Functional Outcome After Anastomotic Leak After Oesophagectomies (FOAL)

Stefan Gutknecht

Status: Not yet enrolling

Conditions: Anastomotic Leak Esophagus; Swallowing Disorder

Treatments: Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05945654

BASEC 2022-01799

Details and patient eligibility

About

The main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to Ivor Lewis. However, despite careful work and refined surgical techniques, anastomotic leakage (AL) occurs in more than 1/10 of the patients. This severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (EVT) has become the crucial therapy for broken-down anastomosis. The hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by EVT after an anastomotic leak, compared to patients without AL.

Full description

The investigators will select patients after oesophagectomy and perform a structured interview regarding their quality of life and subjective swallow function. Results will be compared according to defined subgroups, especially patients with and without anastomotic leak.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received an Ivor Lewis Oesophagectomy with reconstruction due to any reason
• Patients older than 18 years

Exclusion criteria

• Patients with achalasia
• inability to understand study procedure or to provide informed consent

Trial design

30 participants in 2 patient groups

Anastomotic leak

Description:

Patients who had an Ivor Lewis Oesophagectomy and suffered an anastomotic leak (AL) postoperatively. AL, as defined according to ECCG (Esophagectomy Complication Consensus Group) criteria 1-3.

Treatment:

Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy

No anastomotic leak

Description:

Patients who had an Ivor Lewis Oesophagectomy and had no AL postoperatively, ECCG 0.