Surgery for Obesity and Related Diseases 8 (2012) 41– 47
Original article
Novel bariatric technology: laparoscopic adjustable gastric banded plication: technique and preliminary results Chih-Kun Huang, M.D.a,b,c,d,e,*, Chi-Hsien Lo, M.D.a, Asim Shabbir, M.D.a, Chi-Ming Tai, M.D.a,d a Bariatric and Metabolic International Surgery Center, E-Da Hospital, Kaohsiung, Taiwan International Minimally Invasive Surgery Training Center, E-Da Hospital, Kaohsiung, Taiwan c Department of General Surgery, E-Da Hospital, Kaohsiung, Taiwan d Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan e Department of Chemical Engineering, Institute of Biotechnology and Chemical Engineering, I-Shou University, Kaohsiung, Taiwan Received October 8, 2010; accepted March 9, 2011 b
Abstract
Background: The laparoscopic adjustable gastric band has been widely accepted as 1 of the safest bariatric procedures to treat morbid obesity. However, because of variations in the results and the complications that tend to arise from port adjustment, alternative procedures are needed. We have demonstrated, in a university hospital setting, the safety and feasibility of a novel technique, laparoscopic adjustable gastric banded plication, designed to improve the weight loss effect and decrease gastric band adjustment frequency. Methods: We enrolled 26 patients from May 2009 to August 2010. Laparoscopic adjustable gastric banded plication was performed using 5-port surgery. We placed Swedish bands using the pars flaccida method, divided the greater omentum, and performed gastric plication below the band to 3 cm from the pylorus using a single-row continuous suture. The data were collected and analyzed pre- and postoperatively. Results: The mean operative time was 87.3 minutes without any intraoperative complications. The average postoperative hospitalization was 1.33 days. The mean excess weight loss at 1, 3, 6, 9, and 12 months after surgery was 21.9%, 31.9%, 41.3%, 55.2%, and 59.5%, respectively. The mean follow-up time was 8.1 months (range 2–15), and the gastric band adjustment rate was 1.1 times per patient during this period. Two complications developed: gastrogastric intussusception and tube kinking at the subcutaneous layer. Both cases were corrected by reoperation. No mortality was observed. Conclusion: Laparoscopic adjustable gastric banded plication provides both restrictive and reductive effects and is reversible. The technique is safe, feasible, and reproducible and can be used as an alternative bariatric procedure. Comparative studies and long-term follow-up are necessary to confirm our findings. (Surg Obes Relat Dis 2012;8:41– 47.) Crown Copyright © 2012 Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Bariatric surgery; Gastric banding; Gastric plication; Adjustable gastric banded plication; Laparoscopic surgery
It has been established that the use of nonoperative treatment of morbidly obese patients, including diet, exercise, and behavioral modification, rarely results in sustained *Correspondence: Chih-Kun Huang, M.D., Bariatric and Metabolic International Surgery Center, E-Da Hospital, 1, E-Da Road, Kaohsiung City 824 Taiwan. E-mail:
[email protected].
weight loss [1]. Therefore, bariatric procedures are commonly used to ensure long-term efficacy [2,3]. The most effective bariatric procedure, Roux-en-Y gastric bypass and biliopancreatic diversion, not only transect the stomach, but also exclude a portion of the small bowel [4 –7]. Although these procedures provide excellent and long-standing postoperative weight loss, they put patients at a high risk of developing nutritional deficiencies and some metabolic
1550-7289/12/$ – see front matter Crown Copyright © 2012 Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2011.03.005
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complications [8,9]. Recently, sleeve gastrectomy, an emerging restrictive weight loss procedure, has become 1 of the most popular bariatric options in the world. Nocca et al. [10] published a sleeve gastrectomy study in which the patients had an excess weight loss (EWL) of 48.97% at 6 months, 59.45% at 12 months (120 patients), 62.02% at 18 months, and 61.52% at 24 months (98 patients). Although sleeve gastrectomy often leads to considerable weight loss, this irreversible procedure has been associated with surgical complications, including bleeding, leaks, and strictures. Furthermore, postoperative decrease of lower esophageal sphincter pressure was observed and gastroesophageal reflux occurrence was in reported in 6.5% (range 0 – 83%), [11,12]. The use of the laparoscopic adjustable gastric band (LAGB) is thought to be 1 of the safest bariatric procedures for the management of morbid obesity [13–15]. The main effect of weight loss with LAGB arises from a restrictive and adjustable mechanism. Individuals who have received an LAGB must exhibit strict compliance and continuous modification of their diet habits. Despite its drawbacks, the reversibility of the LAGB procedure makes it a valuable option for those who prefer to avoid cutting procedures or gastrointestinal tract resection. More recently, Talebpour and Amoli [16] introduced a new restrictive procedure with a good weight loss effect called “laparoscopic total gastric vertical plication.” About 100 morbidly obese patients underwent the procedure and subsequently experienced an EWL of 54% at 6 months postoperatively, 61% at 12 months, 60% at 24 months, and 57% at 36 months [16]. Ramos et al. [17] also reported the feasibility of this procedure in 42 morbidly obese patients. However, the possibility of postoperative weight regain owing to plicated gastric tube dilation remains debatable. In the present study, we report a novel combination technique involving both gastric banding and plication, which we have termed “laparoscopic adjustable gastric banded plication” (LAGBP) to increase weight loss and compliance and prevent weight regain.
week and 1, 3, 6, 9, 12, 18, and 24 months postoperatively. Furthermore, the band was filled until the weight loss had reached a plateau during the follow-up period. A radiologic Gastrografin study was performed in the third month after surgery. The patients were placed in the supine position with their arms extended laterally. The surgeon stood to the right of the patient and the assistant to the left. Swedish band placement was performed using the standard pars flaccida method [18]. The band was wrapped around the proximal gastric pouch, and 2 anterior gastrogastric sutures were placed to prevent slippage. Dissection of the greater omentum was then started at the greater curvature of the stomach, 3 cm from the pylorus, and continued to the angle of His. A harmonic scalpel (Ethicon Endo-Surgery, Cincinnati, Ohio) was used to release the greater curvature. A 36F orogastric calibration tube was advanced to the distal antrum to act as a size reference stent. We performed the imbrication with 5– 6 interrupted nonabsorbable sutures (2-0 Ethibond Excel Ethicon, St-Stevens-Woluwe, Belgium) to fix the shape of the gastric plication (Fig. 1). Subsequently, continuous seromuscular suturing with 2-0 Ethibond Excel suture was performed from the first interrupted suture at the fundus below the band to the distal antrum to create single-layer plication along the greater curvature (Fig. 2). After we finished the procedure, the calibration tube was removed, and the catheter from the band was exteriorized through the umbilical wound and attached to the subcutaneous access port. All the trocars were removed, and the subcutaneous access port was secured to the rectus fascia with 3-0 Prolene sutures, and the skin was closed. A proton pump inhibitor (pantoprazole) and a gastrokinetic agent (metoclopramide) were intravenously administered to the patients for 1 day postoperatively. A liquid diet was prescribed, and the patients were discharged promptly if they did not exhibit
Methods The present study was registered with Current Controlled Trials (ISRCTN17213539) and was conducted with the approval of the E-DA Hospital institutional review board. From May 2009 to August 2010, we enrolled 26 morbidly obese patients to undergo LAGBP. All patients provided written informed consent. We also collected preoperative patient data, including the demographics, age, gender, height, weight, body mass index, and co-morbidities. Data regarding the intra- and postoperative complications, EWL, and postoperative hospital stay were also recorded and analyzed. All patients were regularly followed up with strict surveillance for complications, weight loss, and gastrointestinal symptoms. The follow-up schedule was conducted at 1
Fig. 1. Use of interrupted sutures to plicate greater curvature and fix shape of gastric imbrication.
LAGB Plication / Surgery for Obesity and Related Diseases 8 (2012) 41– 47
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Table 1 Patient demographics
Fig. 2. Continuous seromuscular suturing with 2-0 Ethibond from fundus of stomach below band to distal antrum to create single-layer plication along greater curvature.
vomiting or specific discomfort. During follow-up, band adjustments were made only when a patient’s weight loss had reached a plateau. The Gastrografin study conducted in the third month postoperatively showed a “sleeve-like” appearance of the plicated stomach (Fig. 3). Results We analyzed a total of 26 surgical patients (16 women and 10 men), with a mean age of 30 ⫾ 8.9 years (range 18 –52) and a mean body mass index of 39.4 ⫾ 4.0 kg/m2 (range 35⫺50.7). The obesity-related co-morbidities in this
Variable
Value
Patients (n) Gender (n) Male Female Age (yr) Mean ⫾ SD Range Preoperative BMI (kg/m2) Mean ⫾ SD Range Co-morbidities (n) Steatohepatitis Hyperlipidemia Hyperuricemia Hypertension Type 2 diabetes mellitus Gallbladder stone
26 10 16 30 ⫾ 8.9 18–52 39.4 ⫾ 4.0 35–50.7 15 14 7 4 3 1
SD ⫽ standard deviation; BMI ⫽ body mass index.
patient group included nonalcoholic steatohepatitis, hyperlipidemia, hyperuricemia, hypertension, diabetes mellitus, and gallstones (Table 1). The mean operation time for band placement and plication was 33.0 ⫾ 13.3 minutes and 59.1 ⫾ 22.2 minutes, respectively. The mean total operation time was 87.3 ⫾ 22.6 minutes. No intraoperative complications developed. The mean postoperative hospitalization stay was 1.1 ⫾ 1.2 days. However, 1 patient returned to the emergency room 2 days after discharge because of prolonged vomiting, which had subsided 1 week later. Also, 2 complications occurred: 1 case each of gastrogastric intussusception and tube kinking at the subcutaneous layer. Both cases required surgical correction (Table 2). The mean EWL at 1, 3, 6, 9, and 12 months was 21.9% ⫾ 7.5% (26 patients), 31.9% ⫾ 10.5% (24 patients), 41.3% ⫾ 10.8% (18 patients), 55.2% ⫾ 14.0% (10 patients), and 59.5% ⫾ 17.9% (5 patients), respectively (Fig. 4). No mortality was observed.
Table 2 Operative results
Fig. 3. Gastrografin study performed 3 months after surgery showing “sleeve-like” appearance of plicated stomach.
Variable
Value
Patients (n) Operation time (min) Mean ⫾ SD Range Postoperative hospitalization (d) Mean ⫾ SD Range Intraoperative complication (n) Postoperative complications (n) Gastrogastric intussusception Gastric band tube kinking
26
SD ⫽ standard deviation.
87.3 ⫾ 22.6 58–140 1.1 ⫾ 1.2 1–3 0 2 1 1
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C.-K. Huang et al. / Surgery for Obesity and Related Diseases 8 (2012) 41– 47
Fig. 4. Percentage of EWL after LAGBP.
Discussion The use of the adjustable gastric band is a standard approach and an excellent option for treating morbid obese patients. However, patients’ failure to attend follow-up appointments and the persistent consumption of calorie-dense liquid foods after this procedure often lead to poor weight loss results [19]. The weight loss variation after gastric banding has been wide, and a prospective randomized study showed that treatment failure occurred in 16.7% of patients who underwent gastric banding but in 0% of patients who underwent gastric bypass [20]. Suter et al. [21] reported that the failure rate of gastric banding increased from 13.2% at 18 months to 23.8% at 3 years, 31.5% at 5 years, and 36.9% at 7 years in a group of 317 patients. Furthermore, only about 60% of these patients maintained acceptable longterm EWL. In some reports, 33.7% of the patients underwent removal of the gastric bands and declined additional bariatric operations [22]. We previously reported our first case in which weight loss was augmented by gastric plication after gastric band placement, a combination that demonstrated the effectiveness of this procedure [23]. Accordingly, we offer this procedure as a new tool in surgeons’ armamentarium that might serve as a salvage procedure for patients who experience band failure. A pertinent subject to be considered when discussing LAGB surgery is the frequent postoperative clinical follow-up visits required for gastric band adjustment, which introduces the potential for access port complications. A previously performed long-term follow-up study of 591 LAGB patients revealed that the complication rate was about 23.3% and included band failure, slippage, erosion, infection, high band position, and other causes. Approxi-
mately 7% of the complications were related to port adjustment [24,25]. In our series, only 1 follow-up adjustment was necessary per patient on average during a mean period of 8 months. This decreased band adjustment frequency could also decrease the potential for port complications. To date, we have not encountered band complications from the patient group in the present study, except for 1 case of tube kinking at the subcutaneous level that was not related to plication or adjustment. Furthermore, the weight loss effect of the LAGBP technique was similar to the results of sleeve gastrectomy and was probably attributable to the plication effect. Future weight loss is expected to be augmented by band adjustments. Filling the band from the beginning might prevent the dilation of the plicated stomach. Because we expected the LAGBP technique to lower the adjustment frequency and decrease the risk of infection around the injection port, we did not fill the band after the weight loss had reached a plateau. After LAGBP, the most frequent patient complaint was vomiting in the early postoperative period, but this had mostly resolved within 48 hours. We assume that this symptom resulted from the edema caused by the gastric plication. It is important to note that a nasogastric tube was not placed after surgery, because LAGBP patients can be treated with generous parenteral hydration and administration of a proton pump inhibitor and gastrokinetic agents to relieve symptoms. The LAGBP procedure can be criticized for its reversibility, a topic that was verified by 1 of the observed postoperative complications, gastrogastric intussusception at the 10 months. The patient who experienced this complication had achieved 92% EWL at that point but suddenly devel-
LAGB Plication / Surgery for Obesity and Related Diseases 8 (2012) 41– 47
oped severe vomiting from gastric obstruction symptoms and accordingly underwent laparoscopic exploration. It was determined that the plicated gastric tube had intussuscepted into the dilated gastric fundus because of an incompletely plicated fundus. We released the plication sutures and verified total plication reversion. The gastric band was left in place to prevent future weight regain. This patient responded well after surgery, and the weight loss was well maintained by band adjustment. Full plication of the stomach or the use of a double row of plication sutures might prevent this complication. According to our short-term follow-up after LAGBP, we consider its weight loss effect to be satisfactory and expect that this procedure would be more readily accepted by patients who hesitate to undergo irreversible procedures. This procedure requires considerably more time than regular LAGB, but the patients subsequently enjoy quicker weight loss owing to the plication. Furthermore, the reversibility of this procedure, minimal vitamin requirement, and accessibility of the whole stomach make the procedure valuable. This new bariatric surgery, which includes a combination of restrictive, reductive, and reversible characteristics, should serve as an arm of bariatric support. It should also be considered as a salvage procedure for patients who have experienced gastric band failure. Conclusion LAGBP is a safe, technically feasible, reproducible, and potentially reversible procedure that results in acceptable weight loss during the early postoperative period. However, comparative studies and long-term follow-up are necessary to confirm our findings. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Fisher BL, Schauer P. Medical and surgical options in the treatment of severe obesity. Am J Surg 2002;12:569 –72. [2] Monteforte MJ, Turkelsoft CM. Bariatric surgery for morbid obesity. Obes Surg 2000;10:391– 401. [3] Pories WJ, Swanson MD, MacDonald KG, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995;222:339 –50. [4] Schauer P, Ikramuddin S, Gourash W, Ramanathan R, Luketich J. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg 2000;233:515–29.
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