Diaphragmatic Hernia Clinical Trials

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Laparoscopic Nissen Versus Toupet Fundoplication for Gastroesophageal Reflux Management in Patients With Hiatal Hernia: A Patient- and Assessor-Blinded Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Bulgaria
UMHAT Sofiamed
RECRUITING
Sofia
Contact Information
Primary
Katya T. Todorova, PhD
katya.todorowa@gmail.com
+359884744833
Backup
Teodor D. Atanasov, Assoc. Prof.
teodor.atanassov@gmail.com
+359899802612
Time Frame
Start Date: 2023-05-29
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 200
Treatments
Active_comparator: Nissen fundoplication
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.
Active_comparator: Toupet 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.
Sponsors
Leads: Sofia Med Hospital

This content was sourced from clinicaltrials.gov