Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSun Yat-sen University

About this trial

This study aims to determine whether postoperative hypoxia (arterial partial pressure of oxygen (PaO₂)\<80 mmHg) is an independent risk factor for anastomotic leakage after esophagectomy. The investigators conducted a retrospective analysis of cases from their center over the past five years, stratifying patients into Low Pa0₂ Group and Normal Pa0₂ Group based on postoperative oxygen levels and comparing the incidence of anastomotic leakage between the groups. The goal is to establish whether hypoxia is a causative risk factor and whether correcting it can reduce the risk of anastomotic leakage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with esophageal carcinoma or benign esophageal tumors

Patients requiring surgical resection of the lesion with subsequent esophageal reconstruction

Patients must have had at least one postoperative arterial blood gas analysis

Patients must have routinely undergone at least one of the following for postoperative evaluation of the anastomosis: endoscopy, CT scan, or esophagram

Disqualifiers

Patients who did not require esophageal reconstruction

Patients undergoing esophageal replacement with colon

Patients with incomplete data

Trial population

This retrospective cohort study included patients diagnosed with esophageal carcinoma or benign esophageal tumors who required surgical resection of the lesion followed by esophageal reconstruction. All patients had at least one postoperative arterial blood gas analysis, and anastomotic healing was assessed via esophagram, CT scan, endoscopy, or typical clinical sign.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 2 trial groups
Group A: Low Pa02 Group
Group B: Normal PaO2 Group

Trial outcomes

Primary outcomes

1

Esophageal Anastomotic Leakage Rate

Anastomotic leak was confirmed by either barium swallow study, CT scan, or endoscopy, or was clinically considered in cases with obvious salivary secretion from the cervical anastomosis. The esophageal anastomotic leakage rate was calculated as (the number of patients with a confirmed anastomotic leakage / the total number of patients who underwent esophagectomy) × 100%.

Time frame
From the date of surgery to 30 days postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

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Sun Yat-sen University

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Collaborator

Affiliated Hospital of North Sichuan Medical College

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

Affiliated Cancer Hospital of Shantou University Medical College

Collaborator

Shanghai Chest Hospital

Collaborator