NCT07299864

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

4.4 years

First QC Date

December 5, 2025

Last Update Submit

December 17, 2025

Conditions

Iatrogenic Colorectal Perforations

Outcome Measures

Primary Outcomes (1)

  • survival rate

    up to 30 days

Secondary Outcomes (6)

  • occurrence of complications classified according to the Clavien-Dindo

    up to 30 days

  • length of hospital stay

    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

  • +1 more secondary outcomes

Study Arms (2)

the nonoperative management group

the surgical treatment group

Eligibility Criteria

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

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

You may qualify if:

  • Patients aged 18 years or older
  • Iatrogenic colorectal perforation confirmed during or after diagnostic or therapeutic colonoscopy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pirogov 1 City Clinical Hospital

Moscow, Russia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 23, 2025

Study Start

January 1, 2021

Primary Completion

May 31, 2025

Study Completion

November 30, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

RU(1)