Clinical trial NCT06675097: Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery
Official title: Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery: Single-center Prospective Study - FLATQUAL- Abdominal Surgery and Gas Transit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complication
Recovery, Physiological
Keywords: transit
surgery
abdomen
stool
gas
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients will be included in the hospital they will be operated on

Brief 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.


Eligibility criteria: 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
* 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

Primary outcomes:
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.
timeFrame: From Day 0 (surgery) to the 90 post-operative days +/- 15 days.
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.
timeFrame: 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.
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.
timeFrame: 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:
measure: to compare the quantity of gas pre- and post-operative
timeFrame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
measure: to compare the quantity of stools pre- and post-operative
timeFrame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
measure: to compare the quality of gases pre- and post-operative
timeFrame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
measure: to compare the quality of stool pre- and post-operative
timeFrame: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers Hospital (visceral surgery department)
Study officials:
References: