NCT07138235

Complications of Laparoscopic Hiatal Hernia Repair Complicated by Gastroesophageal Reflux Disease Using the ERAS Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Osh State University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hiatal Hernia
• Hiatal Hernia With Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
PROCEDURE	laparoscopic hiatal hernia repair	Intraoperative endoscopic control and the use of calibration bougies allow for increasing the accuracy of cardiac sphincter reconstruction and reducing the risk of hyper- or hypocorrection. Endoscopic equipment. The Olympus EVIS EXERA III endoscopic video system (Olympus Medical Systems Corp., Tokyo, Japan), series 190, was used for diagnostic and therapeutic endoscopic examinations. The complex included: * CV-190 video processor with digital image magnification, * CLV-190 light source (xenon/LED), providing high brightness and uniformity of illumination, a high definition (HD) video monitor, * GIF-HQ190, GIF-H190 high-resolution series gastroscopes, * CF-HQ190L/I series colonoscopes (if necessary). These functions made it possible to more accurately assess the condition of the mucous membrane of the esophagus and stomach, as well as to identify pathological changes. Medications: omeprazole/esomeprazole, ondansetron, cephalosporins intravenously, metoclopramide.

Timeline

• Start date: 2016-10-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2025-08-22
• Last updated: 2025-08-22

Regulatory

• FDA-regulated drug study
• FDA-regulated device study