Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias

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.

Conditions

• Hernia, Hiatal

Interventions

PROCEDURE

Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh

A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro™ (Ethicon, Inc.) will be sutured to both crura 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).

PROCEDURE

Laparoscopic primary posterior crural repair

Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable (Ethibond™ 3-0 by Ethicon, Inc.) sutures. In the both arms laparoscopic procedure will be done in a standard fashion: reduction of hernia with excision of hernia sac and mobilization of distal esophagus, exposure of borders of hiatal opening including crura posteriorly to esophagus, repair if hiatal hernia defect (30 Fr esophageal bougie is used), a short (2,5 - 3,5 cm) 360° fundoplication wrap (floppy-Nissen procedure) (30 Fr esophageal bougie is used).

Sponsors & Collaborators

• Odessa National Medical University

  lead OTHER

Principal Investigators

• Volodymyr V. Grubnik, Prof., MD · Department of surgery # 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

2013-01-31

Primary Completion

2014-07-31

Completion

2016-07-31

Countries

• Ukraine

Study Locations