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RATME Vs LATME in Middle and Low Rectal Cancer

ConditionsTotal Mesorectal ExcisionRectal NeoplasmsRobotic Surgical ProceduresLaparoscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Hospital of Jilin University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotic-assisted total mesorectal excision

    Procedure/Surgery

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

  • laparoscopic-assisted total mesorectal excision

    Procedure/Surgery

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

Treatment groups

1,026 Participants
are divided into 2 treatment groups
Group A: RATMEOther 1 intervention
Group B: LATMEOther 1 intervention

Trial outcomes

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

Time frame
during the operation

Secondary outcomes

1

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.

Time frame
during the operation
2

conversion to open

Conversion to open surgery was defined as an abdominal incision larger than necessary for specimen retrieval extraction.

Time frame
during the operation
3

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

Time frame
during the operation
4

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

Time frame
within 30 days after operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Hospital of Jilin University

Lead sponsor

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

Source ClinicalTrials.gov

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