Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945654
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-06-06
Brief Title:
Functional Outcome After Anastomotic Leak After Oesophagectomies
Sponsor:
Stefan Gutknecht
Organization:
Stadtspital Zürich
Study Overview
Official Title:
Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOAL
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 110 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None