Clinical trial NCT06828627: Laparoscopic Total Left-sided Surgical Approach Versus Traditional Bilateral Surgical Approach for Hiatal Hernia
Official title: Laparoscopic Total Left-sided Surgical Approach Versus Traditional Bilateral Surgical Approach for Treating Hiatal Hernia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiatal Hernia
GERD
Keywords: surgical approach
efficacy
safety
randomized controlled trial
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: gastrointestinal quality-of-life index (GIQLI)
timeFrame: postoperative 1-year
measure: esophagitis
timeFrame: 3 years after surgery
measure: DeMeester score
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Incidence of gallstones
timeFrame: postoperative 3-year
measure: Incidence of gastric emptying disorders
timeFrame: 1 year after surgery
measure: gastrointestinal function recovery time
timeFrame: 3 years after surgery
measure: blood glucose
timeFrame: 3 years after surgery
measure: serum lipid levels
timeFrame: 3 years after surgery
measure: operation time
timeFrame: From enrollment to the end of treatment
measure: blood loss
timeFrame: From enrollment to the end of treatment
measure: abdominal drainage fluid volume,
timeFrame: From treatment to 30-days after surgery
measure: total duration of hospitalization
timeFrame: From treatment to 30-days after surgery
measure: incidence of postoperative complications
timeFrame: From treatment to 30-days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References: