Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

laparoscopic surgery using conventional laparoscopic instruments

Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated grasper)

Use of single site system for reduced port robotic surgery

Use of da Vinci SP system for reduced port robotic surgery

A new surgical robot Revo-i developed by Meerae company in Korea

Hyoung-Il Kim

A new surgical instrument is supposed to allow surgeon to do surgery with better performance. However, the learning period before getting used to the new instruments is necessary. The surgeon's stress to overcome the learning effect and the surgical outcome was rarely assessed. The comparative analysis of surgical outcome, surgeon's stress, and utilization of instruments for gastrectomy will be performed in prospective cohort study

Before the surgery, all the eligible patients will be explained regarding the study and informed consent will be given. During the surgery, the surgeon will wear heart rate monitoring device to monitor hear rate variability of the surgeon. The surgical procedure will be recorded. After the surgery, morbidity following surgery will be monitored and recorded. At 1 month after surgery, additional morbidity will be recorded.

Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy

One of the most important surgical outcome, complication will be measured at 1 month after surgery

Yonsei University

Symptoms and General Pathology

Postoperative Complications

Based on newly-designed devices tailored for transanal TME, CS-Compact, GelPoint and Octoport are employed for the clinical applications.

Standard TaTME with circular stapler (Short and straight, CS Compact), designed for extra-corporeal and endo-anal anastomosis procedures.

TaTME with CS-Compact (GelPoint pathway)

Jing Sun, Ph.D., M.D.

Jian-qing YAO, Ph.D.

Wei-Guo HU, Ph.D., M.D.

Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer patients have been considerably improved. However, anatomical limitations in pelvic space hinder the further optimization of surgical treatment Thus, the natural orifice transluminal endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception and single port technique, has been prevailing both in West and East nations, with or without the abdominal laparoscopic assistance. Up to date, there are various kinds of instruments and patterns to complete TaTME with comparable clinical outcomes. However, flaws in each instrument remains according to the feedbacks. This study is therefore designed to clinically evaluate the feasibility and safety of the new instruments specifically for TaTME (CS-Compact, GelPoint pathway).

Rectal cancer comprises the most in colorectal cancer around the world, among which surgery remains the optimal therapeutic intervention. The TME (Total Mesorectal Excision), proposed by Bill Heald, provides novel insights for the eradication of possible disseminated cancer cells and therefore reduces the recurrence and mortality rates. However, either laparoscopic or open TME surgery is limited by the pelvic space and further improvement. For the last decade, the emerging of the natural orifice transluminal endoscopic surgery (NOTES) offers an alternative pattern for rectal cancer surgery, among which, the TaTME (transanal total mesorectal excision) represents the most optimized surgery techniques. Derived from TME, NOTES and modified laparoscopic instruments, TaTME facilitates the dissection process of rectal cancer from caudal to cranial, from indirect to direct vision. TaTME allows for accurate confirmation of resected margin with proper transecting level, better dissection of mesorectum and protection of sphincter, a qualified end-to-end anastomosis and reduced need of endolinear stapler and possible leakage afterwards. However, various kinds of instruments and surgical procedures have been proposed to complete TaTME, all of which have been validated by preclinical and clinical trials in small size. Of note, this study is initiated to apply a suit of instruments specifically designed for TaTME ( GelPoint pathway CS-Compact) and clinically evaluate the feasibility and safety of the new instruments without comparison to other prevailing ones. The CS-Compact and GelPoint pathway has been confirmed both safe and feasible to operate in preclinical trials and clinical trials in western. This study strictly examines the corresponding issues in Chinese rectal cancer patients. The surgeons in our institute have successfully completed the training programs of TaTME in preclinical trials, in animal models and cadavers. Clinical skills and knowledge to safe operations are qualified.

The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer

Number of participants with post-operative complications (e.g. numbers of postoperative bleeding, leakage, infections)

3-year disease free survival rate （the period after curative treatment without any detection of disease ）, the detailed information of 3y-DFS will be obtained by period follow-up of patients by calls and outpatient checking.

3-year overall survival rate （the survival period after curative treatment ）, the detailed information of 3y-OS will be obtained by period follow-up of patients by calls and outpatient checking.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy	NCT04972149	Gastric Cancer ...		- 90 Years	Yonsei University
Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy	NCT04972149	Gastric Cancer ...		- 90 Years	Yonsei University
The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer	NCT02943694	Postoperative C...	TaTME with CS-C...	18 Years - 75 Years	Ruijin Hospital

Spots Global Cancer Trial Database for instrument

Every month we try and update this database with for instrument cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for instrument

Every month we try and update this database with for instrument cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for instrument cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.