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

NCT04436159 | Completed

• 1 other identifier: 2008/179-31
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paraesophageal Hernia; Gastro Esophageal Reflux

Keywords

Nissen fundoplication; Toupet fundoplication; crural repair; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• intra-and postoperative courses

  6 mohths

• length of hospital stay

  6 months

• Watson dysphagia score

  6 months

• Acid reflux control

  6 months

• Quality of Life (SF-36)

  6 months

Study Arms (2)

Nissen fundoplication

ACTIVE COMPARATOR

Addition of 360 fundoplication after crural closure

Procedure: Addition of 360 fundoplication after crural closure

Toupet fundoplication

ACTIVE COMPARATOR

Addition of 180 posterior fundoplication after crural closure

Procedure: Addition of 180 posterior fundoplication after crural closure

Interventions

Addition of 360 fundoplication after crural closure PROCEDURE

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.

Nissen fundoplication

Addition of 180 posterior fundoplication after crural closure PROCEDURE

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.

Toupet fundoplication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Ersta Hospital, Sweden: collaborator

Study Sites (1)

Ersta Hospital

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35511051 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Lars Lundell, professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 17, 2020
• Study Start: May 1, 2009
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)