Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair

Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost
400,000 ventral hernia repairs annually in the United States. There is an even higher
incidence of incisional hernia recurrence after prior repair if the patient is obese. Each
subsequent hernia repair leads to increased morbidity and durability. It is not infrequent
that many surgeons will advise overweight or obese patients to lose substantial weight prior
to complex incisional hernia repair.

However, it is quite difficult for any individual to lose more than 8 pounds a month in a
safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet
and exercise alone. Many patients with incisional hernia are physically debilitated that
they cannot engage in any substantial physical activity to lose weight. Traditional
laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while
feasible, is a technically challenging endeavor since prior abdominal surgeries increase the
amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who
are not candidates for laparoscopic weight loss surgery because of inability to tolerate
pneumoperitoneum due to underlying physiologic dysfunction.

- Novel minimally invasive endoscopic technique may help obese patients with an incisional
hernia lose weight in a safe and rapid fashion. Early case reports and small case series on
gastric bypass revision utilizing such endoscopic technique have shown promise in
efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight
loss.

Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a
primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8
Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for
weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System
(Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight
loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of
not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric
greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11

The intent of this study is not to demonstrate endoscopic suturing to be a primary option
for weight-loss surgery. Preliminary reports have shown such procedure is technically
feasible but not durable and the effects of the procedure varied widely among the study
participants.12 The investigators view this technology as a bridge for morbidly obese
patients, who will need subsequent surgery for another surgical disease, to improve their
body habitus and decrease their postoperative morbidity and mortality. The aims of the
investigators study are:

- Feasibility of endoscopic gastric sleeve plication

- Define the technical aspects of endoscopic suturing for sleeve plication

- Provide long-term follow-up for both weight loss and resolution of their co-morbidities

- Time from the endoscopic procedure to their incisional hernia repair

- Photographic evidence of the stomach after endoscopic plication during the incisional
hernia repair

There are several advantages for the proposed study. First it avoids entering the
intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the
need for stapling which may increase the risk of gastric leak from the staple line.13
Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or
duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device
withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices
will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13,
14

The implications of this study can be far-reaching. Once efficacy is demonstrated where
enough weight loss is achieved that patients can safely and quickly undergo their incisional
hernia surgery, the investigators can then conduct a retrospective case-control
cross-matched study to further delineate its true benefit. If there is a true benefit, then
a randomized control study can be employed in the future.