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

Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux; Paraesophageal Hernia
• Intervention / Treatment: Procedure: Addition of 360 fundoplication after crural closure; Procedure: Addition of 180 posterior fundoplication after crural closure

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Ersta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nissen fundoplication; Addition of 360 fundoplication after crural closure	Procedure: Addition of 360 fundoplication after crural closure; A total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall.
ACTIVE_COMPARATOR: Toupet fundoplication; Addition of 180 posterior fundoplication after crural closure	Procedure: Addition of 180 posterior fundoplication after crural closure; The wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures. Finally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ogilvie dysphagia score	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 .	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra-and postoperative courses	Peri and postoperative complications.	6 mohths
length of hospital stay	postoperative length of hospital stay	6 months
Watson dysphagia score	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.	6 months
Acid reflux control	24-hour pH monitoring	6 months
Quality of Life (SF-36)	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.	6 months
Radiology	Radiologically verified recurrent hiatal hernia	6 months

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Ersta Hospital, Sweden
• Investigators: Principal Investigator: Lars Lundell, professor, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2009
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (ACTUAL): June 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Nissen fundoplication; Toupet fundoplication; crural repair
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Gastroesophageal Reflux; Hernia, Hiatal
• Other Study ID Numbers: 2008/179-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No