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Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

T

Taiyuan Li

Status

Not yet enrolling

Conditions

Natural Orifice Specimen Extraction Surgery
Rectal Neoplasms
Robotic Surgery

Treatments

Procedure: Transanal specimen extraction robotic surgery
Procedure: Transabdominal specimen extraction robotic surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05468944
RO220624

Details and patient eligibility

About

This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.

Full description

In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.

Enrollment

556 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age between 18 to 75 years;
  2. Historically confirmed rectal adenocarcinoma;
  3. Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;
  4. cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;
  5. No evidence of distant metastases;
  6. A maximum of 5cm in diameter;
  7. Body mass index (BMI) ≤ 30 kg / m2;
  8. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion);
  9. Willing to undergo surgery;
  10. Sign the informed consent;

Exclusion criteria

  1. Presence of lateral/inguinal lymph node metastases;
  2. Previous history of malignant colorectal tumor;
  3. Multiple primary colorectal tumors;
  4. Neoadjuvant therapy;
  5. Salvage surgery for endoscopic surgery;
  6. History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion;
  7. Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease;
  8. Comorbid with other malignancies within 5 years;
  9. ASA ≥ IV and/or ECOG performance status score ≥ 2;
  10. Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases;
  11. Serious mental illness;
  12. Pregnant or lactating women;
  13. Uncontrolled infection;
  14. Abnormal anal function or anal stenosis;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

556 participants in 2 patient groups

Transanal group
Experimental group
Description:
Participants in this group underwent robotic surgery with transanal specimen extraction
Treatment:
Procedure: Transanal specimen extraction robotic surgery
Transabdominal group
Active Comparator group
Description:
Participants in this group underwent robotic surgery with transabdominal specimen extraction
Treatment:
Procedure: Transabdominal specimen extraction robotic surgery

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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