Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06513416

Enrollment

265

Registered

2024-07-22

Start date

2023-05-01

Completion date

2026-02-28

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota, Postoperative Pulmonary Complications

Brief summary

An observational cohort was established using preoperatively collected biospecimens and prospectively ascertained postoperative outcomes. A nested case-control metagenomic analysis was subsequently conducted within the cohort, including participants with grade II or higher PPCs and selected participants without PPCs.

Interventions

PROCEDUREElective abdominal surgery

The included elderly patients are those who are preparing for elective abdominal surgery and the surgery time exceeds 2 hours.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age: ≥ 65 years old; 2. Surgery: Major abdominal surgery (expected duration ≥ 2 hours); 3. Anesthesia methods: general anesthesia, tracheal intubation; 4. ASA classification: I-IV levels; 5. Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk 6. Patients or their families are able to understand the research protocol and are willing to participate in this study, providing written informed consent

Exclusion criteria

1. Emergency surgery; 2. This is the second surgery within the past month; 3. Preoperative presence of pulmonary infection or other serious pulmonary complications 4. Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with postoperative pulmonary complications	Within 7 days after surgery	The primary outcome is the occurrence of one or more ppcs, including primarily hypoxemia, atelectasis, and pneumonia, etc.

Secondary

Measure	Time frame	Description
Preoperative gut microbiome composition	Preoperative, before bowel preparation and prophylactic antibiotics	Taxonomic composition and relative abundance derived from shotgun metagenomic sequencing of eligible preoperative faecal samples.
Concentration of inflammatory cytokines in peripheral blood before and after surgery	Before and within 7 days after surgery	Inflammatory factors include high-sensitivity C-reactive protein (CRP) and procalcitonin (PCT)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026