Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer

NCT05961423 | Unknown

• 1 other identifier: 202002011RINB
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial.

Conditions

Colorectal Cancer

Keywords

Lymphadenectomy; Colorectal cancer; D3-D4

Outcome Measures

Primary Outcomes (1)

• The time to recurrence of cancer after curative resection

  The duration between the time of curative resection and the time to cancer recurrence

  Up to 3 years

Secondary Outcomes (5)

• the number of dissected lymph nodes

  An average of 7 days

• The distribution of dissected lymph nodes

  An average of 7 days

• Functional recovery

  Up to 6 months

• The overall costs of both minimally invasive surgical approaches

  Through patients' discharge from hospital, an average of 7 days

• Assessment of disability

  12 months

Study Arms (2)

Laparoscopic surgery

NO INTERVENTION

The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer

Robotic group

ACTIVE COMPARATOR

The patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer

Procedure: Robotic surgery

Interventions

Robotic surgery PROCEDURE

The patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer

Robotic group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically proved adenocarcinoma located at upper rectum (above pelvic peritoneal reflection), recto-sigmoid junction, or distal sigmoid colon (generally 10 to 25 cm above anal verge). Only recto-sigmoid cancers above the peritoneal reflection were investigated because the lymphatic drainage of upper rectum and distal sigmoid colon was along the inferior mesenteric artery to the para-aortic area, and therefore the extent of surgical resection and lymph node mapping were standardized.
• Clinically TNM stage III cancers.
• Curative robotic or laparoscopic surgery.
• American Society of Anesthesiology (ASA) class I to III patients.
• Age between 50 and 75 years. This was because patients \>50 years old are generally deemed to be over the reproductive age, and the D3 dissection was considered too aggressive for patients older than 75 years.
• Patients who are willing to receive minimally invasive surgical procedures to treat their rectosigmoid cancer.

You may not qualify if:

• Tumors located at other anatomic positions;
• Emergency or palliative surgery;
• Evidence of disseminated disease or adjacent organ invasion;
• Primary tumor mass ≥8 cm in diameter;
• Morbidly obese patients (body mass index ≥40 kg/m2);
• Previous major surgery of lower abdomen.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Jin-Tung LIANG

Taipei, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Robotic Surgical Procedures

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

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Jin-Tung LIANG, PhD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Jin-Tung LIANG, PhD

CONTACT

886-9-72651432; jintung@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of colorectal surgery, department of surgery, National Taiwan University Hospital

Model Details: Control group: laparoscopic surgery Interventional group: robotic surgery

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 27, 2023
• Study Start: June 19, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-04

Locations

TW (1)