Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer

NCT05953662 | Active Not Recruiting

• 1 other identifier: E2023044
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Reduced-port laparoscopic surgery has only 3 ports for surgeon and observer, and the surgeon completes the surgery independently, which increases the difficulty of the operation. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery avoids the prolongation of the operation time and parainjury caused by inexperienced assistant. Reduced-port laparoscopy reduces some surgical incisions, resulting in less pain and faster recovery. Reduced-port laparoscopy also reduces the consumables, human resources and medical expenses. This study aims to evaluate the curative effect and safety of reduced-port laparoscopic surgery versus conventional laparoscopic surgery for resectable colorectal cancer.

Conditions

Colorectal Neoplasm

Outcome Measures

Primary Outcomes (1)

• DFS rate

  Disease-free survival rate

  1 year

Secondary Outcomes (7)

• Total opertaion time

  through opertation completion, an average of 2 hours

• Intraoperative blood loss

  through study completion, an average of 50 ml

• Postoperative hospital stay

  through anticipants discharged, an average of 7 days

• Postoperative complication rate

  30 days

• Postoperative mortality

  30 days

Study Arms (2)

Reduced-port laparoscopic surgery

EXPERIMENTAL

locations of trocars: A 10mm trocar is placed in the supraumbilical or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar on the ipsilateral side of the patient according to the intraoperative situation, as the main operation port and the secondary operation port, and the positions of the trocars follow the principle that the lesion is located at the triangular apex of the two trocars.

Procedure: Reduced-port laparoscopic surgery

conventional laparoscopic surgery

ACTIVE COMPARATOR

locations of trocars: A 10mm trocar is placed in the supraumbilicus or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar in a suitable position according to the intraoperative situation as the main operation port and the secondary operation port. The assistant places two 5mm trocars in the appropriate position as the assistant operation port.

Procedure: conventional laparoscopic surgery

Interventions

Reduced-port laparoscopic surgery PROCEDURE

compare different operational styles of colon and upper rectal cancer

Reduced-port laparoscopic surgery

conventional laparoscopic surgery PROCEDURE

conventional laparoscopic surgery

conventional laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old;
• Pathological diagnosis of colorectal adenocarcinoma (including high, medium and low-differentiated adenocarcinoma, excluded: mucinous adenocarcinoma, signet ring cell carcinoma);
• Eastern Cooperative Oncology Group (ECOG) is 0-1 points;
• Chest, whole abdomen, pelvic enhanced CT confirm colon or upper rectal cancer, without distant metastasis;
• No other multiple primary tumors;
• No organ dysfunction;
• The patient and his/her family are able to understand the study protocol and are willing to participate in the study and sign informed consent.

You may not qualify if:

• Age \< 18, or \> 80 years old;
• Combined with simultaneous or heterogeneous (within 5 years) malignant tumors;
• Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who require emergency surgery;
• Joint organ resection is required;
• ASA Class IV or V;
• Suffering from a serious mental illness;
• Patients with severe emphysema, interstitial pneumonia or ischemic heart disease, etc. who cannot tolerate surgery;
• Continuous systemic steroid therapy within 1 months;
• Patients or families are unable to understand the conditions and objectives of this study.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jun Huang, MD

  six affiliated hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 20, 2023
• Study Start: September 1, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)