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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer Patients; Rectal Cancer Surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

• Study Contact: Name: Annalisa Maroli, PhD; Phone Number: 0039 00390282247776; Email: annalisa.maroli@humanitas.it

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Irccs Humanitas Research Hospital
      • Principal Investigator: Antonino Spinelli, MD, PhD
      • Contact: Annalisa Maroli, PhD; Phone Number: 0039 00390282247776; Email: annalisa.maroli@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients who underwent rectal cancer surgery between January 2017 and January 2023.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NOSE; Patients who underwent Natural Orifice Specimen Extraction (NOSE) in combination with Single-Stapled (SS) anastomosis approach
Control; Patients who underwent double-staple or Single-stapled (SS) anastomosis with standard abdominal incision extraction (including Pfannenstiel incision or left iliac fossa incision)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound complications	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.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall postoperative complications	The rate difference of 30-day overall postoperative complications, classified according to the Clavien-Dindo scale.	30 days after surgery
Postoperative 24-hour pain	The median difference of 24-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.	24 hours after surgery
Postoperative 48-hour pain	The median difference of 48-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.	48 hours after surgery
Postoperative 72-hour pain	The median difference of 72-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.	72 hours after surgery

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Antonino Spinelli, MD, PhD, Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Rectal cancer; Wound complications; Natural orifice specimen extraction; Single-stapled anastomosis
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 5572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the local SOP the IPD will uploaded on a public repository (Zenodo) with an appropriate embargo and will be made available upon resonable request only with the approval of the local administration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No