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

NCT ID: NCT04436159

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-01
• Study Completion Date: 2018-09-30

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

Conditions

Paraesophageal Hernia; Gastro Esophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nissen fundoplication

Addition of 360 fundoplication after crural closure

Group Type: ACTIVE_COMPARATOR

Addition of 360 fundoplication after crural closure

Intervention Type: 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.

Toupet fundoplication

Addition of 180 posterior fundoplication after crural closure

Group Type: ACTIVE_COMPARATOR

Addition of 180 posterior fundoplication after crural closure

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ersta Hospital, Sweden

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lars Lundell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Lundell, professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Ersta Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 35511051 (View on PubMed)

Other Identifiers

2008/179-31

Identifier Type: -

Identifier Source: org_study_id