Functional Outcome After Anastomotic Leak After Oesophagectomies (FOAL)

Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak

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.

Study Overview

• Status: Withdrawn
• Conditions: Swallowing Disorder; Anastomotic Leak Esophagus
• Intervention / Treatment: Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8063
      • Stadtspital Zurich, Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients, according to the above mentioned criteria who were operated at Stadtspital Triemli between 01.06.2018 and 31.5.2022

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anastomotic leak; 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.	Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy; Surgical resection of the esophagus with oesophagogastrostomy. Groups depend on postoperative complication
No anastomotic leak; Patients who had an Ivor Lewis Oesophagectomy and had no AL postoperatively, ECCG 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallow function by questionnaires: Sydney Swallow Questionnaire (SSQ)	This questionnaire consists of 17 questions and is mainly based on a visual analog scale (VAS) to assess functional swallowing. The sum of all questions ranges from 0-1700. The calculated upper limit of the reference interval is 234 in a non-dysphagic population. A higher score represents a more severe dysphagia.	earliest 6 months postoperatively
Swallow function by questionnaires: Eckardt Score (ES)	The ES is a questionnaire with four items (weight loss, chest pain, regurgitation, and dysphagia) initially used to evaluate achalasia. The maximum score is 12; the higher the score, the more trouble patients have with swallowing.	earliest 6 months postoperatively
Swallow function by questionnaires: Brief Esophageal Dysphagia Questionnaire (BEDQ)	The BEDQ has 10 questions to score dysphagia specifically. The questions are answered using a Likert scale (low to high), which sums up to a score ranging from 0 (asymptomatic) to 40.	earliest 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life by questionnaires EORTC-C30 (European Organisation for Research and Treatment of Cancer-Cancer 30)	The European Organisation for Research and Treatment of Cancer (EORTC) has a quality-of-life questionnaire for cancer patients. Depending on the tumor localization, a different combination of modules is used. This study combines the general 'C30' module with 30 items and the supplemental oesophagogastric 'OG25' module with 25 items. The transformed score of the C30 module ranges from 0 to 100. A high score represents a high level of symptomatology.	earliest 6 months postoperatively
Quality of life by questionnaires EORTC-OG25 (Oesophagogastric-25)	As stated above, in addition to the EORTC-C30 module, the EORTC OG25 module is used. These items can be analyzed for several symptoms and are standardized by a formula to a value ranging from 0 to 100. Again a higher score represents more severe symptoms.	earliest 6 months postoperatively

Collaborators and Investigators

• Sponsor: Stefan Gutknecht
• Investigators: Principal Investigator: Stefan Gutknecht, MD, Stadtspital Zürich

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): April 22, 2026
• Study Completion (Actual): April 22, 2026

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: BASEC 2022-01799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No