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

NCT06675097 | Recruiting

• 1 other identifier: 49RC24_0335
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Recovery, Physiological; Postoperative Complication

Keywords

transit; surgery; abdomen; stool; gas

Outcome Measures

Primary Outcomes (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.

  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).

  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

  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

  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

  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

  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

  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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Immediate post-operative intensive care

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers Hospital (visceral surgery department)

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Aurelien VENARA, MD, PhD

CONTACT

33 2 41 35 36 18; AuVenara@chu-angers.fr

UH Angers DRCI

CONTACT

33 2 41 35 54 96; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: January 31, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)