Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
The patients will be included in the hospital they will be operated on
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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 daysSecondary 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 hospitalized2
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 hospitalized3
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 hospitalized4
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 hospitalizedSponsors and contacts
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Source ClinicalTrials.gov