Clinical trial NCT06105203: RATME Vs LATME in Middle and Low Rectal Cancer
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Total Mesorectal Excision
Rectal Neoplasms
Robotic Surgical Procedures
Laparoscopy
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Jilin Provincial Tumor Hospital
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: The Second Affiliated Hospital of Dalian Medical University
name: The Second Affiliated Hospital of Harbin Medical University
First posted: 2023-10-27
Enrollment: 1026
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: intersphincteric resection (ISR)
timeFrame: during the operation
Secondary outcomes:
measure: coloanal anastomosis (CAA)
timeFrame: during the operation
measure: conversion to open
timeFrame: during the operation
measure: conversion to transanal TME (TaTME)
timeFrame: during the operation
measure: 30-day postoperative morbidity
timeFrame: within 30 days after operation
measure: 30-day postoperative mortality
timeFrame: within 30 days after operation
measure: 3-year disease-free survival (DFS)
timeFrame: 3 years after operation
measure: 3-year local recurrence rate (LR)
timeFrame: 3 years after operation
measure: 3-year overall survival (OS)
timeFrame: 3 years after operation
measure: distance to distal resection margin (DRM)
timeFrame: within 30 days after operation
measure: distance to circumferential resection margin (CRM)
timeFrame: within 30 days after operation
measure: 3-year urinary function
timeFrame: 3 years after operation
measure: The proportion of patients receiving abdominoperineal resection
timeFrame: during the operation
measure: 3-year quality of life
timeFrame: 3 years after operation
measure: 3-year sexual function
timeFrame: 3 years after operation
measure: 3-year defecation function
timeFrame: 3 years after operation
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, Ph.D.
role: STUDY_CHAIR
References: