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Clinical Trials in Italy / NCT07358247
Starting soon Observational

Postoperative Outcomes of Single-stapled Anastomosis Combined With Transanal Natural Orifice Specimen Extraction

NCT07358247 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Clinico Humanitas
Phase
Observational
Started
2026-01-31
Last updated
2026-01-22

Condition(s) studied

Rectal Cancer PatientsRectal Cancer Surgery

Study summary

Natural Orifice Specimen Extraction (NOSE) eliminates the need for additional abdominal incisions in minimally invasive colorectal procedures, potentially reducing the risk of wound complications and postoperative pain. In the context of restorative Total Mesorectal Excision (TME), single-stapling (SS) techniques facilitate NOSE through transanal rectal transection, as opposed to the conventional double-stapling technique. This study aims to explore the potential advantages of NOSE combined with SS anastomosis compared to conventional abdominal extraction in minimally invasive restorative TME.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients aged more than 18 years old at the time of surgery * Patients with a histological diagnosis of rectal adenocarcinoma * Patients who underwent surgery between January 2017 and January 2023 * Patients with a low rectal tumor meeting the Low Rectal Cancer Development Programme (LOREC) criteria Exclusion Criteria: * Patients who underwent non-restorative procedures (including abdominoperineal resection or Hartmann's procedures). * Patients who underwent immediate or delayed coloanal anastomosis. * Patients who underwent open surgery. * Patients who underwent unplanned conversion from minimally invasive to open approach. * Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD).

Primary outcome measure(s)

  • Wound complications — 30 days after surgery
    The difference rate of 30-day wound complications between the study groups. Wound complications include Surgical Site Infections (SSI)- defined according to the definition of the Center for Disease Control and Prevention (CDC)-, wound hematoma, and wound seroma.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Humanitas Research Hospital Rozzano Milan

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Other trials for the same condition

SCARLET - Italian proSpeCtionAl obseRvationaL multicEntre Study on Treatment for recTal pT1 Cancer Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358247 on ClinicalTrials.gov ↗ ← All trials in Italy