A Short History of Gastric Volume Reduction
We use the term WRAP (Weight Reduction Assistance Procedure) as an easier way for patients to refer to a type of gastroplasty (gastro = stomach; plasty = to change the form or shape). Surgical techniques similar to WRAP have been advertised under many different names including Gastric Plication Surgery (“GPS”), Gastric Imbrication, Greater Curve Plication, Total Gastric Folds, Laparoscopic Total Gastric Vertical Plication, and Greater Curve Inversion Surgery. The idea of “gastric volume reduction” has been a topic of interest and investigation for decades, but for some reason seemed to have been left behind with the introduction of the era of laparoscopic weight loss surgery. Here is a brief overview of the history of this surgical concept:
In 1991, the National Institute of Health sponsored a two-day meeting of “surgeons, gastroenterologists, endocrinologists, psychiatrists, nutritionists, and other health care professionals as well as the public” to discuss, among other issues, the use of surgery to treat obesity (http://consensus.nih.gov/1991/1991gisurgeryobesity084html.htm). The consensus supported a relatively arbitrary criterion of using a BMI > 40 or a BMI > 35 kg/m2 if the patient had diseases or conditions associated with excess body weight. BMI is short for Body Mass Index, or essentially the number derived when a person’s weight is divided by his/her surface area. You can calculate your BMI on the Confidential Inquiry form (see the box to the right of this page). Since the time of that meeting over 20 years ago, surgical management of morbid obesity has continued to provide the most effective long-term weight loss, weight maintenance, and reduction of co-morbidities.
In the interval, the evolution of minimally invasive surgery continues to have profound effects on weight loss surgery accessibility, including the growth of outpatient surgeries. Studies have recently affirmed the safety of weight loss surgery over the past decade (“Perioperative Safety in the Longitudinal Assessment of Bariatric Surgery” by the Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; N Engl J Med 2009;361:445-54) http://www.ncbi.nlm.nih.gov/pubmed/19641201
Until now, the least invasive generally available weight loss procedure was Gastric Banding. While this technique produces approximately 45% loss of excess body weight ‘on average’ (the range varies between patients, starting body weights, surgeons, clinics, and countries), it has the complications of difficulty in swallowing, slippage of the band requiring surgical repositioning, and adjustment-port discomfort, migration, or breakage. Some patients also often have difficulty in maintaining an optimal or sometimes even a minimal adjustment scheduled.
While traditional guidelines seem to remain relatively unchanged despite significant clinical changes, it is clear that the issue of excess body weight continues to loom on the healthcare horizon. Currently, approximately 195 million persons in the US are at least overweight, and many will progress to lifelong obesity without effective intervention. Only recently, in 2011, was a gastric band manufacturer was allowed to openly advertise their product to patients in the BMI 30-35 range.
Gastric volume reduction in its various forms, that don’t require intestinal surgery per se, has been utilized in the past era of open surgery, with promising results.
Kirk (1969) investigated several types of gastric inversion in rats. Infolding of the long side of the stomach was most successful. Kirk noted that in-folding of the greater curve was successful in slowing, stopping, or reversing weight gain compared to controls. The technique in this study was deemed to be successful despite subsequent enlargement of the stomach; this was felt to be similar to the effects seen in human procedures in which the stomach is removed. Kirk concluded that in-folding of the stomach was safe and effective in reducing or reversing weight gain.
An Experimental Trial of Gastric Plication as a Means of Weight Reduction in the Rat.
Br J Surg. 1969 Dec;56(12):930-3
Tretbar (1976) suggested the pursuit of a ‘minimalist’ technique as an alternative to traditional, but much more aggressive surgeries such as Jejuno-Ilieal Bypass and Gastric Bypass. His surgery design was based on the observation of weight loss occurring in almost 400 anti-reflux (heartburn prevention) procedures. While the described technique for 20 patients was safe, it required a traditional open incision with 5-10 days of hospital recovery. In the patients with longest follow-up (at that time of the article, patients were 5-16 months after surgery) average Excess Body Weight Loss was 36%.
Weight reduction. Gastric Plication for Morbid Obesity.
Tretbar LL, Taylor TL, Sifers EC.
J Kans Med Soc. 1976 Nov;77(11):488-90
Wilkinson (1980) introduced animal and human models for gastric reservoir reduction in 1980 when he expanded on the idea by reinforcing the gastric folding with a type of plastic mesh or screen. Weight loss was deemed satisfactory, but there was significant incidence of complications specifically related to the use of the mesh.
Reduction of Gastric Reservoir Capacity.
Am J Clin Nutr. 1980 Feb;33(2 Suppl):515-7
Wilkinson (1981) reported his open (large, traditional incision) surgical experience in 100 consecutive patients. By one year, 90% of patients lost 35% or more of their total body weight. No metabolic or pregnancy complications were reported. The use of the plastic mesh contributed to several complications.
Gastric (Reservoir) Reduction for Morbid Obesity.
Wilkinson LH, Peloso OA.
Arch Surg. 1981 May;116(5):602-5
Curley and Weaver, with Wilkinson (1987) presented their experience of adding a different kind of screen, a silicone mesh, to their technique. The authors felt that the effect of folding the stomach around the outside of itself (the opposite direction used in WRAP) in conjunction with the use of the plastic screen contributed to the creation of a hole in the stomach.
Late Complications After Gastric Reservoir Reduction with External Wrap.
Curley SA, Weaver W, Wilkinson LH, Demarest GB.
Arch Surg. 1987 Jul;122(7):781-3
Hoekstra (1993) reported a study comparing 52 gastric bypass patients to 53 patients with outward-folding of the top of the stomach, then wrapped in a Teflon screen. Complications appeared to be related to the over-restriction of the mesh; despite this finding, the weight loss, weight maintenance, and patient satisfaction were reportedly higher with this folding technique when compared to bypass.
A Comparison of the Gastric Bypass and the Gastric Wrap for Morbid Obesity.
Hoekstra SM, Lucas CE, Ledgerwood AM, Lucas WF.
Surg Gynecol Obstet. 1993 Mar;176(3):262-6
Neumayer (2004) described the “significant” weight loss ascribed to an anti-heartburn surgery known as Nissen fundoplication, without the use of mesh. The weight loss appeared stable and sustained after 12 months. This review supported the idea of induced and sustained weight loss without the cutting and rearranging the stomach or intestines (as in the gastric bypass) or plastic type devices.
Significant Weight Loss After Laparoscopic Nissen Fundoplication.
Neumayer C, Ciovica R, Gadenstatter M et al.
Surg Endosc 2005; 19: 15-20
Fusco, et al (2006) compared in-folding of the outer long curve of the stomach to control subjects in rat studies, and found statistically significant weight loss. The authors suggest that such a technique was an “opportunity to diminish gastric capacity and produce early satiety without partitioning or prosthesis related morbidity.”
Evaluation of Gastric Greater Curvature Invagination for Weight Loss in Rats.
Fusco PE, Poggetti RS, Younes RN, Fontes B, Birolini D.
Obes Surg. 2006 Feb;16(2):172-7
Fusco, et al (2007) followed up the 2006 study by comparing in-folding the front wall of the stomach to in-folding the left, long side (“greater curve“). Subjects lost more weight with inversion of the greater curve, but at the end of study there was no overall statistical difference in weight loss or gastric volume between the two techniques.
Comparison of Anterior Gastric Wall and Greater Gastric Curvature Invaginations for Weight Loss in Rats.
Fusco PE, Poggetti RS, Younes RN, Fontes B, Birolini
D. Obes Surg. 2007 Oct;17(10):1340-5
Talebpour and Amoli (2007) probably presented the first modern clinical report of gastric volume reduction through the use of laparoscopic in-folding of the stomach wall as a stand-alone option in weight loss surgery. “Total gastric vertical plication” was used in 100 patients with relatively “minimal” complications. Average reported weight loss after 1 year was 61%, after 2 years was 60%, and after 3 years was 57% (in 56, 50, and 11 cases, respectively).
Laparoscopic Total Gastric Vertical Plication In Morbid Obesity.
Talebpour M, Amoli BS.
J Laparoendosc Adv Surg Tech A. 2007 Dec;17(6):793-8.
Skrekas (2009) presented the results of his investigation of a “new” laparoscopic weight loss technique, the “Total Gastric Vertical Plication” used in the treatment of obesity in 52 patients. The report included patients who were followed up from 6 to 16 months after surgery. The ‘average’ weight loss was about 65 pounds, or about 62% of excess body weight, with an ‘average’ drop in BMI of 31 points. In all, 80% of patients lost more than half their excessive body weight. Skrekas concluded that this in-folding of the stomach as a weight loss technique was “a safe and effective restrictive bariatric operation. In comparison to the published results from gastric banding studies, weight loss after LΤGVP comes sooner and is more intense, at the same time interval.”
Weight Loss After Laparoscopic Total Gastric Vertical Plication. Early Results
George Skrekas MD
Euro-Mediterranean & Middle East Laparoscopic Meeting.
Ramos, et. al. (2010) examined “greater curve [left side of stomach] plication” in 42 patients, and found a mean loss of excess body weight of 62% in patients completing eighteen months of follow-up in nine patients. No patient in this report had gained weight.
Laparoscopic Greater Curvature Plication: Initial Results of an Alternative Restrictive Bariatric Procedure.
Ramos A, Galvao Neto M, Galvao M, Evangelista LF, Campos JM, Ferraz A.
Obes Surg. 2010 Jul;20(7):913-8./p>
Narwaria, et al. (2010) reported their experience with volume reduction by in-folding (imbrication) to treat obesity in seven patients. These patients lost an ‘average’ of approximately 49% of their excess body weight after one year.
Gastric Imbrications for Morbid Obesity: Early Results of New Technique
Narwaria M, Tank T, Cottom D
ASMBS Poster 2010
Brethauer, et. al. (2011) presented data on gastric plication as an alternative to surgeries that require stapling or banding. Reduction in the amount of food the stomach can hold was employed by two techniques: folding in the front part of the stomach in nine patients was compared to folding in the left side (greater curve) of the stomach in six patients, who were noted to lose significantly more excessive body weight by one-year after surgery (‘averaging’ 53% compared to 23%). The authors concluded that “early weight loss results have been encouraging” and that this technique “warrants additional investigation as a primary bariatric procedure.”
Laparoscopic Gastric Plication for the Treatment of Severe Obesity
Stacy Brethauer, MD; Jason L. Harris, PhD; Matthew Kroh, MD, et al
Surgery for Obesity and Related Diseases Vol 7;1:15-22 (January 2011)
ASMBS Policy Statement on Gastric Plication
March 8, 2011
The following statement is issued by the American Society for Metabolic and Bariatric Surgery in response to numerous inquires made to the Society by patients, physicians, society members, hospitals, and others regarding laparoscopic gastric plication as a treatment for obesity. The recommendation is based on current clinical knowledge, expert opinion, and published peer-reviewed scientific evidence available at this time. The statement is not intended as, and should not be construed as, stating or establishing a local, regional, or national standard of care. Laparoscopic gastric plication, also known as laparoscopic greater curvature plication, has recently emerged as a new bariatric procedure. The rationale for this procedure addresses issues that may limit the acceptance of other bariatric procedures. Specifically, the gastric plication does not involve gastric resection, intestinal bypass, or placement of a foreign body, and this could potentially provide a lower risk alternative that will appeal to patients and referring physicians. The operation involves mobilizing
the greater curvature of the stomach similar to the dissection for a sleeve gastrectomy and infolding or imbricating the stomach to achieve gastric restriction. There are increasing numbers of gastric plication procedures being performed worldwide and this operation is being marketed as a new option for surgical weight loss by some practices. The quantity (4 studies, <300 patients) and quality (prospective or retrospective case series) of the data available at this time is insufficient to draw any definitive conclusions regarding the safety and efficacy of this procedure. The Society will continue to monitor the data on this procedure as it emerges and will issue a formal evidence-based position statement at the appropriate time. We currently support the following recommendations regarding gastric plication for the treatment of obesity:
1. Gastric plication procedures should be considered investigational at this time. This procedure should be performed under a study protocol with third party oversight (local or regional ethics committee, Institutional Review Board, Data Monitoring and Safety Board, or equivalent authority) to ensure continuous evaluation of patient safety and to review adverse events and outcomes. [See Below] 2. Reporting of short- and long-term safety and efficacy outcomes in the medical literature is strongly encouraged. Data for these procedures should also be reported to a program’s center of excellence database. 3. Any marketing or advertisement for this procedure should include a statement to the effect that this is an investigational procedure. These recommendations are not intended to impede innovation within our field. Rather, the Society encourages and supports the development of new and innovative procedures that can benefit our patient population. It is imperative, though, that these procedures be conducted responsibly under appropriate supervision and after appropriate training.
WaldrepWRAP follows guidelines which were granted an Institutional Review Board Certificate of Approval (August 2010), prior to the recommendation by ASMBS.
Size, volume and weight of the stomach in patients with morbid obesity compared to controls.
Csendes A, Burgos AM.
Obes Surg. 2005 Sep;15(8):1133-6
Function of the proximal stomach after partial versus complete laparoscopic fundoplication.
Lindeboom MY, Vu MK, Ringers J, van Rijn PJ, Neijenhuis P, Masclee AA (2003)
Am J Gastroenterol 98: 284-290
Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial.
Obrien PE, Dixon JB, Laurie C, et al
Ann Intern Med.2006:144(9):625-633
Laparoscopic Roux-en-Y Gastric Bypass for BMI < 35 kg/m(2): a tailored approach
Cohen R, Pinheiro JS, Correa JL, Schiavon CA
Surg Obes Relat Dis. 2006:2 (3);401-404
Laparoscopic adjustable gastric banding for patients with body mass index of <35 kg/m2.
Parikh M, Duncombe J, Fielding GA
Surg Obes Relat Dis.2006:2;518-522