Influence of the Actual Diameter of the Gastric Pouch Outlet in Weight Loss After Silicon Ring Roux-en-Y Gastric Bypass: An Endoscopic Study

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1 OBES SURG (2010) 20: DOI /s CLINICAL RESEARCH Influence of the Actual Diameter of the Gastric Pouch Outlet in Weight Loss After Silicon Ring Roux-en-Y Gastric Bypass: An Endoscopic Study Jorge Mali Jr. & Fernando Augusto Mardiros Herbella Fernandes & Antonio Carlos Valezi & Tiemi Matsuo & Mariano de Almeida Menezes Published online: 16 May 2010 # Springer Science+Business Media, LLC 2010 Abstract Some sort of restriction of the pouch emptying is supported by many surgeons to allow a sustained weight loss through the use of a ring placed circumferentially around the gastric pouch. Most previous studies focused on the length of the ring, not the actual diameter of the gastric pouch outlet. This study aims to evaluate the association between the actual diameter of the gastric pouch outlet and the weight loss in obese patients submitted to silicon ring Roux-en-Y gastric bypass. We studied prospectively 257 patients that underwent silicon ring (65 mm) Roux-en-Y gastric bypass between July 2005 and August Upper digestive endoscopy was performed to measure the diameter of the gastric pouch outlet at 1 and 2 years with the aid of calibrated balloons. The diameter of the gastric pouch outlet ranged from 9 to 14 mm (mean=11 mm). Excess weight loss ranged from 37% to 127% (mean=69%) during the first year and 29% to 110% (mean=69%) during the second year. A negative correlation between the diameter of the gastric pouch outlet and excess weight loss at first year (r= 0.792, p<0.001) and at the second year of follow-up (r= 0.921, p<0.001) was found. The actual diameter of the gastric J. Mali Jr. : A. C. Valezi (*) : M. de Almeida Menezes Department of Surgery, State University of Londrina, 1302 Santos St, , Londrina, Parana, Brazil valezi@sercomtel.com.br J. Mali Jr. : F. A. M. H. Fernandes Department of Surgery, Federal University of Sao Paulo, Sao Paulo, Brazil T. Matsuo Division of Statistics, State University of Londrina, Londrina, Brazil pouch outlet was associated with weight loss after silicon ring Roux-en-Y gastric bypass during the 2-year follow-up. Keywords Gastric bypass. Endoscopy. Weight loss. Gastric pouch outlet Introduction Roux-en-Y gastric bypass (RYGB) is probably the most performed operation for morbid obesity. To improve the results of weight loss, some modifications of the surgical technique have been suggested, such as different limb lengths or different pouch configurations and sizes. In addition, some surgeons prevent long-term weight loss regain by restricting the size of the outlet to the gastric pouch. Possible strategies designed to address weight gain following RYGB include a calibrated anastomosis [1] or the insertion of a ring made from silicon or other material [2, 3]. Some sort of restriction of the pouch emptying is supported by many surgeons to allow a sustained weight loss, although the ideal procedure is still elusive. Some groups advocate the use of a silicon ring placed circumferentially around the pouch because it determines fixed diameter of gastric outlet and does not suffer late dilation as occurs with anastomosis [2, 3]. Most studies with this technique focused on the length of the ring, not the actual diameter of the gastric pouch outlet [4 7]. We previously noticed that gastric pouch outlet may vary even though identical sizes of rings are applied [8]. This study aims to evaluate the association between the diameters of the gastric pouch outlet and the weight loss in obese patients submitted to RYGB.

2 1232 OBES SURG (2010) 20: Methods Population Two hundred and ninety-one morbidly obese patients (body mass index (BMI) between 35 and 39.9 kg/m 2 with co-morbidities or BMI 40 kg/m 2 ) submitted to silicon ring RYGB between July 2005 and August 2007 were prospectively studied. Patients in which the diameter of the gastric pouch outlet varied during sequential measurements (n=7) or those that did not complete the 2-year follow-up (n=20) were excluded from the study. Two hundred and fifty-seven patients (183 (71%) females, mean age 41±11 years (18 69)) were included in the final analysis. The mean preoperative body mass index (BMI) was 45± 7 kg/m 2 (35 82 kg/m 2 ). Surgical Technique All patients underwent RYGB by the same surgical team in the Londrina State University Hospital, Brazil [9]. The patient underwent median laparotomy, and, initially, a Roux-en-Y jejunal loop of length 100 cm was created, with jejuno-jejunal anastomosis 50 cm distal to Treitz` ligament. Following this, a gastric pouch was constructed along lesser gastric curvature, with a volume of approximately 50 ml, using linear stapler. A 6.5-cm silicon ring was placed around the distal part of the gastric pouch at about 1.0 cm above its distal margin. It was then closed using 0 polypropylene that was passed through the lumen of the ring. In the next step, the Roux-en-Y jejunal loop was passed by the transmesocolic and retrogastric route. Following this, the silicon ring was fixed between the interposed jejunal loop and the gastric pouch by unresorbable sutures (cotton 2/0). End-to-side anastomosis (4-cm diameter) was then performed by manual suture in two layers with Vicryl 3.0. The follow-up was made through monthly clinical appointments on the first year and every 3 months on the second year. The evaluation was done by the same multidisciplinary team. Clinical Evaluation Postoperative weight loss evaluation was based on the percentage of excess weight loss (EWL). Metropolitan Life Insurance Company ideal weight and height tables (USA, 1983) were used as reference. The inability to lose more than 50% of exceeding weight in a 2-year postoperative period was considered a therapeutic failure. Statistics Data was collected using Microsoft Excel Variables are presented as mean ± standard deviation (range). Statistical Package for the Social Sciences (SPSS 15.0) and Statistical Analysis System (SAS 10.2) were used for statistical analysis. Pearson and Spearman correlation test, analysis of variance, and Bonferroni adjustments were used as indicated. Ethics This study was approved by the medical research ethics committee of the Londrina State University Hospital and Federal University of São Paulo. Results Gastric Outlet Diameter The diameter of gastric pouch outlet was 11.2±1.5 (9 14) mm. Patients with variable outlet measurements were excluded as previously mentioned. The distribution of the diameters is graphically depicted in Fig. 1. Upper Digestive Endoscopy Upper digestive endoscopy was performed by the same endoscopist to measure the diameter of the gastric pouch outlet with the aid of calibrated balloon catheters (CRE Wireguided Balloon Dilator 8 10, 10 12, Boston Scientific). This procedure was carried out 1 year and 2 years after operation. The outlet of the gastric pouch was defined as the area inside the pouch where the ring was fixed. Fig. 1 Distribution of patients according to the diameter of the gastric pouch outlet

3 OBES SURG (2010) 20: Weight Loss EWL was 68%±12 (37 127) on the first year and 69% (29 110) kg/m 2 on the second year. Therapeutic failure was noticed in 11 (4.5%) patients: one with an 11-mm gastric outlet diameter, three with 13 mm, and seven with 14 mm. Correlation Between Gastric Outlet Diameter and Weight Loss A negative correlation between the diameter of the gastric pouch outlet and excess weight loss at first year (r= 0.792, p<0.001) and at the second year of follow-up (r= 0.921, p<0.001) was found (Figs. 2 and 3). EWL differed according to gastric outlet diameter in the first and the second year of follow-up (Table 1). Endoscopy The endoscopy was performed at the first and second year of follow-up to evaluate the diameter of gastric pouch outlet. There was no worry with the anastomosis size which was large (4-cm diameter). Only seven patients (2.6%) showed increased gastric outlet diameter caused by ring opening between the first and the second year of follow-up. There was no evidence of any other band-related complication, such as peptic ulcer, slippage, or erosion. Discussion RYGB is considered by some as the gold-standard operation for morbid obesity, and it remains the operation of choice for weight loss and reduction of co-morbidities. Fobi, Capella, and others have indicated the use of a silicon ring to prevent the enlargement of the gastric pouch outlet and to slow the time of gastric emptying [10 14]. White et Fig. 3 Correlation between excess weight loss (EWL) and gastric pouch outlet diameter (DGPO) at second year of follow-up al. showed that weight loss maintenance after 14 years of follow-up is related to the permanence of the silicon ring and the weight recovery is associated with the removal of the ring [14]. However, there is no wide acceptance for ring placement; in fact, a minority of surgeons uses the technique. Some recent evidence is emerging to indicate that weight loss is better maintained in those patients in whom a ring has been used [15, 16]. The necessity of restricting gastric pouch emptying is accepted among bariatric surgeons. It can be done in two different ways: calibrated anastomosis using a stapler or a bougie to perform the manual anastomosis [17, 18]. It can also be done using a prosthetic material such as polypropylene mesh or silicon ring [19]. The anastomosis can dilate over time, causing unexpected weight loss or weight regain, as reported by MacArthur et al. in 8.4% of the patients submitted to gastric bypass [20]. Some obese patients (10 20%) may have therapeutic failure after the 3-year follow-up [21]. It can be due to increase volume intake from pouch dilation and enlargement of the gastrojejunal anastomosis, although the evidences are controversial [10, 22]. Fobi et al. defend the Table 1 Comparison among different gastric pouch outlet diameter using analysis of variance and Bonferroni adjustment Time DGPO Number Mean SD Median Range Range p* Fig. 2 Correlation between excess weight loss (EWL) and gastric pouch outlet diameter (DGPO) at first year of follow-up 1st year 2nd year <0.001* <0.001*

4 1234 OBES SURG (2010) 20: use of silicon rings because they overcome spontaneous dilation which could occur with a sutured stoma [23]. Linner and Drew [24] applied for the first time a silicon ring around the gastrojejunostomy. Latter Fobi et al. [25] modified the technique by applying the ring proximal to the anastomosis. The band is used in order to prevent dilation and limit outflow of the gastric pouch at the level of the prosthesis not at the anastomosis level. Based on this premise, we focused in the measurement of the inner diameter of the gastric pouch outlet at the level of the silicon ring, not the gastrojejunostomy. The large anastomosis was deliberately created (4 cm of diameter) because we think that the limiting factor gastric pouch emptying was exercised by the silicon ring, so the diameter of the anastomosis does not bother us. The main argument against the use of a ring is the historical experience of erosion and frequent regurgitation when a ring/band circumference of cm was most commonly used [26 28]. The initial recommendation by Fobi for a ring size of 5.5-cm circumference in gastric bypass led to a ring removal rate approaching 20% due to severe eating restriction and regurgitation. Crampton et al. recommended increasing the ring size to 6.0 or 6.5 cm. They reported, with rings of this size, lesser ring erosion and regurgitation [4, 5]. The recent experience of Stubbs et al. suggests that a 6.5-cm circumference ring achieves an optimum balance between quality of eating, weight loss, and likelihood of the need for ring removal [26]. Band-related complications may affect the diameter of the gastric pouch outlet such as disruption (opening) of the ring noticed in seven patients. This fact was radiologically confirmed. Other band-related complications associated to changes in the diameter of the pouch outlet (slippage, erosion, ulceration) were not seen in our series. The suture fixation of the ring to the pouch, as described here, could contribute to reducing the incidence of the slippage. Even though the size of the ring may be standardize, it is certain that the inner diameter of the gastric pouch outlet depends on the amount and thickness of the surrounding tissues, in addition to the strength applied to the knot that holds the ring [29]. Valezi et al. showed a relevant difference in the inner diameter of the gastric pouch outlet in obese patients submitted to RYGB by the same surgical team and with the same ring size [8]. Our study supported their results and showed that weight loss is influenced not by the size of the ring but by the diameter of gastric pouch outlet. Based on our results, we believe that obese patients submitted to RYGB who failed in the therapy should be submitted to upper digestive endoscopy to evaluate the actual inner diameter of the gastric pouch outlet. If an enlarged outlet is observed, this patient should be submitted to revisional surgery. In conclusion, our results show that the actual diameter of the gastric pouch outlet was associated with weight loss after silicon ring RYGB. Conflicts of interest statement References There is no conflict of interest. 1. Talieh J, Kirgan D, Fisher BL. Gastric bypass for morbid obesity: a standard surgical technique by consensus. Obes Surg. 1997;7 (3): Fobi MAL, Lee H. The surgical technique of the Fobi-pouch operation for obesity (The transected Silastic vertical gastric bypass). Obes Surg. 1998;8(3): Capella RF, Capella JF, Mandac H, et al. Vertical banded gastroplasty-gastric bypass: preliminary report. Obes Surg. 1991;1: Crampton NA, Izvornikov V, Stubbs RS. 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