NCT07358247

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 13, 2026

Last Update Submit

January 13, 2026

Conditions

Rectal Cancer PatientsRectal Cancer Surgery

Keywords

Single-stapled anastomosisNatural orifice specimen extractionRectal cancerWound complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Overall postoperative complications

    30 days after surgery

  • Postoperative 24-hour pain

    24 hours after surgery

  • Postoperative 48-hour pain

    48 hours after surgery

  • Postoperative 72-hour pain

    72 hours after surgery

Study Arms (2)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Antonino Spinelli, MD, PhD

    Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

00390282247776annalisa.maroli@humanitas.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

January 31, 2026

Primary Completion

March 31, 2026

Study Completion

April 30, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

IT(1)