Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery

NCT ID: NCT06675097

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The recovery of transit after surgery is an important parameter in postoperative evaluation. It generally reflects simple postoperative outcomes and allows the patient to return home.

The quality of gas recovery after surgery has not been studied to our knowledge, but it is not uncommon for an operated patient to emit some gas considered as a recovery of transit when it is ultimately a false transit preceding a postoperative ileus. Furthermore, intestinal gases and their composition reflect the intestinal microbiota. This microbiota has been shown to be predictive of the appearance of an operative complication. As the analysis of this microbiota cannot be carried out routinely, it is important to be able to use a reflection of this microbiota in routine practice and to correlate it with the surgical outcomes. Intestinal gas therefore seems to be the tool of choice.

The main objective is to evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality.

The secondary objectives are to compare the quantity and quality of gases pre- and post-operatively and to define a predictive score for surgical complications, based on the number and quality of post-surgical gases.

Data regarding gas transit are collected by the patient in a questionnaire the two days before the surgery and until the patient leaves hospital (or until day 15 post-operative if the patient is still hospitalized).

Data regarding possible complications ((defined according to Dindo-Clavien as any deviation from the expected postoperative outcomes within 90 days following surgery) are collected throughout the hospital stay (day 0 : surgery to day 15 post-operatively), during the post-operative consultation (day 30) and during a telephone call to the patient (day 90).

The expected results are to highlight a correlation between the quality/quantity of gases and post-operative outcomes. A predictive score for complications could then be proposed and validated during this study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Complication Recovery, Physiological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients ≥18 years old
* Indication for open or laparoscopic abdominal surgery
* Whose expected length of stay is ≥ 2 days


* Patients requiring a stomy on the initial surgery
* Need for immediate postoperative intensive care
* Emergency surgery
* Patient not knowing how to read or write
* Poor understanding of the French language
* Person deprived of liberty by judicial or administrative decision
* Person subject to psychiatric care under duress
* Person subject to a legal protection measure
* Person unable to express consent
* Person objecting to participating in research

Exclusion Criteria

-Immediate post-operative intensive care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Angers Hospital (visceral surgery department)

Angers, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aurelien VENARA, MD, PhD

Role: CONTACT

33 2 41 35 36 18

UH Angers DRCI

Role: CONTACT

33 2 41 35 54 96

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aurélien VENARA, MD, PhD

Role: primary

33 2 41 35 36 18

UH Angers DRCI

Role: backup

33 2 41 35 54 96

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

49RC24_0335

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enhancing Outcomes After Colon Surgery
NCT00227526 COMPLETED PHASE2