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AbstractNatural orifice translumenal endoscopic surgery (NOTES) has been introduced as a less invasive approach to performing intra-abdominal surgery. Any natural orifice may be used, although the ideal portal remains to be determined. Transvaginal surgery has been performed by gynecologists for decades and there is abundant literature supporting the efficacy and safety using this approach. Surgeons have also used the vagina for specimen removal after laparoscopic surgery to minimize the transabdominal incision. More recently, several animal NOTES experiments have used the transvaginal approach to complete a variety of gastrointestinal and urologic surgeries. Given the success with animal experiments, the transition to clinical surgery has begun, with several groups reporting their success with transvaginal cholecystectomy. At present, it appears that the transvaginal approach may be the best suited NOTES portal in those patients in whom it is possible. Future studies are needed to address NOTES' specific concerns, and these potentially less invasive techniques will ultimately need to be compared with standard laparoscopic surgery before their true value can be ascertained. [ABSTRACT FROM AUTHOR]

Enthusiasm for natural orifice transluminal endoscopic surgery (NOTES) has been partly tempered by the reality that most NOTES procedures to date have been laparoscopically assisted. After safely performing transvaginal cholecystectomy in an IACUC-approved porcine model, the authors embarked on an institution review board (IRB)-approved protocol for ultimate performance of pure NOTES cholecystectomy in humans. They describe their experience performing a true NOTES transvaginal cholecystectomy after safely accomplishing three laparoscopically assisted or hybrid procedures in humans. One of the patients was a 35-year-old woman presenting with symptoms of biliary colic. Ultrasound confirmed gallstones, and her liver enzymes were normal. Pneumoperitoneum to 15 mmHg was obtained via a transvaginal trocar placed through a colpotomy made under direct vision. A double-channel endoscope then was advanced into the abdomen. To overcome the retracting limitations of currently available endoscopes, the authors used an extra-long 5-mm articulating retractor placed into the abdomen via a separate colpotomy made under direct vision using the flexible endoscope in a retroflexed position. Endoscopically placed clips were used for control of both the cystic duct and the artery. These techniques obviated the need for any transabdominally placed instruments or needles. This patient was the first to undergo a completely NOTES cholecystectomy at the authors’ institution, and to their knowledge, in the United States. She was discharged on the day of surgery and at this writing has not experienced any complication after 1 month of follow-up evaluation. Performance of NOTES transvaginal cholecystectomy without aid of laparoscopic or needleoscopic instruments is feasible and safe for humans. Additional experience with this technique are required before studies comparing it with standard laparoscopy and hybrid techniques are appropriate. [ABSTRACT FROM AUTHOR]

A response by Luca Milone and Marc Bessler to their article "Esophageal Dilation After Laparoscopic Adjustable Gastric Banding," that was published in a previous issue is presented.

Natural orifice transluminal endoscopic surgery (NOTES) is considered the new frontier for minimally invasive surgery. NOTES procedures such as peritoneoscopy, splenectomy, and cholecystectomy in animal models have been described. The aim of our experiment was to determine the feasibility and technical aspects of a new endoluminal surgical procedure. After approval from Columbia’s IACUC, a transvaginal laparoscopically assisted endoscopic cholecystectomy was performed on four 30 kg Yorkshire pigs. The first step was to insert a 1.5 cm endoscope into the vagina under direct laparoscopic vision. Then the gallbladder was reached and, with the help of a laparoscopic grasper to hold up the gallbladder, the operation was performed. At the end of the procedure the gallbladder was snared out through the vagina attached to the endoscope. There were no intraoperative complications such as bleeding, common bile duct or endo-abdominal organ damage. Total operative time ranged between 110 and 155 min. Based on our experience in the porcine model, we believe that a transvaginal endoscopic cholecystectomy is feasible in humans. [ABSTRACT FROM AUTHOR]

A response by Marc Bessler to a letter to the editor about his article "Esophageal dilation after laparoscopic adjustable gastric banding" in the 2010 issue is presented.

A response by Marc Bessler, Peter Stevens, Luca Milone, Andrew Gumbs, and Dennis Fowler to a letter to the editor about their article "Transvaginal laparoscopic cholecystectomy: laparoscopically assisted" in the 2008 issue is presented.

Fibrinolysis is initiated by tissue-type plasminogen activator (tPA) and inhibited by plasminogen activator inhibitor 1 (PAI-1). In obese humans, plasma PAI-1 and tPA proteins are increased, but PAI-1 dominates, leading to reduced fibrinolysis and thrombosis. To understand tPA-PAI-1 regulation in obesity, we focused on hepatocytes, a functionally important source of tPA and PAI-1 that sense obesity-induced metabolic stress. We showed that obese mice, like humans, had reduced fibrinolysis and increased plasma PAI-1 and tPA, due largely to their increased hepatocyte expression. A decrease in the PAI-1 (SERPINE1) gene corepressor Rev-Erbα increased PAI-1, which then increased the tPA gene PLAT via a PAI-1/LRP1/PKA/p-CREB1 pathway. This pathway was partially counterbalanced by increased DACH1, a PLAT-negative regulator. We focused on the PAI-1/PLAT pathway, which mitigates the reduction in fibrinolysis in obesity. Thus, silencing hepatocyte PAI-1, CREB1, or tPA in obese mice lowered plasma tPA and further impaired fibrinolysis. The PAI-1/PLAT pathway was present in primary human hepatocytes, and associations among PAI-1, tPA, and PLAT in livers from obese and lean humans were consistent with these findings. Knowledge of PAI-1 and tPA regulation in hepatocytes in obesity may suggest therapeutic strategies for improving fibrinolysis and lowering the risk of thrombosis in this setting. [ABSTRACT FROM AUTHOR]

Background: Laparoscopic sleeve gastrectomy (SG) has surpassed Roux-en-Y gastric bypass (RYGB) as the most prevalent bariatric procedure worldwide. While RYGB and SG demonstrate equivalent short-term weight loss, long-term weight loss tends to be greater after RYGB. Differences in the effect of these procedures on gastrointestinal hormones that regulate energy homeostasis are felt to partially underlie differences in outcomes. The objective of this study was to prospectively quantify blood levels of gut hormones of energy and glucose homeostasis at one year follow up to delineate possible reasons for greater efficacy of RYGB over SG in achieving weight loss. Methods: Patients undergoing SG (n = 19) and RYGB (n = 40) were studied before surgery and at 2,12, 26, and 52 weeks postoperatively. Blood samples drawn in the fasted state and after a liquid mixed meal were assayed at baseline, 26, and 52 weeks for peptide YY (PYY), glucagon-like peptide-1 (GLP-1), ghrelin, insulin, glucose, and leptin. Fasting and postprandial appetitive sensations were assessed by visual analog scale. Results: At 1 year there was greater weight loss in RYGB compared with SG patients (30% vs 27%; P = 0.03). Area under the curve (AUC) after the mixed meal for PYY was greater in RYGB patients (P<0.001). RYGB patients had significant increases in GLP-1 AUC compared to baseline (P = 0.002). Ghrelin levels decreased only after SG compared to baseline (P<0.001) but were not significantly different from RYGB. There was a trend toward decreased sweet cravings in RYGB patients (P = 0.056). Conclusions: Differences in gastrointestinal hormones that regulate energy and glucose homeostasis are a possible mechanism for greater efficacy of RYGB compared to SG. [ABSTRACT FROM AUTHOR]

Bariatric surgery is a treatment option for obese patients with type 2 diabetes mellitus (T2DM). Although sleeve gastrectomy (SG) is growing in favor, some randomized trials show less weight loss and HbA1c improvement compared with Roux-en-Y gastric bypass (RYGB). The study objective was to compare changes in beta-cell function with similar weight loss after SG and RYGB in obese patients with T2DM. Subjects undergoing SG or RYGB were studied with an intravenous glucose tolerance test before surgery and at 5-12% weight loss post-surgery. The primary endpoint was change in the disposition index (DI). Baseline BMI, HbA1c, and diabetes-duration were similar between groups. Mean total weight loss percent was similar (8.4% ± 0.4, p = 0.22) after a period of 21.0 ± 1.7 days. Changes in fasting glucose, acute insulin secretion (AIR), and insulin sensitivity (Si) were similar between groups. Both groups showed increases from baseline to post-surgery in DI (20.2 to 163.3, p = 0.03 for SG; 31.2 to 232.9, p = 0.02 for RYGB) with no significant difference in the change in DI between groups (p = 0.53). Short-term improvements in beta-cell function using an IVGTT were similar between SG and RYGB. It remains unclear if longer-term outcomes are better after RYGB due to greater weight loss and/or other factors. [ABSTRACT FROM AUTHOR]

Background and study aims Staple-line leaks occur in 1 % - 7 % of patients who undergo sleeve gastrectomy, and can be challenging to treat. The success of endoscopic approaches decreases as leaks develop into chronic sinus tracts. Endoscopic septotomy has been used to facilitate healing of refractory leaks by incision and enlargement of the tract to allow direct communication with the gastric lumen and internal drainage. Patients and methods We reviewed the technique and outcomes among patients who underwent endoscopic septotomy at two centers for the management of sleeve gastrectomy-associated gastric fistulas and perigastric collections refractory to occlusive endoscopic therapies. Results Nine patients underwent endoscopic septotomy at a mean of 8.6 weeks after leak diagnosis, following failure of percutaneous and conventional endoscopic modalities. Perigastric collections ranged from 3 cm to 10 cm in size. The mean procedure time for endoscopic septotomy was 87.2 minutes. Multiple endoscopic septotomy procedures (mean 2.3, range 1 - 4) were required to achieve radiological resolution. The mean follow-up period was 21.2 weeks, and all nine patients achieved symptom resolution without the need for surgery. Bleeding at the time of endoscopic septotomy occurred in three patients, and was managed with endoscopic clips and did not require transfusion. No other adverse events or delayed complications were recorded. Conclusions Endoscopic septotomy appears to be a safe and effective technique for the management of sleeve gastrectomy-associated fistulae and collections, including those refractory to other endoscopic and percutaneous methods. [ABSTRACT FROM AUTHOR]

Improvement in type 2 diabetes after Roux-en-Y gastric bypass (RYGB) has been attributed partly to weight loss, but mechanisms beyond weight loss remain unclear. We performed an ancillary study to the Diabetes Surgery Study to assess changes in incretins, insulin sensitivity, and secretion 1 year after randomization to lifestyle modification and intensive medical management (LS/IMM) alone (n = 34) or in conjunction with RYGB (n = 34). The RYGB group lost more weight and had greater improvement in HbA1c. Fasting glucose was lower after RYGB than after LS/IMM, although the glucose area under the curve decreased comparably for both groups. Insulin sensitivity increased in both groups. Insulin secretion was unchanged after LS/IMM but decreased after RYGB, except for a rapid increase during the first 30 min after meal ingestion. Glucagon-like peptide 1 (GLP-1) was substantially increased after RYGB, while gastric inhibitory polypeptide and glucagon decreased. Lower HbA1c was most strongly correlated with the percentage of weight loss for both groups. At baseline, a greater C-peptide index and 90-min postprandial C-peptide level were predictive of lower HbA1c at 1 year after RYGB. β-Cell glucose sensitivity, which improved only after RYGB, and improved disposition index were associated with lower HbA1c in both groups, independent of weight loss. Weight loss and preserved β-cell function both predominantly determine the greatest glycemic benefit after RYGB. [ABSTRACT FROM AUTHOR]

Marked improvement in glycemic control occurs in patients with type 2 diabetes mellitus shortly after Roux-en-Y gastric bypass surgery (RYGB) and before there is major weight loss. The objective of this study was to determine whether the magnitude of this change is primarily due to caloric restriction or is unique to the surgical procedure. We studied eleven subjects who underwent RYGB and fourteen subjects mean-matched for BMI, HbA1c, and diabetes duration who were admitted to our inpatient research unit and given a very low-calorie diet (VLCD) of 500 kcal/day with a macronutrient content similar to that consumed by patients after RYGB. Frequently sampled intravenous glucose tolerance tests were performed before and after interventions. Both groups lost an equivalent amount of weight over a mean study period of 21 days. Insulin sensitivity, acute insulin secretion after intravenous glucose administration, and β-cell function as determined by disposition index improved to a similar extent in both groups. Likewise, changes in fasting glucose and fructosamine levels were similar. Based on these data, VLCD improves insulin sensitivity and β-cell function just as well as RYGB in the short term. [ABSTRACT FROM AUTHOR]

Marked improvement in glycemic control occurs in patients with type 2 diabetes mellitus shortly after Roux-en-Y gastric bypass surgery (RYGB) and before there is major weight loss. The objective of this study was to determine whether the magnitude of this change is primarily due to caloric restriction or is unique to the surgical procedure. We studied eleven subjects who underwent RYGB and fourteen subjects mean-matched for BMI, HbA1c, and diabetes duration who were admitted to our inpatient research unit and given a very low--calorie diet (VLCD) of 500 kcal/day with a macronutrient content similar to that consumed by patients after RYGB. Frequently sampled intravenous glucose tolerance tests were performed before and after interventions. Both groups lost an equivalent amount of weight over a mean study period of 21 days. Insulin sensitivity, acute insulin secretion after intravenous glucose administration, and β-cell function as determined by disposition index improved to a similar extent in both groups. Likewise, changes in fasting glucose and fructosamine levels were similar. Based on these data, VLCD improves insulin sensitivity and β-cell function just as well as RYGB in the short term. [ABSTRACT FROM AUTHOR]

Importance: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown.Objective: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors.Design, Setting, and Participants: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008.Interventions: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized.Main Outcomes and Measures: Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg.Results: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group.Conclusions and Relevance: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events.Trial Registration: clinicaltrials.gov Identifier: NCT00641251. [ABSTRACT FROM AUTHOR]

Importance Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. Objective To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. Design, Setting, and Participants A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Interventions Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Main Outcomes and Measures Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. Results All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1 % vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. Conclusions and Relevance In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. Trial Registration clinicaltrials.gov Identifier: NCT00641251 [ABSTRACT FROM AUTHOR]

An important aspect of a new surgical technique is whether it can be performed by other surgeons in other institutions. The authors report the first 297 cases in a multi-institutional and multinational review of laparoscopic cholecystectomy performed via a single portal of entry. Data were collected retrospectively for the initial patients undergoing single-port cholecystectomy by 13 surgeons who performed these procedures in their institutions after training by the authors. The review included operative time, blood loss, incision length, length of hospital stay (LOS), necessary additional trocars, and other parameters important to cholecystectomy. A database of all the single-port-access (SPA) surgeries performed by the surgeons included demographic and procedural details, LOS, complications, and initial follow-up data. To date, 297 single-port cholecystectomies have been performed for a variety of diagnoses, primarily cholelithiasis. The average operative time was 71 min, and the average LOS was 1–2 days. The average blood loss was minimal. The use of additional port sites outside the umbilicus occurred in 34 of the cases. Of the 35 intraoperative cholangiograms performed, 34 were successful. No significant complications occurred except for seromas and minor postoperative wound infections. These results are comparable with those for standard multiport cholecystectomy. In addition, no access site hernias (ASH) occurred. The findings demonstrate that SPA surgery is an alternative to multiport laparoscopy with fewer scars and better cosmesis. One factor affecting the rate for adoption of SPA surgery among other surgeons is the reproducibility of this new procedure. Although this study had insufficient data to determine fully the benefits of SPA surgery, the feasibility of this procedure with safe, acceptable results was demonstrated in this initial large series across multinational institutions. [ABSTRACT FROM AUTHOR]

Weight regain after Roux-en-Y gastric bypass may be caused by pouch enlargement or dilatation of the gastrojejunostomy (stoma). In order to avoid the substantial morbidity of revisional bariatric surgery, investigators have recently demonstrated the feasibility of reducing stoma diameter using transoral endoscopic suturing techniques. Our aim was to demonstrate the feasibility of performing both pouch and stomal reduction using transoral endoscopically placed tissue anchors in an ex vivo and acute animate model. Part I: We created an ex vivo model of a dilated gastric pouch and stoma using four explanted porcine stomachs. The stomach was divided to create an upper pouch of approx. 100 ml volume, which was reconnected to the lower portion of the stomach (gastric remnant) via an anastomosis of 18 to 20 mm diameter. Endoscopically placed anchors were then used to create plications of the stoma and reduce its diameter. In two stomachs, anchor plications were also used to decrease pouch volume. Pouch volumes and stoma diameters were measured pre- and post-procedure. Part II: A similar experimental model was created in vivo using three pigs. Anchors were placed in the stoma and pouch. The animals were immediately sacrificed and similar measurements were obtained. In the ex vivo model, stoma diameter was successfully reduced in all four stomachs by a mean of 8 mm (41%). This represented a mean decrease in cross-sectional area of 65%. Pouch volume was reduced by a mean of 28 ml (30%) in two stomachs. Stomal plications were successfully placed in two of the live animals, with a mean stoma diameter reduction of 11.5 mm (53%). Feasibility of pouch reduction using plicating anchors was confirmed. This is the first study to demonstrate the feasibility of using endoscopically placed tissue anchors to reduce both stoma diameter and pouch volume. This technique may ultimately be clinically useful in treating weight regain after gastric bypass surgery. [ABSTRACT FROM AUTHOR]

Enthusiasm for natural orifice transluminal endoscopic surgery (NOTES) has been partly tempered by the reality that most NOTES procedures to date have been laparoscopically assisted. After safely performing transvaginal cholecystectomy in an IACUC-approved porcine model, the authors embarked on an institution review board (IRB)-approved protocol for ultimate performance of pure NOTES cholecystectomy in humans. They describe their experience performing a true NOTES transvaginal cholecystectomy after safely accomplishing three laparoscopically assisted or hybrid procedures in humans. One of the patients was a 35-year-old woman presenting with symptoms of biliary colic. Ultrasound confirmed gallstones, and her liver enzymes were normal. Pneumoperitoneum to 15 mmHg was obtained via a transvaginal trocar placed through a colpotomy made under direct vision. A double-channel endoscope then was advanced into the abdomen. To overcome the retracting limitations of currently available endoscopes, the authors used an extra-long 5-mm articulating retractor placed into the abdomen via a separate colpotomy made under direct vision using the flexible endoscope in a retroflexed position. Endoscopically placed clips were used for control of both the cystic duct and the artery. These techniques obviated the need for any transabdominally placed instruments or needles. This patient was the first to undergo a completely NOTES cholecystectomy at the authors' institution, and to their knowledge, in the United States. She was discharged on the day of surgery and at this writing has not experienced any complication after 1 month of follow-up evaluation. Performance of NOTES transvaginal cholecystectomy without aid of laparoscopic or needleoscopic instruments is feasible and safe for humans. Additional experience with this technique are required before studies comparing it with standard laparoscopy and hybrid techniques are appropriate. [ABSTRACT FROM AUTHOR]

A recently convened Consortium at the Cleveland Clinic agreed on the term Laparo-Endoscopic Single-Site (LESS) surgery to describe minimally invasive techniques that use a single incision to accomplish laparoscopic procedures. These procedures are done by using either a single port through one fascial incision or multiple ports placed through separate fascial incisions. Because of cost containment issues and the lack of widespread availability of a single port, we currently use multiple reusable ports placed through three separate fascial incisions via a transumbilical incision. As opposed to standard laparoscopic cholecystectomy, a deflecting laparoscope and one articulating instrument are utilized to improve the safety and ease of this procedure. Presented in this video are the steps necessary to perform a LESS cholecystectomy via a transumbilical incision with commercially available instruments. [ABSTRACT FROM AUTHOR]

Natural orifice transluminal endoscopic surgery (NOTES) is considered the new frontier for minimally invasive surgery. NOTES procedures such as peritoneoscopy, splenectomy, and cholecystectomy in animal models have been described. The aim of our experiment was to determine the feasibility and technical aspects of a new endoluminal surgical procedure. After approval from Columbia's IACUC, a transvaginal laparoscopically assisted endoscopic cholecystectomy was performed on four 30 kg Yorkshire pigs. The first step was to insert a 1.5 cm endoscope into the vagina under direct laparoscopic vision. Then the gallbladder was reached and, with the help of a laparoscopic grasper to hold up the gallbladder, the operation was performed. At the end of the procedure the gallbladder was snared out through the vagina attached to the endoscope. There were no intraoperative complications such as bleeding, common bile duct or endo-abdominal organ damage. Total operative time ranged between 110 and 155 min. Based on our experience in the porcine model, we believe that a transvaginal endoscopic cholecystectomy is feasible in humans. [ABSTRACT FROM AUTHOR]