Health TrialsbyHealthPanel

Nissen Versus Dor Hiatal Hernia Repair

ConditionsHiatal HerniaParaesophageal HerniaRecurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKuopio University Hospital

About this trial

Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation

Participants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

Type II-IV hiatal hernia, confirmed by radiology or endoscopy

Scheduled for mini-invasive hiatal hernia repair

Emergency mini-invasive surgery for hiatal hernia

Disqualifiers

Recurrent hiatal hernia

Need for esophageal lengthening procedure (Collis)

Gangrene or need for any resection during (emergency) surgery

Need for laparotomy or thoracotomy/thoracoscopy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nissen fundoplication

    Procedure/Surgery

    Hiatal hernia repair and Nissen fundoplication

  • Dor fundoplication

    Procedure/Surgery

    Hiatal hernia repair and Dor fundoplication

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Nissen fundoplicationActive comparator 1 intervention
Group B: Dor fundoplicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anatomical recurrence of hiatal hernia

Computed tomography based recurrence after Nissen versus Dor fundoplication

Time frame
12 months after the surgery
2

Symptomatic recurrence of hiatal hernia

Anatomical recurrence with questionnaire based gastroesophageal reflux disease (GERD) or dysphagia symptoms, or need for reoperation for recurrence

Time frame
12 months after the surgery

Secondary outcomes

1

Symptomatic versus asymptomatic recurrence rates

Symptomatic versus asymptomatic recurrence rates at 12 months

Time frame
12 months
2

Reoperation rates

Reoperation rates at 3-, 5-, 10- and 20-years following the surgery

Time frame
20 years
3

Managing GERD symptoms with Nissen vs Dor fundoplication

The efficacy of Nissen vs Dor fundoplication techniques in improving the Gastroesophageal Reflux Disease-Health Related Quality of Life instrument (GERD-HRQL) scores at 12 months. Minimum score 0 = no symptoms, maximum score 75 = worst symptoms.

Time frame
12 months
4

Dysphagia symptoms after Nissen vs Dor fundoplication

The effect of different fundoplication techniques on dysphagia symptoms assessed by Eating Assessment Tool (EAT-10 ) at 12 months. Score range from 0 to 40 with higher scores indicating more severe dysphagia.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kuopio University Hospital

Lead sponsor

Source ClinicalTrials.gov
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