RATME Vs LATME in Middle and Low Rectal Cancer

A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.

This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Neoplasms; Laparoscopy; Robotic Surgical Procedures; Total Mesorectal Excision
• Intervention / Treatment: Procedure: Robotic-assisted total mesorectal excision; Procedure: laparoscopic-assisted total mesorectal excision

Detailed Description

Robotic-assisted total mesorectal excision (RATME) has been gradually applied by colorectal surgeons. Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision (TME) in rectal cancer, especially middle and low rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME (LATME) in middle and low rectal cancer.

This is a multicenter, superior, randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measures will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.

• Study Type: Interventional
• Enrollment (Estimated): 1026
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuchen Guo, Ph.D.; Phone Number: +8613630598312; Email: guoyuchen8688@live.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
      • Contact: Yuchen Guo, Ph.D.; Phone Number: +8613630598312; Email: guoyuchen8688@live.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. male patients diagnosed with rectal cancer by pathological biopsy;
2. abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;
3. Preoperative rectal magnetic resistance (MR) evaluation showed that the tumor was located at or below the peritoneal reflux plane, and at least 1cm above the anal sphincter groove, and did not invade the external anal sphincter;
4. Tumors located above the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-3, cN0-1, M0, and MRF (-); The tumors located below the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-2, cN0-1, M0, and MRF (-). After neoadjuvant treatment, the tumor above the hiatus of levator ani muscle is ycT3NxM0 or below; The tumor below the hiatus of levator ani muscle is ycT2NxM0;
5. The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.

Exclusion Criteria:

1. multiple primary cancers;
2. history of open surgery;
3. no preoperative MR evaluation and inadequate evaluation of tumor stage;
4. Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;
5. Pregnant or patients with concomitant inflammatory bowel disease;
6. Patients with preoperative complete bowel obstruction or requiring emergency surgery;
7. Preoperative evaluation indicates that patient may require combined organ resection;
8. Recently receiving treatment for other malignant tumors;
9. Bordeaux type IV low rectal cancer;
10. The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.

Exit Criteria

1. Refuse surgical treatment after randomization;
2. Open surgery was performed for treatment after randomization;
3. Patients request to withdraw from the study at any time during the entire study process after randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RATME; In RaTME groups, the low anterior resection and TME was finished with the assistance of robot (da Vinci Xi surgical system)	Procedure: Robotic-assisted total mesorectal excision; TME will be performed with the assistance of robot in rectal cancer
Other: LATME; In LaTME groups, the low anterior resection and mesorectal excision procedures was completed under laparoscopy.	Procedure: laparoscopic-assisted total mesorectal excision; TME will be performed with the assistance of laparoscopy in rectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intersphincteric resection (ISR)	The primary outcome is the incidence of ISR. ISR is defined according to the definition by a Japanese study group. When the distal resection margin is from dentate line to the intersphincteric groove, ISR will be recorded.The distal resection line of the internal anal sphincter was at the intersphincteric groove in total ISR, between the dentate line and the intersphincteric groove in subtotal ISR and at the dentate line in partial ISR	during the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
coloanal anastomosis (CAA)	CAA was defined as the anastomosis of distal colon and surgical anal canal. In CAA anastomosis, the distal resection margin is below the upper level of the levator ani muscle. Conversion to open was defined as an abdominal incision larger than necessary for specimen retrieval.	during the operation
conversion to open	Conversion to open surgery was defined as an abdominal incision larger than necessary for specimen retrieval extraction.	during the operation
conversion to transanal TME (TaTME)	Conversion to TaTME was defined as TME that cannot be finished via transabdominal approach, and have to be finished by transanal approach with the help of imaging system and endoscopic instruments. It should be noted that if TME was completely done via transabdominal approach, simply dissecting the internal sphincter and intersphincteric space or finish the coloanal anastomosis via transanal approach were not classified as TaTME	during the operation
30-day postoperative morbidity	The 30-day morbidity is defined as intraoperative adverse events and postoperative complications within 30 days. The intraoperative adverse events include intraoperative bleeding (>200 ml), pelvic vascular and nerve injury, vascular injury in other parts, digestive tract injury, ureteral injury, and anastomotic defect. Furthermore, the 30-day postoperative complications are evaluated according to Clavien-Dindo classification	within 30 days after operation
30-day postoperative mortality	The 30-day mortality is defined as death within 30 day after operation	within 30 days after operation
3-year disease-free survival (DFS)	DFS is defined as the time from randomization to the discovery of local recurrence, distant metastasis, or death of the tumor	3 years after operation
3-year local recurrence rate (LR)	LR is defined as tumor recurrence (evaluated by positron emission tomography, computed tomography, or magnetic resistance) that occurs in the pelvic cavity, perineal area, root of inferior mesenteric artery, descending colon, and sigmoid mesenteric area, and is confirmed through pathological biopsy or reoperation.	3 years after operation
3-year overall survival (OS)	OS is defined as the time from randomization to death due to any cause.	3 years after operation
distance to distal resection margin (DRM)	The distance to the DRM is defined as the shortest length between the tumor and the DRM. DRM positivity is defined as a distal margin within 1 mm of the tumor.	within 30 days after operation
distance to circumferential resection margin (CRM)	The distance to the CRM is defined as the shortest length between the tumor and the CRM. CRM positivity is defined as tumor cells within 1 mm from the CRM by microscopy	within 30 days after operation
3-year urinary function	Urinary function will be evaluated by International consultation on incontinence questionnaire short form (ICIQ-SF). The patients will be asked to complete ICIQ-SF every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.	3 years after operation
The proportion of patients receiving abdominoperineal resection	the proportion of patients receiving abdominoperineal resection	during the operation
3-year quality of life	Quality of life will be evaluated by EORTC quality of life questionnaire-core 30 (QLQ-C30) form. The patients will be asked to complete QLQ-C30 every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.	3 years after operation
3-year sexual function	Sexual function of male will be evaluated by International Index of Erectile Function (IIEF-5). Sexual function of female will be evaluated by Female Sexual Function Index (FSFI). Evaluation will be performed every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.	3 years after operation
3-year defecation function	Defecation function will be evaluated by low anterior resection syndrome (LARS) form. The patients will be asked to complete LARS form every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.	3 years after operation

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Collaborators: Jilin Provincial Tumor Hospital; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; The Second Affiliated Hospital of Harbin Medical University; The Second Affiliated Hospital of Dalian Medical University
• Investigators: Study Chair: Quan Wang, Ph.D., The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: September 3, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: STARS-RC05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No