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Functional Outcome After Anastomotic Leak After Oesophagectomies (FOAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05945654
Recruitment Status : Not yet recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Information provided by (Responsible Party):
Stefan Gutknecht, Stadtspital Zürich

Brief 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.

Condition or disease Intervention/treatment
Anastomotic Leak Esophagus Swallowing Disorder 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : February 28, 2024

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.

Primary Outcome Measures :
  1. Swallow function by questionnaires: Sydney Swallow Questionnaire (SSQ) [ Time Frame: earliest 6 months postoperatively ]
    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.

  2. Swallow function by questionnaires: Eckardt Score (ES) [ Time Frame: earliest 6 months postoperatively ]
    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.

  3. Swallow function by questionnaires: Brief Esophageal Dysphagia Questionnaire (BEDQ) [ Time Frame: earliest 6 months postoperatively ]
    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.

Secondary Outcome Measures :
  1. Quality of life by questionnaires EORTC-C30 (European Organisation for Research and Treatment of Cancer-Cancer 30) [ Time Frame: earliest 6 months postoperatively ]

    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.

  2. Quality of life by questionnaires EORTC-OG25 (Oesophagogastric-25) [ Time Frame: earliest 6 months postoperatively ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05945654

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Contact: Stefan Gutknecht, MD +41444164309

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Stadtspital Zurich, Triemli
Zürich, ZH, Switzerland, 8063
Sponsors and Collaborators
Stefan Gutknecht
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Principal Investigator: Stefan Gutknecht, MD Stadtspital Zurich
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Responsible Party: Stefan Gutknecht, Principal Investigator, Stadtspital Zürich Identifier: NCT05945654    
Other Study ID Numbers: BASEC 2022-01799
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Anastomotic Leak
Postoperative Complications
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases