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Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Robotic surgery
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Lymphadenectomy, Colorectal cancer, D3-D4

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jin-Tung LIANGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Laparoscopic surgery

Robotic group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the number of dissected lymph nodes
The total numbers of lymph node harvested during the operation
The distribution of dissected lymph nodes
The total numbers of lymph node harvested in different lymph node area during the operation
Functional recovery
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
The total medical costs including medication fee and equipment fee are recorded.
Assessment of disability
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.

Full Information

First Posted
July 9, 2023
Last Updated
July 27, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05961423
Brief Title
Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Lymphadenectomy, Colorectal cancer, D3-D4

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group: laparoscopic surgery Interventional group: robotic surgery
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic surgery
Arm Type
No Intervention
Arm Description
The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer
Arm Title
Robotic group
Arm Type
Active Comparator
Arm Description
The patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer
Intervention Type
Procedure
Intervention Name(s)
Robotic surgery
Intervention Description
The patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer
Primary Outcome Measure Information:
Title
The time to recurrence of cancer after curative resection
Description
The duration between the time of curative resection and the time to cancer recurrence
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
the number of dissected lymph nodes
Description
The total numbers of lymph node harvested during the operation
Time Frame
An average of 7 days
Title
The distribution of dissected lymph nodes
Description
The total numbers of lymph node harvested in different lymph node area during the operation
Time Frame
An average of 7 days
Title
Functional recovery
Description
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).
Time Frame
Up to 6 months
Title
The overall costs of both minimally invasive surgical approaches
Description
The total medical costs including medication fee and equipment fee are recorded.
Time Frame
Through patients' discharge from hospital, an average of 7 days
Title
Assessment of disability
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tung LIANG, PhD
Phone
886-9-72651432
Email
jintung@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tung LIANG, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jin-Tung LIANG
City
Taipei
ZIP/Postal Code
886
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tung LIANG, PhD
Phone
886-9-72651432
Email
jintung@ntu.edu.tw

12. IPD Sharing Statement

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Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer

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