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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
Sponsor:
Information provided by (Responsible Party):
Stefan Gutknecht, Stadtspital Zürich

Tracking Information
First Submitted Date June 6, 2023
First Posted Date July 14, 2023
Last Update Posted Date July 14, 2023
Estimated Study Start Date September 1, 2023
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2023)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 6, 2023)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Outcome After Anastomotic Leak After Oesophagectomies
Official Title Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Anastomotic Leak Esophagus
  • Swallowing Disorder
Intervention Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy
Surgical resection of the esophagus with oesophagogastrostomy. Groups depend on postoperative complication
Study Groups/Cohorts
  • 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.
    Intervention: Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy
  • No anastomotic leak
    Patients who had an Ivor Lewis Oesophagectomy and had no AL postoperatively, ECCG 0.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 6, 2023)		 30
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2024
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Stefan Gutknecht, MD +41444164309 stefan.gutknecht@stadtspital.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT05945654
Other Study ID Numbers BASEC 2022-01799
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Stefan Gutknecht, Stadtspital Zürich
Original Responsible Party Same as current
Current Study Sponsor Stefan Gutknecht
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Stefan Gutknecht, MD Stadtspital Zurich
PRS Account Stadtspital Zürich
Verification Date July 2023