RATME vs LATME in Middle and Low Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06105203
• Other study ID #: STARS-RC05
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 2031

Study information

• Verified date: October 2023
• Source: The First Hospital of Jilin University
• Contact: Yuchen Guo, Ph.D.
• Phone: +8613630598312
• Email: guoyuchen8688[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1026
• Est. completion date: January 2031
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopy
• Rectal Neoplasms
• Robotic Surgical Procedures
• Total Mesorectal Excision

Intervention

Procedure:
• Robotic-assisted total mesorectal excision
TME will be performed with the assistance of robot in rectal cancer
• laparoscopic-assisted total mesorectal excision
TME will be performed with the assistance of laparoscopy in rectal cancer

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (5)

Lead Sponsor	Collaborator
The First Hospital of Jilin University	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Jilin Provincial Tumor Hospital, The Second Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	conversion to open	Conversion to open surgery was defined as an abdominal incision larger than necessary for specimen retrieval extraction.	during the operation
Secondary	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
Secondary	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
Secondary	30-day postoperative mortality	The 30-day mortality is defined as death within 30 day after operation	within 30 days after operation
Secondary	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
Secondary	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
Secondary	3-year overall survival (OS)	OS is defined as the time from randomization to death due to any cause.	3 years after operation
Secondary	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
Secondary	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
Secondary	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
Secondary	The proportion of patients receiving abdominoperineal resection	the proportion of patients receiving abdominoperineal resection	during the operation
Secondary	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
Secondary	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
Secondary	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