Clinical trial NCT04436159: Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
Official title: Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraesophageal Hernia
Gastro Esophageal Reflux
Keywords: Nissen fundoplication
Toupet fundoplication
crural repair
Quality of Life
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Ersta Hospital, Sweden
First posted: 2020-06-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Ogilvie dysphagia score
timeFrame: 6 months
Secondary outcomes:
measure: intra-and postoperative courses
timeFrame: 6 mohths
measure: length of hospital stay
timeFrame: 6 months
measure: Watson dysphagia score
timeFrame: 6 months
measure: Acid reflux control
timeFrame: 6 months
measure: Quality of Life (SF-36)
timeFrame: 6 months
measure: Radiology
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
Study officials:
affiliation: Karolinska Institutet
name: Lars Lundell, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Analatos A, Lindblad M, Ansorge C, Lundell L, Thorell A, Hakanson BS. Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial. BJS Open. 2022 May 2;6(3):zrac034. doi: 10.1093/bjsopen/zrac034.