Hiatal HerniaNCT06828627
Laparoscopic Total Left-sided Surgical Approach Versus Traditional Bilateral Surgical Approach for Hiatal Hernia
A study testing TLSA and TBSA in people with Hiatal Hernia and GERD, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hiatal Hernia, GERD
- What is being tested?
- TLSA and TBSA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (I) HH (type II/III/IV) diagnosed by gastroscopy, high-resolution esophageal manometry, and 24-hour esophageal pH monitoring.
- 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.
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Total Left-sided Surgical Approach Versus Traditional Bilateral Surgical Approach for Treating Hiatal Hernia: a Randomized Controlled Trial
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
- Conditions
- Hiatal Hernia, GERD
- Being tested
- TLSA, TBSA
- Keywords
- surgical approach, efficacy, safety, randomized controlled trial
- Medical subject headings
- Hernia, Hiatal, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLSAProcedure or surgery
TLSA surgery procedure. (A) On the greater curvature of the stomach, the gastrocolic ligament is incised along the avascular area between the left and right gastric omentum vessels, and the gastric fundus is separated upward to the cardia to protect the vagus nerve.
(B) The cardia, lower esophagus, and diaphragm is exposed, and the confluence of the left and right crus of the diaphragm is revealed.
The retroperitoneum at the left and right crus of the diaphragm is incised, and the lower esophagus is dissociated for about 3-5 cm. The gastric fundus and the posterior wall of the esophagus are fully dissociated from the upper spleen. (C) Non-absorbable thread is used to intermittently suture the left and right crus of diaphragm in order to reconstruct the esophagus hiatus with a diameter of about 1.5 cm. (D) Then, the surgeon inserts the patch and fixes it on the crus of diaphragm if the hiatal hernia is larger than 5 cm or the diaphragm on both sides is weak. (E) A small incisio
TBSAProcedure or surgery
Traditional bilateral surgical approach (TBSA) surgery procedure. (A) Separation is initiated from the avascular area of the lesser omentum, and the hepatic branch of vagus nerve is preserved as far as possible. Careful separation is performed upward to expose the right crus of diaphragm. (B) At the greater curvature of the stomach, two to three short gastric vessels are cut off to expose the left crus of diaphragm, and the space between the anterior and posterior of esophagus is dissociated. (C) The diaphragmatic esophageal membrane is incised and the lower part of the esophagus is dissociated about 4-5 cm, then the gastroesophageal valve flap is reformed and the His angle is restored. During the operation, it mainly protects the anterior and posterior trunk of the vagus nerve. The anterior and posterior trunk of the vagus nerve are mainly protected during the operation. (D) Both sides of the crus of the diaphragm are intermittently sutured with non-absorbable thread to reconst
| Study group | Role | What they receive |
|---|---|---|
| Total left-sided surgical approach; TLSA | Experimental | TLSA surgery procedure. (A) On the greater curvature of the stomach, the gastrocolic ligament is incised along the avascular area between the left and right gastric omentum vessels, and the gastric fundus is separated upward to the cardia to protect the vagus nerve.
(B) The cardia, lower esophagus, and diaphragm is exposed, and the confluence of the left and right crus of the diaphragm is revealed.
The retroperitoneum at the left and right crus of the diaphragm is incised, and the lower esophagus is dissociated for about 3-5 cm. The gastric fundus and the posterior wall of the esophagus are fully dissociated from the upper spleen. (C) Non-absorbable thread is used to intermittently suture the left and right crus of diaphragm in order to reconstruct the esophagus hiatus with a diameter of about 1.5 cm. (D) Then, the surgeon inserts the patch and fixes it on the crus of diaphragm if the hiatal hernia is larger than 5 cm or the diaphragm on both sides is weak. (E) A small incision Receives: Procedure: TLSA |
| Traditional bilateral surgical approach; TBSA | Active comparator | Traditional bilateral surgical approach (TBSA) surgery procedure. (A) Separation is initiated from the avascular area of the lesser omentum, and the hepatic branch of vagus nerve is preserved as far as possible. Careful separation is performed upward to expose the right crus of diaphragm. (B) At the greater curvature of the stomach, two to three short gastric vessels are cut off to expose the left crus of diaphragm, and the space between the anterior and posterior of esophagus is dissociated. (C) The diaphragmatic esophageal membrane is incised and the lower part of the esophagus is dissociated about 4-5 cm, then the gastroesophageal valve flap is reformed and the His angle is restored. During the operation, it mainly protects the anterior and posterior trunk of the vagus nerve. The anterior and posterior trunk of the vagus nerve are mainly protected during the operation. (D) Both sides of the crus of the diaphragm are intermittently sutured with non-absorbable thread to recons Receives: Procedure: TBSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal quality-of-life index (GIQLI)
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.
Measured: postoperative 1-year
esophagitis
varified by gastroscopy （LA-standard）
Measured: 3 years after surgery
DeMeester score
varified by high-resolution esophageal manometry and 24-hour esophageal pH monitoring； >4% indicate abnormal acid reflux
Measured: 3 years after surgery
Secondary outcomes (10)
Incidence of gallstones
Measured: postoperative 3-year
Incidence of gastric emptying disorders
Measured: 1 year after surgery
gastrointestinal function recovery time
Measured: 3 years after surgery
blood glucose
Measured: 3 years after surgery
serum lipid levels
Measured: 3 years after surgery
operation time
Measured: From enrollment to the end of treatment
blood loss
Measured: From enrollment to the end of treatment
abdominal drainage fluid volume,
Measured: From treatment to 30-days after surgery
total duration of hospitalization
Measured: From treatment to 30-days after surgery
incidence of postoperative complications
Measured: From treatment to 30-days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Jul 2020
- Primary completion31 Dec 2023
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828627
- Sponsor's protocol ID
- ChiCTR2000034028
- Status last verified
- Jul 2020
- First submitted
- 21 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Total Left-sided Surgical Approach Versus Traditional Bilateral Surgical Approach for Treating Hiatal Hernia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06828627
- Acronym / sponsor ID
- ChiCTR2000034028
- Conditions
- Hiatal Hernia, GERD
- Keywords
- surgical approach, efficacy, safety, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total left-sided surgical approach; TLSA | Experimental | Procedure: TLSATLSA surgery procedure. (A) On the greater curvature of the stomach, the gastrocolic ligament is incised along the avascular area between the left and right gastric omentum vessels, and the gastric fundus is separated upward to the cardia to protect the vagus nerve. (B) The cardia, lower esophagus, and diaphragm is exposed, and the confluence of the left and right crus of the diaphragm is revealed. The retroperitoneum at the left and right crus of the diaphragm is incised, and the lower esophagus is dissociated for about 3-5 cm. The gastric fundus and the posterior wall of the esophagus are fully dissociated from the upper spleen. (C) Non-absorbable thread is used to intermittently suture the left and right crus of diaphragm in order to reconstruct the esophagus hiatus with a diameter of about 1.5 cm. (D) Then, the surgeon inserts the patch and fixes it on the crus of diaphragm if the hiatal hernia is larger than 5 cm or the diaphragm on both sides is weak. (E) A small incision |
| Traditional bilateral surgical approach; TBSA | Active comparator | Procedure: TBSATraditional bilateral surgical approach (TBSA) surgery procedure. (A) Separation is initiated from the avascular area of the lesser omentum, and the hepatic branch of vagus nerve is preserved as far as possible. Careful separation is performed upward to expose the right crus of diaphragm. (B) At the greater curvature of the stomach, two to three short gastric vessels are cut off to expose the left crus of diaphragm, and the space between the anterior and posterior of esophagus is dissociated. (C) The diaphragmatic esophageal membrane is incised and the lower part of the esophagus is dissociated about 4-5 cm, then the gastroesophageal valve flap is reformed and the His angle is restored. During the operation, it mainly protects the anterior and posterior trunk of the vagus nerve. The anterior and posterior trunk of the vagus nerve are mainly protected during the operation. (D) Both sides of the crus of the diaphragm are intermittently sutured with non-absorbable thread to recons |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (I) HH (type II/III/IV) diagnosed by gastroscopy, high-resolution esophageal manometry, and 24-hour esophageal pH monitoring.
- 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.
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLSATLSA surgery procedure. (A) On the greater curvature of the stomach, the gastrocolic ligament is incised along the avascular area between the left and right gastric omentum vessels, and the gastric fundus is separated upward to the cardia to protect the vagus nerve. (B) The cardia, lower esophagus, and diaphragm is exposed, and the confluence of the left and right crus of the diaphragm is revealed. The retroperitoneum at the left and right crus of the diaphragm is incised, and the lower esophagus is dissociated for about 3-5 cm. The gastric fundus and the posterior wall of the esophagus are fully dissociated from the upper spleen. (C) Non-absorbable thread is used to intermittently suture the left and right crus of diaphragm in order to reconstruct the esophagus hiatus with a diameter of about 1.5 cm. (D) Then, the surgeon inserts the patch and fixes it on the crus of diaphragm if the hiatal hernia is larger than 5 cm or the diaphragm on both sides is weak. (E) A small incisio | Procedure or surgery | Total left-sided surgical approach; TLSA |
| TBSATraditional bilateral surgical approach (TBSA) surgery procedure. (A) Separation is initiated from the avascular area of the lesser omentum, and the hepatic branch of vagus nerve is preserved as far as possible. Careful separation is performed upward to expose the right crus of diaphragm. (B) At the greater curvature of the stomach, two to three short gastric vessels are cut off to expose the left crus of diaphragm, and the space between the anterior and posterior of esophagus is dissociated. (C) The diaphragmatic esophageal membrane is incised and the lower part of the esophagus is dissociated about 4-5 cm, then the gastroesophageal valve flap is reformed and the His angle is restored. During the operation, it mainly protects the anterior and posterior trunk of the vagus nerve. The anterior and posterior trunk of the vagus nerve are mainly protected during the operation. (D) Both sides of the crus of the diaphragm are intermittently sutured with non-absorbable thread to reconst | Procedure or surgery | Traditional bilateral surgical approach; TBSA |
Primary outcome
gastrointestinal quality-of-life index (GIQLI)
Time frame: 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
Time frame: 3 years after surgery
varified by gastroscopy （LA-standard）
DeMeester score
Time frame: 3 years after surgery
varified by high-resolution esophageal manometry and 24-hour esophageal pH monitoring； >4% indicate abnormal acid reflux
10 secondary outcomes
Incidence of gallstones
Time frame: postoperative 3-year
Incidence of gastric emptying disorders
Time frame: 1 year after surgery
gastrointestinal function recovery time
Time frame: 3 years after surgery
blood glucose
Time frame: 3 years after surgery
serum lipid levels
Time frame: 3 years after surgery
operation time
Time frame: From enrollment to the end of treatment
blood loss
Time frame: From enrollment to the end of treatment
abdominal drainage fluid volume,
Time frame: From treatment to 30-days after surgery
total duration of hospitalization
Time frame: From treatment to 30-days after surgery
incidence of postoperative complications
Time frame: From treatment to 30-days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLSA and TBSA in people with Hiatal Hernia and GERD, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal quality-of-life index (GIQLI) (time frame: postoperative 1-year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.