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Not yet recruiting NCT06105203

RATME Vs LATME in Middle and Low Rectal Cancer

No phase Interventional Total Mesorectal Excision Rectal Neoplasms Robotic Surgical Procedures Laparoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic-assisted total mesorectal excision, laparoscopic-assisted total mesorectal excision.
Who it may be relevant to
Registry conditions: Total Mesorectal Excision, Rectal Neoplasms, Robotic Surgical Procedures, Laparoscopy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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.

Interventions

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

Primary outcome measures

  • intersphincteric resection (ISR) [Time frame: during the operation]
Secondary outcome measures (12)
  • coloanal anastomosis (CAA) [Time frame: during the operation]
  • conversion to open [Time frame: during the operation]
  • conversion to transanal TME (TaTME) [Time frame: during the operation]
  • 30-day postoperative morbidity [Time frame: within 30 days after operation]
  • 30-day postoperative mortality [Time frame: within 30 days after operation]
  • 3-year disease-free survival (DFS) [Time frame: 3 years after operation]
  • 3-year local recurrence rate (LR) [Time frame: 3 years after operation]
  • 3-year overall survival (OS) [Time frame: 3 years after operation]
  • distance to distal resection margin (DRM) [Time frame: within 30 days after operation]
  • distance to circumferential resection margin (CRM) [Time frame: within 30 days after operation]
  • 3-year urinary function [Time frame: 3 years after operation]
  • The proportion of patients receiving abdominoperineal resection [Time frame: during the operation]

Eligibility criteria

Inclusion criteria

  • male patients diagnosed with rectal cancer by pathological biopsy;
  • abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;
  • 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;
  • 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;
  • The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.

Exclusion criteria

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

Exit Criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of Jilin University — Changchun

Publications

  • Guo Y, He L, Tong W, Chi Z, Ren S, Cui B, Wang Q. A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial. Trials. 2024 Oct 21;25(1):703. doi: 10.1186/s13063-024-08561-4. PMID 39434171

Identifiers

NCT: NCT06105203 · STARS-RC05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗