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

Not Applicable

Completed

• Conditions: Paraesophageal Hernia; Gastro Esophageal Reflux

• Registration Number: NCT04436159
• Lead Sponsor: Karolinska University Hospital

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

Study Timeline

• Study Start: 2009-05-01
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-28
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ogilvie dysphagia score	6 months	The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow .

Secondary Outcome Measures

Name	Time	Method
Acid reflux control	6 months	24-hour pH monitoring
intra-and postoperative courses	6 mohths	Peri and postoperative complications.
length of hospital stay	6 months	postoperative length of hospital stay
Watson dysphagia score	6 months	Watson dysphagia score is a validated instrument for benign dysphagia where the patient is asked whether he/she always, sometimes or never has difficulty swallowing nine different groups of liquid and food items.; This gives a score ranging from zero to 45, where 45 represents the worst possible dysphagia.
Quality of Life (SF-36)	6 months	The Swedish version of this validated global questionnaire is presented as physical and mental summary component scores (PCS and MCS, respectively). Each subscale scores reaches a value of at the most 100, where higher values reflect better health status.
Radiology	6 months	Radiologically verified recurrent hiatal hernia

Trial Locations

Locations (1)

Ersta Hospital; 🇸🇪 Stockholm, Sweden