Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT07138235
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol
Sponsor:
Osh State University
Organization:
Study Overview
Official Title:
Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol
Status:
COMPLETED
Status Verified Date:
2025-08
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:
hiatal hernia
Brief Summary:
Nissen fundoplication with cruroraphy performed according to ERAS protocols in patients with HH complicated by GERD.
Detailed Description:
The surgery was performed in accordance with the following stages. Preparation for surgery included premedication, thromboembolic prophylaxis, and intravenous administration of broad-spectrum antibiotics 30 minutes before induction of anesthesia. Patient position and approaches: the patient was on the operating table in the spinal position with the lower limbs abducted, the head was raised by 15-20° to improve visualization of the subdiaphragmatic space. Four ports were used: one 10-mm port in the umbilical region (for optics), two 5 mm ports in the right hypochondrium and epigastrium, and one 10 mm port in the left hypochondrium. Based on the analysis of early experience of laparoscopic interventions in the cardioesophageal zone, we modified the standard port technique. In particular, the rejection of the classic fan-shaped installation of five trocars turned out to be justified, since two trocars in the left hypochondrium anatomically conflict and limit the maneuverability of the instruments, also the use of an ultrasonic dissector, allowing for simultaneous coagulation and dissection of tissue, which significantly reduced the need for an additional assistant instrument. This ensured more ergonomic manipulations, reduced the duration of the operation and the need for an additional fifth port.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: