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Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT05961423
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Clinical Trial Center, National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE July 9, 2023
First Posted Date  ICMJE July 27, 2023
Last Update Posted Date August 1, 2023
Actual Study Start Date  ICMJE June 19, 2020
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2023)		 The time to recurrence of cancer after curative resection [ Time Frame: Up to 3 years ]
The duration between the time of curative resection and the time to cancer recurrence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2023)
  • the number of dissected lymph nodes [ Time Frame: An average of 7 days ]
    The total numbers of lymph node harvested during the operation
  • The distribution of dissected lymph nodes [ Time Frame: An average of 7 days ]
    The total numbers of lymph node harvested in different lymph node area during the operation
  • Functional recovery [ Time Frame: Up to 6 months ]
    Functional questionnaire regarding fecal continence and bowel function will be completed by an assistant not aware of the randomization status of the patient right after completion of the manometric studies. Continence was recorded as Grade 1 (perfect continence), Grade 2 (incontinence of flatus), Grade 3 (occasional minor soiling), Grade 4 (frequent major soiling), and Grade 5 (total incontinence).
  • The overall costs of both minimally invasive surgical approaches [ Time Frame: Through patients' discharge from hospital, an average of 7 days ]
    The total medical costs including medication fee and equipment fee are recorded.
  • Assessment of disability [ Time Frame: 12 months ]
    The time for the patients after the operation to resume partial activity, full activity, and return to work will be recorded to evaluate the disability.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2023)
  • the number of dissected lymph nodes [ Time Frame: An average of 7 days ]
    The total numbers of lymph node harvested during the operation
  • The distribution of dissected lymph nodes [ Time Frame: An average of 7 days ]
    The total numbers of lymph node harvested in different lymph node area during the operation
  • Functional recovery [ Time Frame: Up to 6 months ]
    Functional questionnaire regarding fecal continence and bowel function will be completed by an assistant not aware of the randomization status of the patient right after completion of the manometric studies. Continence was recorded as Grade 1 (perfect continence), Grade 2 (incontinence of flatus), Grade 3 (occasional minor soiling), Grade 4 (frequent major soiling), and Grade 5 (total incontinence).
  • The overall costs of both minimally invasive surgical approaches [ Time Frame: Through patients' discharge from hospital, an average of 7 days ]
    The total medical costs including medication fee and equipment fee are recorded.
  • The defecation function [ Time Frame: 6 months ]
    Continence, urgency, leakage, use of pad, stool frequency, incomplete defecation, fragmentation, use of laxatives, use of antidiarrheal agent, use of enema, and digital evacuation.
  • Assessment of disability [ Time Frame: 12 months ]
    The time for the patients after the operation to resume partial activity, full activity, and return to work will be recorded to evaluate the disability.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer
Official Title  ICMJE Robotic Versus Laparoscopic D3-D4 Lymphadenectomy for Patients With Advanced Colorectal Cancer… A Randomized Prospective Clinical Trial for the Comparison of Oncologic and Functional Outcomes
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.
Detailed Description

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.

In the upcoming three years (2020/4/1-2023/3/31),consecutive recto-sigmoid cancer patients with metastasis to para- aortic lymph node will be screened and randomized to patient groups undergoing either robotic or laparoscopic D3-D4 lymph node dissection. The extent of D4 lymph node dissection includes extirpation of the extra-mesenteric lymphatic basin along bilateral common iliac arteries and veins, inferior vena cava, and abdominal aorta upward to the level just below the duodenal third portion and left renal vein, besides the traditional mesenteric dissection of paracolic (N1) lymph nodes, intermediate (N2) mesenteric lymph nodes, and lymph nodes around the root of inferior mesenteric artery (N3). The harvested lymph nodes were mapped and managed according to the Japanese guidelines. The metrics of surgical outcomes included: the number of harvested lymph nodes; time to recurrence of cancer after surgery; the length of operation time; blood loss; intra-operative and post-operative complications; and wound size. Functional recovery was evaluated by length of post-operative flatus passage, the restoration of urinary function, hospitalization, and degree of post-operative pain. A subjective-response standardized questionnaire was given to patients to assess disability, which included the number of days until return to partial activity, full activity, and work.

Since the current randomized prospective study in this field is still lack of, the investigators believe that this study will be of academic importance. And, clinically, the presented study can to help set up the standard operation procedures for such patient, and provide the level one evidence for National Health Insurance Administration in evaluating the reimbursement of HTA (high technology assessment) procedures.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Control group: laparoscopic surgery Interventional group: robotic surgery
Masking: None (Open Label)
Masking Description:
No masking
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Procedure: Robotic surgery
The patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer
Study Arms  ICMJE
  • No Intervention: Laparoscopic surgery
    The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer
  • Active Comparator: Robotic group
    The patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer
    Intervention: Procedure: Robotic surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2023)		 286
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2024
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jin-Tung LIANG, PhD 886-9-72651432 jintung@ntu.edu.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05961423
Other Study ID Numbers  ICMJE 202002011RINB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Taiwan University Clinical Trial Center, National Taiwan University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Taiwan University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jin-Tung LIANG, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP