Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2a Non-randomized Controlled Study Based on the IDEAL Framework

What this Trial Is About

Researchers are evaluating the safety and short-term clinical effectiveness of single-port robotic total mesorectal excision compared to multi-port robotic total mesorectal excision in patients with rectal cancer. This phase 2a clinical trial follows the IDEAL framework and focuses on outcomes such as complications during and after surgery, blood loss, operation time, and recovery markers like time to first flatus and hospital stay length. The study also assesses secondary measures including pain, specimen quality, and incision length. The study includes two phases: Phase I is a single-arm study involving 20 patients undergoing single-port robotic surgery. Phase II is a prospective non-randomized controlled study comparing 100 patients receiving single-port robotic surgery to 100 patients receiving multi-port robotic surgery. Both groups undergo robotic total mesorectal excision performed with different numbers of ports. Participants will be assessed for intraoperative and postoperative complications within 30 days, conversion to other procedures during surgery, pain levels for three days post-surgery, and quality of surgical specimens. Researchers will monitor incision length and other clinical outcomes. The study starts in October 2024 and continues through December 2025, with participants followed closely during the perioperative period.

Single-port Versus Multi-port Robotic Surgery for Rectal Cancer