Mini-laparotomy versus transrectal natural orifice specimen extraction for minimally invasive colorectal cancer surgery: study protocol for a randomized controlled trial (MINITR-NOSE trial, TCAR2514 protocol)

Minimally invasive surgery (MIS) has improved colorectal cancer (CRC) treatment by reducing recovery time, pain, and infection risk compared to traditional open surgery, though a mini laparotomy is still needed for specimen removal. Natural orifice specimen extraction (NOSE) offers a promising alternative by using natural body openings for extraction, potentially minimizing complications further, yet requires more evidence to confirm its safety and effectiveness over conventional methods. This single-center randomized controlled trial at Linkou Chang-Gung Memorial Hospital includes CRC patients meeting specific eligibility criteria, randomly assigned to undergo either NOSE or conventional MIS. Primary outcomes focus on postoperative C-reactive protein (CRP) levels as a marker of inflammation, with secondary outcomes evaluating short-term complications, recovery, readmission, and long-term survival. Both groups will receive routine perioperative care following modified Enhanced Recovery After Surgery (ERAS) protocols, with postoperative pain and complications systematically recorded and graded. This study seeks to determine whether the NOSE approach offers advantages over conventional MIS by reducing inflammation and complications, potentially improving patient recovery and outcomes. If effective, NOSE may present a less invasive alternative for CRC resection, contributing to advancements in colorectal surgical oncology. ClinicalTrials.gov NCT05740267. Registered on March 1, 2023.