Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Infections

Colonic Neoplasms

Syndrome

Inflammation

Peritonitis

Systemic Inflammatory Response Syndrome

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Shock

Communicable Diseases

Intraabdominal Infections

Peritoneal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients undergoing robotic-assisted colectomy for colonic neoplasm

Patients undergoing conventional laparoscopic colectomy for colonic neoplasm

Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology

Robotic-assisted colectomy

Conventional laparoscopic colectomy

Pedja Cuk, MD

The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial

Levels of cytokines are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A as well as IL-1RA and CRP. All cytokines are measured in pg/mL, CRP measured in mg/L

Recovery is measured according to quality of recovery 15 score (QoR-15). The score ranges from 0-150. A high score indicates a good recovery.

Number of mortality obtained from medical charts

The heart rate will continuously recorded by ECG intra- and postoperatively

The two surgical methods will be compared in order to obtain any differences in the local or metastatic cancer recurrence

The cytokine levels are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A and IL-1RA. All cytokines are measured in pg/mL

Number of complications obtained from medical records

Region of Southern Denmark

University of Southern Denmark

Wounds and Injuries

Pain

incisionless laparoscopic colectomy: Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.

conventional laparoscopic colectomy: The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis

Arm 1:Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.

incisionless laparoscopic colectomy

Arm 2: Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis

conventional laparoscopic colectomy

Yui Shan Cheung, FRACS

To compare the two surgical options in their short-term and long term outcomes in the management of early left-sided colorectal cancers. The hypothesis is that the incisionless approach will result in less postoperative pain and wound related complications.

For the left-sided colorectal cancer, the investigators performed colectomy with primary anatomosis. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:

1. Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
2. Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the Transanal Endoscopic Operation (TEO) device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.

These two operations are essentially identical except for the surgical access for the delivery of specimen and insertion of anvil. Laparoscopic colectomy and the use of Transanal Endoscopic Operation(TEO)device have been practiced in the United States and Europe for over 10 years. Large scale studies in the literature have demonstrated the safety and benefits of laparoscopic colectomy for colonic tumors and the oncological outcomes have not shown to be inferior to open approach. With the use of TEO device, the investigators can perform laparoscopic colectomy without abdominal incision for those early left-sided colonic tumors and thus it can eliminate the wound-related complications theoretically. In order to find out which one is a better procedure, the investigators are carrying out a clinical trial to compare the two surgical options in their short-term and long term outcomes.The results of this study may have an impact on the care of similar patients in the future.

Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors

From the start of operation till operation finished

From the date after operation to date of discharge,an expected average of within 1 week

participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week

The patient will be followed for up to 30 days after the operation or till occurrence of event

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer	NCT04687384	Colonic Neoplas... Colon Cancer Systemic Inflam... Inflammation Robotic Surgica... Laparoscopy Peritoneal Infl...	Robotic-assiste... Conventional la...	18 Years -	University of Southern Denmark
Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors	NCT01762254	Pain, Postoperative W...	incisionless la... conventional la...	18 Years -	Pamela Youde Nethersole Eastern Hospital

Spots Global Cancer Trial Database for conventional laparoscopic colectomy