Anastomotic Leak EsophagusFOALNCT05945654
Functional Outcome After Anastomotic Leak After Oesophagectomies
An observational study of Anastomotic Leak Esophagus and Swallowing Disorder, run by Stefan Gutknecht at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak Esophagus, Swallowing Disorder
- What is being tested?
- Anastomotic Leak after Ivor Lewis Oesophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2023to 22 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients, according to the above mentioned criteria who were operated at Stadtspital Triemli between 01.06.2018 and 31.5.2022
Who may be able to join
- Patients who received an Ivor Lewis Oesophagectomy with reconstruction due to any reason
- Patients older than 18 years
Who cannot join
- Patients with achalasia
- inability to understand study procedure or to provide informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Stadtspital Zurich, Triemli
Zurich, Canton of Zurich, 8063
About this study
Official title: 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.
Read the 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.
- Conditions
- Anastomotic Leak Esophagus, Swallowing Disorder
- Being tested
- Anastomotic Leak after Ivor Lewis Oesophagectomy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastomotic Leak after Ivor Lewis OesophagectomyProcedure or surgery
Surgical resection of the esophagus with oesophagogastrostomy. Groups depend on postoperative complication
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Anastomotic Leak after Ivor Lewis Oesophagectomy | |
| No anastomotic leak | Patients who had an Ivor Lewis Oesophagectomy and had no AL postoperatively, ECCG 0. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: earliest 6 months postoperatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: earliest 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Sep 2023
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Why it stopped: no funds to start study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leak EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefan Gutknecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Gutknecht, Stadtspital Zürich
- Investigators
- Stefan Gutknecht, MD, Principal investigator, Stadtspital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945654
- Sponsor's protocol ID
- BASEC 2022-01799
- Acronym
- FOAL
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak
- ClinicalTrials.gov ID
- NCT05945654
- Acronym / sponsor ID
- FOAL / BASEC 2022-01799
- Conditions
- Anastomotic Leak Esophagus, Swallowing Disorder
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no funds to start study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stefan GutknechtUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastomotic leak | – | Procedure: Anastomotic Leak after Ivor Lewis OesophagectomyPatients 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. |
| No anastomotic leak | – | –Patients who had an Ivor Lewis Oesophagectomy and had no AL postoperatively, ECCG 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients, according to the above mentioned criteria who were operated at Stadtspital Triemli between 01.06.2018 and 31.5.2022
Key inclusion criteria (2 listed)
- Patients who received an Ivor Lewis Oesophagectomy with reconstruction due to any reason
- Patients older than 18 years
Key exclusion criteria (2 listed)
- Patients with achalasia
- inability to understand study procedure or to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anastomotic Leak after Ivor Lewis OesophagectomySurgical resection of the esophagus with oesophagogastrostomy. Groups depend on postoperative complication | Procedure or surgery | Anastomotic leak |
Primary outcome
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.
2 secondary outcomes
Quality of life by questionnaires EORTC-C30 (European Organisation for Research and Treatment of Cancer-Cancer 30)
Time frame: earliest 6 months postoperatively
Quality of life by questionnaires EORTC-OG25 (Oesophagogastric-25)
Time frame: earliest 6 months postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Gutknecht, MD principal investigator
Stadtspital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak Esophagus and Swallowing Disorder, run by Stefan Gutknecht at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallow function by questionnaires: Sydney Swallow Questionnaire (SSQ) (time frame: earliest 6 months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.