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Clinical Trials/NCT07138235
NCT07138235CompletedNot Applicable

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

Osh State University0 sites106 target enrollmentStarted: October 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
106
Primary Endpoint
decreased complication rate and high patient satisfaction

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •were clinically significant hiatal hernia complicated by GERD, confirmed endoscopically and by radiological methods, age from 18 to 80 years and ineffectiveness of drug therapy for more than 6 months.

Exclusion Criteria

  • •were patients who had previously undergone surgery on the upper abdominal organs and oncological diseases. All patients underwent a comprehensive preoperative examination, including general clinical and biochemical tests, ECG, endoscopy and X-ray of the esophagus, stomach and duodenum.

Outcomes

Primary Outcomes

decreased complication rate and high patient satisfaction

Time Frame: October 2016 to June 2025

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Osh State University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhypargul Abdullaeva

PhD, Lecturer

Osh State University

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