, clinical treatment, and other aspects of the complicated gynecologic diseases. The cervical cancer database v1.10 including more than 10,000 cases and more than 200 variables has been established.

The biobank collects blood, fluids, tissue samples, and related clinical data from consenting patients with gynecologic neoplasms, such as cervical cancer, ovarian cancer, endometrial cancer, choriocarcinoma, uterine myoma, endometriosis. Besides, blood samples of population-based healthy people with informed consent are also collected.

Clinical Database and Biobank of Patients With Gynecologic Neoplasms

A Large Multicentre Clinical Database and Biobank of Patients With Gynecologic Neoplasms

Zhejiang University

Hunan Province Tumor Hospital

Guangxi Medical University

First Affiliated Hospital Xi'an Jiaotong University

West China Second University Hospital

Obstetrics & Gynecology Hospital of Fudan University

Shanghai First Maternity and Infant Hospital

Peking University People's Hospital

Wuhan Central Hospital

Huazhong University of Science and Technology

Director of the department of Obstetrics and Gynecology, Tongji Hospital

Behaviors and Mental Disorders

Quality of Life

Chronic Graft Versus Host Disease

all patients having a consultation doctor during the recruiting time

questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)

Connor Davidson Resilience Scale (CD-RISC 10)

Viola Heinzelmann-Schwarz, Prof. Dr. MD

The intended pilot project aims at evaluating the feasibility and acceptability of questionnaires about resilience and quality of life in two different patient groups (either with a gynaecological carcinoma ora chronic gynaecological disease). The results provided by this pilot study will build the basis of an upcoming, larger project including these questionnaires and the main objective of assessing resilience. More precisely, the study aims at answering the following questions. How is the overall resilience and quality of life in the target population at one assessment point? Are the instruments used in this pilot feasible for the target population when assessing resilience and quality of life?

Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases

Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases: A Pilot Study

visual analogue scale (VAS) about Feeling healthy: Score 0 to 100 the higher the score the better is Quality of life

Total Score of the resilience questions is 0 to 40, 10 subscales from 0 to 4 (summed up for total score), the higher the score the better the resilience

Questions about Quality of life: Total score 0-25, 5 subscales 0 to 5 (summed up for total score), the higher the score the lower is Quality of life.

University Hospital, Basel, Switzerland

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Validation of an ERAS Protocol in Gynecological Surgery	NCT03347409	Surgery Hysterectomy Gynecologic Dis... Gynecologic Can... Anesthesia	Changes in preo... Changes in intr... Changes in post...	18 Years - 75 Years	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection	NCT05781581	Intestines Canc... Pulmonary Cance... Liver Cancer Trauma Fractures, Bone Gynecologic Dis...	no intervention	18 Years -	RenJi Hospital
Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)	NCT03629626	Gynecologic Dis... Gynecologic Can...	ERAS protocol	18 Years - 70 Years	Shandong University
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology	NCT06392997	Gynecologic Dis... Gynecologic Can... Endometriosis Ovarian Cancer Cyst Ovary Fibroid Cervical Cancer Uterine Cancer	Saliva sample	18 Years -	ZIWIG
A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection	NCT05781581	Intestines Canc... Pulmonary Cance... Liver Cancer Trauma Fractures, Bone Gynecologic Dis...	no intervention	18 Years -	RenJi Hospital
Clinical Investigation of the da Vinci Surgical System	NCT05682742	Thymoma Mediastinal Tum... Gynecologic Dis... Gynecologic Can... Pelvic Organ Pr... Prostate Diseas... Prostate Cancer Inguinal Hernia Ventral Hernia Obesity, Morbid	Robotic-assiste...	21 Years -	Intuitive Surgical
Prognostic Markers of Gynecologic Cancers	NCT00290459	Gynecologic Dis... Gynecologic Can...		18 Years -	University of Louisville
Clinical Database and Biobank of Patients With Gynecologic Neoplasms	NCT01267851	Cervical Cancer Ovarian Cancer Endometrial Can... Choriocarcinoma Uterine Myoma Endometriosis		18 Years - 75 Years	Huazhong University of Science and Technology
Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases	NCT03916445	Gynecologic Dis... Gynecologic Can...	Connor Davidson...	18 Years -	University Hospital, Basel, Switzerland

Spots Global Cancer Trial Database for gynecologic disease