Laparoscopic Greater Curvature Plication: An Alternative Restrictive Bariatric Procedure

by Almino C. Ramos, MD; Manoel Galvão Neto, MD;
Josemberg Marins Campos, PhD; and Claudio Cora Mottin, PhD

Drs. Neto and Ramos are from the Gastro Obeso Center in São Paulo, Brazil. Drs. Neto and Ramos are international consultants for Ethicon Endo-Surgery, Inc. Dr. Campos is from Federal University of Pernambuco, Recife, Brazil. Dr. Mottin is from Pontific Catholic University, Porto Alegre, Brazil.

Bariatric Times. 2010;7(5):8–10

Abstract
Vertical sleeve gastrectomy is a restrictive surgical technique that involves resection of a significant portion of the stomach by means of stapling the greater curvature. This procedure is rapidly gaining popularity and acceptance as a primary bariatric procedure with good results on weight loss. The other restrictive bariatric procedure is the adjustable gastric band. As the results on the vertical sleeve gastrectomy and the adjustable gastric band vary, there is still a gap that can be fulfilled by another procedure. The authors present an alternative procedure that is under investigation that can be as restrictive as sleeve gastrectomy with no staple line or prostheses. This procedure is called laparoscopic greater curvature plication, which is similar to vertical gastric banding, but without the need for gastric resection. The stomach is reduced by dissecting the greater omentum and short gastric vessels, as in vertical sleeve gastrectomy, then the greater curvature is invaginated using multiple rows of nonabsorbable suture over bougie to ensure a patent lumen. This article includes the background, method, initial results, and a brief discussion on this new procedure.

Introduction
Traditionally, the primary mechanisms through which bariatric surgery achieves its outcomes are believed to be the mechanical restriction of food intake, reduction in the absorption of ingested foods, or a combination of both.[1,2] Adjustable gastric banding (AGB) and vertical sleeve gastrectomy (VSG) are restrictive approaches commonly used in bariatric practice.[5,6] Although these procedures have proven to be good therapeutic options for some patients, they are not without significant complications, such as erosion or slippage of the gastric band or gastric leaks in VSG.[3,4,7,13,14] Leaks in VSG pose a particularly difficult challenge when they occur near the angle of His, potentially generating severe clinical conditions that require reoperation and may even cause death.[4]

Since 2006, the authors have been evaluating the safety and initial results of the laparoscopic greater curvature plication (LGCP™), a restrictive bariatric surgical technique that has the potential to eliminate the complications associated with AGB and VSG by creating restriction without the use of an implant and without gastric resection and staple.

Methods
Using the National Institute of Health’s (NIH) inclusion criteria for bariatric surgery (patients with a body mass imdex >40kg/m[2] or BMI over 35kg/m[2] with at least one comorbidity), all patients underwent a multidisciplinary evaluation (endocrinologist, cardiologist, psychologist, and nutritionist), blood tests, abdominal ultrasonography, and upper endoscopy to establish baseline. The study design was a prospective, noncomparative case series that received approval from the local ethics committee with patients signing informed consent.

From January 2007 to March 2010, 62 patients (44 female) were submitted to LGCP. Mean age was 33.5 years (ranging from 23 to 48 years) and mean BMI was 41kg/m2 (ranging from 35 to 46kg/m[2]).

Technique
Patients were placed under general anesthesia in supine positions. A Five-trocar port technique, similar to Nissen fundoplication, was used. Trocar placement was one 10mm trocar above and slightly to the right of the umbilicus for the 30-degree laparoscope; one 10mm trocar in the upper right quadrant (URQ); one 5mm trocar also in the URQ below the 10mm trocar at the axilary line; one 5mm trocar below the xiphoid appendices; and one 5mm trocar in the upper left quadrant (ULQ). The procedure began with angle of His dissection and removal of the fat pad, followed by careful dissection of the gastric greater curvature using the Harmonic™ scalpel (Ethicon Endo-Surgery, Inc., Cincinnati, Ohio), opening the greater omentum at the transition between the gastric antrum and gastric body. Once access to the posterior wall was achieved, the greater curvature vessels were dissected distally up to the pylorus and proximally up to the angle of His. Posterior gastric adhesions were also dissected to allow optimal freedom for creating a greater curvature flap.

Gastric plication created by imbrication of the greater curvature over a 32-Fr bougie applying a first row of extramucosal interrupted stitches of 2-0 Ethibond™ (Ethicon, Inc. Somerville, New Jersey) sutures. This row guided two subsequent rows created with extramucosal running suture lines of 2-0 Prolene™ (Ethicon, Inc., Somerville, New Jersey). In the final aspect, the stomach was shaped like a sleeve gastrectomy but slightly larger. Leak tests were performed with methylene blue in all cases. No drains were left.

Patients were discharged as soon as they accepted a liquid diet without vomiting. They also received a prescription of daily proton-pump inhibitor (PPI; single dose) for 60 days. Ondasentron and hyoscine (anti-spasmodic) were prescribed for seven days. The postoperative diet was a customized liquid diet for two weeks, with progressive return to solid foods in a stepwise fashion. Dietary restrictions were removed after 4 to 6 weeks, depending on patient adherence.

Follow-up visits for the assessment of safety and weight loss were scheduled for 1 week and 1, 3, 6, 12, 18, and 24 months in the postoperative period. Endoscopic evaluations were scheduled for 1, 6, and 12 months postoperatively.

Results
All procedures were performed laparoscopically without conversions. Mean operative time was 55 minutes (40–110 minutes). Mean hospital stay was 36 hours (24 to 96 hours). On average, patients returned to normal activities seven days (4–13 days) following surgery. Mean percentage of excess weight loss (EWL) was calculated to be 20 percent at one month, 32 percent at three months, 48 percent at six months, 60 percent at 12 months, 62 percent at 18 months, and 61 percent at 24 months.

No intraoperative complications were documented. All patients had lost at least 10 percent of total body weight. In the first postoperative week, however, nausea, vomiting, and sialorrhea in occurred in 22, 14, and 33 percent of patients, respectively. In all cases, these symptoms were resolved within two weeks. There has been no record of weight regain in any patient to date.

Postoperative upper endoscopy and radiologic evaluation were performed on 12 patients at one and six months and in seven patients at up to 12 months. Qualitatively, the upper endoscopies suggest that the initial greater curvature fold is smaller at six months when compared with the initial fold size at one month, but appears unchanged at 12 months. Mild esophagitis (Grade A of Los Angeles classification) occurred in four patients at one month postoperatively; these patients were symptomatic (nausea, vomiting, and sialorrhea) and were kept on PPI, following the standard protocol. The six-month endoscopic evaluation identified no lesions or symptoms. Lumen size appeared stable (e.g., no dilation) based on upper gastrointestinal (GI) radiologic series performed on these patients at one and six months

Discussion
Reducing stomach capacity to promote mechanical restriction to food intake is one of the traditionally accepted mechanisms used in bariatric procedures to promote weight loss. There are at least two surgical procedures that appear to rely on this principle in current clinical practice, AGB and VSG. AGB achieves around 50 percent EWL, but unsatisfactory weight loss occurs in more than 20 percent of patients with failure rate requiring surgical revision in up to 25 percent of patients.[7]

VSG as a primary bariatric procedure shows medium-term results to be adequate (>60% EWL), with improvements in comorbidities.[4,14] These promising results are associated with some complications, however, such as esophagites, stenosis, fistulas, and gastric leaks near the angle of His. These leaks and fistulas are reported in nearly one percent of cases and can be very difficult to treat.[4,14]

LGCP is notably similar to a VSG in that it generates a gastric tube and eliminates the greater curvature, but does so without gastric resection. Initial clinical reports by Talebpour and Amoli[10] and Sales[11] demonstrate satisfactory weight loss up to three years. Brethauer et al12 reported increased weight loss in patients receiving LGCP when compared to plication of the anterior surface.

The present series, compared to findings reported in some series involving AGB, has the lowest early complication rates among all bariatric procedures. Even with no major complications to report in the present series, Talebpour and Amoli[10] report one case of a gastric leak associated with a more aggressive version of LGCP, which they attributed to excessive vomiting in the early postoperative period. Adverse events described by patients were minor, lasting up to two weeks. These events may be related to the restriction induced by the invagination of the greater curvature and/or edema caused by venous stasis. Qualitative endoscopic findings suggest that the greater curvature fold gets smaller. This may be related with the resolution of the initial edema, although the radiological findings did not reveal significant dilation of the LGCP at six months. The percent EWL achieved a satisfactory 61 percent at 24 months in eight patients, with all patients achieving at least a 10-percent loss of initial weight. This can be favorably compared with results from VSG.

This series is limited by the low number of patients, the simple study design, lack of a control group, the noninclusion of patients with BMI >50kg/m[2], and the incomplete follow-up period. This limits the broader acceptance of these results. These limitations limit the broader acceptance of these results. In order to better study this procedure, an international multicentric trial with centers in the United States, Chez Repuplic, and Brazil was designed (ClinicalTrials.gov Identifier NCT01077193).

LGCP seems to be feasible, safe, and effective in the short term as a promising bariatric procedure on this initial series

Acknowledgment
Experimental evaluation was provided by Fusco et al8,9 that had published two articles about gastric plication on anterior wall and greater curvature of wistar rats achieving good results in weight loss analogy and significant better results of the greater curvature group. Recent clinical experience with variations of this technique has been described by few surgical groups. The authors’ initial experience was sent to the journal Obesity Surgery and was accepted for publication. More actualized data are described in this present paper.

Images
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References
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Tags: greater curvature plication, Laparoscopic bariatric surgery, Morbid obesity, restrictive procedure, vertical sleeve gastrectomy

Category: Past Articles, Review