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

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 repair is more effective in terms of recurrence rate compared to sub-lay partially absorbable lightweight mesh repair, and is characterized by at least similar safety in terms of oesophageal complications. 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.

Conditions

• Hernia, Hiatal

Interventions

DEVICE

Nitinol-framed lightweight PTFE mesh for hiatal repair

The heart-shaped nitinol-framed lightweight PTFE prosthesis "Rebound HRD-Hiatus hernia" (Minnesota Medical Development, Inc.) of small (4,0 x 4,5 cm) to large size (5,5 х 6,0 cm) is sutured to the crura posteriorly to oesophagus with 3 or 5 interrupted non-absorbable (Ethibond 3-0 by Ethicon, Inc.) sutures, thus performing complete tension-free hiatal repair.

DEVICE

Partially absorbable lightweight mesh for hiatal repair

A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro (Ethicon, Inc.) will be sutured to both crura posteriorly to oesophagus with 3 to 5 interrupted non-absorbable (Ethibond 3-0 by Ethicon, Inc.) sutures (as tension-free repair). Subsequent 2 to 3 interrupted non-absorbable sutures will approximate crura to completely cover a mesh to preclude its contact with the esophagus (original "sandwich" sub-lay technique). In both arms procedure will be done in a standard fashion: placement of 30 Fr esophageal bougie, reduction of hernia with excision of hernia sac and mobilization of distal esophagus, exposure of borders of hiatal opening, repair of hiatal hernia defect, a short (2,5 - 3,5 cm) 360° fundoplication wrap (floppy-Nissen procedure).

Sponsors & Collaborators

• Odessa National Medical University

  lead OTHER

Principal Investigators

• Volodymyr V. Grubnik, Prof., MD · Department of surgery No. 1 of Odessa national medical university

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2015-01-31

Completion

2017-02-28

Countries

• Ukraine

Study Locations