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NCT Number: NCT07358247

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location contact

Annalisa Maroli, PhD

CONTACT

[email protected]

00390282247776 ext. 0039

Antonino Spinelli, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Minimally invasive restorative total mesorectal excision (TME) conventionally requires an abdominal incision for specimen removal that limits its ability to reduce postoperative pain and would infection occurrence. Wound-related complications, including infections and incisional hernia, are well-recognized postoperative morbidities after minimally invasive colorectal surgery- with reported rates up to 20%- and the mini-laparotomy is often the primary site of infections and postoperative pain in colorectal surgery. Avoiding the abdominal wall extraction site may improve short-term outcomes and help reduce the cost associated with wound complications. As a result, there has been growing interest in natural orifice specimen extraction (NOSE), which eliminates the need for an extraction incision for specimen retrieval. Initially employed primarily for benign conditions, both transvaginal and transanal approaches have gradually expanded their utility to include colorectal cancer surgery without compromising bacteriological safety and oncological outcomes.

The introduction of the transanal techniques for rectal transection and single stapling anastomosis (TTSS) has enabled a more standardized application of NOSE in low rectal cancer surgery, where a complete TME and a low stapled colorectal anastomosis is required.

This study aims to compare short-term outcomes of low rectal cancer patients undergoing minimally invasive restorative TME with NOSE combined with single-stapling (SS) technique and conventional abdominal extraction incision and double-stapled anastomosis.

The primary objective of this study is to compare the postoperative outcomes of NOSE combined with SS anastomosis (NOSE) versus conventional abdominal extraction combined either with SS or double-stapled anastomosis (control), using a binary logistic regression-based Propensity Score Matched (PSM) approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Wound complications

    Time frame: 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.

Secondary outcomes

  1. Overall postoperative complications

    Time frame: 30 days after surgery

    The rate difference of 30-day overall postoperative complications, classified according to the Clavien-Dindo scale.

  2. Postoperative 24-hour pain

    Time frame: 24 hours after surgery

    The median difference of 24-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.

  3. Postoperative 48-hour pain

    Time frame: 48 hours after surgery

    The median difference of 48-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.

  4. Postoperative 72-hour pain

    Time frame: 72 hours after surgery

    The median difference of 72-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Annalisa Maroli, PhD

CONTACT

[email protected]

00390282247776 ext. 0039

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Postoperative Outcomes of Transanal Transection and Single-stapled Technique Combined With Transanal Natural Orifice Specimen Extraction: a Single-center Retrospective Cohort Study

Acronym: NOSE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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