Functional Outcome After Anastomotic Leak After Oesophagectomies

NCT ID: NCT05945654

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-02-28

Brief Summary

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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

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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

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Anastomotic Leak Esophagus Swallowing Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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.

Anastomotic Leak after Ivor Lewis Oesophagectomy

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

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Anastomotic Leak after Ivor Lewis Oesophagectomy

Surgical resection of the esophagus with oesophagogastrostomy. Groups depend on postoperative complication

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stefan Gutknecht

OTHER

Sponsor Role lead

Responsible Party

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Stefan Gutknecht

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Stefan Gutknecht, MD

Role: PRINCIPAL_INVESTIGATOR

Stadtspital Zurich

Locations

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Stadtspital Zurich, Triemli

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Stefan Gutknecht, MD

Role: CONTACT

+41444164309

Other Identifiers

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BASEC 2022-01799

Identifier Type: -

Identifier Source: org_study_id

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