Not Yet RecruitingNot Applicable

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

Italy190 participantsStarted 2026-01-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Wound complications

Timeframe: 30 days after surgery

Trial details

NCT IDNCT07358247

SponsorIstituto Clinico Humanitas

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-31

Contact for this trial

Annalisa Maroli, PhD

00390282247776 annalisa.maroli@humanitas.it