Functional Outcome After Anastomotic Leak After Oesophagectomies

Swallowing Disorder Clinical Trial

— FOAL  

Official title:

Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05945654
• Other study ID #: BASEC 2022-01799
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: July 2023
• Source: Stadtspital Zürich
• Contact: Stefan Gutknecht, MD
• Phone: +41444164309
• Email: stefan.gutknecht[@]stadtspital.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 28, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Esophagus
• Deglutition Disorders
• Swallowing Disorder

Intervention

Procedure:
• Anastomotic Leak after Ivor Lewis Oesophagectomy
Surgical resection of the esophagus with oesophagogastrostomy. Groups depend on postoperative complication

Locations

Country	Name	City	State
Switzerland	Stadtspital Zurich, Triemli	Zürich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Stefan Gutknecht

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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