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RecruitingNCT06675097FLATQUALUpdated Aug 10, 2026

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

An observational study in Postoperative Complication and Recovery, Physiological, sponsored by University Hospital, Angers. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Postoperative Complication
  • Recovery, Physiological

Keywords

  • transit
  • surgery
  • abdomen
  • stool
  • gas
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patients will be included in the hospital they will be operated on

Inclusion criteria

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

Non Inclusion Criteria:

  • Patients requiring a stomy on the initial surgery
  • 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

Exclusion Criteria:

-Immediate post-operative intensive care with patient intubation

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality.

    Operative complication is defined according to Dindo-Clavien as any deviation from the expected postoperative outcomes within 90 days following surgery. Complications are then classified according to the Dindo-Clavien classification from 1 (simplest) to 5 (death).

    Time frame: From Day 0 (surgery) to the 90 post-operative days +/- 15 days.

  2. 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 resumption of gas transit will be defined as the emission of gas for at least 2 days in a row. • The quantity corresponds to the number / 24 hours of gas

    Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized.From Day 0 (surgery) to the 90 post-operative days +/- 15 days.

  3. 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 resumption of gas transit will be defined as the emission of gas for at least 2 days in a row. • The quality is defined by: * Single or multiple over the same time * Noisy or soundless * Dry or wet (no stools but mucus or transparent liquids) * Accompanied by stools * Non-odorous, slightly odorous, very smelly * Painful before the show * Relief after emission

    Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized.From Day 0 (surgery) to the 90 post-operative days +/- 15 days

Secondary outcomes

  1. to compare the quantity of gas pre- and post-operative

    • gas quantity corresponds to number/24 H of gas (data are daily collected by the patient in a questionnaire)

    Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized

  2. to compare the quantity of stools pre- and post-operative

    • Stoll quantity corresponds to number/24 H of stool (data are daily collected by the patient in a questionnaire)

    Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized

  3. to compare the quality of gases pre- and post-operative

    • Gas quality is defined by : * Single or multiple over the same time * Noisy or soundless * Dry or wet (no stools but mucus or transparent liquids) * Accompanied by stools * Non-odorous, slightly odorous, very smelly * Painful before the show * Relief after emission .Data from gas are daily collected by the patient in a questionnaire.

    Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized

  4. to compare the quality of stool pre- and post-operative

    •stool quality is defined by the Bristol scale (type 1: separate hard lumps (severe constipation); type 2: lumpy and sausage-like (mild constipation); type 3: sausage shape with cracks (normal); type 5: soft blobs with clear-cut edges (lacking fiber); type 6: mushy consistency with ragged edges (mild diarrhea); type 7: liquid consistency with no solid pieces (severe diarrhea). .data are daily collected by the patient in a questionnaire

    Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized

06

Study locations

2 of 2 sites recruiting
  • University Hospital of Nantes, CIC Institut des Maladies de l'appareil digestif, CHU Nantes, 1 place Alexis Ricordeau 44093 Nantes cedex 01
    Nantes, Loire Atlantique 44093, France
    Recruiting
  • Angers Hospital (visceral surgery department)
    Angers, 49933, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06675097
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Nov 5, 2024
Start date
Jan 31, 2025
Primary completion
Jan 31, 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Aurelien VENARA, MD, PhD
Contact
AuVenara@chu-angers.fr
33 2 41 35 36 18
UH Angers DRCI
Contact
DRCI-Promotion-Interne@chu-angers.fr
33 2 41 35 54 96

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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