Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05201508

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. For symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. However, recurrence rates are high between 12 and 42%. In order to reduce recurrences, mesh has been used with various materials and techniques with conflicting results. Non-absorbable mesh has been linked with adverse events including erosion of esophageal wall. Traditionally used biological mesh materials are expensive and therefore problematic in routine use. Use of polyglactin (Vicryl®) mesh, which degrades in 6-8 week, has been reported in paraesophageal hernia surgery. Previously, no randomized controlled trial comparing sutures only and polyglactin mesh has been performed. In this trial, the aim was to randomize total of 110 patients to receive sutures only or mesh repair. Primary outcome was recurrence of paraesophageal hernia at 6 months after the repair based on computed tomography scan. Secondary outcomes included symptomatic recurrences, reoperation rate, quality of life, reoperations up to 20-years after surgery and use of proton pump inhibitors up to 20-years after surgery.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90220, Finland

Location status: Recruiting

Location contact

Olli Helminen, MD, PhD

CONTACT

[email protected]

+35883152011

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years old
  • Type III-IV PEH with either radiologic or endoscopic confirmation
  • Scheduled for laparoscopic PEH repair
  • The informed consent is acquired

Exclusion criteria

  • Need for esophagus lengthening procedure (Collis gastroplasty)
  • Recurrent PEH
  • Emergency surgery
  • No written consent

Treatment and study plan

Polyglactin mesh

Procedure

Polyglactin mesh is used in keyhole manner to enforce hiatal closure

Sutures only

Procedure

Traditional hiatal closure with non-absorbable sutures.

Primary outcomes

  1. Radiographic recurrence of PEH

    Time frame: 6 months after surgery

    Computed tomography based recurrence after sutures only versus polyglactin mesh

Secondary outcomes

  1. Symptomatic versus asymptomatic recurrence rates

    Time frame: 6 months

    Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding

  2. Reoperation rate

    Time frame: 20 years

    Reoperation rate related to hiatal hernia recurrence

  3. Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)

    Time frame: 6 months

    The impact of PEH repair method to health-related quality of life score in esophago-gastric questionnaire (EORTC qlq-og25) at 6 months compared to preoperative level. Score is given between 25 and 100 points with higher score meaning worse quality of life.

  4. Hiatal defect size related to recurrence rate

    Time frame: 6 months

    The correlation with size of hiatal defect (cm^2) to recurrence rate (scatter plot with defect size in x-axis and recurrent hernias in y-axis)

  5. BMI and the risk of recurrence

    Time frame: 6 months

    The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)

  6. Proton pump inhibitor (PPI) use

    Time frame: 20 years

    Use on proton pump inhibitors at 1- 3-, 5-, 10- and 20-years after surgery related to intervention method (sutures only or polyglactin mesh)

  7. Age and the risk of recurrence

    Time frame: 6 months

    The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis)

  8. Albumin level and the risk of recurrence

    Time frame: 6 months

    The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis)

Study contacts

Contact information is provided by the study sponsor or research team.

Olli Helminen, MD, PhD

CONTACT

[email protected]

+35883152011

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Collaborators

  • Central Finland Hospital District

Registry information

Official study title

Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.

Important dates

Study start
2022
Primary completion
2024
Study completion
2043
First posted
Jan 21, 2022
Registry last updated
Mar 27, 2023

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.

Published trials that share one or more normalized conditions with this study.