Postoperative ComplicationFLATQUALNCT06675097
Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery
An observational study of Postoperative Complication and Recovery, Physiological, run by University Hospital, Angers at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complication, Recovery, Physiological
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jan 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The patients will be included in the hospital they will be operated on
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- -Immediate post-operative intensive care with patient intubation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Angers Hospital (visceral surgery department)
Angers, 49933
Aurélien VENARA, MD, PhD, 33 2 41 35 36 18, AuVenara@chu-angers.fr
UH Angers DRCI, 33 2 41 35 54 96, DRCI-Promotion-Interne@chu-angers.fr
- 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
Emilie DUCHALAIS-DASSONVILLE, MD, 02 40 08 30 22, emilie.duchalais@chu-angers.fr
UH Angers DRCI, PhD, 33 2 41 35 54 96, DRCI-Promotion-Interne@chu-angers.fr
About this study
Official title: Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery: Multicentric-center Prospective Study - FLATQUAL- Abdominal Surgery and Gas Transit
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.
Read more
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.
- Keywords
- transit, surgery, abdomen, stool, gas
- Medical subject headings
- Postoperative Complications, Mucopolysaccharidosis IV
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Day 0 (surgery) to the 90 post-operative days +/- 15 days.
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
Measured: 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.
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
Measured: 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 (4)
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)
Measured: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
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)
Measured: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
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.
Measured: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
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
Measured: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start31 Jan 2025
- Primary completion31 Jan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675097
- Sponsor's protocol ID
- 49RC24_0335
- Acronym
- FLATQUAL
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery: Multicentric-center Prospective Study - FLATQUAL- Abdominal Surgery and Gas Transit
- ClinicalTrials.gov ID
- NCT06675097
- Acronym / sponsor ID
- FLATQUAL / 49RC24_0335
- Keywords
- transit, surgery, abdomen, stool, gas
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Nov 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be included in the hospital they will be operated on
Key inclusion criteria (13 listed)
- 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
- Emergency surgery
Key exclusion criteria (1 listed)
- -Immediate post-operative intensive care with patient intubation
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
To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality.
Time frame: From Day 0 (surgery) to the 90 post-operative days +/- 15 days.
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).
To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality.
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.
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
To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality.
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
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
4 secondary outcomes
to compare the quantity of gas pre- and post-operative
Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
to compare the quantity of stools pre- and post-operative
Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
to compare the quality of gases pre- and post-operative
Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
to compare the quality of stool pre- and post-operative
Time frame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complication and Recovery, Physiological, run by University Hospital, Angers at 2 sites in France.
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 13 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurelien VENARA, MD, PhD (33 2 41 35 36 18, AuVenara@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality. (time frame: From Day 0 (surgery) to the 90 post-operative days +/- 15 days.). The study lists 3 primary outcomes in all. 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 10 Aug 2026.