RATME Vs LATME in Middle and Low Rectal Cancer

NCT06105203 | Not Yet Recruiting DMC

• 1 other identifier: STARS-RC05
• Study Type: interventional
• Target: 1,026
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• coloanal anastomosis (CAA)

  during the operation

• conversion to open

  during the operation

• conversion to transanal TME (TaTME)

  during the operation

• 30-day postoperative morbidity

  within 30 days after operation

• 30-day postoperative mortality

  within 30 days after operation

Study Arms (2)

RATME

OTHER

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

LATME

OTHER

In LaTME groups, the low anterior resection and mesorectal excision procedures was completed under laparoscopy.

Procedure: laparoscopic-assisted total mesorectal excision

Interventions

Robotic-assisted total mesorectal excision PROCEDURE

TME will be performed with the assistance of robot in rectal cancer

RATME

laparoscopic-assisted total mesorectal excision PROCEDURE

TME will be performed with the assistance of laparoscopy in rectal cancer

LATME

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• Jilin Provincial Tumor Hospital: collaborator
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Quan Wang, Ph.D.

  The First Hospital of Jilin University

  STUDY CHAIR

Central Study Contacts

Yuchen Guo, Ph.D.

CONTACT

+8613630598312; guoyuchen8688@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: October 27, 2023
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)