Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.

Karolinska University Hospital

Status: Completed

Conditions: Gastro Esophageal Reflux; Paraesophageal Hernia

Treatments: Procedure: Addition of 180 posterior fundoplication after crural closure; Procedure: Addition of 360 fundoplication after crural closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04436159

2008/179-31

Details and patient eligibility

About

Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication

Full description

Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should be included in the hiatal reconstruction in order to reduce the risk of postoperative gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be recommend is yet to be determined.

One might argue that the overall durability and effectiveness of a partial fundoplication in the control of reflux might be less reliable than a total wrap, but on the contrary, the latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.

We therefore designed a double blind randomized clinical trial in which patients with symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total (Nissen) fundoplication after hernia reduction and crural repair.

Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery of para-esophageal hernia with addition of total fundoplication vs posterial partial fundoplication.

Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36: physical and mental component scores.

Time points: 1, 3 and 6 months after surgery

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital and Karolinska University Hospital

Exclusion criteria

• age below 18 years
• axial sliding hiatal hernia only (type I)
• missing informed consent
• previous hiatal hernia surgery
• American Society of Anesthesiologists (ASA) score IV or above
• achalasia
• Zollinger-Ellison syndrome
• malignant tumor
• inability or unwillingness to complete questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Nissen fundoplication

Active Comparator group

Description:

Addition of 360 fundoplication after crural closure

Treatment:

Procedure: Addition of 360 fundoplication after crural closure

Toupet fundoplication

Active Comparator group

Description:

Addition of 180 posterior fundoplication after crural closure

Treatment:

Procedure: Addition of 180 posterior fundoplication after crural closure