Laparoscopic Total Left-sided Surgical Approach Versus Traditional Bilateral Surgical Approach for Hiatal Hernia

Not Applicable

Completed

• Conditions: Hiatal Hernia; GERD

• Registration Number: NCT06828627
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Background: In China, guidelines for the treatment of hiatal hernia (HH) are lacking. Furthermore, efficacy and safety assessments of surgical approaches for HH and for the protection of the vagus nerve and organ function are needed. Therefore, the present clinical trial is being conducted to establish the normative treatment for HH. Methods: The current trial is an ongoing, single-center, randomized controlled trial of patients with HH. The total sample size required for the trial (July 2020-December 2023) is approximately 114 patients.

Patients will be randomly assigned to either an experimental group (total left-sided surgical approach; TLSA) or a control group (traditional bilateral surgical approach; TBSA) at a ratio of 1:1 using the block randomization method. We will use case report forms (CRFs) and electronic data capture (EDC) systems to obtain demographic information, preoperative laboratory tests, auxiliary examination results, operation information, and postoperative condition. The patients will be followed up for 3 years after surgery. The primary endpoint is the gastrointestinal quality-of-life index (GIQLI) at 1 year. The secondary endpoints include an efficacy evaluation index \[consisting of the incidence of gallstones and gastric emptying disorders, gastrointestinal function recovery time, visual analog scale (VAS) scores, objective evaluation of postoperative indices, and surgical information\] and a safety evaluation index (consisting of the incidence of postoperative complications, the 30-day postoperative mortality rate, and the HH recurrence rate at 1 and 3 years after surgery). Discussion: TLSA can protect the normal physiological function of organs to a certain extent by protecting the vagus nerve from injury, and has satisfactory short- and long-term efficacy. There is no significant difference in the incidence of postoperative complications and surgical safety between TLSA and TBSA. Our findings will facilitate clinical decision-making for HH and improve the life quality of patients.

Trial registration: Chinese Clinical Trial Registry, ChiCTR2000034028 (registration date: June 21, 2020). Keywords: Hiatal hernia (HH); surgical approach; efficacy; safety; randomized controlled trial

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2025-01-15
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• (I) HH (type II/III/IV) diagnosed by gastroscopy, high-resolution esophageal manometry, and 24-hour esophageal pH monitoring.

(II) Aged 18-65 years, with no sex restrictions. (III) Eastern Cooperative Oncology Group score of ≤2 points and an American Society of Anesthesiologists score of ≤2 points.

Exclusion Criteria

• (I) patients with cerebrovascular injury that occurred within the 6 months prior, unstable angina, or myocardial infarction; (II) patients with a history of uncontrolled epilepsy, central nervous system disease, or malignant tumor, or those with impaired judgment or mental illness who cannot cooperate with the research (III) patients with a history of digestive system tumors, or thoracic or abdominal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
gastrointestinal quality-of-life index (GIQLI)	postoperative 1-year	GIQLI is related to the QOL for gastrointestinal disorders. It contains 5 subscales, with a total score of 144 points. The higher the score, the better the patient's QOL and the better the surgical effect.
esophagitis	3 years after surgery	varified by gastroscopy （LA-standard）
DeMeester score	3 years after surgery	varified by high-resolution esophageal manometry and 24-hour esophageal pH monitoring； \>4% indicate abnormal acid reflux

Secondary Outcome Measures

Name	Time	Method
Incidence of gallstones	postoperative 3-year
Incidence of gastric emptying disorders	1 year after surgery
gastrointestinal function recovery time	3 years after surgery
blood glucose	3 years after surgery
serum lipid levels	3 years after surgery
operation time	From enrollment to the end of treatment
blood loss	From enrollment to the end of treatment
abdominal drainage fluid volume,	From treatment to 30-days after surgery
total duration of hospitalization	From treatment to 30-days after surgery
incidence of postoperative complications	From treatment to 30-days after surgery

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China