Hiatal Hernia, ParaesophagealNCT07718828
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
A study testing Laparoscopic Nissen Fundoplication and Laparoscopic Toupet Fundoplication in people with Hiatal Hernia, Paraesophageal and Hiatal Hernia Large, run by Sofia Med Hospital at 1 site in Bulgaria.
Trial summary
This randomized controlled trial compares laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in patients undergoing surgical treatment for hiatal hernia associated with gastroesophageal reflux disease. Participants will be randomly assigned to one of two surgical groups. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hiatal Hernia, Paraesophageal, Hiatal Hernia Large, Hiatal Hernia With Gastroesophageal Reflux Disease
- What is being tested?
- Laparoscopic Nissen Fundoplication and Laparoscopic Toupet Fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBulgaria
- Study dates
- 29 May 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 90 years
- Patients diagnosed with primary hiatal hernia by fibrogastroscopy and/or barium swallow examination
- Patients with symptoms of gastroesophageal reflux disease
- Patients scheduled for elective laparoscopic hiatal hernia repair with fundoplication
- Patients able to provide informed consent
Who cannot join
- Patients younger than 18 years or older than 90 years Patients with recurrent hiatal hernia Patients who are not suitable for general anesthesia Patients who prefer a surgical approach other than laparoscopic surgery Patients who are unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site, 1 recruiting
- Recruiting
UMHAT Sofiamed
Sofia, Sofia-Grad, 1517
Katya T. Todorova, PhD, 0884744833, katya.todorowa@gmail.com
teodor.atanassov@gmail.com
About this study
Official title: Laparoscopic Nissen Versus Toupet Fundoplication for Gastroesophageal Reflux Management in Patients With Hiatal Hernia: A Patient- and Assessor-Blinded Randomized Controlled Trial
This randomized controlled trial compares laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in patients undergoing surgical treatment for hiatal hernia associated with gastroesophageal reflux disease. Participants will be randomly assigned to one of two surgical groups. The study will evaluate postoperative pain, health-related quality of life, hospital stay, recurrence of reflux symptoms, gas-bloat symptoms, operative time, fundoplication time, and postoperative complications.
- Conditions
- Hiatal Hernia, Paraesophageal, Hiatal Hernia Large, Hiatal Hernia With Gastroesophageal Reflux Disease
- Being tested
- Laparoscopic Nissen Fundoplication, Laparoscopic Toupet Fundoplication
- Keywords
- Hiatal hernia, Gastroesophageal reflux disease, Laparoscopic fundoplication, Toupet fundoplication, Antireflux surgery
- 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.
Laparoscopic Nissen FundoplicationProcedure or surgery
The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
Laparoscopic Toupet FundoplicationProcedure or surgery
The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.
| Study group | Role | What they receive |
|---|---|---|
| Nissen fundoplication | Active comparator | Participants assigned to this arm will undergo laparoscopic hiatal hernia repair with Nissen fundoplication. The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery. Receives: Procedure: Laparoscopic Nissen Fundoplication |
| Toupet Fundoplication | Active comparator | Participants assigned to this arm will undergo laparoscopic hiatal hernia repair with Toupet fundoplication. The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery. Receives: Procedure: Laparoscopic Toupet Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score at 24 hours
Postoperative pain will be assessed 24 hours after surgery using the Visual Analog Scale. The score will be used to compare early postoperative pain between participants undergoing laparoscopic Nissen fundoplication and those undergoing laparoscopic Toupet fundoplication.
Measured: 24 hours after surgery
Postoperative Pain Score at 7 Days
Postoperative pain will be assessed 7 days after surgery using the Visual Analog Scale. The score will be used to evaluate and compare short-term postoperative pain between the two intervention groups.
Measured: 7 days after surgery
Change in Health-Related Quality of Life After Surgery
Health-related quality of life will be assessed using the GERD-Health Related Quality of Life questionnaire. Preoperative scores will be compared with postoperative scores in order to evaluate changes in reflux-related symptoms and quality of life after laparoscopic Nissen or Toupet fundoplication.
Measured: Preoperatively, 1 week, 4 weeks
Postoperative Hospital Stay
Postoperative hospital stay will be measured as the number of days from the day of surgery until hospital discharge. The duration of hospital stay will be compared between the Nissen and Toupet fundoplication groups.
Measured: From the day of surgery until hospital discharge - up to 30days
Recurrence of Gastroesophageal Reflux Symptoms
Recurrence of gastroesophageal reflux symptoms will be assessed during postoperative follow-up. The presence or absence of recurrent reflux symptoms will be recorded and compared between the two intervention groups.
Measured: 4 weeks and 1 year after surgery
Secondary outcomes (4)
Operative Timе
Operative time will be measured in minutes from the beginning to the end of the laparoscopic surgical procedure. Total operative time will be compared between participants undergoing Nissen fundoplication and those undergoing Toupet fundoplication.
Measured: Intraoperative
Fundoplication Time
Fundoplication time will be measured in minutes as the time required to perform the fundoplication component of the procedure. This measure will be used to compare the technical duration of Nissen and Toupet fundoplication.
Measured: Intraoperative
Gas-Bloat Symptoms
Postoperative gas-bloat symptoms will be assessed during follow-up. The presence or absence of symptoms such as bloating, inability to belch, or increased abdominal gas-related discomfort will be recorded and compared between the two groups.
Measured: 3 days; 1 week
Postoperative Complications
Postoperative complications will be recorded according to type and frequency. The number and nature of postoperative complications will be compared between the Nissen and Toupet fundoplication groups.
Measured: Up 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 posted22 Jul 2026
- Study start29 May 2023
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal Hernia, ParaesophagealStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group will undergo laparoscopic hiatal hernia repair with Nissen fundoplication, and the other group will undergo laparoscopic hiatal hernia repair with Toupet fundoplication. Outcomes will be compared between the two groups at predefined postoperative follow-up time points.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sofia Med Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katya Todorova, Sofia Med Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718828
- Sponsor's protocol ID
- 25/2023
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Nissen Versus Toupet Fundoplication for Gastroesophageal Reflux Management in Patients With Hiatal Hernia: A Patient- and Assessor-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07718828
- Acronym / sponsor ID
- 25/2023
- Conditions
- Hiatal Hernia, Paraesophageal, Hiatal Hernia Large, Hiatal Hernia With Gastroesophageal Reflux Disease
- Keywords
- Hiatal hernia, Gastroesophageal reflux disease, Laparoscopic fundoplication, Toupet fundoplication, Antireflux surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sofia Med HospitalUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 22 Jul 2026 (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.
This randomized controlled trial compares laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in patients undergoing surgical treatment for hiatal hernia associated with gastroesophageal reflux disease. Participants will be randomly assigned to one of two surgical groups. The study will evaluate postoperative pain, health-related quality of life, hospital stay, recurrence of reflux symptoms, gas-bloat symptoms, operative time, fundoplication time, and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group will undergo laparoscopic hiatal hernia repair with Nissen fundoplication, and the other group will undergo laparoscopic hiatal hernia repair with Toupet fundoplication. Outcomes will be compared between the two groups at predefined postoperative follow-up time points.
| Arm | Type | Receives |
|---|---|---|
| Nissen fundoplication | Active comparator | Procedure: Laparoscopic Nissen FundoplicationParticipants assigned to this arm will undergo laparoscopic hiatal hernia repair with Nissen fundoplication. The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery. |
| Toupet Fundoplication | Active comparator | Procedure: Laparoscopic Toupet FundoplicationParticipants assigned to this arm will undergo laparoscopic hiatal hernia repair with Toupet fundoplication. The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 90 years
- Patients diagnosed with primary hiatal hernia by fibrogastroscopy and/or barium swallow examination
- Patients with symptoms of gastroesophageal reflux disease
- Patients scheduled for elective laparoscopic hiatal hernia repair with fundoplication
- Patients able to provide informed consent
Key exclusion criteria (1 listed)
- Patients younger than 18 years or older than 90 years Patients with recurrent hiatal hernia Patients who are not suitable for general anesthesia Patients who prefer a surgical approach other than laparoscopic surgery Patients who are unable or unwilling to provide informed consent
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 |
|---|---|---|
| Laparoscopic Nissen FundoplicationThe procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery. | Procedure or surgery | Nissen fundoplication |
| Laparoscopic Toupet FundoplicationThe procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery. | Procedure or surgery | Toupet Fundoplication |
Primary outcome
Postoperative pain score at 24 hours
Time frame: 24 hours after surgery
Postoperative pain will be assessed 24 hours after surgery using the Visual Analog Scale. The score will be used to compare early postoperative pain between participants undergoing laparoscopic Nissen fundoplication and those undergoing laparoscopic Toupet fundoplication.
Postoperative Pain Score at 7 Days
Time frame: 7 days after surgery
Postoperative pain will be assessed 7 days after surgery using the Visual Analog Scale. The score will be used to evaluate and compare short-term postoperative pain between the two intervention groups.
Change in Health-Related Quality of Life After Surgery
Time frame: Preoperatively, 1 week, 4 weeks
Health-related quality of life will be assessed using the GERD-Health Related Quality of Life questionnaire. Preoperative scores will be compared with postoperative scores in order to evaluate changes in reflux-related symptoms and quality of life after laparoscopic Nissen or Toupet fundoplication.
Postoperative Hospital Stay
Time frame: From the day of surgery until hospital discharge - up to 30days
Postoperative hospital stay will be measured as the number of days from the day of surgery until hospital discharge. The duration of hospital stay will be compared between the Nissen and Toupet fundoplication groups.
Recurrence of Gastroesophageal Reflux Symptoms
Time frame: 4 weeks and 1 year after surgery
Recurrence of gastroesophageal reflux symptoms will be assessed during postoperative follow-up. The presence or absence of recurrent reflux symptoms will be recorded and compared between the two intervention groups.
4 secondary outcomes
Operative Timе
Time frame: Intraoperative
Fundoplication Time
Time frame: Intraoperative
Gas-Bloat Symptoms
Time frame: 3 days; 1 week
Postoperative Complications
Time frame: Up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Nissen Fundoplication and Laparoscopic Toupet Fundoplication in people with Hiatal Hernia, Paraesophageal and Hiatal Hernia Large, run by Sofia Med Hospital at 1 site in Bulgaria.
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 5 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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 Bulgaria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katya T. Todorova, PhD (+359884744833, katya.todorowa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score at 24 hours (time frame: 24 hours after surgery). The study lists 5 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 22 Jul 2026.