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

Launched by TAIYUAN LI · Jul 20, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to remove cancer from the rectum using robotic surgery. One method involves taking out the cancer through the anus, while the other method involves making an incision in the abdomen. The goal is to see which method is safer and easier for patients with rectal cancer.

To participate, you need to be between 18 and 75 years old and have been diagnosed with a specific type of rectal cancer that hasn't spread to other parts of the body. You should also be healthy enough to undergo surgery and willing to give your consent to participate. If you join the trial, you will receive the surgery as part of the study and be monitored closely to ensure your safety during the process. It's important to know that this trial is not yet recruiting participants, so more information will be available once it starts.

Gender

ALL

Eligibility criteria

• 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;