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)

微创结直肠癌手术中小切口与经直肠自然腔道标本取出术的比较:一项随机对照试验的研究方案(MINITR-NOSE 试验,TCAR2514 方案)

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Abstract

BACKGROUND: 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. 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05740267. Registered on March 1, 2023.

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