Non-Operative Management in Patients With Iatrogenic Colorectal Perforations

Non-Operative Management in Patients With Iatrogenic Colorectal Perforations: A Retrospective Multicenter Study

This is a retrospective, multicenter observational study that aims to evaluate the efficacy and safety of non-operative management in patients with iatrogenic colorectal perforations.

Study Overview

• Status: Completed
• Conditions: Iatrogenic Colorectal Perforations

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia
    • Pirogov 1 City Clinical Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed iatrogenic colorectal perforations occurring during diagnostic or therapeutic colonoscopy at three high-volume tertiary care hospitals

Description

Inclusion Criteria:

• • Patients aged 18 years or older

  • Iatrogenic colorectal perforation confirmed during or after diagnostic or therapeutic colonoscopy.

Exclusion Criteria:

• • Patients diagnosed with colorectal perforations due to trauma, acute diverticulitis, anastomotic dehiscence or surgical interventions not related to diagnostic or therapeutic colonoscopy

  • Incomplete records or missing data

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
the nonoperative management group
the surgical treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
survival rate	up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
length of hospital stay	up to 30 days
occurrence of complications classified according to the Clavien-Dindo	up to 30 days
need for ICU admission	up to 30 days
duration of ICU stay	up to 30 days
stoma formation rate	up to 30 days
re-operation rate	up to 30 days

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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