Iatrogenic Colorectal PerforationsNCT07299864
Non-Operative Management in Patients With Iatrogenic Colorectal Perforations
An observational study of Iatrogenic Colorectal Perforations, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iatrogenic Colorectal Perforations
- How many people
- 32 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2021to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed iatrogenic colorectal perforations occurring during diagnostic or therapeutic colonoscopy at three high-volume tertiary care hospitals
Who may be able to join
- • Patients aged 18 years or older
- Iatrogenic colorectal perforation confirmed during or after diagnostic or therapeutic colonoscopy.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Iatrogenic Colorectal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the nonoperative management group | Not described | |
| the surgical treatment group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: up to 30 days
Secondary outcomes (6)
occurrence of complications classified according to the Clavien-Dindo
Measured: up to 30 days
length of hospital stay
Measured: up to 30 days
need for ICU admission
Measured: up to 30 days
duration of ICU stay
Measured: up to 30 days
stoma formation rate
Measured: up to 30 days
re-operation rate
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2021
- Primary completion31 May 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic Colorectal PerforationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taras V. Nechay, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299864
- Sponsor's protocol ID
- 3
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Operative Management in Patients With Iatrogenic Colorectal Perforations: A Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07299864
- Acronym / sponsor ID
- 3
- Conditions
- Iatrogenic Colorectal Perforations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the nonoperative management group | – | – |
| the surgical treatment group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed iatrogenic colorectal perforations occurring during diagnostic or therapeutic colonoscopy at three high-volume tertiary care hospitals
Key inclusion criteria (2 listed)
- • Patients aged 18 years or older
Key exclusion criteria (2 listed)
- • Patients diagnosed with colorectal perforations due to trauma, acute diverticulitis, anastomotic dehiscence or surgical interventions not related to diagnostic or therapeutic colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival rate
Time frame: up to 30 days
6 secondary outcomes
occurrence of complications classified according to the Clavien-Dindo
Time frame: up to 30 days
length of hospital stay
Time frame: up to 30 days
need for ICU admission
Time frame: up to 30 days
duration of ICU stay
Time frame: up to 30 days
stoma formation rate
Time frame: up to 30 days
re-operation rate
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Colorectal Perforations, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.