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

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)

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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