Clinical Trial: Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias

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

Official Title: Prospective Randomized Phase III Study of Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias

Brief Summary: This study is prospective randomized trial enrolling at least 100 participants which compares efficacy and safety of two alternative methods of laparoscopic hiatal repair for large (i.e. with hiatal surface area (HSA) ranging from 10 to 20 sq.cm, which corresponds to diameter of defect from 5 to 8 cm) types I, II, and III hiatal hernias: primary crural repair and repair with partially absorbable lightweight mesh. According to the literature, rates of anatomical failure and recurrence of GERD after primary repair of large hiatal hernias reach 42 %. Mesh repair decreases rates of failures, however, polypropylene and composite PTFE meshes used most widely, result in unacceptable rates of long-term dysphagia and oesophageal strictures. Our own experience 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 and a few cases of long-term dysphagia. Thus, final conclusions could be established by prospective randomized study. Our hypothesis is: original technique of lightweight mesh repair is highly effective for prevention of recurrences compared to primary repair and safe in terms of mesh-related dysphagia and oesophageal strictures. The long-term results (24 months post surgery for every patient) will be studied using symptom questionnaires, quality of life and satisfaction questionnaires, barium studies, endoscopic examinations, 24-hour pH testing, and analysis of possible reoperations.

Detailed Summary:

Methods of laparoscopic repair of large and giant hiatal hernias are the most challenging questions in gastrointestinal minimally invasive surgery. The literature demonstrates high rates of anatomical and functional recurrence after laparoscopic repair of large hiatal hernias, particularly following primary crural repair. Different methods of mesh repair were introduced and several trials showed their benefits. However, necessity and method of prosthetic repair remain questionable as mesh repair results in high frequency of long-term dysphagia and oesophageal strictures.

There is insufficient grade 1 evidence for choice of optimal method of repair of large hiatal hernias. Only 3 prospective randomized trials comparing prosthetic and primary hiatal repair were published by Frantzides et al (2002), Granderath et al (2005), and Oelschlager et al (2006). However, these trials could not recommend effective, safe, and relatively inexpensive method of repair. Although Frantzides et al (2002) showed statistically significant decrease of recurrence rate in composite (ePTFE) mesh arm, the study included only patients with diameter of defect 8 cm and greater, thus it is still unknown whether mesh should be used for hernias with smaller diameter of hernia defect, for example, between 5 and 8 cm. Most specialists use mesh when the diameter of the defect is just greater than 5 cm, based on their own experience and widespread literature data, including studies of Champion et al (1998, 2003). In addition, hiatal surface area (HSA), first described by Granderath et al (2007), is more sensitive measure than diameter of hiatal hernia defect, and further trials should focus on it. Finally, ePTFE prosthesis is rather expensive.

The trial of Granderath et al (2005) also was not primarily focused of relation between diameter of hernia defect and
Sponsor: Odessa National Medical University

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

Recurrence of hiatal hernia, i.e. anatomical recurrence, will be assessed by symptom questionnaire with visual analogue scales, MAINLY by barium study, and data from possible redo procedures. Recurrence of GERD, i.e. functional recurrence, will be evaluated by symptom questionnaire with visual analogue scales, endoscopic examination with assessment of degree of reflux-oesophagitis according to Los-Angeles classification, and 24 hour pH-testing with calculation of DeMeester score.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Repair-related dysphagia/oesophageal stricture/prosthetic erosion [ Time Frame: 24 months ]
    Short- and 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
  • Operative time [ Time Frame: 1 day ]
  • Morbidity [ Time Frame: 1 month ]
  • Postoperative hospital stay [ Time Frame: 1 month ]
  • Influence on extra-oesophageal complications [ Time Frame: 24 months ]
    Extra-oesophageal complications to be assessed are: asthma, COPD, laryngitis, angina, and arrhythmias


Original Secondary Outcome: Same as current

Information By: Odessa National Medical University

Dates:
Date Received: August 1, 2011
Date Started: January 2013
Date Completion: July 2016
Last Updated: October 13, 2015
Last Verified: October 2015