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Completed

NCT Number: NCT04436159

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

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

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Key information

Conditions

Paraesophageal Hernia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastro Esophageal Reflux Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ersta Hospital

Stockholm, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Ogilvie dysphagia score

    Time frame: 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 outcomes

  1. intra-and postoperative courses

    Time frame: 6 mohths

    Peri and postoperative complications.

  2. length of hospital stay

    Time frame: 6 months

    postoperative length of hospital stay

  3. Watson dysphagia score

    Time frame: 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.

  4. Acid reflux control

    Time frame: 6 months

    24-hour pH monitoring

  5. Quality of Life (SF-36)

    Time frame: 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.

  6. Radiology

    Time frame: 6 months

    Radiologically verified recurrent hiatal hernia

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Ersta Hospital, Sweden

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2020
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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