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Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.

17. juli 2026 opdateret af: Katya Todorova, Sofia Med Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Bulgarien
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1517
        • Rekruttering
        • UMHAT Sofiamed
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Teodor D Atanasov, Assoc. prof.
        • Ledende efterforsker:
          • Katya T Todorova
        • Underforsker:
          • Alexander I Tsvetanov

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

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 informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedure: Laparoscopic Nissen Fundoplication
The procedure includes a complete 360° fundoplication performed as part of standard laparoscopic antireflux surgery.
Aktiv komparator: 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.
Procedure: Laparoscopic Toupet Fundoplication
The procedure includes a partial posterior 270° fundoplication performed as part of standard laparoscopic antireflux surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pain score at 24 hours
Tidsramme: 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.
24 hours after surgery
Postoperative Pain Score at 7 Days
Tidsramme: 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.
7 days after surgery
Change in Health-Related Quality of Life After Surgery
Tidsramme: 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.
Preoperatively, 1 week, 4 weeks
Postoperative Hospital Stay
Tidsramme: 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.
From the day of surgery until hospital discharge - up to 30days
Recurrence of Gastroesophageal Reflux Symptoms
Tidsramme: 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 weeks and 1 year after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Operative Timе
Tidsramme: Intraoperative
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.
Intraoperative
Fundoplication Time
Tidsramme: Intraoperative
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.
Intraoperative
Gas-Bloat Symptoms
Tidsramme: 3 days; 1 week
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.
3 days; 1 week
Postoperative Complications
Tidsramme: Up to 30 days after surgery
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.
Up to 30 days after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sofia Med Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. maj 2023

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

31. januar 2027

Datoer for studieregistrering

Først indsendt

19. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25/2023

Plan for individuelle deltagerdata (IPD)

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