An interventional study of Laparoscopic Nissen Fundoplication and Laparoscopic Toupet Fundoplication in Hiatal Hernia, Paraesophageal, Hiatal Hernia Large and Hiatal Hernia With Gastroesophageal Reflux Disease, sponsored by Sofia Med Hospital. Recruiting at 1 site in Bulgaria. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Sofia Med Hospital · Not applicable, Interventional, and Treatment
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Sofia Med Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Laparoscopic Nissen Fundoplication
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.
Procedure: Laparoscopic Toupet Fundoplication
The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks and 1 year after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 30 days after surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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