Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Fibrinolytic Agents

Anticoagulants

Anesthetics

Heparin

Calcium heparin

The tattooing was performed at 24-48 hours before the surgery. When the lesion was identified by endoscopy, 2-3 ml of the patient's peripheral venous blood without heparin preparation were injected submucosally at the distal side and proximal side of the lesion using a conventional endoscopic needle without submucosal injection of normal saline.

Under general anesthesia with endotracheal intubation, the patient was placed in the modified lithotomy position. After routine laparoscopic exploration, CO2-insufflated intraoperative colonoscopy was performed using a flexible videocolonoscope. Upstream small bowel clamping was applied before intraoperative colonoscopy. During intraoperative colonoscopy, CO2 pneumoperitoneum was maintained by the insufflator so that the laparoscope could guide the colonoscope effectively.

This is one of the routine procedures used for colorectal cancer resection.

Laparoscopic colorectal cancer resection

Xiao-hua Jiang, MD

Shun Zhang, MD

Xiaohua Jiang, MD

Laparoscopic colorectal surgery has been proved to have similar oncological outcomes with open surgery. Due to the lack of tactile perception, surgeons may have misjudgments in laparoscopic colorectal surgery. Therefore, the accurate localization of a tumor before surgery is important, especially in the early stages of cancer. Recently, some retrospective studies reported the use of patients' autologous blood for preoperative colonic localization in colorectal cancer with successful detection by laparoscopy, but its benefits remain controversial. This study aimed to assess the accuracy and safety of autogenous blood marker localization in laparoscopic radical resection for colorectal cancer.

Laparoscopic surgery has become the standard for management of colorectal cancer(CRC) with the advantages of less traumatic procedure, but similar oncological outcomes to open surgery. Due to the lack of tactile perception (haptic feedback), surgeons may have misjudgments in patients with small or flat early colon cancer, malignant polyps resected by endoscopic mucosal resection or endoscopic submucosal dissection. Therefore, the accurate localization of a tumor before surgery is important, especially in the early stages of cancer, to clarify the extent of surgical resection.

Several methods are currently being proposed and used to identify the location of tumors. These include endoscopic tattooing with India ink, indocyanine green (ICG), preoperative endoscopic metal clipping with detection using an x-ray or palpation during surgery, and intraoperative endoscopy.

Recently, some retrospective studies reported the use of patients' autologous blood for preoperative colonic localization in CRC with successful detection by laparoscopy. Autologous blood was thought a feasible and safe tattooing agent for preoperative endoscopic localization. Nonetheless, all currently available evidence comes from observational studies that are susceptible to bias. We therefore proposed to conduct this randomized controlled clinical trial to evaluate the accuracy and safety of autogenous blood marker localization in laparoscopic radical resection for colorectal cancer.

Assessment of Autologous Blood Marker Localization in Laparoscopic Colorectal Cancer Surgery

Assessment of Autologous Blood Marker Localization and Intraoperative Colonoscopy Localization in Laparoscopic Colorectal Cancer Surgery: a Randomized Controlled Trial

While checking the intraperitoneal cavity at the start of the surgery, the visibility of tattooing will be first checked. After the complete resection of the colon segment, resected colon specimen will be checked the localization with autologous blood tattooing. The localization accuracy of autologous blood marker will be similar to that of intraoperative colonoscopy localization.

The secondary endpoint is the localization safety. Adverse events related to endoscopic tattooing, such as perforation, abscess formation, peritonitis, post-tattoo fever, post-tattoo abdominal pain, and intraperitoneal spillage of tattooing agent, were evaluated in autologous blood group.

Shanghai East Hospital

Participants in this arm undergo colorectal cancer resection via minilaparotomy.

Participants in this arm undergo laparoscopic colorectal cancer resection.

According to the cancer location, a 7 cm incision is made in specific area of the patient's abdomen. The whole procedure of operation will be finished within this incision. If the incision must be lengthen due to the surgical demand, the failure of the minilaparotomy is determined.

Colorectal cancer resection via minilaparotomy

Zi-Ye ZHAO, MD

En-Da YU, MBBS

The primary aim of this study is

- to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy..

Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other.

* 3-year disease free survival, 3y DFS
* 5-year overall survival, 5y OS
* 5-year disease free survival, 5y DFS
* Local recurrence rate, LRR
* Postoperative complications Incidence and mortality at 30 days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of Autologous Blood Marker Localization in Laparoscopic Colorectal Cancer Surgery	NCT05597384	Colorectal Canc...	Laparoscopic co...	18 Years - 80 Years	Shanghai East Hospital
Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer	NCT03843398	Colorectal Canc...	Colorectal canc... Laparoscopic co...	18 Years - 80 Years	Changhai Hospital
Assessment of Autologous Blood Marker Localization in Laparoscopic Colorectal Cancer Surgery	NCT05597384	Colorectal Canc...	Laparoscopic co...	18 Years - 80 Years	Shanghai East Hospital

Spots Global Cancer Trial Database for laparoscopic colorectal cancer resection