Hiatal Hernia Clinical Trial
Official title:
Randomized Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestine Submucosa (SIS)
In 2006 this research group reported their initial findings of a multi-center prospective
trial comparing primary repair and primary repair buttressed with a biologic mesh made from
porcine small intestinal submucosa (SIS). We were able to accrue 108 patients from
7/2002-3/2005 and followed each patient over 6 months and performed an UGI to check the
durability of the repair and rule out a recurrence. The results suggested a significant
benefit for the use of SIS mesh in the short-term, with the primary group having a 26%
recurrence rate and the mesh group a 9% recurrence rate.
While these results are encouraging, it is important to know what is the durability and the
longer term benefits of the use of SIS mesh. For this reason we propose a follow-up of the
original study patients with the same outcome measures (symptom questionnaire, SF-36, and
UGI). This should give us a very good idea about the long-term success of laparoscopic PEH
repair with primary and SIS mesh.
Traditionally paraesophageal hernias were repaired by thoracotomy or laparotomy with
morbidity around 20% and mortality of 2%.1,2 The advent and later popularization of
antireflux operations via the minimally invasive approach led to the development of a
similar (laparoscopic) approach to the treatment of paraesophageal hernia. This approach
called for the excision of the sac, a thorough esophageal mobilization, primary closure of
the hiatus and a Nissen fundoplication. 3,4 Laparoscopy appears to have some of the benefits
of thoracotomy (the hiatus can be accessed easier, the esophagus can be dissected under
direct vision and high mobilization of the esophagus is possible) and some of the advantages
of the laparotomy (less morbidity, no need to collapse the lung, no need for postoperative
chest tube). In fact, most PEH are currently repaired via a laparoscopic approach.
Hashemi et al in 2000 reported that patients who had had a repair of a paraesophageal hernia
via the laparoscopic approach had a higher recurrence rate when compared to those operated
on via thoracotomy and laparotomy.5 The only other study comparing open and laparoscopic
repair revealed a higher incidence of recurrence in the open repair group (8% vs. 0%),6 but
was also based solely on symptoms. Case series of LPEHR which evaluate recurrent hiatal
hernia by x-ray or endoscopy have found the recurrence rate to be between 12-42%,3,5,7
suggesting significant room for improvement.
It is not surprising that primary repair of the paraesophageal hiatal hernia by suturing the
pillars of the diaphragm together under tension is at significant risk for disruption. With
the development and wide application of mesh materials for tension-free repair of inguinal
and ventral hernias, many surgeons have applied the technique of tension-free closure with a
mesh to the hiatal hernia. Two randomized trials have demonstrated a significant reduction
in recurrence rates by using synthetic mesh in large hiatal hernia repairs.8,9 However,
there are potential problems introduced by using synthetic mesh at the dynamic hiatus such
as mesh erosion, ulceration, stricture, and dysphagia.9,10,11 Recently, a number of
biomaterials have been developed for hernia repair. The idea behind them is that a biologic
scaffold, usually containing extracellular collagen, serves as a temporary matrix, thus
strengthening a natural hernia closure.12,13 One such mesh is derived from porcine small
intestinal submucosa (SIS) (Cook Surgical Indianapolis, IN). A pilot study using SIS for PEH
repair suggested that is was safe and possibly effective in reducing recurrence.14 We then
organized and carried out a multi-center randomized trial comparing primary repair of the
crura and buttressing a primary repair with SIS mesh during laparoscopic PEH repair. The
results at 6 months after operation demonstrated a nearly 3-fold reduction in the recurrence
rate with the use of mesh (26% to 9%).15 Furthermore, there were no mesh related
complications such as dysphagia, infection, or erosion. These results have been met with
tempered enthusiasm in the surgical community. The only question in many surgeon's minds is
whether buttressed repair of the hiatus is durable. To answer this question we need to
complete longer term follow-up in these patients.
The aim of this study is to determine if the use of SIS to reinforce the closure of the
hiatus in patients with paraesophageal hernias results in a lower recurrence rate at 2.5-5
years after operation, and results in improved outcomes, without an increase in the
complication rate.
;
Observational Model: Case Control, Time Perspective: Retrospective
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