Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)

Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Laparoscopic ultra-radical lymph node debulking

Antonio Simone Laganà, M.D., Ph.D.

Vito Chiantera

Mariano Catello Di Donna

Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable.

To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases.

Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)

Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Universita di Verona

University of Palermo

Principal Investigator

Behaviors and Mental Disorders

All Conditions

Quality of Life

The patients in the experimental group will use the mobile-based care support application developed within the scope of the research.

It is the group in which no intervention will be made other than data collection.

In the first pre-operative interview at the gynecological oncology outpatient clinic of the relevant hospital, the purpose of the research will be explained to the patients and an informed consent form will be filled. The patients in the experimental group will use the mobile-based care support application developed within the scope of the research.

Education Group

Çisem Baştarcan

Cisem Bastarcan

This study was planned in a randomized controlled prospective experimental design in order to determine the effect of mobile-based education given to patients undergoing gynecological oncology surgery on quality of life.

Research Hypotheses:

H1. Education given with mobile application in gynecological oncology patients positively affects symptom control of patients.

H2. The education given with the mobile application in gynecological oncology patients positively affects the quality of life of the patients.

Power analysis was conducted to determine the number of people to be included in the study. The power of the test was calculated with the G\*Power 3.1 program. As a result of the power analysis, the sample size should be 50, 25 experimental and 25 control groups, at 95% power, 5% significance level, and 0.690 effect size (df=24; t=1,710). In the research, it was aimed to reach a total of 70 women, 35 people in each group, considering the high power of the test and the losses.

Introductory Information Form, Symptom Evaluation Form, Functional Assessment of Cancer Therapy-General (FACT-G) and Turkish-Computer System Usability Questionnaire (T-CSUQ- SV) planned to be used as data collection tools in the study.

The women included in the study sample will be divided into two groups as experimental and control groups according to randomization. Experimental group; the group to be trained. control group; This is the group in which no attempt will be made other than data collection.

Statistical Analysis of Data: The data obtained in the research will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Homogeneity of descriptive features between groups will be tested by chi-square analysis and independent group t-test. The differentiation status of the scales between the groups will be analyzed with the independent group t-test and the changes within the group will be analyzed with the repeated measures ANOVA test.

The women included in the study sample will be divided into two groups as experimental and control groups according to randomization. Experimental group; the group to be trained. control group; This is the group in which no attempt will be made other than data collection.

The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life

The patients' quality of life will be measured with Functional Assessment of Cancer Therapy-General (FACT-G). All questions are aimed at assessing the patients' quality of life in the last 7 days. A higher score from the scale indicates a better quality of life.

The patients' symptom will be measured with Symptom Evaluation Form. The symptom evaluation form was created by the researchers by scanning the relevant literature and determining the most common postoperative symptoms of patients who underwent gynecological oncology surgery.

Istanbul University - Cerrahpasa (IUC)

PhD student

Symptoms and General Pathology

Postoperative Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Antiemetics

Gastrointestinal Agents

Anesthetics

Anti-Bacterial Agents

Pre-operative: Assessment, counseling and education; preoperative nutritional drink up to 4 h prior to surgery, bowel preparation, only oral intestinal cleaner，antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia keeping temperature at 36 ±0.5℃, antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery).

pre-operative assessment：pre-operative fasting at least 8h, bowel preparation for traditional surgery, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.

Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

pre-operative assessment, counseling and FT management education

pre-operative assessment, counseling and education

Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used

Preoperative nutritional drink up to 4 h prior to surgery

patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool

bowel preparation

preoperative treatment with carbohydrates (patients without diabetes).

preoperative treatment with carbohydrates

fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;

fast solid

avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.

avoiding hypothermia

Postoperative glycaemic control

postoperative nausea and vomiting (PONV) control;

early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).

early postoperative diet

pre-operative fasting at least 8h

Oral bowel preparations or mechanical bowl until liquid stool

bowel preparation for traditional surgery

6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

began to take solid diet after anal exhaust

Ling Cui, MD

Yu Shi

Hong Liu

Dengfeng Wang

Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.

The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.

Methods/Design

Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis and APACHE II score.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.

Patients were randomly divided into two groups（ FTS group/traditional group）, after that doctors and patients were aware of the grouping situation.

Fast-track Surgery After Gynecological Oncology Surgery

Fast-track Surgery After Gynaecological Oncological Surgery

days from operation date to discharge date

Count of patients with complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis.

infection(wound infection, lung infection, intraperitoneal infection, operation space infection)

it was recognized that nausea and vomiting are common side effects of surgical recovery

is a disruption of the normal propulsive ability of the gastrointestinal tract

Evidence of blood loss from drains or based on ultrasonography

Evidence of blood thrombosis of participants after surgery

Ling Cui

Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes).

Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.

Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).

Fast-track Surgery

pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.

Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

pre-operative fasting at least 8h

Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool

intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade

began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

Traditional Surgery

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

China

Region of Enrollment

Body surface area

Body Mass Index

Patients scheduled for gynaecological oncology surgery (including radical hysterectomy and lymphadenectomy, hysterectomy and lymphadenectomy, and cytoreductive procedures for both open and laparoscopic surgery)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)	NCT05318170	Gynecologic Can...	Laparoscopic ul...	18 Years - 80 Years	University of Palermo
The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life	NCT05694208	Gynecologic Can...	Education Group	18 Years -	Istanbul University - Cerrahpasa (IUC)
Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)	NCT05318170	Gynecologic Can...	Laparoscopic ul...	18 Years - 80 Years	University of Palermo
Fast-track Surgery After Gynecological Oncology Surgery	NCT02687412	Length of Stay Postoperative C... CRP	pre-operative a... Preoperative nu... bowel preparati... preoperative tr... fast solid avoiding hypoth... Postoperative g... postoperative n... early postopera... pre-operative f... bowel preparati... began to take s...	18 Years - 70 Years	Sichuan Cancer Hospital and Research Institute

Spots Global Cancer Trial Database for gynecological oncology