Functional Outcome After Anastomotic Leak After Oesophagectomies (FOAL)
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ClinicalTrials.gov Identifier: NCT05945654 |
Recruitment Status :
Not yet recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
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Condition or disease | Intervention/treatment |
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Anastomotic Leak Esophagus Swallowing Disorder | Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy |
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 |
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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.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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.
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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 |
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
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 ClinicalTrials.gov identifier (NCT number): NCT05945654
Contact: Stefan Gutknecht, MD | +41444164309 | stefan.gutknecht@stadtspital.ch |
Switzerland | |
Stadtspital Zurich, Triemli | |
Zürich, ZH, Switzerland, 8063 |
Principal Investigator: | Stefan Gutknecht, MD | Stadtspital Zurich |
Responsible Party: | Stefan Gutknecht, Principal Investigator, Stadtspital Zürich |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Deglutition Disorders Anastomotic Leak Postoperative Complications Pathologic Processes Esophageal Diseases |
Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |