Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOulu University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years old

Type III-IV PEH with either radiologic or endoscopic confirmation

Scheduled for laparoscopic PEH repair

The informed consent is acquired

Disqualifiers

Need for esophagus lengthening procedure (Collis gastroplasty)

Recurrent PEH

Emergency surgery

No written consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Polyglactin mesh

    Procedure/Surgery

    Polyglactin mesh is used in keyhole manner to enforce hiatal closure

  • Sutures only

    Procedure/Surgery

    Traditional hiatal closure with non-absorbable sutures.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Sutures onlyActive comparator 1 intervention
Group B: Polyglactin meshExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic recurrence of PEH

Computed tomography based recurrence after sutures only versus polyglactin mesh

Time frame
6 months after surgery

Secondary outcomes

1

Symptomatic versus asymptomatic recurrence rates

Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding

Time frame
6 months
2

Reoperation rate

Reoperation rate related to hiatal hernia recurrence

Time frame
20 years
3

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

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.

Time frame
6 months
4

Hiatal defect size related to recurrence rate

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)

Time frame
6 months

Other outcomes

Sponsors and contacts

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Oulu University Hospital

Lead sponsor

Central Finland Hospital District

Collaborator