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The training set is a dataset used to train the model, which includes randomly enrolled patients with colon and rectal cancer. The inputs include data such as gender, age, height, weight, BMI, tumor stage, tumor pathology type, and the output information is whether NOSES surgery was successful or not. During training, the model learns from this dataset to make predictions on whether new patients with colon and rectal cancer can undergo NOSES surgery successfully.

The test set is a dataset used to evaluate the performance of a trained machine learning model. It includes another randomly enrolled group of patients with colon and rectal cancer, as well as their clinical and pathological data and surgical outcomes. The outputs are not used during training, but are used to test the trained model to evaluate its predictive ability on unknown data. The purpose is to evaluate the model's generalization ability, that is, its performance on new and unknown data.

Natural Orifice Specimen Extraction Surgery (NOSES) is a minimally invasive surgical technique that aims to reduce the size and number of incisions required during certain surgeries. In NOSES, the surgical specimen (such as a diseased organ or tumor) is removed from the body through a natural orifice (such as the mouth, anus, or vagina), rather than through an incision in the abdominal wall. In this trial, we will extract surgical specimens from the rectum to reduce trauma to the abdominal wall.

Natural Orifice Specimen Extraction Surgery

Yanxin Luo, PhD,MD

Yaoyi Huang, BS

The goal of this observational study is to test in patients with resectable rectosigmoid cancers. The main question it aims to answer is establishment of a feasibility model for predicting natural orifice specimen extraction surgery (NOSES) based on machine learning.

Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning

Establishment of a Feasibility Model for Predicting Natural Orifice Specimen Extraction Surgery (NOSES) Based on Machine Learning.

Accuracy will be calculated by the number of successful operations performed

Accuracy will be calculated by the number of successful operations actually completed.

Sixth Affiliated Hospital, Sun Yat-sen University

Principal Investigator

Neoplasms

Digestive System Diseases

All Conditions

Wounds and Injuries

Rectal Neoplasms

Surgical Wound

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Participants in this group underwent robotic surgery with transanal specimen extraction

Participants in this group underwent robotic surgery with transabdominal specimen extraction

Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.

Transanal specimen extraction robotic surgery

Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.

Transabdominal specimen extraction robotic surgery

Xishan Wang

Hongliang Yao

Dehai Xiong

Chunkang Yang

Xiangfu Zeng

Fanghai Han

Guiyu Wang

Taiyuan Li

Ye Wei

Junjun She

Jianchun Cai

Junhong Hu

This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.

In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.

Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.

Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.

Detection of serum levels of Interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10) (pg/L) to evaluate surgical stress response and immune function.

Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.

Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.

Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.

Visual analogue scale (VAS) will be used to evaluate the postoperative pain. If analgesics were needed, the type and dose of analgesics after operation should be recorded.

Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.

LARS scale(0\~20 points are defined as no LARS, Scores from 21 to 29 were defined as mild LARS, and from 30 to 42 as severe LARS. The higher the score, the worse the anal bowel function) will be used to evaluate the defecation function.

Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours, and perform auscultation of bowel sounds regularly every day after operation), the time to first ambulation (hours), the time to first eating (hours) and the time to first defecation (hours).

To assess the quality of life of all cancer patients.

To assess the quality of life in patients with rectal cancer.

To assess the quality of surgical specimens.

To assess the quality of surgical specimens and postoperative pathological evaluation.

To assess the financial burden difference.

To assess the long-term postoperative outcomes.

Professor

Colonic Diseases

Patients with colorectal cancer underwent transanal or transvaginal specimen extraction

We perform laparoscopic colorectal cancer resection, intracorporeal anastomosis and transanal or transvaginal specimen extraction

Natural orifice specimen extraction

Mingguang Zhang

Xishan Wang, M.D.

Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.

Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study

Rate of complications occurred within 30 days after surgery

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participants in this group underwent robotic assisted rectal cancer resection

Participants in this group underwent robotic rectal cancer resection assisted rectal with natural orifice extraction

participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.

Robotic Assisted Rectal Cancer Resection Alone

participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.

Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction

Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question.

Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question. From January 2015 to November 2016, a consecutive wave of 49 patients underwent robotic rectal cancer resection with natural orifice extraction and 49 matched patients underwent conventional robotic assisted rectal cancer resection were systematically analyzed in this study.

The resected specimens were kept and sent to the laboratory for pathological examination

Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction

To determine the survival differences between NOSE group and RARC group. Overall survival is defined as the time from surgery to death from any causes

To determine the survival differences between NOSE group and RARC group. Disease-free survival is defined as the time from surgery to local or distant recurrence

To determine the differences between NOSE group and RARC group

To determine the surgical and patients burdern differences between NOSE group and RARC group

To determine the surgical differences between NOSE group and RARC group. Maxium sacle is 10, miniun scale is 0. 0 represents no pain. 10 represents maximun pain.

To determine the surgical differences between NOSE group and RARC group

to determine the patients burden differences between NOSE group and RARC group

To determine the pathological differences between NOSE group and RARC group

To determine the surgical stress response differences NOSE group and RARC group

Prof., Chief physician, Head of The Fifth Department of General Surgery

Participants in this group underwent robotic natural orifice specimen extraction surgery

Participants in this group underwent robotic transabdominal specimen extraction surgery

robotic natural orifice specimen extraction surgery

R-NOSES group

robotic transabdominal specimen extraction surgery

R-TSES group

A retrospective cohort study, conducted nationwide（China） and across multiple centers, aimed to compare the surgical quality and short-term outcomes of R-NOSES （robotic natural orifice specimen extraction surgery）with R-TSES （robotic transabdominal specimen extraction surgery） for early-stage rectal cancer.

In this retrospective cohort study, data from 1086 patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023 were collected from a prospectively maintained database of 8 experienced surgeons from 8 high-volume centers in china. The study was aimed to compare the surgical quality and short-term outcomes of R-NOSES with R-TSES for early-stage rectal cancer.

Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer

Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Rectal Cancer: a Multicentre Propensity Score-Matched Analysis

Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours) and time to first oral feeding.

The EORTC QLQ-C30 includes functional score, symptom score, and Global Health Status. All project scores range from 0 to 100. The Functional score includes physical functioning, role functioning, emotion functioning, social functioning and cognitive functioning. The higher the functional score, the better the functional status of the patient. Symptom score includes nausea and vomiting, pain, dyspnoea, insomnia, loss of appetite, constipation, diarrhea, financial impact. A higher symptom score is associated with more severe symptoms and worse outcomes. The higher the Global Health Status, the better the health of the patient.

The BIQ is an eight-item questionnaire incorporating body image and cosmetic subscales, The body image scale measures patients' perception and satisfaction with their bodies after surgery. it ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars for a score range of 3-24, with a higher score indicating greater cosmetic satisfaction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning	NCT05797064	Machine Learnin... Surgery Rectosigmoid Ca... Natural Orifice...	Natural Orifice...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial	NCT05468944	Rectal Neoplasm... Robotic Surgery Natural Orifice...	Transanal speci... Transabdominal ...	18 Years - 75 Years	The First Affiliated Hospital of Nanchang University
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial	NCT05468944	Rectal Neoplasm... Robotic Surgery Natural Orifice...	Transanal speci... Transabdominal ...	18 Years - 75 Years	The First Affiliated Hospital of Nanchang University
Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning	NCT05797064	Machine Learnin... Surgery Rectosigmoid Ca... Natural Orifice...	Natural Orifice...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study	NCT06350370	Colorectal Canc...	Natural orifice...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction	NCT04265417	Rectal Neoplasm... Robotic Surgery Natural Orifice...	Robotic Assiste... Robotic Assiste...	18 Years - 75 Years	The First Affiliated Hospital of Nanchang University
Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer	NCT06405308	Rectal Cancer Robotic Surgery Natural Orifice...	R-NOSES group R-TSES group	20 Years - 86 Years	The First Affiliated Hospital of Nanchang University
Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study	NCT06350370	Colorectal Canc...	Natural orifice...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for natural orifice specimen extraction surgery