JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES Volume 24, Number 10, 2014 ª Mary Ann Liebert, Inc. DOI: 10.1089/lap.2014.0104
Full Report
Laparoscopic Sleeve Gastrectomy with Endoscopic Versus Bougie Calibration: Results of a Prospective Study Jaime Ruiz-Tovar, MD, PhD,1 Javier Sola-Vera, MD, PhD,2 Elena Miranda, MD,3 Jose´ Luis Mun˜oz, MD,3 Estefania Perez-Rabasco, MD,2 Antonio Arroyo, MD, PhD,1 and Rafael Calpena, MD, PhD,1 for the OBELCHE Group 4,*
Abstract
Introduction: The use of the endoscope for the calibration of the gastric sleeve, instead of the standard use of the bougie, is a safe procedure and gives the surgeon a higher sense of security. The aim of this study was to evaluate the effect of the use of endoscopic guidance on postoperative complications and mid-term results of the bariatric procedure. Patients and Methods: A prospective, nonrandomized study was performed at the General University Hospital of Elche (Alicante, Spain) between 2010 and 2013. The patients were divided into the bougie calibration group and the endoscopic calibration group. The decision of which method to use depended on the availability of an endoscopist at the time of the surgery. Results: Fifty patients were included in the study, 44 females (88%) and 6 males (12%), with a mean age of 43.3 years and a preoperative mean body mass index of 50.6 kg/m2. In the endoscopic calibration group, a bleeding point in the staple line was detected and sclerosed with adrenaline in 1 patient. In the bougie calibration group there were no cases of postoperative digestive bleeding. The intraoperative tightness check with blue dye and air insufflation through an orogastric tube in the bougie calibration group was negative in all the patients. In the endoscopic calibration group the check with blue dye was also negative in all cases, but the second test with air detected the exit of air bubbles in 1 case. There were no significant differences in the operation time between groups. A significant reduction in the major complications rate was observed in the endoscopic calibration group (odds ratio = 0.9; P = .034). Conclusions: Endoscopic calibration is associated with lower postoperative complications after laparoscopic sleeve gastrectomy.
that the use of the endoscope for the calibration of the gastric sleeve, instead of the standard use of the bougie, is a safe procedure and gives the surgeon a higher sense of security.5–7 The aim of this study was to evaluate the effect of the use of endoscopic guidance on postoperative complications and mid-term results of the bariatric procedure.
Introduction
L
aparoscopic sleeve gastrectomy (LSG) is becoming increasingly established as a stand-alone procedure for weight reduction. The restrictive and the humoral features of this procedure assure postoperative weight loss of up to 70%– 80% after 1 year.1,2 However, complications might also appear after this technique. The main sources of postoperative morbidity and mortality are a staple line leak and bleeding. To avoid both, several measures have been adopted, including the oversewing of the staple line or the use of buttressing material, but, despite these mesures, both complications continue being life-threatening conditions.3,4 Several authors have shown
Patients and Methods
A prospective, nonrandomized study was performed at the Obesity Unit of the General University Hospital of Elche (Alicante, Spain) between May 2010 and January 2013. The inclusion criterion was a body mass index (BMI) of > 40 kg/m2
Departments of 1Surgery, 2Gastroenterology, and 3Anaesthesiology, 4Obesity Unit, General University Hospital Elche, Alicante, Spain. *Members of the OBELCHE Group are Jose Maria Bonete, MD, Marı´a Diez, MD, Rosana Martı´nez, PhD, Ana Murcia, PhD, Maria Dolores Pico, MD, Jose Maria Rico, MD, Francisco Uceda, MD, Narcis Va´zquez, MD, Luis Fernando Vences, MD, and Lorea Zubiaga, MD.
1
2
or a BMI of > 35 kg/m2 with associated comorbidities. Exclusion criteria were the evidence of gastroesophageal reflux disease and the absence of preoperative weight loss with a 1200 Kcal diet (reflection of nonadherence to the diet). Calculated sample size was made on an expected complications rate of 5% in the bougie calibration group, based on epidemiology data at our institution, and on an expected complications rate of 1% in the endoscopic calibration group, corresponding to the best results reported in literature.1,3 With 80% power and a P value of .05, it was necessary to include 25 patients in each group. The patients were divided into the bougie calibration group and the endoscopic calibration group, according to the sleeve calibration method. The decision on the method used depended on the availability of an endoscopist at the time of the surgery. An endoscopist was available only on 50% of the days when a sleeve gastrectomy was performed. All the operations were performed by the same surgeon. Preoperative evaluation
A multidisciplinary team, including surgeons, endocrinologists, endoscopists, anesthesiologists, psychiatrists and psychologists, and specialized nurses, performed a combined medical, nutritional, and endocrinological work-up to evaluate potential surgical candidates. A weight loss of at least 5% of the patient’s overweight was considered an indispensable condition to be selected as a candidate for LSG. Patients with documented gastroesophageal reflux disease or patients not achieving the required weight loss (reflection of nonadherence to the diet) were excluded and selected to undergo a gastric bypass. Surgical technique
Three 12-mm ports were placed in the right and left upper abdomen and in the midline 15 cm below the xiphoid; two 5mm ports were placed in the left flank and in the subxiphoideal position. The short gastric vessels from the greater curvature were divided with a bipolar dissector (Ligasure; Covidien, Mansfield, MA), from the incisura angularis up to the gastroesophageal junction. For calibration of the sleeve, in the endoscopic calibration group, a colonoscope (Fuji EC-250 WL5; FUJI Photo Optical, Saitama, Japan) was used. The outer diameter of the scope is 12.8 mm, which corresponds to a 38-French bougie, and its working length is 169 cm. The colonoscope was inserted along the smaller curvature and advanced beyond the pylorus into the distal duodenum. During insertion of the colonoscope the least amount of air was insufflated. However, the stomach was mostly distended with air during insertion of the endoscope. To avoid this circumstance, the colonoscope was rectified and removed until the tip was located in the gastric antrum, while the pylorus was displayed on the screen. In this situation it was possible to suck all the air from the stomach to allow the gastrectomy. Insuflation with room air was used in all cases. The endoscopic procedures were performed by three gastroenterologists with extensive experience in upper endoscopy. In the bougie calibration group, a 40-French bougie was inserted through the mouth by the anesthesiologist and placed along the smaller curvature, advanced up to the pylorus. Finally, gastrectomy was performed along the calibration device (endoscope or bougie) using an endoscopic stapler (Echelon;
RUIZ-TOVAR ET AL.
Ethicon Endo-Surgery, a Johnson & Johnson Company, Norderstedt, Germany). A staple line inversion was performed with a continuous oversewing with polypropylene 3/0. In the bougie calibration group, once the oversewing suture was finished, an orogastric tube was inserted, and the sleeve was filled with methylene blue dye, while the oversewed staple line was observed for eventual disruptures. Later, a second tightness check with air, insufflated through the orogastric tube, was performed. In the endoscopic calibration group, once suturing had been completed, the endoscope was retracted in order to inspect the gastric staple line for any bleeding points or points suspicious for a gastric staple line disruption. Then the gastric sleeve was filled with diluted methylene blue dye through the working channel of the endoscope, in order to check for any leaks. Finally, a second tightness check with air was performed. The abdomen was filled with water and air was insufflated through the colonoscope in the gastric sleeve, trying to detect air bubbles with the laparoscope. Any bleeding or suspected leak points were immediately strengthened with figure-of-eight stitches, and both tightness tests were repeated. The resected stomach was removed through the 12-mm upper left port. A Jackson–Pratt drain was placed along the staple line. Upon discharge, the patients received a liquid diet for 2 weeks, followed by 2 weeks of soft, semiliquid diet. After this period, a 1200-Kcal diet was administered. Follow-up
The follow-up rate was 100%, and follow-up was for at least 12 months. All the patients were followed up by the surgeon and the endocrinologist at 1, 3, 6, and 12 months after surgery. Patients were seen regularly by a dietician to follow a calorie-reduced and protein-rich diet. Changes in body weight and comorbidities were monitored. Medical treatment, such as antidiabetic and antihypertensive drugs, was adjusted according the current needs of the patient. Postoperatively, daily proton pump inhibitor and multivitamin supplements were uniformly prescribed. At least 1 hour of daily moderate exercise/fitness (walking, swimming, etc.) was recommended to the patients. Variables
The clinical variables investigated were age, gender, comorbidities, BMI before and 12 months postoperatively, excess weight loss, complications, mortality, surgical time, and hospital stay. All kinds of complications were recorded, but special attention was paid to staple line leak and intraluminal hemorrhage. Staple line leak was defined as the evidence of staple line disruption by exit of blue dye through the drainage, visualization of luminal content in contrast enhanced imaging tests, or, in a patient with hemodynamic instability who underwent exploratory laparoscopy, the intraoperative identification of staple line disruption. Hemorrhage was defined as the appearance of postoperative hematemesis, melenas, or continuous decrease of hemoglobin levels in postoperative blood samples. Intraabdominal abscess was considered as a different type of complication, unless there is an evidence of extravasation of the intraluminal contrast into the abscess in the computed tomography scan; in such cases, they would be also included as staple line leaks.
ENDOSCOPIC VERSUS BOUGIE CALIBRATION IN LSG Statistics
Statistical analysis was performed with the statistical software SPSS version 19.0 for Windows (SPSS, Inc., Chicago, IL). Quantitative variables that followed a normal distribution were defined by the mean and standard deviation. For nonGaussian variables, the median and range were used. Qualitative variables were defined by number and percentage of cases. Comparison of variables was performed with a Student’s t test (the Mann–Whitney test was used for non-Gaussian variables). Comparison of qualitative variables was performed with the chi-squared test; in those cases with fewer than five observations in the cell, Fisher’s exact probability method was used. P < .05 was regarded as significant. All the patients signed an informed consent form for the surgical technique and for inclusion in the study. This study was approved by the local ethics committee. Results
During the period analyzed, 60 patients were evaluated at the Bariatric Surgery Unit of our institution. Ten patients (20%) were excluded from the study, as they were sent to another institution to undergo a different bariatric approach. The reasons were gastroesophageal reflux in 7 patients and nonadherence to the diet in 3 patients. In total, 50 patients were included in the study, 44 females (88%) and 6 males (12%), with a mean age of 43.3 – 10.4 years, ranging from 20 to 62 years. Comorbidities included type 2 diabetes mellitus in 15 (30%) of the patients, dyslipidemia in 24 (48%) (18 patients [36%] with hypercholesterolemia and 6 patients [12%] with hypertriglyceridemia), hypertension in 15 (30%), osteoarthritis in 8 (16%), and obstructive sleep apnea hypopnea syndrome in 7 (14%). All the patients with diabetes mellitus, hypertension, and dyslipidemia were receiving pharmacological therapy. There were no significant differences in demographic data and comorbidities between the groups (Table 1). Mean preoperative weight was 132.6 – 20.8 kg, and mean preoperative BMI was 50.6 – 6.9 kg/m2. One year later, mean weight was 73 – 9.9 kg, and mean BMI was 28.1 – 2.5 kg/m2. Mean excess BMI loss was 86.6% after 1 year. Twenty-five patients were included in each group. There were no significant differences in anthropometric measurements between groups (Table 2). In the endoscopic calibration group, a bleeding point in the staple line was detected and sclerosed with adrenaline in 1
3
Table 2. Anthropometric Measurements Between Groups Bougie calibration
Endoscopic calibration
P
Preoperative weight (kg) 130.5 – 14.3 134.1 – 13.8 NS Preoperative BMI (kg/m2) 49.6 – 8.3 51.6 – 7.8 NS 1-year weight (kg) 71.1 – 9 76.1 – 11.3 NS 27.8 – 3.1 28.3 – 2.7 NS 1-year BMI (kg/m2) 1-year excess weight loss 85.7% 87.5% NS BMI, body mass index; NS, not significant.
patient. This patient presented an uneventful postoperative course, without any sign of bleeding or decrease of hemoglobin levels postoperatively. In the bougie calibration group there were no cases of digestive bleeding or decrease of hemoglobin values in the postoperative course. The intraoperative tightness check with blue dye and air insufflation in the bougie calibration group was negative in all the patients. In the endoscopic calibration group the check with blue dye was also negative in all cases, but the second test with air detected the exit of air bubbles in 1 case. A figure-of-eight stitch was performed closing the defect. Both tightness tests were repeated, being this time both negative. This patient presented an uneventful postoperative course. Operation time was 117.3 – 15.2 minutes in the bougie calibration group versus 127.2 – 14.8 minutes in the endoscopic calibration group (P = .235). The global major complications rate was 6%: 3 patients (12%) in the bougie calibrated group (a staple line leak, an esophageal perforation when introducing the bougie, and an intraabdominal abscess). There were no complications in the endoscopic calibrated group (odds ratio = 0.9; 95% confidence interval, 0.77–0.99; P = .034). Minor complications appeared in 1 patient in each group (3.3%), consisting of wound infections in both cases. The infected wound was the port site of the specimen extraction. One patient in the bougie calibration group died (difference not significant): the patient with esophageal perforation developed a massive pulmonary thromboembolism resulting in death. Median hospital stay was 4 days in both groups (difference not significant) (Table 3). Discussion
Frezza et al.7 were the first to describe the performance of an LSG with endoscopic guidance. They reported, in 2008,
Table 1. Demographic Data and Comorbidities Between Groups
Age (years) Gender (male/female) Diabetes mellitus Hypertension Hypertriglyceridemia Hypercholesterolemia Osteoarthritis SAHS
Bougie calibration (n = 25)
Endoscopic calibration (n = 25)
P
43.3 – 10.2 2/23 8 (32%) 7 (28%) 3 (12%) 9 (36%) 4 (16%) 3 (12%)
43.2 – 10.9 3/22 7 (28%) 8 (32%) 3 (12%) 9 (36%) 4 (16%) 4 (16%)
NS NS NS NS NS NS NS NS
NS, not significant; SAHS, sleep apnea hypopnea syndrome.
Table 3. Operation Time, Complications, Mortality, and Hospital Stay Between Groups Bougie calibration
Endoscopic calibration
Operation time 117.3 – 15.2 127.2 – 14.8 (minutes) Major complications 3 (12%) 0 Minor complications 1 (4%) 1 (4%) Mortality 1 (4%) 0 Hospital stay (days) 4 (range, 3–22) 4 (range, 3–5) NS, not significant.
P NS .034 NS NS NS
4
20 LSGs without complications, excepting a case of oozing from the staple line. Later, Kockerling and Schug-Pass6 reported 38 patients undergoing gastroscopically controlled LSG. In this series, postoperative complications appeared in 2 patients (5.2%): a staple line bleeding and a stenosis. In 2010, a group from Greece5 described 25 patients undergoing this procedure without morbidity and mortality. There are differences from the technical point of view between the above-mentioned studies and our study. For instance, we leave the tip of the endoscope in the antrum, instead of leaving it in the duodenum.5 This enables the suction of air from the stomach through the working channel of the endoscope and obviates the need for a nasogastric tube in parallel with the endoscope to suck the air. The main difference between these series and ours is the size of endoscope. Whereas the abovementioned studies used a 10-mm gastroscope (30 French), we used a 12.8-mm colonoscope (38 French). Our reason for selecting a colonoscope was to use a similar size of calibration device; thus a 40-French bougie is the smaller size we have at our institution. It has been argued that with smaller bougies better results are obtained, in terms of weight loss. The reason for the use of progressively smaller bougies was the intention to create gastric remnants with residual volumes smaller than 80– 100 mL in order to enhance the restrictive potential of the operation.8 Moreover, a narrow gastric sleeve with no residual fundus seems to be less susceptible to a long-term gastric dilation, although this potential mechanism of long-term failure is not based on hard data.9 Notwithstanding, it has been also demonstrated that the use of a 40-French or larger bougie may decrease the risk of leak.10 This fact could not be confirmed in our series, in which using a 40-French bougie or a similar-size calibration method, one leak (4%) appeared, a slightly higher rate than data published in the literature.10 Anyway, our series represents the experience of a small, district hospital and includes the learning curve of the surgeon and anesthesiologists; therefore morbidity and mortality rates are slightly higher than those reported by experienced groups in the literature.1,3 On the other hand, regarding weight loss, our results, overcoming 85% of excess weight loss 1 year after surgery, contrast with the results reported in the literature of 1-year excess weight loss between 60% and 70%.11 In our opinion, the weight loss depends more on a correct selection of patients, who present a strong compromise with following a correct diet and adopting healthy dietary habits in the future, rather than the size of the sleeve, as we have already published.12 As it could be expected in our actual series, there were no significant differences in weight loss after 1 year between groups. A significant reduction in the major complications rate could be demonstrated in our group, justifying the use of endoscopic calibration. In the bougie calibration group an esophageal perforation occurred. This complication has been widely described during upper gastrointestinal surgery, especially in hiatal hernia repair, when a calibration bougie is inserted. This is a life-threatening complication as esophageal perforation might develop a mediastinitis, associated with high mortality.13 The endoscopic guidance has diminished the risk for upper esophageal perforation, when compared with the blind insertion of the bougie.14 Another advantage of the endoscopic calibration is the opportunity to check from the inner part of the staple line for any bleeding points or points suspicious for a leak. This entity appeared in 1 patient in our sample and could be endoscop-
RUIZ-TOVAR ET AL.
ically controlled with adrenaline sclerosis. This complication has been widely described in the literature.3,4 Finally, with cautious insufflation of the gastric remnant, it is feasible to check for leaks intraabdominally, if the perigastric area is filled with water, by trying to detect air bubbles, which is equivalent or even superior to any dye injection in the gastric sleeve.5 This is one of the most important issues of our study. In 1 patient we observed that the first tightness test with methylene blue dye was negative, but when checking it with air insufflations, air bubbles appeared, confirming the superiority of this checking method. The false-negative rate of methylene blue is estimated as around 2%.15 Performing a double tightness checking, this rate can be probably reduced to nearly 0%. In the bougie calibration group, an air-tightness check was also performed, but the air insufflation pressure is higher with the endoscope, leading to a greater distension of the gastric tube, and therefore the sensitivity for detecting leaks is probably higher. The main disadvantage of a routine endoscopic guidance is the logistics. Several groups defend that the endoscopy can be performed by the same surgical team, but, in our opinion, the performance of endoscopy by an expert gastroenterologist is absolutely necessary. There are several barriers that can only be overcome by experienced endoscopists, such as the difficult insertion of the endoscope, as the mouth and oropharynx are already occupied by the endotracheal tube; furthermore, the patient lies in the supine position and not in the standard left lateral decubitus, a fact that changes the standard orientation landmarks. Moreover, the advancement of the endoscope toward the duodenum only with intraluminal guidance is much more difficult because the whole major gastric curvature has been dissected and the stomach is mobile and not anchored as it is during a normal endoscopy. Finally, there is no way to remove the air from the stomach when the endoscope lies inside the duodenum. This would greatly hamper the effort to divide the stomach and makes it imperative that the air of the endoscope has to be completely aspirated. An expert endoscopist can place the endoscope adjacent to the pylorus, allowing the aspiration of the air, but still remaining parallel to the smaller curvature of the stomach.5 Although the participation of endoscopists can lead to a prolongation of the operation time, this can be minimized when a close coordination between the groups is achieved. One of the limitations of this study is that the logistics at our institution did not allow us, during the performance of an intraoperative endoscopy in the bougie calibration group, testing for leaks and, especially, looking for bleeding points in the same way in both groups. Future randomized studies should be conducted, with intraoperative endoscopy in both groups, to confirm our actual results. Conclusions
The use of intraoperative endoscopic calibration is associated with lower postoperative complications rates. Disclosure Statement
No competing financial interests exist. References
1. Braghetto I, Csendes A, Lanzarini E, Papapietro K, Ca´rcamo C, Molina JC. Is laparoscopic sleeve gastrectomy
ENDOSCOPIC VERSUS BOUGIE CALIBRATION IN LSG
2.
3.
4.
5.
6. 7. 8. 9.
an acceptable primary bariatric procedure in obese patients? Early and 5-year postoperative results. Surg Laparosc Endosc Percutan Tech 2012;22:479–486. Lemanu DP, Srinivasa S, Singh PP, Hill AG, MacCormick AD. Laparoscopic sleeve gastrectomy: Its place in bariatric surgery for the severely obese patient. N Z Med J 2012; 125:41–49. Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: A systematic review and meta-analysis of 9991 cases. Ann Surg 2013;257:231–237. Glaysher M, Khan OA, Mabvuure NT, Wan A, Reddy M, Vasilikostas G. Staple line reinforcement during laparoscopic sleeve gastrectomy: Does it affect clinical outcomes? Int J Surg 2013;11:286–289. Diamantis T, Alexandrou A, Pikoulis E, et al. Laparoscopic sleeve gastrectomy for morbid obesity with intraoperative endoscopic guidance. Immediate peri-operative and 1-year results after 25 patients. Obes Surg 2010;20:1164–1170. Kockerling F, Schug-Pass C. Gastroscopically controlled laparoscopic sleeve gastrectomy. Obes Facts 2009;2:15–18. Frezza EE, Barton A, Herbert H, Wachtel MS. Laparoscopic sleeve gastrectomy with endoscopic guidance in morbid obesity. Surg Obes Relat Dis 2008;4:575–579. Baltasar A, Serra C, Perez N, et al. Laparoscopic sleeve gastrectomy: A multi-purpose bariatric operation. Obes Surg 2005;15:1124–1128. Langer FB, Bohdjalian A, Felberbauer FX, et al. Does gastric dilatation limit the success of sleeve gastrectomy as a sole operation for morbid obesity? Obes Surg 2006;16: 166–171.
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10. Aurora AR, Khaitan L, Saber AA. Sleeve gastrectomy and the risk of leak: A systematic analysis of 4,888 patients. Surg Endosc 2012;26:1509–1515. 11. Yuval JB, Mintz Y, Cohen MJ, Rivkind AI, Elazary R. The effects of bougie caliber on leaks and excess weight loss following laparoscopic sleeve gastrectomy. Is there an ideal bougie size? Obes Surg 2013;23:1685–1691. 12. Ruiz-Tovar J, Oller I, Tomas A, et al. Midterm impact of sleeve gastrectomy, calibrated with a 50-Fr bougie, on weight loss, glucose hemostasis, lipid profiles and comorbidities in morbidly obese patients. Am Surg 2012;78: 969–974. 13. Trus TL, Bax T, Richardson WS, et al. Complications of laparoscopic paraesophageal hernia repair. J Gastrointest Surg 1997;1:221–228. 14. Lowham ES, Filipi CJ, Hinder RA, et al. Mechanisms and avoidance of esophageal perforation by anesthesia personnel during laparoscopic foregut surgery. Surg Endosc 1996; 10:979–982. 15. Ferrer-Ma´rquez M, Ferrer-Ayza M, Belda-Lozano R, et al. Gastric leak after laparoscopic sleeve gastrectomy. Obes Surg 2010; 20:1306–1311.
Address correspondence to: Jaime Ruiz-Tovar, MD, PhD Corazon de Maria, 64, 7 J 28002, Madrid Spain E-mail: [email protected]
Full Report
Laparoscopic Sleeve Gastrectomy with Endoscopic Versus Bougie Calibration: Results of a Prospective Study Jaime Ruiz-Tovar, MD, PhD,1 Javier Sola-Vera, MD, PhD,2 Elena Miranda, MD,3 Jose´ Luis Mun˜oz, MD,3 Estefania Perez-Rabasco, MD,2 Antonio Arroyo, MD, PhD,1 and Rafael Calpena, MD, PhD,1 for the OBELCHE Group 4,*
Abstract
Introduction: The use of the endoscope for the calibration of the gastric sleeve, instead of the standard use of the bougie, is a safe procedure and gives the surgeon a higher sense of security. The aim of this study was to evaluate the effect of the use of endoscopic guidance on postoperative complications and mid-term results of the bariatric procedure. Patients and Methods: A prospective, nonrandomized study was performed at the General University Hospital of Elche (Alicante, Spain) between 2010 and 2013. The patients were divided into the bougie calibration group and the endoscopic calibration group. The decision of which method to use depended on the availability of an endoscopist at the time of the surgery. Results: Fifty patients were included in the study, 44 females (88%) and 6 males (12%), with a mean age of 43.3 years and a preoperative mean body mass index of 50.6 kg/m2. In the endoscopic calibration group, a bleeding point in the staple line was detected and sclerosed with adrenaline in 1 patient. In the bougie calibration group there were no cases of postoperative digestive bleeding. The intraoperative tightness check with blue dye and air insufflation through an orogastric tube in the bougie calibration group was negative in all the patients. In the endoscopic calibration group the check with blue dye was also negative in all cases, but the second test with air detected the exit of air bubbles in 1 case. There were no significant differences in the operation time between groups. A significant reduction in the major complications rate was observed in the endoscopic calibration group (odds ratio = 0.9; P = .034). Conclusions: Endoscopic calibration is associated with lower postoperative complications after laparoscopic sleeve gastrectomy.
that the use of the endoscope for the calibration of the gastric sleeve, instead of the standard use of the bougie, is a safe procedure and gives the surgeon a higher sense of security.5–7 The aim of this study was to evaluate the effect of the use of endoscopic guidance on postoperative complications and mid-term results of the bariatric procedure.
Introduction
L
aparoscopic sleeve gastrectomy (LSG) is becoming increasingly established as a stand-alone procedure for weight reduction. The restrictive and the humoral features of this procedure assure postoperative weight loss of up to 70%– 80% after 1 year.1,2 However, complications might also appear after this technique. The main sources of postoperative morbidity and mortality are a staple line leak and bleeding. To avoid both, several measures have been adopted, including the oversewing of the staple line or the use of buttressing material, but, despite these mesures, both complications continue being life-threatening conditions.3,4 Several authors have shown
Patients and Methods
A prospective, nonrandomized study was performed at the Obesity Unit of the General University Hospital of Elche (Alicante, Spain) between May 2010 and January 2013. The inclusion criterion was a body mass index (BMI) of > 40 kg/m2
Departments of 1Surgery, 2Gastroenterology, and 3Anaesthesiology, 4Obesity Unit, General University Hospital Elche, Alicante, Spain. *Members of the OBELCHE Group are Jose Maria Bonete, MD, Marı´a Diez, MD, Rosana Martı´nez, PhD, Ana Murcia, PhD, Maria Dolores Pico, MD, Jose Maria Rico, MD, Francisco Uceda, MD, Narcis Va´zquez, MD, Luis Fernando Vences, MD, and Lorea Zubiaga, MD.
1
2
or a BMI of > 35 kg/m2 with associated comorbidities. Exclusion criteria were the evidence of gastroesophageal reflux disease and the absence of preoperative weight loss with a 1200 Kcal diet (reflection of nonadherence to the diet). Calculated sample size was made on an expected complications rate of 5% in the bougie calibration group, based on epidemiology data at our institution, and on an expected complications rate of 1% in the endoscopic calibration group, corresponding to the best results reported in literature.1,3 With 80% power and a P value of .05, it was necessary to include 25 patients in each group. The patients were divided into the bougie calibration group and the endoscopic calibration group, according to the sleeve calibration method. The decision on the method used depended on the availability of an endoscopist at the time of the surgery. An endoscopist was available only on 50% of the days when a sleeve gastrectomy was performed. All the operations were performed by the same surgeon. Preoperative evaluation
A multidisciplinary team, including surgeons, endocrinologists, endoscopists, anesthesiologists, psychiatrists and psychologists, and specialized nurses, performed a combined medical, nutritional, and endocrinological work-up to evaluate potential surgical candidates. A weight loss of at least 5% of the patient’s overweight was considered an indispensable condition to be selected as a candidate for LSG. Patients with documented gastroesophageal reflux disease or patients not achieving the required weight loss (reflection of nonadherence to the diet) were excluded and selected to undergo a gastric bypass. Surgical technique
Three 12-mm ports were placed in the right and left upper abdomen and in the midline 15 cm below the xiphoid; two 5mm ports were placed in the left flank and in the subxiphoideal position. The short gastric vessels from the greater curvature were divided with a bipolar dissector (Ligasure; Covidien, Mansfield, MA), from the incisura angularis up to the gastroesophageal junction. For calibration of the sleeve, in the endoscopic calibration group, a colonoscope (Fuji EC-250 WL5; FUJI Photo Optical, Saitama, Japan) was used. The outer diameter of the scope is 12.8 mm, which corresponds to a 38-French bougie, and its working length is 169 cm. The colonoscope was inserted along the smaller curvature and advanced beyond the pylorus into the distal duodenum. During insertion of the colonoscope the least amount of air was insufflated. However, the stomach was mostly distended with air during insertion of the endoscope. To avoid this circumstance, the colonoscope was rectified and removed until the tip was located in the gastric antrum, while the pylorus was displayed on the screen. In this situation it was possible to suck all the air from the stomach to allow the gastrectomy. Insuflation with room air was used in all cases. The endoscopic procedures were performed by three gastroenterologists with extensive experience in upper endoscopy. In the bougie calibration group, a 40-French bougie was inserted through the mouth by the anesthesiologist and placed along the smaller curvature, advanced up to the pylorus. Finally, gastrectomy was performed along the calibration device (endoscope or bougie) using an endoscopic stapler (Echelon;
RUIZ-TOVAR ET AL.
Ethicon Endo-Surgery, a Johnson & Johnson Company, Norderstedt, Germany). A staple line inversion was performed with a continuous oversewing with polypropylene 3/0. In the bougie calibration group, once the oversewing suture was finished, an orogastric tube was inserted, and the sleeve was filled with methylene blue dye, while the oversewed staple line was observed for eventual disruptures. Later, a second tightness check with air, insufflated through the orogastric tube, was performed. In the endoscopic calibration group, once suturing had been completed, the endoscope was retracted in order to inspect the gastric staple line for any bleeding points or points suspicious for a gastric staple line disruption. Then the gastric sleeve was filled with diluted methylene blue dye through the working channel of the endoscope, in order to check for any leaks. Finally, a second tightness check with air was performed. The abdomen was filled with water and air was insufflated through the colonoscope in the gastric sleeve, trying to detect air bubbles with the laparoscope. Any bleeding or suspected leak points were immediately strengthened with figure-of-eight stitches, and both tightness tests were repeated. The resected stomach was removed through the 12-mm upper left port. A Jackson–Pratt drain was placed along the staple line. Upon discharge, the patients received a liquid diet for 2 weeks, followed by 2 weeks of soft, semiliquid diet. After this period, a 1200-Kcal diet was administered. Follow-up
The follow-up rate was 100%, and follow-up was for at least 12 months. All the patients were followed up by the surgeon and the endocrinologist at 1, 3, 6, and 12 months after surgery. Patients were seen regularly by a dietician to follow a calorie-reduced and protein-rich diet. Changes in body weight and comorbidities were monitored. Medical treatment, such as antidiabetic and antihypertensive drugs, was adjusted according the current needs of the patient. Postoperatively, daily proton pump inhibitor and multivitamin supplements were uniformly prescribed. At least 1 hour of daily moderate exercise/fitness (walking, swimming, etc.) was recommended to the patients. Variables
The clinical variables investigated were age, gender, comorbidities, BMI before and 12 months postoperatively, excess weight loss, complications, mortality, surgical time, and hospital stay. All kinds of complications were recorded, but special attention was paid to staple line leak and intraluminal hemorrhage. Staple line leak was defined as the evidence of staple line disruption by exit of blue dye through the drainage, visualization of luminal content in contrast enhanced imaging tests, or, in a patient with hemodynamic instability who underwent exploratory laparoscopy, the intraoperative identification of staple line disruption. Hemorrhage was defined as the appearance of postoperative hematemesis, melenas, or continuous decrease of hemoglobin levels in postoperative blood samples. Intraabdominal abscess was considered as a different type of complication, unless there is an evidence of extravasation of the intraluminal contrast into the abscess in the computed tomography scan; in such cases, they would be also included as staple line leaks.
ENDOSCOPIC VERSUS BOUGIE CALIBRATION IN LSG Statistics
Statistical analysis was performed with the statistical software SPSS version 19.0 for Windows (SPSS, Inc., Chicago, IL). Quantitative variables that followed a normal distribution were defined by the mean and standard deviation. For nonGaussian variables, the median and range were used. Qualitative variables were defined by number and percentage of cases. Comparison of variables was performed with a Student’s t test (the Mann–Whitney test was used for non-Gaussian variables). Comparison of qualitative variables was performed with the chi-squared test; in those cases with fewer than five observations in the cell, Fisher’s exact probability method was used. P < .05 was regarded as significant. All the patients signed an informed consent form for the surgical technique and for inclusion in the study. This study was approved by the local ethics committee. Results
During the period analyzed, 60 patients were evaluated at the Bariatric Surgery Unit of our institution. Ten patients (20%) were excluded from the study, as they were sent to another institution to undergo a different bariatric approach. The reasons were gastroesophageal reflux in 7 patients and nonadherence to the diet in 3 patients. In total, 50 patients were included in the study, 44 females (88%) and 6 males (12%), with a mean age of 43.3 – 10.4 years, ranging from 20 to 62 years. Comorbidities included type 2 diabetes mellitus in 15 (30%) of the patients, dyslipidemia in 24 (48%) (18 patients [36%] with hypercholesterolemia and 6 patients [12%] with hypertriglyceridemia), hypertension in 15 (30%), osteoarthritis in 8 (16%), and obstructive sleep apnea hypopnea syndrome in 7 (14%). All the patients with diabetes mellitus, hypertension, and dyslipidemia were receiving pharmacological therapy. There were no significant differences in demographic data and comorbidities between the groups (Table 1). Mean preoperative weight was 132.6 – 20.8 kg, and mean preoperative BMI was 50.6 – 6.9 kg/m2. One year later, mean weight was 73 – 9.9 kg, and mean BMI was 28.1 – 2.5 kg/m2. Mean excess BMI loss was 86.6% after 1 year. Twenty-five patients were included in each group. There were no significant differences in anthropometric measurements between groups (Table 2). In the endoscopic calibration group, a bleeding point in the staple line was detected and sclerosed with adrenaline in 1
3
Table 2. Anthropometric Measurements Between Groups Bougie calibration
Endoscopic calibration
P
Preoperative weight (kg) 130.5 – 14.3 134.1 – 13.8 NS Preoperative BMI (kg/m2) 49.6 – 8.3 51.6 – 7.8 NS 1-year weight (kg) 71.1 – 9 76.1 – 11.3 NS 27.8 – 3.1 28.3 – 2.7 NS 1-year BMI (kg/m2) 1-year excess weight loss 85.7% 87.5% NS BMI, body mass index; NS, not significant.
patient. This patient presented an uneventful postoperative course, without any sign of bleeding or decrease of hemoglobin levels postoperatively. In the bougie calibration group there were no cases of digestive bleeding or decrease of hemoglobin values in the postoperative course. The intraoperative tightness check with blue dye and air insufflation in the bougie calibration group was negative in all the patients. In the endoscopic calibration group the check with blue dye was also negative in all cases, but the second test with air detected the exit of air bubbles in 1 case. A figure-of-eight stitch was performed closing the defect. Both tightness tests were repeated, being this time both negative. This patient presented an uneventful postoperative course. Operation time was 117.3 – 15.2 minutes in the bougie calibration group versus 127.2 – 14.8 minutes in the endoscopic calibration group (P = .235). The global major complications rate was 6%: 3 patients (12%) in the bougie calibrated group (a staple line leak, an esophageal perforation when introducing the bougie, and an intraabdominal abscess). There were no complications in the endoscopic calibrated group (odds ratio = 0.9; 95% confidence interval, 0.77–0.99; P = .034). Minor complications appeared in 1 patient in each group (3.3%), consisting of wound infections in both cases. The infected wound was the port site of the specimen extraction. One patient in the bougie calibration group died (difference not significant): the patient with esophageal perforation developed a massive pulmonary thromboembolism resulting in death. Median hospital stay was 4 days in both groups (difference not significant) (Table 3). Discussion
Frezza et al.7 were the first to describe the performance of an LSG with endoscopic guidance. They reported, in 2008,
Table 1. Demographic Data and Comorbidities Between Groups
Age (years) Gender (male/female) Diabetes mellitus Hypertension Hypertriglyceridemia Hypercholesterolemia Osteoarthritis SAHS
Bougie calibration (n = 25)
Endoscopic calibration (n = 25)
P
43.3 – 10.2 2/23 8 (32%) 7 (28%) 3 (12%) 9 (36%) 4 (16%) 3 (12%)
43.2 – 10.9 3/22 7 (28%) 8 (32%) 3 (12%) 9 (36%) 4 (16%) 4 (16%)
NS NS NS NS NS NS NS NS
NS, not significant; SAHS, sleep apnea hypopnea syndrome.
Table 3. Operation Time, Complications, Mortality, and Hospital Stay Between Groups Bougie calibration
Endoscopic calibration
Operation time 117.3 – 15.2 127.2 – 14.8 (minutes) Major complications 3 (12%) 0 Minor complications 1 (4%) 1 (4%) Mortality 1 (4%) 0 Hospital stay (days) 4 (range, 3–22) 4 (range, 3–5) NS, not significant.
P NS .034 NS NS NS
4
20 LSGs without complications, excepting a case of oozing from the staple line. Later, Kockerling and Schug-Pass6 reported 38 patients undergoing gastroscopically controlled LSG. In this series, postoperative complications appeared in 2 patients (5.2%): a staple line bleeding and a stenosis. In 2010, a group from Greece5 described 25 patients undergoing this procedure without morbidity and mortality. There are differences from the technical point of view between the above-mentioned studies and our study. For instance, we leave the tip of the endoscope in the antrum, instead of leaving it in the duodenum.5 This enables the suction of air from the stomach through the working channel of the endoscope and obviates the need for a nasogastric tube in parallel with the endoscope to suck the air. The main difference between these series and ours is the size of endoscope. Whereas the abovementioned studies used a 10-mm gastroscope (30 French), we used a 12.8-mm colonoscope (38 French). Our reason for selecting a colonoscope was to use a similar size of calibration device; thus a 40-French bougie is the smaller size we have at our institution. It has been argued that with smaller bougies better results are obtained, in terms of weight loss. The reason for the use of progressively smaller bougies was the intention to create gastric remnants with residual volumes smaller than 80– 100 mL in order to enhance the restrictive potential of the operation.8 Moreover, a narrow gastric sleeve with no residual fundus seems to be less susceptible to a long-term gastric dilation, although this potential mechanism of long-term failure is not based on hard data.9 Notwithstanding, it has been also demonstrated that the use of a 40-French or larger bougie may decrease the risk of leak.10 This fact could not be confirmed in our series, in which using a 40-French bougie or a similar-size calibration method, one leak (4%) appeared, a slightly higher rate than data published in the literature.10 Anyway, our series represents the experience of a small, district hospital and includes the learning curve of the surgeon and anesthesiologists; therefore morbidity and mortality rates are slightly higher than those reported by experienced groups in the literature.1,3 On the other hand, regarding weight loss, our results, overcoming 85% of excess weight loss 1 year after surgery, contrast with the results reported in the literature of 1-year excess weight loss between 60% and 70%.11 In our opinion, the weight loss depends more on a correct selection of patients, who present a strong compromise with following a correct diet and adopting healthy dietary habits in the future, rather than the size of the sleeve, as we have already published.12 As it could be expected in our actual series, there were no significant differences in weight loss after 1 year between groups. A significant reduction in the major complications rate could be demonstrated in our group, justifying the use of endoscopic calibration. In the bougie calibration group an esophageal perforation occurred. This complication has been widely described during upper gastrointestinal surgery, especially in hiatal hernia repair, when a calibration bougie is inserted. This is a life-threatening complication as esophageal perforation might develop a mediastinitis, associated with high mortality.13 The endoscopic guidance has diminished the risk for upper esophageal perforation, when compared with the blind insertion of the bougie.14 Another advantage of the endoscopic calibration is the opportunity to check from the inner part of the staple line for any bleeding points or points suspicious for a leak. This entity appeared in 1 patient in our sample and could be endoscop-
RUIZ-TOVAR ET AL.
ically controlled with adrenaline sclerosis. This complication has been widely described in the literature.3,4 Finally, with cautious insufflation of the gastric remnant, it is feasible to check for leaks intraabdominally, if the perigastric area is filled with water, by trying to detect air bubbles, which is equivalent or even superior to any dye injection in the gastric sleeve.5 This is one of the most important issues of our study. In 1 patient we observed that the first tightness test with methylene blue dye was negative, but when checking it with air insufflations, air bubbles appeared, confirming the superiority of this checking method. The false-negative rate of methylene blue is estimated as around 2%.15 Performing a double tightness checking, this rate can be probably reduced to nearly 0%. In the bougie calibration group, an air-tightness check was also performed, but the air insufflation pressure is higher with the endoscope, leading to a greater distension of the gastric tube, and therefore the sensitivity for detecting leaks is probably higher. The main disadvantage of a routine endoscopic guidance is the logistics. Several groups defend that the endoscopy can be performed by the same surgical team, but, in our opinion, the performance of endoscopy by an expert gastroenterologist is absolutely necessary. There are several barriers that can only be overcome by experienced endoscopists, such as the difficult insertion of the endoscope, as the mouth and oropharynx are already occupied by the endotracheal tube; furthermore, the patient lies in the supine position and not in the standard left lateral decubitus, a fact that changes the standard orientation landmarks. Moreover, the advancement of the endoscope toward the duodenum only with intraluminal guidance is much more difficult because the whole major gastric curvature has been dissected and the stomach is mobile and not anchored as it is during a normal endoscopy. Finally, there is no way to remove the air from the stomach when the endoscope lies inside the duodenum. This would greatly hamper the effort to divide the stomach and makes it imperative that the air of the endoscope has to be completely aspirated. An expert endoscopist can place the endoscope adjacent to the pylorus, allowing the aspiration of the air, but still remaining parallel to the smaller curvature of the stomach.5 Although the participation of endoscopists can lead to a prolongation of the operation time, this can be minimized when a close coordination between the groups is achieved. One of the limitations of this study is that the logistics at our institution did not allow us, during the performance of an intraoperative endoscopy in the bougie calibration group, testing for leaks and, especially, looking for bleeding points in the same way in both groups. Future randomized studies should be conducted, with intraoperative endoscopy in both groups, to confirm our actual results. Conclusions
The use of intraoperative endoscopic calibration is associated with lower postoperative complications rates. Disclosure Statement
No competing financial interests exist. References
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Address correspondence to: Jaime Ruiz-Tovar, MD, PhD Corazon de Maria, 64, 7 J 28002, Madrid Spain E-mail: [email protected]
