Clinical Trial: Laparoscopic Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Prospective Randomized Phase III Study of Laparoscopic Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh

Brief Summary: This study is prospective randomized trial enrolling at least 50 participants which compares efficacy and safety of two alternative methods of laparoscopic hiatal repair for giant (i.e. with hiatal surface area (HSA) exceeding 20 sq.cm) types II and III hiatal hernias: partially absorbable lightweight mesh repair, and nitinol-framed lightweight polytetrafluoroethylene (PTFE) mesh repair. In the literature, mean rate of anatomical recurrence of giant hiatal hernias is 25 %, reaching 42 %. Polypropylene and composite PTFE meshes used most widely, result in unacceptable rates of long-term dysphagia (10-15 %) and oesophageal strictures. Own experience of the interventors of more than 400 repairs using partially absorbable lightweight mesh Ultrapro (Ethicon) and original sub-lay technique of its fixation precluding contact of the mesh with the oesophagus, showed low recurrence rate for large hernias and a few cases of long-term dysphagia. For giant hiatal hernias, this technique provides acceptable results (20 % of recurrence) which correspond to the literature. Nevertheless, these results may be improved, probably by using of new type of prosthesis. Thus, in collaboration with Minnesota Medical Development, Inc., USA, the interventors created fundamentally new method of hiatal repair by using new prosthesis - Rebound HRD-Hiatus hernia. This prosthesis is heart-shaped lightweight PTFE mesh with peripheral nitinol frame. It is easily fixated to the crura posteriorly to the oesophagus completely covering hernia defect, and supports a strong framework of the hiatus, and, therefore, allows to save a principle a real tension-free repair. Mid-term results (mean follow-up period of 15 months) of 29 procedures showed no recurrences or oesophageal complications. Naturally, final conclusions regarding superiority of the new technique could be established by prospective randomized study. The hypothesis of the current trial is: new method of nitinol-framed lightweight PTFE mesh repa

Detailed Summary:

Giant hiatal hernias, i.e. hernias with hiatal surface area (HSA), as described by Granderath et al (2007), exceeding 20 sq.cm, is one of the most challenging problem in minimally invasive gastrointestinal surgery. On one hand, according to the literature, the rate of utilization of laparoscopic repair of such hernias does not exceed 80 % [Nguyen et al, 2011]. It means that great proportion of patients is still treated using open approach producing 8 % of postoperative complications [Nguyen et al, 2011]. Therefore, improvement of laparoscopic techniques for this disorder is very actual question. On the other hand, the mean rate of anatomical recurrence following laparoscopic repair of paraoesophageal hernias is 25 % as reported in a meta-analysis [Rathore et al, 2007]. It reaches 42 % in some centers according to recent literature reviews [Draaisma et al, 2005; Johnson et al, 2006]. Hence, creation of new method of hiatal repair diminishing recurrence rate is essential. To interventors' opinion, this new method must follow at least a principle of tension-free repair.

As the most concerning problem or repair of giant hiatal hernias is anatomical recurrence, a conception of prosthetic repair was applied for hiatal closure using different types of meshes. This dramatically decreased recurrence rate as demonstrated by several recent studies. Namely, Frantzides et al (2002) prospectively compared primary repair with on-lay PTFE repair and obtained statistically significant decrease of recurrence rate in favor of mesh arm: 0% versus 22%. Then, Granderath et al (2004) compared primary suturing and on-lay polypropylene mesh repair in prospective randomized trial; the rate of recurrence was significantly lower in the mesh arm: 8% versus 26%. Unfortunately, these studies were not primarily addressed to relation between hernia size and results. Most specialists use mesh when the dia
Sponsor: Odessa National Medical University

Current Primary Outcome: Anatomical and functional recurrence of hiatal hernia and GERD [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Repair-related dysphagia/oesophageal stricture/prosthetic erosion [ Time Frame: 24 months ]
  Long-term dysphagia, including due to repair-related oesophageal stricture, will be assessed by symptom questionnaire with visual analogue scales, barium study, endoscopic examination, and data from possible redo procedures. Patients also will be endoscopically assessed for such rare complication as prosthetic erosion of oesophagus.
• Quality of life and satisfaction [ Time Frame: 24 months ]
  Quality of life and satisfaction will be assessed by GERD-HRQL score
• Morbidity [ Time Frame: 1 month ]
• Time to discharge [ Time Frame: 1 month ]
  Time to discharge will be measured in days, from the day of primary surgical procedure, i.e. laparoscopic hiatal hernia repair, to the day of discharge from the hospital
• Number of participants completely recovered from extra-oesophageal complications of hiatal hernia following surgical procedure [ Time Frame: 24 months ]
  Extra-oesophageal complications of hiatal hernia to be assessed are: asthma, chronic obstructive pulmonary disease, laryngitis, angina, and arrhythmias

Original Secondary Outcome: Same as current

Information By: Odessa National Medical University

Dates:
Date Received: January 26, 2013
Date Started: June 2013
Date Completion: February 2017
Last Updated: June 28, 2016
Last Verified: June 2016