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

NCT04436159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-09-02

No results posted yet for this study

Summary

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

Conditions

  • Paraesophageal Hernia
  • Gastro Esophageal Reflux

Interventions

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.

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.

Sponsors & Collaborators

  • Ersta Hospital, Sweden

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Lars Lundell, professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-01
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04436159 on ClinicalTrials.gov