Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Analgesics, Opioid

Analgesics, Non-Narcotic

Patients in this group will be managed according to an specifically designed FAST-TRACK protocol which will include: Preoperatory nutritional management and coaching by surgeon, anesthetist, nutritionist and specifically trained nurse personnel, reduced preoperatory fasting, avoiding use of intraabdominal drainages, specific anesthetic management to reduce intraoperative stress, avoiding use of Nasogastric tube, avoiding the need for major opioid in postoperatory analgesia and use of an standardized postoperatory management protocol directed to obtain an early oral intake and mobilization with a the goal of normal diet and deambulation in the 3rd day after surgery.

Patients assigned to this group will receive the standard management preformed in our center until now. This management includes a preoperatory control exclusively by the surgeon and anesthetist, minimum of 8h fasting previous to surgery, loose use of intraabdominal drainage , systematic use of nasogastric tube whenever rectum resection or omentectomy is performed, Postoperative analgesia following standing Vall d'Hebron protocols for Moderate-severe postoperative pain, which include use of combined analgesia with non opioids drugs and major Opioids, and usual flexible, non standardized postoperatory management with mobilization and oral intake progression depending on perceived evolution by attending surgeon.

Fast-Track Protocol

Usual management

Antonio Gil Moreno, MD

José Luis Sánchez Iglesias, MD

The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new approach to the management of patients undergoing major surgery that re-examine traditional practices, replacing them if necessary with the best evidence based practices, creating a multimodal perioperative care pathway designed to achieve early recovery. In Colorectal Cancer Surgery , as well as in a number of other procedures it has been shown to reduce Hospitalization by more than 30% without increasing the rate complications or readmissions.

However information on the results of Fast-track protocols when applied to Gynecological patients is sparse, being especially notorious the lack of data regarding the efficacy of Fast-track in the management of Advanced Gynecological cancer.

Hypothesis: the application of a Fast-Track protocol in the management of patients with advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery of these patients allowing for an early discharge and significant cost reduction, when compared with de usual management, without increasing the number readmission or surgery related complications.

Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management

Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado

To determine if there is an statistically significant difference in the readmission rate related to postoperative complications between the Fast-track and Classical management groups.

To determine if there is an statistically significant difference in surgery related complications rates between the Fast-track and Classical management groups.

The number and severity will be recorded. as graded in the Clavien-Dindo Classification of Surgical Complications.

To determine if the application of a Fast-Track protocol in advanced ovarian cancer patients generates a significant cost per patient reduction when compared with classical management. The total cost for Hospitalization , readmissions and surgery related complications will be assessed according to the Public prices published in : SLT/383/2009, 21th January "Diari Oficial de la Generalitat de Catalunya" Núm. 5325 - 24.2.2009.

Hospital Universitari Vall d'Hebron Research Institute

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Other Dietary Supplements

Benzocaine

Tannic Acid

HFNC group was given heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery to maintain oxygen saturation at 92% \~ 95%.Chest CT was reviewed 36-48 hours after surgery.

The control group was given conventional nasal catheter oxygen inhalation on the day of surgery and the first day after surgery, and oxygen flow was adjusted to maintain oxygen saturation at 92% \~ 95%.Chest CT was reviewed 36-48 hours after surgery.

HFNC can accurately provide 21% \~ 100% oxygen concentration through air oxygen mixer. And through the heating and humidification device to provide 37℃, relative humidity of 100% gas, the maximum flow of 70L/min.

heated humidified high flow nasal cannula oxygen therapy, HFNC

Nasal cannula oxygen has become a routine part of postoperative treatment

Nasal cannula oxygen

Dengfeng Wang, M.D.

Patients at high risk of post-operative pulmonary complications (PPC) will be screened out from gynecological tumor patients undergoing surgical treatment, and randomly assigned into the HFNC group and control group, which uses conventional nasal cannula oxygen therapy. The primary outcome is the incidence of PPC, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

This randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. The study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

A Randomized Controlled Trial on the Preventive Effect of Heated Humidified High Flow Nasal Cannula Oxygen Therapy on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

IPD will be available to be shared 9 months after the study is published with a reasonable research plan.

The primary outcome measures were the incidence of PPC in the treatment group and the control group, including the incidence of postoperative hypoxemia, atelectasis, pneumonia, etc.

Postoperative Hospitalization Days and ICU Stay Days

The use of antibiotics, including the type, usage, use time, etc.

Adverse events Associated with Oxygen Therapy

Sichuan Cancer Hospital and Research Institute

Attending Physician

Symptoms and General Pathology

Tissue Adhesions

Myoma

Cicatrix

Fibrosis

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Pharmaceutical Solutions

Standard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure)

A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.

Adhibit Adhesion Prevention Gel

standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure

Standard of Care Comparator

Liselotte METTLE, MD, PhD

The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas

Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.

Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation

A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery

Angiotech Pharmaceuticals

Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center

Capture NIR video of flap site beginning at time of ICG injection. At time of subjective peak intensity, capture video of flap and recipient wound bed. Measure rate of ICG egress from the global flap at 60, 120, and 180 seconds after initial dye injection from intraoperative video

ICG-NIR angiography

Nadeem Abu-Rustum, MD

The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.

A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery

Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary purpose of this study is to introduce ICG-NIR angiography in abdominopelvic skin and myocutaneous pedicle flap-based reconstruction during gynecologic oncology surgery and determine the percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans.

Memorial Sloan Kettering Cancer Center

Wounds and Injuries

Nutritional and Metabolic Diseases

Obesity

Postoperative Complications

Standard surgical closure of the fascia and skin.

Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

Standard Wound Closure

At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.

Prevena™ Incision Management System

Deanna G. Teoh, M.D.

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of \> 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients.

This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial

Masonic Cancer Center, University of Minnesota

Negative Pressure Wound Therapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Deanna GK Teoh

Negative Pressure Wound Therapy vs. Standard Wound Closure

Follow up data is not available for 2 participants

Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)

Only those participants who received adjuvant therapies were analyzed in both arms. Rest of the patients didn't have cancer that required subsequent therapies.

Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies

Overall Study

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

Participants in the intervention arm will receive the standard surgical teaching while in the operating room (master-apprentice model (MAM)), plus the intervention of reviewing the recorded video with the surgical coach after performing their first attempt at laparoscopic closure of the vaginal vault.

Participants in the control arm will receive the standard surgical teaching while in the operating room (master-apprentice model-(MAM)).

The coaching session will follow the Wisconsin Coaching Framework (Greenberg 2015). The surgical coaching session will last at maximum 30 minutes and will occur within 1-2 week following the procedure. The surgical coaching session will occur over Zoom. The second attempt will occur within 1 week following the coaching session.

Video-based coaching

Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).

Standard surgical teaching (master-apprentice model - (MAM))

Brenna Swift

Danielle Vicus, MD

Evan Tannenbaum, MD, MSc

Stephane Laframboise, MD

This multi-centre, randomized controlled trial aims to assess the role of video-based coaching (VBC) in residency education in gynecologic and gynecologic oncology surgery. It involves a trainee and a surgical coach, who together review a recording of the trainee performing a surgical skill or procedure and coaching is provided for skill improvement. Resident performance will be evaluated using a standardized scoring scale by two experienced surgeons before and after the intervention and compared to the control group receiving the standard surgical teaching curriculum.

Achieving technical excellence is a core component of surgical training. Historically, a combination of didactic teaching, surgical simulation and the master-apprentice model (MAM) were the cornerstone of surgical education. With restrictions on resident duty hours and operating time with the COVID-19 pandemic and a shift to competency-based medical education, there is an opportunity to transform surgical education and improve educational efficiency. The purpose of this study is to assess the effect of video-based coaching (VBC) on resident skill acquisition in laparoscopic suturing of the vaginal vault at the time of laparoscopic hysterectomy.

Participants will include year 3 to 5 Obstetrics and Gynecology residents completing gynecology and gynecologic oncology rotations at the study sites. Participants will be randomized to the control (standard surgical curriculum) and intervention (standard curriculum and VBC) arms on the day of the first attempt. The effectiveness of VBC will be measured by the difference in baseline and post-intervention standardized blinded score between the intervention and control group during laparoscopic closure of the vaginal cuff.

All residents will be video recorded performing laparoscopic closure of the vaginal cuff at the time of hysterectomy using video recording built into the laparoscopic equipment in the operating rooms. Residents in the control group will receive standard surgical teaching (MAM), then they will be video-recorded performing the skill at their second attempt. Residents in the intervention group will receive the standard surgical teaching plus the intervention of reviewing the recorded video with the surgical coach at the end of the procedure (MAM plus VBC). The surgical coach will provide specific personalized feedback on performance and suggestions for improvement following the Wisconsin Coaching Framework during their coaching session. Participants will then be recorded on their subsequent attempt.

All raw video footage will be edited to include only the relevant portion of the film. This will facilitate the assessment process (i.e., the assessors will view only the relevant footage). The edited video segments for both groups on both attempts will be scored independently using the validated surgical assessment tool by two blinded, experienced gynecologic laparoscopists to evaluate surgical performance (blinded to attempt number and randomization group). The average score between both assessors will be used for statistical analysis. The effectiveness of VBC will be evaluated by comparing the difference in assessment scores between the baseline and post-intervention scores between the control and intervention groups.

Participants will be randomized to the intervention (video-based coaching plus standard surgical teaching following the master-apprentice model) or the control (standard surgical teaching following the master-apprentice model)

Due to the nature of the intervention, the participants and the surgical coach will not be blinded. The participants will be informed of their assignment after completing the first attempt. The staff surgeon in the operating room for each attempt will be blinded. The experienced laparoscopists who will be scoring the videos will be blinded to the group allocation and the attempt number.

Video-based Coaching (VBC) in Gynecologic Surgery

A Multicentre, Randomized Controlled Trial to Assess Video-based Feedback for Surgical Coaching in Gynecology and Gynecologic Oncology

The modified OSATS score is a standardized rubric for assessing technical skills

Desirability of the intervention will be evaluated based on the proportion of eligible residents who enrol in the study (number enrolled/number eligible).

Participants in the intervention arm will complete a surgical coachee questionnaire to determine if the participants in the intervention arm found the coaching experience to be useful for developing their surgical skills.

Surgical coach will complete a questionnaire immediately after the coaching activity, which will collect time for video-editing, time for coaching session and receptivity of the participant to coaching

The intraclass correlation coefficient (ICC) between the two score for each video will be calculated

Sunnybrook Health Sciences Centre

University Health Network, Toronto

Mount Sinai Hospital, Canada

Assistant Professor, Obstetrician/Gynecologist

Alayne Yamada, PhD

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

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

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

Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial

Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial

Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017

Use and dosage of opioids in the postoperative period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management	NCT02172638	Median Length o... Readmission Rat... Surgery Related... Cost Per Patien...	Fast-Track Prot... Usual managemen...	18 Years -	Hospital Universitari Vall d'Hebron Research Institute
A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms	NCT05526534	Gynecologic Sur... High-flow Nasal... Post-operative ...	heated humidifi... Nasal cannula o...	18 Years - 90 Years	Sichuan Cancer Hospital and Research Institute
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation	NCT00562471	Myoma	Adhibit Adhesio... Standard of Car...	18 Years -	Angiotech Pharmaceuticals
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery	NCT05071976	Gynecologic Sur...	ICG-NIR angiogr...	18 Years -	Memorial Sloan Kettering Cancer Center
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients	NCT02309944	Postoperative C... Obesity Gynecologic Neo...	Standard Wound ... Prevena™ Incisi...	18 Years -	Masonic Cancer Center, University of Minnesota
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients	NCT02309944	Postoperative C... Obesity Gynecologic Neo...	Standard Wound ... Prevena™ Incisi...	18 Years -	Masonic Cancer Center, University of Minnesota
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
Video-based Coaching (VBC) in Gynecologic Surgery	NCT05086783	Education Surgery Gynecologic Can...	Video-based coa... Standard surgic...	-	Mount Sinai Hospital, Canada
Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial	NCT04596800	Gynecologic Can... Enhanced Recove...	Prehabilitation... Enhanced Recove...	18 Years - 80 Years	Instituto Brasileiro de Controle do Cancer
Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management	NCT02172638	Median Length o... Readmission Rat... Surgery Related... Cost Per Patien...	Fast-Track Prot... Usual managemen...	18 Years -	Hospital Universitari Vall d'Hebron Research Institute

Spots Global Cancer Trial Database for gynecologic surgery