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

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Nathan Lawrentschuk, MBBS,PhD, FRACS

Farleigh Reeves, MBBS, PhD

Damien Bolton

Lih-Ming Wong

Marlon Perara

Nathan Lawrentschuk

Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.

By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.

The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.

To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

The present study aims to model integration of clinical workflow data from Electronic Medical Records (EMR) to a research database using REDCap platform to enhance Prostate Cancer (PCa) research.

The objectives of the Victorian Robotic-assisted Radical Prostatectomy database are:

1. Collect functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline (pre-surgery), 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
2. Gather detailed insights into surgical measures in terms of demographics, operative and post-operative characteristics.

   1. Operative characteristics will include: Protein-Specific Antigen (PSA) at surgery, surgery Gleason score, International Society of Urological Pathologists (ISUP) grade group, pathological T score, scans at surgery, amount of blood loss, operation duration, type of anesthesia, survival status, mortality, surgical margins and pain score.
   2. Post-operative characteristics will include: length of hospital stay, duration of catheter use, complications (if any) and reasons of readmission (if any).
3. Collect the oncological measures in terms of biochemical recurrence and margin status.
4. Track the progress of surgeons learning curve by comparing the surgeons' training data with Patient Reported Outcome Measures (PROM).

Males who are diagnosed with localized Prostate cancer

National Robotics-Assisted Radical Prostatectomy Database

National Robotics Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcomes

* Patient data will only be transferred and analysed in a coded form by mentioned investigators.
* Transferring patient data will require host organisation's formal approval
* Individual patients will not be identifiable from the presented or published material.
* The institution and the researcher must comply with all relevant laws and standards in relation to the use of the material.
* The institution and researcher must not use the material for any purpose other than the specified research or other purposes expressly permitted under the terms of the Agreement.
* Data linkage across sites will be set up when necessary. Once linkage has been completed, identifiers will be removed from the data to be used in the research, unless consent has been given for its identifiable use.

Standardize notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

The first set of outcome variables will be the functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire

The second set of outcome variables will gather detailed insights into surgical measures in In terms of operative and post-operative characteristics.

The third set of outcome variables will collect the oncological measures in terms of Biochemical re-occurrence and margin status.

Peter MacCallum Cancer Centre, Australia

Epworth Healthcare

St Vincent's Hospital

Austin Health

Melbourne Health

Professor

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

directly went for surgery after diagnosis of rectal cancer

neoadjuvant therapy per RAPIDO protocol (Patients under RAPIDO group underwent 25Gy/5 sessions of short course radiotherapy followed by 6 cycles of neoadjuvant XELOX similar to that of the RAPIDO trial protocol)

RAPIDO TNT

LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine

LCRT

Aim: We evaluated the surgical outcomes of 3 groups of patients with rectal cancers - RAPIDO vs standard long course radiotherapy (LCRT) vs upfront surgery to objectively determine the effects of TNT on TME.

Methods: A review of prospectively collected data was performed for patients who have rectal cancer and underwent low anterior resection from January 2016 to May 2022. Data on patient demographics, disease staging, peri-operative details and up to 2-year follow-up outcomes were analysed. The surgical and oncological outcomes were compared. Patients were followed up until 31 May 2022.

A review of prospectively collected data was performed for all patients who were diagnosed with rectal cancer and who underwent ultra-low anterior resection (ULAR) from January 2016 to May 2022 in a single institution in Singapore. Exclusion criteria of this study included patients who underwent emergency surgery and patients with unresectable metastatic disease at presentation. All patients were discussed at multi-disciplinary tumour board for recommendation and decision of the respective treatment protocols. Patients were analysed in 3 main categories: neoadjuvant therapy per RAPIDO protocol, LCRT and upfront surgery. Patients under RAPIDO group underwent 25Gy/5 sessions of short course radiotherapy followed by 6 cycles of neoadjuvant XELOX similar to that of the RAPIDO trial protocol while patients in LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine. All cases were performed by 7 consultant-grade colorectal surgeons in the department.

Patient demographics and peri-operative details were collected. Histopathological stage of disease was in accordance with the American Joint Committee on Cancer (AJCC) staging manual after surgical resection with review of the resected specimen by consultant-grade pathologists who were blinded to the type of pre-operative treatment the patients received.

Primary outcome for the study was the operative time required for primary resection of rectal tumour. If combined surgery was performed for oligometastatic disease, we removed the operating time for non-rectal component as this was separately defined in the operation notes.

Secondary outcomes included the intraoperative blood loss, duration to stoma function, failure to remove urinary catheter, presence of post-operative ileus, duration of hospitalisation after surgery. Presence of stoma function was defined as enteric content of significant amount (\>200ml or presence of formed faecal material). Failure of removal of urinary catheter is defined as acute urinary retention requiring re-insertion of catheter post-operatively. Post-operative ileus is defined as ileus which persist beyond 7 days from operation.

Follow-up outcomes and data for patients were collected until 31 May 2022. Local-regional recurrence was defined as the first clinical, radiologic and/or pathologic evident tumour of the same histological type at the region of the anastomosis and pelvis. Distant recurrent was defined similarly at sites outside primary malignancy such as liver, lung, bone, brain, para-aortic region. Presence of recurrence in patients was recorded, disease-free interval was calculated in months from date of surgery to date of recurrence.

Statistical analysis All data was analysed with SPSS version 28 (SPSS Inc, Chicago, III). Patients with missing data were accounted for and excluded during the statistical analysis of this data. Categorical variables were presented as percentages while median and interquartile ranges were presented for continuous variables. Differences between categorical variables were analysed using either Chi-square or Student t-test. Differences between continuous variables were treated as non-parametric and analysed using either Kruskal Willis or Mann-Whitney U. Two-sided tests were used, with p value \<0.05 treated as significant. Kaplan Meier curves were plotted for survival data including disease free survival and overall survival.

RAPIDO vs LCRT vs Upfront Surgery - a Prospective Cohort Study

Novel Objective Comparison of Short-term Surgical Outcomes From Total Mesorectal Excision Between Total Neoadjuvant Therapy - Rapido Protocol, Standard Long Course Radiotherapy and Upfront Surgery

yes/no, and in days to successful removal

Sengkang General Hospital

Consultant

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Liver Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Anti-Infective Agents

Central Nervous System Depressants

Other Dietary Supplements

Ethanol

Anesthetics

Benzocaine

Tannic Acid

The main aim of the virtual multimodal hub is to prepare participants for surgery (including the role of Enhanced Recovery after Surgery (ERAS) pathway) and support declines in physiological and psychological function associated with preoperative treatments (e.g., chemo-radiotherapy) and major surgery. The post-hospital discharge interventions will focus on the recovery of activities of daily living, occupational tasks, and recreational activities. Aided by standardised assessment tools, a comprehensive holistic baseline (first preoperative multimodal session) and post-discharge (first postoperative multimodal session) assessment of patients' physical, nutritional, psychological and overall health status, presence of co-morbidities and medical history will determine the frequency, intensity, time, type, volume, and progression of the multimodal interventions.

Participants allocated to the control group will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits. Participants will be asked to maintain their normal daily activities.

Aerobic (HIIT) Endurance Respiratory Muscle Strength Education

Preoperative Exercise

Aerobic Muscle Strength Walking Program Education

Postoperative Exercise

Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support

Preoperative Nutrition

Postoperative Nutrition

CBT skills Skills training Emotional validation Behavioural activation Psycho-education

Preoperative Psychology

Postoperative Psychology

Comorbidities Managing pain Wound care Complications Surgical education ERAS

Preoperative Nursing

Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education

Postoperative Nursing

Weekly sessions moderated by a social worker including patients and carers:

Safe space Share experiences/ideas Support Education

Preoperative Peer Support Group

Postoperative Peer Support Group

Participants allocated to the control group will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits.

Usual Care

Daniel Steffens, PhD

Michael Solomon, DMed

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications.

Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care.

The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.

Randomised Type I Hybrid Effectiveness-Implementation Trial

Consenting participants will undergo baseline assessment immediately prior to randomisation to intervention (virtual multimodal hub and usual care) or control group (usual care alone). The randomisation sequence will be prepared a priori using a central secure randomisation service (1:1 allocation ratio in random permuted blocks of sizes 4 or 2 stratified by hospital, to ensure balance intreatment assignment within hospital) to ensure concealment of treatment allocation and blinding of surgeon, all trial personnel and statistician. Due to the nature of the intervention, it is not possible to blind the clinicians delivering the intervention (virtual multimodal hub); however, the investigators will ensure that all patients' interactions are standardised.

PRIORITY-CONNECT 2 Pilot Trial

Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial

Feasibility will be determined by the following outcomes:

(i) Number of eligible participants recruited to the pilot trial; (ii) Retention rate: defined as the percentage of participants who completed the trial; (iii) Adherence rates: defined as the percentage of planned sessions attended by those who were randomised to the intervention group.

Patients, clinicians and carers acceptability to the virtual multimodal hub (Intervention) will be assessed with a semi-structured questionnaire administered at 3-months (last survey). The semi- structured questionnaire contains 11 questions and participants (Patients, clinicians and carers) will be instructed to use a 5-point Likert Scale to express how much they agree or disagree with each statement. In addition, patients will be asked how satisfied they were with the virtual multimodal program and if the program negatively affected them. The investigators have also taken the opportunity to seek further feedback about the virtual multimodal hub (open ended question). The questionnaire has been used on previous pilot trials.

Defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. The risk of developing complications following gastrointestinal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and gastrointestinal cancer treatment costs.

EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item cancer-specific tool measuring five functioning scales, nine symptom scales, financial impact and overall QoL. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

EORTC QLQ-OG25 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 25-item tool measuring function and symptoms specific to oesophoago-gastric cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

EORTC QLQ-CR29 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 29-item tool measuring function and symptoms specific to colorectal cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

DAH-30, 90 (days at home 30, 90): Validated (Australian population) patient-centred outcome metrics that integrates length of hospital stay, discharge destination (other than home), hospital readmission and early death. The number of days at home - reduced by complications, discharge to a care facility, re-admission, and death is quantified as the days alive and at home during the 30 days after surgery. DAH-30, 90 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0).

(Costs): Patient and health system resource use, including the cost of the virtual multimodal hub interventions, hospitalisations, will be collected (surveys) from randomisation (1-6 weeks prior to surgery) to 3 months post index surgery.

RE-AIM Framework, including:

Reach: Measured through trial participation, baseline characteristics (referral pathways, age, postcode, marital, work status, and Culturally And Linguistically Diverse \[CALD\]) of all potential participants.

RE-AIM Framework, including:

Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.

RE-AIM Framework, including:

Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention).

RE-AIM Framework, including:

Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol.

RE-AIM Framework, including:

Maintenance: Measured through rates of referral over time of the study; stakeholder interviews regarding refinements and infrastructure needed to maintain and scale intervention beyond the project period.

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
National Robotics-Assisted Radical Prostatectomy Database	NCT06279260	Database Prostate Cancer Robotic-assiste... Surgical Outcom... Oncological Out... Patient Reporte... Learning Curve		16 Years - 90 Years	Melbourne Health
RAPIDO vs LCRT vs Upfront Surgery - a Prospective Cohort Study	NCT06212128	Rectal Cancer	RAPIDO TNT LCRT	21 Years - 99 Years	Sengkang General Hospital
Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)	NCT05318170	Gynecologic Can...	Laparoscopic ul...	18 Years - 80 Years	University of Palermo
PRIORITY-CONNECT 2 Pilot Trial	NCT06212700	Liver Cancer Pancreas Cancer Oesophageal Can... Gastric Cancer Colorectal Canc...	Preoperative Ex... Postoperative E... Preoperative Nu... Postoperative N... Preoperative Ps... Postoperative P... Preoperative Nu... Postoperative N... Preoperative Pe... Postoperative P... Usual Care	18 Years -	Surgical Outcomes Research Centre (SOuRCe)

Spots Global Cancer Trial Database for surgical outcomes