Effect of Pyloric Balloon Dilatation on GERD after LSG
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1 Med. J. Cairo Univ., Vol. 83, No. 1, December: , Effect of Pyloric Balloon Dilatation on GERD after LSG AHMAD Y.I. ABD EL-DAYEM, M.Sc.; MOHAMMAD E. EL-QOUSY, M.D.; IBRAHIM G. KHALIFA, M.D. and TAREK O. HIGAZY, M.D. The Department of General Surgery, Faculty of Medicine, Cairo University 171 that a high Body Mass Index (BMI) is a risk factor for the development of this condition [2-7]. The mechanism by which a high BMI increases esophageal acid exposure is not completely understood. Increased intra-gastric pressure and gastroesophageal pressure gradient, incompetence of the Lower Esophageal Sphincter (LES), and increased frequency of transient LES relaxations may all play a role in the pathophysiology of GERD in patients who are morbidly obese. The therapeutic implication of such a premise is that the correction of reflux in patients who are morbidly obese might be better achieved with a procedure that first controls obesity. One of the most famous procedures evolving in the bariatric surgical scene is LSG. LSG effectively treats most of the comorbid medical problems associated with obesity. The one exception is GERD. Patients with GERD experience less resolution of their symptoms after LSG than do patients with LAGB, even when the LABG patients lost less weight overall [8]. Patients who have longstanding severe GERD may not be good candidates for LSG. GERD is a potential drawback for the LSG and more work is being done in order to reduce the risk for GERD after LSG [9,15,16]. This may be attributed to functioning pyloric sphincter, as the relative increase in gastric contents in the narrow sleeve results in increased intragastric pressure and, ultimately, increased pressure against the lower esophageal sphincter. This pressure eventually defeats the LES and leads to reflux. Aim of the Work: The aim of the study is to evaluate the addition of balloon dilatation of the pylorus (pyloromyotomy) during LSG aiming at reduction of increased intraluminal pressure in gastric tube and the impact of this procedure on GERD.
2 172 Effect of Pyloric Balloon Dilatation on GERD after LSG (Table 2) [12], before and till 6 months after their surgical procedure. The patients are specifically asked to score the severity and frequency of their reflux, regurgitation, epigastric pain, sensation of fullness, dysphagia, and cough symptoms. Table (2): Gastroesophageal reflux symptoms questionnaire and scoring. Severity Frequency Heartburn: Before After : Before After Epigastric or chest pain: Before After Epigastric fullness: Before After Table (1): ASA physical classification system. ASA class Status 1 - Normal healthy patient 2 - Patient with mild systemic disease 3 - Patient with severe systemic disease 4 - Patient with severe systemic disease that is a constant threat to life 5 - Moribund patient not expected to survive without operation Data from cuvillon et al., [11]. In the current study two groups of sleeve gastrectomy were studied, in the first group pyloromyotomy was added to 2 cases of sleeve gastrectomy and compared to the other group in which no pyloromyotomy was done. The GERD symptoms are recorded before the operation, on the day of surgery and 3 and 6 months after the operation and also the need for anti GERD medication as Proton Pump Inhibitors (PPI). Intraoperative, early post-operative complication (<3 days) and hospital stay are also recorded. Pre-operative preparation: All patients have preoperative abdominal US, Pulmonary function test, ECG, full blood picture, liver and kidney function and stratified according to medical fitness by using ASA score [11]. They are all interviewed regarding their reflux symptoms using the GERD score questionnaire, Dysphagia: Before After Cough: Before After Data from Allen et al., [12]. Severity scale: Frequency scale: = Not at all. = Absent. 1 = Mild. 1 = Symptoms occurred once a month. 2 = Moderate. 2 = Symptoms occurred once a week. 3 = Severe. 3 = Symptoms occurred 2-4 times a week. 4 = Symptoms occurred daily. After establishing the pneumoperitoneum using the veress needle and insertion of 5 ports, the operation starts by mobilization of the greater omentum attachment to the greater curvature using the harmonic ultrasonic shears (Harmonic Ace (R) Curved shears, Ethicon Endosurgery, USA) reaching the first part of the duodenum downwards and upwards opening angle of His, exposing the left crus of the diaphragm. A 36 F bougie is orally advanced into the stomach and the pylorus along the lesser curvature of the stomach, till it reaches the first part duodenum. Device description: The Gastric Calibration Tube is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. It provides the ability to decompress the stomach, drain and remove gastric fluid, and size a gastric pouch.
3 Ahmad Y.I. Abd El-Dayem, et al. 173 leaks and infections, % EWL after 6 months focusing on GERD symptoms on day zero, 3 & 6 months after using the GERD score questionnaire [12]. Results Fig. (1): Inflatable balloon [13]. The Gastric Calibration Tube is a non-sterile, single patient use instrument consisting of a 745 mm long silicone tube with an approximate 38 F (12.7mm) rounded, closed tip. At the proximal end, the tube is equipped with a check valve which mates with a syringe used to fill a balloon located approximately 6.8cm from the distal tip. At the distal end, the tube has two suction/irrigation holes that allow the removal of fluids and/or irrigation during the procedure, if necessary. Reference markings are provided on the tube shaft, with the zero reference located approximately 39.6cm from the proximal end of the balloon. After reaching the duodenum, assuring the presence of the balloon in the pylorus, the balloon was inflated until blanching of the pyloric wall is noted by the laparoscope, then the inflated balloon is withdrawn back across the pyloric ring to ensure dilatation. Then a reticulating linear stapler (Echelon Flextm Enopath (R), Ethicon Endosurgery, USA) is used to create the gastric sleeve around the bougie starting just proximal to the pyloric ring till reaching the angle of His. A methylene blue test is applied and one drain is inserted along the staple line. Post-operative care: Patients are encouraged to move out of bed few hours after surgery, minimizing the need for anticoagulation medications. We start administration of IV PPI and anti-emetics from first post-operative day, which is continued orally after patients start oral feeding. Patients start oral fluid intake on the 2 nd postoperative day which is continued for 3 weeks, with gradual return to normal diet. Follow-up: All patients will be followed-up for early postoperative complications (<3 days) like bleeding, Among our patients, 16 (4%) patients had preoperative GERD symptoms, 1 (25%) patients had heartburn and regurgitation. One patient (2.5%) had epigastric pain and none of them had dysphagia or cough. Only 13 patients (32.5%) of them needed Proton Pump Inhibitors (PPIs) to control the condition. Table (3): Comparison between both groups regarding preoperative symptoms scores. Heart burn pre: Pyloromyotomy (n=2) Without pyloromyotomy (n=2) N % N % p - value NS pre: NS Epigastric pain pre: NS Dysphagia pre: NS Cough pre: NS Medications pre: Yes No NS By the end of the study, we had 29 (7.7%) patients with GERD symptoms and heartburn, 23 (56%) had regurgitation, 2 (5%) patients had epigastric pain, 3 (7.5%) patients had cough and none of them had dysphagia. Of the 29 patients, 2 needed PPIs by the end the study.
4 174 Effect of Pyloric Balloon Dilatation on GERD after LSG Table (4): Comparison between both groups regarding symptoms scores post-operative. Pyloromyotomy (n=2) Without pyloromyotomy (n=2) N % N % p - value Heart burn post : < S Heart burn post 3: S Heart burn post 3: Present Absent NS Heart burn post 6: S Heart burn post 6: Present Absent NS post: NS Epigastric pain post: NS Dysphagia post: NS Cough post: NS Medications post: Yes No NS Chi-square test. In the current study two groups of sleeve gastrectomy were studied, in the first group pyloromyotomy was added to 2 cases of sleeve gastrectomy and compared to the other group in which no pyloromyotomy was done. At the day of surgery, 19 patients of the pyloromyotomy group (95%) had score zero HB, compared to 7 patients of the without pyloromyotomy group (35%) had score zero HB, the rest of patients had score 1. This relation is statistically highly significant (p-value <.1). 3 months after surgery, only 3 patients of the had score zero HB, com- pared to 7 patients of the without pyloromyotomy group. 17 patients of the had score zero HB, compared to 9 patients of the without. Only 4 patients of the without had score 2 HB. This means that 17 patients of the pyloromyotomy group had experienced HB, compared to 13 patients of the without regardless of scores, a difference that is not significant ( p- value=.2). 6 months after surgery, 16 patients of the pyloromyotomy group had experienced HB, compared to 13 patients of the without regardless of scores, a difference that is also insignificant (p-value=.3). % % Heart burn Heart burn Heart burn Heart burn preoperative on day zero after after 3 months 6 months 65 3 Progress of heart burn within Fig. (2): Progress of HB among Heart burn Heart burn Heart burn Heart burn preoperative on day zero after after 3 months 6 months Progress of heart burn for without Fig. (3): Progress of HB among without pyloromyotomy group
5 Ahmad Y.I. Abd El-Dayem, et al. 175 Regarding rest of GERD symptoms, regurgitation was present pre-operatively in 3 patients (15%) in the and 7 patients (35%) in the without and progressed post-operatively to 7 patients (35%) and 11 patients (55%) patients in the pyloromyotomy and without s respectively % % preoperative postoperative Progress of regurgitation within Fig. (4): Progress of regurgitation among pyloromyotomy group. Progress of regurgitation for without preoperative postoperative Fig. (5): Progress of regurgitation among the without pyloromyotomy group. Epigastric pain was present pre-operatively in only one patient (5%) in the without pyloromyotomy group and progressed to 2 patients (1%) in the without and one patient of the (5%) developed epigastric pain post-operatively. Only 3 cases of cough in the without pyloromyotomy group and no dysphagia were present. 7 patients compared to 13 were dependent on medications post-operatively in the first and second groups respectively. 9.5 Discussion Laparoscopic Sleeve Gastrectomy (LSG) has taken the bariatric surgical scene by storm over the past 5 to 1 years. LSG effectively treats most of the co-morbid medical problems associated with obesity. The one exception is GERD. Patients with GERD experience less resolution of their symptoms after LSG than do patients with LAGB, even when the LABG patients lost less weight overall [8]. Howard and colleagues [14] found through a study including 28 patients- using the GERD score questionnaire to evaluate their reflux symptomsthat 22% of them experienced a new-onset-post sleeve gastrectomy-gerd symptoms despite receiving daily antireflux therapy. In a systematic review by Chiu et al., [9], a total of 15 reports met the inclusion criteria. Of the 15 reports, 2 had included GERD as a primary outcome of LSG and 13 had studied GERD as a secondary outcome. The duration of follow-up ranged from 6 months to 5 years. The 15 reports retrieved from a systematic data search of GERD after LSG reported diverging results. Of the 15 studies, 4 studies found an increased prevalence of GERD symptoms after LSG, but 7 studies showed a reduced prevalence. From the studies in which an overall reduced prevalence was reported, the investigators had noted that patients with pre-existing GERD had shown improvement but that new cases of GERD had developed after LSG. Himpens et al., noted that of the patients with pre-existing GERD, 75% had had resolution. However, 21.8% new cases had developed at 1 year after LSG. Melissas et al., noted the same trend of a reduction in pre-existing GERD but also 2 new cases. However, the studies did not report the statistical significance of the new cases. The studies by Himpens et al., [17], Weiner et al., [1], and Melissas et al., [18] found worsening GERD symptoms early after LSG but resolution at 2-3 years [9]. In our study, the pre-operative GERD prevalence was 45%, and by the end of the study was 8%, yet the difference was not significant ( p- value=.3). The incidence of GERD resolution post-operative was 5%, while the new onset GERD cases were 4%. The Second International Consensus Summit for Sleeve Gastrectomy [19] surveyed attendees and reported that their prevalence of postoperative GERD ranged from % to 83% (average 6.5%).
6 176 Effect of Pyloric Balloon Dilatation on GERD after LSG Conclusion: In the current study we have tried to reduce the high pressure in the gastric tube after sleeve gastrectomy by this technique of pyloric dilatation. In conclusion we found that pyloromyotomy has reduced the gastric pressure to an extent that was adequate to relieve heart burn and other symptoms of GERD but only in the immediate postoperative period, was not sustained for a long period. Perhaps the most important issue to discuss is how this information should influence practice. All patients undergoing LSG should be informed of the likelihood of GERD symptoms postoperatively as a part of the informed consent process. However, the question remains whether LSG should be performed on patients with a history of GERD. References 1- PATTI M.G. and KATZ J.: Gastroesophageal Reflux Disease. Available at article/ overview#a156 Accessed, 16/4/ HAMPEL H., ABRAHAM N.S. and EL-SERAG H.B.: Meta-analysis: Obesity and the risk for gastroesophageal reflux disease and its complications. Ann. Intern. Med. Aug. 2, 143 (3): , HERBELLA F.A., SWEET M.P., TEDESCO P., NIPOM- NICK I. and PATTI M.G.: Gastroesophageal reflux disease and obesity. Pathophysiology and implications for treatment. J. Gastrointest. Surg. Mar., 11 (3): 286-9, MERROUCHE M., SABATÉ J.M., JOUET P., HARNOIS F., SCARINGI S., COFFIN B., et al.: Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients before and after bariatric surgery. Obesity Surgery. Jul., 17 (7): 894-9, MURRAY L., JOHNSTON B., LANE A., HARVEY I., DONOVAN J., NAIR P., et al.: Relationship between body mass and gastro-oesophageal reflux symptoms: The Bristol Helicobacter Project. Int. J. Epidemiol. Aug., 32 (4): 645-5, PANDOLFINO J.E., EL-SERAG H.B., ZHANG Q., SHAH N., GHOSH S.K. and KAHRILAS P.J.: Obesity: A challenge to esophagogastric junction integrity. Gastroenterology. Mar., 13 (3): , EL-SERAG H.B., GRAHAM D.Y., SATIA J.A. and RA- BENECK L.: Obesity is an independent risk factor for GERD symptoms and erosive esophagitis. American Journal of Gastroenterology. Jun., 1 (6): , HUTTER M.M., SCHIRMER B.D., JONES D.B., et al.: First report of the American College of Surgeons Bariatric Surgery Center Network: Laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann. Surg., 254: 41-22, CHIU S., BIRCH D.W., SHI X., SHARMA A.M. and KARMALI S.: Effect of sleeve gastrectomy on gastroesophageal reflux disease: A systematic review. Surg. Obes. Relat. Dis., 7 (4): 51-5, WEINER R.A., WEINER S., POMHOFF I., et al.: Laparoscopic sleeve gastrectomy-influence of sleeve size and resected gastric volume. Obesity Surgery, 17: , CUVILLON P., NOUVELLON E., MARRET E., AL- BALADEJO P., FORTIER L.P., FABBRO-PERRAY P., MALINOVSKY J.M. and RIPART J.: American Society of Anesthesiologists' physical status system: A multicentre Francophone study to analyse reasons for classification disagreement, Oct., 28 (1): 742-7, ALLEN C.J., PARAMESWARAN K., BELDA J. and ANVARI M.: Reproducibility, validity, and responsiveness of a disease-specific symptom questionnaire for gastroesophageal reflux disease. Dis. Esophagus., 13: 265-7, Ethicon Endo-Surgery, Gastric Calibration Tube, Available at HOWARD D.D., CABAN A.M., CENDAN J.C. and BEN- DAVID K.: Gastroesophageal reflux after sleeve gastrectomy in morbidly obese patients. Surg. Obes. Relat. Dis., 7 (6): 79-13, SORICELLI E., IOSSA A., CASELLA G., ABBATINI F., CALI B. and BASSO N.: Sleeve gastrectomy and crural repair in obese patients with gastroesophageal reflux disease and/or hiatal hernia. Surg. Obes. Relat. Dis., 9 (3): , DAES J., JIMENEZ M.E., SAID N., DAZA J.C. and DENNIS R.: Laparoscopic sleeve gastrectomy: Symptoms of gastroesophageal reflux can be reduced by changes in surgical technique. Obesity Surgery, 22 (12): , HIMPENS J., DAPRI G. and CADIERE G.B.: A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: Results after 1 and 3 years. Obesity Surgery, 16: 145-6, MELISSAS J., KOUKOURAKI S., ASKOXYLAKIS J., et al.: Sleeve gastrectomy: A restrictive procedure?. Obesity Surgery, 17: 57-62, GAGNER M., DEITEL M., KALBERER T.L., ERICK- SON A.L. and CROSBY R.D.: The second International Consensus Summit for Sleeve Gastrectomy, March 19-21, 29. Surgery for Obesity and Related Diseases, 5: , 29.
7 Ahmad Y.I. Abd El-Dayem, et al. 177
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