GH

Abstract

The Intragastric Balloon (IGB) is an endoscopic method to reduce weight within a short period. It is less invasive and cheaper than bariatric surgery, but can only be left in the stomach for 6 months. This is a well known procedure since the eighties, and it has been refreshed in the nineties, with a new generation of devices that have been more reliable and safer. This technique provides only a temporary weight-loss, which can be sustained further on if the proper diet counselling is not discontinued.

Keywords

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Gastric Balloon

Principles

The Intragastric Balloon (IGB) is an endoscopic method to reduce weight within a short period. It is less invasive and cheaper than bariatric surgery, but can only be left in the stomach for 6 months. This is a well known procedure since the eighties, and it has been refreshed in the nineties, with a new generation of devices that have been more reliable and safer. This technique provides only a temporary weight-loss, which can be sustained further on if the proper diet counselling is not discontinued.

The overall results need to be reminded, such as in Imaz et al. 2008: Fifteen papers (3,608 patients) have been reviewed in this meta-analyzis: The mean weight-loss after balloon removal has been 14.7 kg (12.4–17), i.e. 12.2 % of initial weight (10–14.3), 5.7 BMI Unit (4.4–6.9) and 32.1 % excess-weight (26.9–37.4). Two control and randomized series have been accounted for (balloon versus placebo) with a total of 75 patients, showing a difference in weight-loss of 6.7 kg (17.6 % excess-weight loss). These two studies were thorough and double-blinded; they proved that weight-loss during the time of balloon insertion was genuine. On the other hand, there are few studies on results after balloon removal: two studies have been considered non eligible (more than 50 % of patients were lost for follow-up), and two studies have been acknowledged, with 143 patients (weight-loss at the time of removal  =  15.9 kg, weight-regain ­during the next year  =  6.3 kg, namely 39.6 % of the previous weight-loss). Even if sporadic reports have mentioned a continuation of weight-loss or weight maintenance after balloon removal, the common assumption is that weight-regain will occur to some degree during the following months, whatever diet support is provided.

Similarities

The balloon competes with any non invasive bariatric procedure. Because of its anteriority, it provides a benchmark to any trial in this field (see section “Benchmarking of Novel Technologies in Bariatric Surgery”): not only the effect of new devices should last longer in terms of weight-maintenance, but they should also match the weight-loss that has been achieved in the studies that have been reported for 30 years.

Fig. 15

(a) Air-filled Intra Gastric Balloon (Heliogast), (b) Serum-filled Intra Gastric Balloon (Allergan)

Results

We picked up three recent papers pertaining respectively to a general and typical experience, a comparison between two balloons, and the use of the balloon as a pre-operative tool (weight-loss for any surgical procedure, or in super-obese patients before bariatric surgery), which has been for a long time the “official” ­recommendation of this device.

Poliwoda et al. (2011): report the results of 55 patients in Klinikum Großhadern. Methods: 24 water-filled and 31 air-filled balloons were implanted by gastroscopy. The length of therapy was 6 months. The patients were interviewed three times during therapy and also 6 and 12 months after explantation. In addition to the weight-­reduction we analysed life-quality, change of lifestyle and complications. Results: Weight-loss after 6 months of therapy was 11 kg (−12 kg up to +41 kg). They could reduce their BMI by 4 kg/m² (−4 kg/m² up to +13 kg/m²). 17 patients lost more than 15 kg during therapy (30.9 %), 8 patients lost less than 5 kg (14.5 %). The % EWL was 20 % within 6 months of treatment – the major part of weight-loss occurred within the first 3 months. IGB was more effective in patients with a higher initial weight (BMI over 40 kg/m²), who lost 14 kg (−12 kg up to +41 kg). Patients with an initial BMI under 40 kg/m² lost 10 kg (−6 kg up to +35 kg). Water filled balloons seem to effect a better weight reduction (13 kg) than air filled ones (11 kg). Patients, who started physical activity (14 kg) or changed their eating habits (15 kg) could benefit more than ­others (7.5 kg; 4 kg). During the first 4 weeks of therapy 89 % (n  =  49) of the patients complained about side effects like nausea and stomach pain. In four cases (7.2 %) severe complications occurred (erosive gastritis, perforation with peritonitis, pylorus obstruction, ulcer with acute abdomen). In three cases balloons lost volume within 180 days.

Seventeen patients underwent bariatric surgery or a second balloon treatment afterwards and continued losing weight. Long-term results are not satisfying: At the time of balloon removal the median weight of our observed group was 115 kg (71–237 kg), 12 months after treatment the median weight was 109 kg (72–165 kg) kg. During the first 6 months after therapy most of our patients lost weight, but 6–12 months after removal, most of them regained weight. Health insurance covered the cost of the treatment in 26 cases only, although 39 patients had more than two comorbidities. Conclusions: IGB treatment is an effective method to reduce weight in a short period of time. Especially in super-obese objects it can be an effective method before bariatric surgery. Long-term results without subsequent bariatric surgery are not satisfactory, because they depend on the readiness and commitment of the patients to change their life habits.

Bozkurt et al. (2011) report the results in terms of safety and efficiency using two different kind of liquid-filled balloons. Materials and methods: Fifty obese patients were prospectively divided into two groups. In the first group Bioenterics IGB (n  =  25) and in the second group Silimed IGB (n  =  25) were implanted endoscopically under deep-sedation anaesthesia. At the end of the 6 month period IGBs were removed. The absolute weight loss, percentage of body mass index loss (% EBMIL), % EWL, complication rates were recorded. Results: In Bioenterics IGB group there were 10M/15F, mean age 31.8  ±  12.3 years (range 16–61), mean BMI 40.6  ±  7 kg/m². In Silimed IB group there were 13M/12F with mean age 36.3  ±  10.5 years (range 17–56), mean BMI 39  ±  8 kg/m². There was no statistical difference between two groups in terms of demographics. The placement and removal of balloons in both groups were uneventful. The patients were discharged within 4 h after the procedures. No mortality or major complications were seen in both groups. Minor complications like transient nausea, vomiting (32 % vs 28 %) and pain (20 % vs 16 %) were equally seen in two groups. These minor complications were treated medically. In both groups the mean BMI went down significantly (p  <  0.001 in both). But the absolute weight loss, % EWL and % EBMIL at the end of the treatment were statistically insignificant between the two groups (t:−0.415; p:0.680 and t:−0.239; p:0.812 and t:−0.177; p:0.860 respectively). Conclusions: Both Bioenterics IGB and Silimed IGB are equally safe and effective in weight reduction in morbidly obese patients. The Silimed IGB was found to be technically more convenient and simple.

Zerrweck et al. (2011): Super-super obesity (BMI  >  60 kg/m²) increases morbi-mortality in bariatric surgery. We have shown previously that a significant weight-loss can be obtained in these patients with an intragastric balloon (IGB). We explored the potential benefit of preoperative IGB on the outcome of laparoscopic RYGB. Methods: We compared in a case-control study the prospectively collected records of 60 super-super obese patients (66.5  ±  3.4 kg/m²) submitted to a LGBP between 2004 and 2009, with preoperative IB (n  =  23, cases) or without (n  =  37, controls). Results: Baseline characteristics were homogenous in both groups. In the case group, IGB was maintained during 155  ±  62 days and induced an 11.2  ±  3.2 of % EBMIL, resulting in a lower BMI at surgery (60.5  ±  4.3 kg/m² vs 66.3  ±  6.8 kg/m² in controls; p  <  0.05). Systolic blood pressure and GGT were also decreased after IB therapy (p  <  0.05 vs baseline). Operative time was reduced after IGB (146  ±  47 min vs 201  ±  81 min in controls; p  <  0.01) and mean ICU/overall hospital stay were lower than in the control group (NS). The composite end point of significant adverse outcomes (conversion, reoperation, ICU stay >2 days, overall stay >2 weeks) was significantly reduced in the IGB group (2 vs 13 in controls; p  <  0.05). All patients were alive at 1 year and overall weight loss was similar in the case (52.4  ±  17.3 % EBMIL) and control group (50.3  ±  12.7 % EBMIL). Conclusion: Preoperative weight loss induced by IGB prior to laparoscopi RYGB in super-super obese patients was associated with a reduced operative time and a lower overall risk of significant adverse outcomes.

Gastric Balloon Without Endoscopy

Swallowing a balloon would mean that an intra-operative endoscopy is not necessary during balloon placement. This dream could come true owing to current research. Feasability studies are available and we must wait till the next edition of our directory to get results… Balloon elimination assessment could require an endoscopy or other exams though. The possibility of adding a second (and even a third) balloon has been mentioned.

Principles

Intragastric balloons have been used for weight loss with varying success. Widespread use of intragastric balloons has been limited because balloons must be placed in, and removed from the stomach endoscopically. Development of a balloon that does not require endoscopy suggests that obesity treatment with intragastric balloons has more potential. The Ullorex OIB is a large capsule that is injected with citric acid and swallowed. After 4 min, the balloon inflates to 300 cm3. Stomach acid degrades a plug on the balloon over 25–30 days, when the balloon deflates and passes in feces.

Similarities

It competes with the other types of gastric balloon. The fact that no endoscopy is necessary could be a huge advantage. A similar device is being currently tested (Obalon^®)

Results

Corby et al. (2007): The purpose of this study was to test the Ullorex^® oral intragastric balloon (OIB) in a sample of human participants. The Ullorex OIB was tested in 12 humans (two participants received placebo capsules). Body weight was monitored before and after balloon placement, and test meals quantified food intake among 6 of the 12 participants, all of whom received one balloon. Results: A single significant adverse event occurred. The one participant randomized to receive three balloons developed nausea and vomiting, requiring intravenous fluids, which was likely influenced by noncompliance (eating solid foods after balloon placement). Participants who received balloons had a significant mean weight loss over 2 weeks, amounting to 1.5 kg (p  <  0.05). A marginally significant food intake reduction from baseline to week 1 was found (149 kcal, 24.4 %) (p  =  0.055). Conclusions: The Ullorex OIB was successfully utilized in this study, with one serious adverse event that was likely influenced by noncompliance. Body weight and food intake data suggest that the Ullorex OIB be tested further as a possible treatment for obesity.

Gastric Plication (Laparoscopic Greater Curve Plication or LGCP)

Principles

Laparoscopic vertical gastric plication (LGCP) is a new surgical technique that falls into the restrictive procedure category and has gained interest in the bariatric community since a few initial studies have shown favorable results in the short term. Restrictive procedures involved the use of a foreign material, stapling devices or partial gastric resection, the LGCP surgery only involves shape modification of the stomach to achieve restriction by folding the greater curvature of the stomach inward with suture materials, thus reducing gastric capacity.

Similarities

LGCP is a strong competitor to the sleeve gastrectomy itself, although no one knows if it is likely to replace it. In this respect, the term “sleeve-killer” seems slightly exaggerated. On the other hand, LGCP could be matched by gastric internal ­plication (see section “Transport G-Prox “ROSE” for Re-do After Failed Gastric Bypass and “POSE” for Primary Cases”) if a longer portion of the stomach could be plicated through this approach.

Fig. 16

Laparoscopic Greater Curve Plication

Results

This topic being a hot subject of controversy, we picked-up several recent and relevant papers coming either from “emerging” countries that accumulated a great amount of data (Mexico, Iran) and/or western teams commencing their experience (UK, USA, Greece).

Lapatsanis et al. (2011): From January 2009 to January 2011 a total of 155 obese patients had a restrictive bariatric procedure – 76 LGCP and 79 LSG. These patients were compared in terms of postoperative weight-loss, mean % EWL and % EBMIL. Results: In the LGCP group, mean preoperative weight and body mass index (BMI) were 115  ±  18.2 kg (range 75–161) and 40.8 ±4.5 Kg/m² (range 35–59) respectively. Out of 76 patients, 15 had a BMI above 45 Kg/m². Mean follow-up was 14  ±  2.1 months (range 6–24). The mean postoperative weight-loss was 36 Kg and the mean excess weight loss (% EWL) was 81.1 % after 12 months and 82.9 % after 24 months. The average time of follow-up was 18 months. In the group of LSG the mean postoperative % EWL was 83.7 % 1 year postoperatively and 84.9 % after 2 years. The mean % EBMIL was 81.6 %. The average time of follow-up was 18 months. Conclusions: Laparoscopic sleeve gastrectomy is a safe restrictive operation for the treatment of morbid obesity, gaining acceptance worldwide. Laparoscopic total vertical gastric plication is a valuable alternative, less expensive, with similar results, especially in patients with BMI  <  45 kgr/m². Long-term outcomes are still required in order to evaluate the efficacy of the method, compared with other restrictive bariatric techniques.

Ortiz Lagardere et al. (2011): A total of 259 gastric plication surgeries by the same surgical team in a single bariatric center have been performed from July 2010 to March 2011, the surgical technique involved a two layered complete plication of the greater gastric curvature including anterior and posterior gastric surface, starting 1 cm from the esophageal gastric junction, ending 3–4 cm from the pylorus. Results: Of the 259 patients (Mean BMI 40.2 kg/m²), 21 had conversions from gastric band to gastric plication surgery. Mean surgery time was 55 min, ranging from 32 to 125 min. Mortality rate was 0 %. Surgical complications occurred in eight patients (two patients with intra-abdominal bleeding that required surgical revision and blood transfusion, two cases of upper GI bleeding from ulcer formation in the plicated stomach and four cases of post operative obstructions that required redoing the plication in three patients and reversal in one). During a 3–6 months follow-up period of 118 patients (104 with no previous gastric surgery and 14 with a previous adjustable gastric band) we found a mean 42 % EWL (range 5–72 %). Out of the 118 patients, eight have undergone revision surgery to further plicate the stomach because of complete loss of restriction (six patients with previous gastric band surgery and two in the group with no previous surgery), none had complications during revision surgery. Conclusion: Although long term data on gastric plication surgery is still not available, our initial experience with this procedure has offered positive results. Additional studies and long term follow-up are needed to further define the clinical applications of this procedure.

Talebpour et al. (2011): We present 11 years experience of a new technique (vertical gastric plication), enabling us to decrease the gastric volume with long time results. History: We examined plication of different types in the sheep’s stomach in 2000, then started anterior plication with voluntary patients. The details were changed three times. Methods: Three 5 mms and one 10 mm trocars are usually used. Dissection started at the greater curvature behind the pylorus and continued up to 2 cm to the angle of His. The plication went from the anterior wall of the stomach to the posterior wall (imbrication of the greater curvature inside the stomach). Nylon 2/0 was used and the bulk of each stitch was 1.5 cm, with a 1.5 cm interval. In order to preserve the fundus, deep sutures were usually added to the main row of sutures (two rows for one suture). Results: 620 patients were operated, mean age: 28 years, 500F/120M, mean BMI  =  42.7 (59–35), over 11 years by a single surgeon, in Tehran, Iran (2000–2011). Mean weight loss was 20 % EWL at 1 month (475), 60 % at 6 months (354), 62 % at 12 months (235), 65 % at 24 months (127), 57 % at 36 months (103) and 56 % at 48 months (75). The weight-loss curve was prominent in the first 6 months, less during the next period of time until 3 years, although the end-result was the same as other techniques. The mean time of operation was 81 min (49–152), with a discharge at 3 days on average. There were no mortality, no embolism, early intolerance. Five patients were reoperated because of a micro perforation (3), obstruction at a suture knot (1), and permanent vomiting due to adhesion between the traumatized liver and the stomach (1). The rate of weight-regain was 15 % at 4 years (11/75 cases) of operation, 30 % at 7 years (10/35) and 50 % at 10 years (5/10 cases). Conclusion: The percentage of EWL in this technique is comparable to other gastric volume restriction methods, with a limited rate of complications (mortality 0 %, reoperation 1 %, unrelated morbidity 1 %).

Narwaria et al. (2011): We aimed at comparing the surgical outcome after sleeve gastrectomy and gastric imbrication in patient with morbid obesity. Methods: This was a prospective randomized study conducted at Asian Surgicentre, Ahmedabad from September 2009 to September 2010. There were 30 patients with morbid obesity with BMI more than 35 kg/m². The option for surgery was chosen by randomization. The study was approved by local Independent Ethical Committee. Weight, height, and BMI of all the patients were recorded before surgery. All the associated co-morbidities with duration were recorded. The patients were followed every other month till 1 year after surgery. Results: Among 30 patients, 16 and 14 patients were operated by sleeve Gastrectomy and gastric imbrication respectively. All patients have completed 6 month follow up. 10 (33.3 %) patients have completed 1 year follow up. After 6 month mean excess weight loss in LSG and LGI was 35 % and 30 %. Mean % EBMIL was 31.1 and 24.4 % respectively. After 1 year mean excess weight loss in LSG and LGI was 49 and 45 %. Mean % EBMIL was 35.5 and 26.6 % respectively. One patient had a gastric perforation outside of the suture line and required re-laparoscopy, suture removal and closure of gastric perforation. There was no mortality. Conclusion: Both procedures are effective in reducing weight but none of them are free of ­complications in form of perforation and leak. Gastric Imbrication could be the best procedure for patient who wish reversion. More studies are required for long-term outcome.

Gastric Plication Associated with Banding

A gastric plication can be proposed as an adjuvant of a gastric banding (or vice and versa!). If one can be skeptical about such a combination, attention should be paid to the results of these procedures.

Huang CK promoted this combination procedure and presented it at the Ist NonInva meeting (Lyon, May 2011): The weight loss effect of laparoscopic adjustable gastric banded plication (LAGBP) was similar to sleeve gastrectomy in the early stage because of added plication effect, improving the weight loss and patient compliance. His recent case-matched study showed similar weight-loss effect up to nearly 70 % excess-weight loss and resolution of co-morbidity with sleeve gastrectomy at 2 years. It could be expected that the lower frequency of adjustment will decrease the risk of erosion and infection of the band. It combined three mechanisms, with restrictive, reductive and reversible characteristics. In the long-run, it could act to prevent weight regain after band adjustment, and can be suggested as a salvage procedure for gastric band failure.

Mozzi et al. (2011): Laparoscopic adjustable gastric banding (LAGB) is one of the most widely performed surgical procedures for morbid obesity, allowing up to 55 % of EWL. There is however a wide group of patients with EWL ranging between 25 and 50 %, where an increased effect of LAGB could be useful. Laparoscopic gastric plication (LGCP) is a new restrictive procedure that does not to require gastric resection, is reversible, and can be added to LAGB because it increases the restrictive effect while avoiding contamination of the prosthetic material. A synergistic effect may be obtained because LAGB reduces the esogastric transit, while LGCP reduces the gastric volume. Our aim was to evaluate the effect of LGCP in patients who had experienced poor weight-loss after LAGB and needed revisional surgery. Methods: 5 patients with poor weight-loss after LAGB needed revisional surgery for band slippage (2), tube disconnection in peritoneum (1), band rupture (1), isolated poor weight loss (1). They underwent LGCP in addition to band revision, in order to increase the effectiveness of LAGB. Surgical technique: two 5 mm and two 10 mm trocars were inserted, as in usual LAGB operation. After band revision, a greater curvature omentectomy was performed with the harmonic scalpel from the antrum (3–4 cm from pylorus) to the angle of His. The LGCP was then created with assistance of a 32-Ch bougie, invaginating the greater curvature with a first row of interrupted stitches of 2–0 Polypropylene. A second row of running suture of the same material was done over the whole length of the first one. Results: Postoperative course was uneventful, except slight nausea in the first few days. A gastrografin swallow on the first postoperative day showed a slow gastric transit, the band in place and the ­tubular shape of the plication clearly visible. The patients were discharged on the 3^rd postoperative day on a liquid diet, and resumed a solid diet within 4 weeks. The mean preoperative BMI was 37.3  ±  5.19. After 3 months, while the band still was not inflated, all patients lost weight, % EWL was 18.6  ±  16.9. No symptoms of vomiting or reflux were observed. Conclusions: Surgical revisions are frequent after LAGB, in a range of 5–32 %: main causes are pouch dilatation or connecting tube complications. If band revision is needed, a % EWL lower than 50 % may be an indication to LGCP.

G-Prox for Morbid Obesity

(See section “Transport G-Prox “ROSE” for Re-do After Failed Gastric Bypass and “POSE” for Primary Cases”)