Is There Still a Role for Video-Assisted Laparoscopic Gastric Banding in Severe Obesity?

Abstract

Introduction:

Gastric banding is the most commonly used surgical procedure to lose weight. The aim of this study is to report our experience with the use of the hand-assisted technique for gastric banding in severe obesity.

Materials and Methods:

The study included all cases treated for severe obesity between January 2005 and July 2012 at the authors' institutions. Inclusion and exclusion criteria for the study were created; early and late complications and outcomes were also considered.

Results:

A total of 313 patients were treated during the study period. Median preoperative weight was 120.6 kg (range 82–150 kg) with a median body–mass index of 44 kg/m² (range 36.6–47.8 kg/m²); median operating time was 47 min (range 29–103 min). No patient needed conversion to open surgery, while 4% of cases showed intolerance. None of the study patients underwent further bariatric procedures.

Conclusions:

The hand-assisted technique is safe and useful and it permits a shorter operating time than standard laparoscopy and guarantees better placement of the gastric band.

Introduction

Laparoscopic adjustable gastric banding (LAGB) has been proven a safe and efficient surgical treatment of morbid obesity. The first laparoscopic implantations of gastric bands were carried out in Belgium in 1990 by two different surgeons, Cadière¹ and Belachew.²

LAGB remains the most commonly performed bariatric procedure worldwide,³ but in many cases, patients had to reduce their weight before procedures. Many studies showed that it has a shorter learning curve and lower rates of early complications, two aspects that have probably contributed to the popularity of the procedure. The most invasive bariatric surgery techniques, such as the restrictive techniques, usually show a long learning curve and certainly need the supervision of surgeons highly skilled in that specific technique.^4–9

Video-assisted techniques, including the hand-assisted one, have been used so far to perform many different types of surgery (nephrectomy, colectomy, splenectomy, etc.) and in derivative and restrictive procedures to gain weight loss.^10–15

The purpose of this study is to describe our experience with the hand-assisted technique for the management of severe obesity without any wait for weight loss.

Materials and Methods

A retrospective analysis of a prospectively maintained database of all patients undergoing hand-assisted laparoscopic surgical procedures for severe obesity was carried out between January 2005 and July 2012. Eligibility for surgery was defined according to the 1991 National Institutes of Health (NIH) consensus criteria for bariatric surgery. Inclusion criteria for the study were indicated as follows: body–mass index (BMI) above 40 or between 35 and 40 with comorbidities that could improve with weight loss (type 2 diabetes, hypertension, high cholesterol, nonalcoholic fatty liver disease, obstructive sleep apnea, and gastroesophageal reflux); age between 16 and 65 years; failure of medically supervised dietary therapy (for about 6 months); and history of obesity (up to 5 years). Exclusion criteria were the following: patients lost to follow-up or who underwent other bariatric procedures; alcohol or drug dependence; and emotionally unstable patients or with severe learning/cognitive disabilities. The study was approved by the internal Institutional Review Board.

Surgical procedure

The patient is intubated and secured to the operating table in the supine position with the legs spread apart. Using the French position, the operators take their place around the patient: pneumoperitoneum is obtained with blind access to the abdominal cavity by inserting the Veress needle through the Palmer point. While the first operator firmly holds the needle in place, the second operator connects the warm CO₂ insufflation line to the Veress needle after a small amount of CO₂ is inflated through the line to eliminate possible residual air. After positioning of the trocar camera and another trocar in the left upper abdominal quadrant, the subcostal minilaparotomic 7-cm incision is performed. With a blunt dissection, the operator prepares the retrogastric passage just below the diaphragm, medially including the pars flaccida as well. When the operator reaches the cardias, the band is wrapped anteriorly around the stomach; with one finger, the operator grasps an extremity of the band through the retrogastric passage previously created, thus completing its placement. The band is closed by operating the locking mechanism with an atraumatic grasping forceps; then, the operator sutures the area with two braided nonabsorbable sero-serosal stitches sewed between the new gastric pouch and the distal stomach with an antislippage function (Fig. 1).

FIG. 1.

Hand-assisted laparoscopic banding—band closure.

Demographic and weight data, operative data, hospital stay, morbidity, mortality, and procedure-related complications were recorded and reported. Morbidity was defined as early within 30 days of surgery or late after the first 30 postoperative days. Procedure-related complications included bleeding, slippage, leakage, stricture formation, and ulceration. The following complications could also be observed: gastritis (irritated stomach tissue), gastroesophageal reflux (regurgitation), heartburn, gas bloat, dysphagia (difficulty swallowing), and dehydration. Slippage was defined as herniation of the stomach from below the band upward, resulting in pouch enlargement. All the procedures were performed by the same team of two surgeons, both experienced in advanced laparoscopic surgery (at least 50 laparoscopic banding procedures). The few cases treated by surgeons with no previous experience in bariatric surgery were supervised by one of the two experienced bariatric surgeons to ensure safety and efficacy of the procedure in compliance with international guidelines.

Patients were admitted to the hospital on the day of surgery. Postoperative pureed diet started the first day after surgery and patients were discharged 2 days after surgery. Outcomes of weight loss and comorbidities were analyzed with a follow-up at 3 and 6 months and 1 and 2 years after surgery. At each follow-up visit, comorbidities were generally reported as present or absent. Patients with a follow-up more than 3 years were also considered. Percentage of excessive weight loss was also reported and considered as 30% at 2 years.

Statistical analysis was performed using the Student's t-test, chi-square, and Fischer exact tests. Significance value was set at p < 0.05. The analysis was conducted with the Statistical Package for Social Sciences (SPSS) software version 15 for Windows (SPSS, Inc., Chicago, IL).

Results

Between January 2005 and July 2012, 313 patients underwent hand-assisted LAGB at the authors' institutions.

The male-to-female ratio was 1:4 (63 males and 250 females). Median age at operation was 39 years (range 16–65 years); median preoperative weight was 120.6 kg (range 82–150 kg) with a median BMI of 44 kg/m² (range 36.6–47.8 kg/m²). All patients were ASA (American Society of Anesthesiologists) 2 or 3; median operating time was 47 min (range 29–103 min) and median hospital stay was 2 days (range 1–4 days).

Hypertension (37%), arthropathy (23%), dyslipidemia (21%), obstructive sleep apnea (18%), gastroesophageal reflux disease (14%), and diabetes (12%) were the most reported comorbidities at baseline. At baseline, 243 patients (77.6%) reported at least one comorbidity.

The patients were treated with 44 SAGB (Swedish Adjustable Gastric Band Ethicon Endosurgery, Cincinnati, OH), 229 A.M.I. SGB Premium (Soft Gastric Band manufactured by Agency for Medical Innovations GmbH-Austria EU), and 25 Lap Band AP (Allergan, Irvine, CA). The type of band to be used in each case depended entirely on the surgeon's preference; all surgeons used all types of bands. All bands were positioned using the pars flaccida technique. Twelve patients (3.8%) received concomitant cholecystectomy during the procedure. None of the patients had band-related problems at follow-up.

Weight loss

Two-year postoperative outcomes were available in 264 (84.3%) patients; BMI change could not be calculated in 49 patients lost to follow-up (available the follow-up at 6 months).

The mean follow-up time was 23.6 months, and the mean total weight loss was 22.3 ± 9.5 kg. The number of patients with postoperative follow-up at 3 months, 6 months, 1 year, and 2 years was 313/313 (100%), 313/313 (100%), 295/313 (94.2%), and 264/313 (84.3%), respectively. Compared with the mean preoperative BMI of 44 ± 6.4 kg/m², there was a significant decrease in mean BMI after 3 months (40 ± 6.1 kg/m²; range 32.8–43.9 kg/m²; p < 0.05), 6 months (37.2 ± 4.2 kg/m²; range 29.5–39.9 kg/m²; p < 0.05), 1 year (29.8 ± 3.1 kg/m²; range 21.3–34.2 kg/m²; p < 0.05), and 2 years (31 ± 5.8 kg/m²; range 20.1–36.5 kg/m²; p < 0.05). The %EWL at 3 months, 6 months, 1 year, and 2 years was 26.6% ± 16.4%, 38.0% ± 23.2%, 43.2% ± 25.3%, and 43.7% ± 28.4%, respectively. The nonresponder rate (%EWL <30%) at 2 years was 25.7% (68/264 patients).

At 2-year follow-up, the data about comorbidities were reported in 32.5% of patients (86/264). The number of patients with multiple comorbid conditions was reduced at 2 years with a mean number of comorbidities per patient falling from 2.1 before surgery to 0.7 at 2-year follow-up.

Study results and band complications are reported in Tables 1 and 2 and compared with data by the most popular studies published in literature.^15–28

Table 1.

Band Complications and Correlation with Literature

Band complications	Literature	Case series
Band erosion (%)	2.1–9.5	0%
Band intolerance (%)	2–11	2.8% early intolerance (9 patients; <30 days p.o.); 1.5% late intolerance (5 patients; >30 days p.o.)
Band leakage (%)	1.1–4.9	0%
Band slippage (%)	4–18	2.2% (7 patients)
Bowel perforation (%)	0.5–3.1	0%
Esophageal dilation (%)	6–14	0%

Table 2.

Port Complications and Correlation with Literature

Port complications	Literature	Case series
Flip/inversion–dislodgement (%)	2.1–10.3	1.2% (4 patients)
Port leakage (%)	1.1–4.9	0%
Port infection (%)	1.5–5.3	0%
Port dislocation (%)	4–6.9	0%
Skin infection (%)	0.5–3.1	0%

There were no cases of gastroesophageal reflux disease, gastritis, hiatal hernia, or dyspepsia. Two study cases (0.6%) had spontaneous band opening after surgery (>1 year after surgery); in these cases, bands were removed and repositioned. There were also two cases of incisional hernia (subcostal incision) treated surgically with mesh.

None of the study patients needed conversion to open surgery and there were no cases of major complications during surgery; none had intraoperative bleeding.

No complication was correlated with the type of band used and there was also no correlation between the type of complication or operating time and surgeon's surgical skills (p > 0.05). No patient reported discomfort caused by the subcostal incision and wound healing was well tolerated. There were no cases of ventral hernia.

One patient died (0.3%) after band placement during wound closure due to cardiac arrest. Autopsy confirmed that death had occurred following a cardiac arrest caused by sclerotic myocardial malignant arrhythmia, hypertensive hypertrophic cardiomyopathy, and coronarosclerosis. It was later discovered that this patient was a regular consumer of cocaine and that she had omitted this detail to the study staff during presurgery visits.

Discussion

Hand-assisted laparoscopic surgery (HALS) was introduced in the mid-1990s as a useful alternative to totally laparoscopic procedures. HALS utilizes all the principles of standard transperitoneal laparoscopy. The only difference between standard laparoscopy and hand-assisted laparoscopy is that the surgeons are also able to introduce their hand into the operative field. This technique has allowed the laparoscopist to maintain the use of the most versatile instrument available, the surgeon's hand, for exposing, retracting, dissecting, and maintaining hemostasis. The hand may assist in more advanced laparoscopic techniques such as intracorporeal suturing and knot tying. By maintaining the tactile sense, the surgeon is able to palpate vessels and adjacent organs, minimizing the chance of injury to vital structures, particularly during difficult laparoscopy dissections. All of these factors can contribute in reducing the operative time. It is well recognized that the HALS procedure is best suited for the obese, especially those with BMI of 40 or more, as the conversion rate is high if the procedure is conducted laparoscopically. This experience is especially reported for colorectal surgery.^29,30

We performed HALS for severe obesity to reduce operative time and to have fewer complications (band slippage and port dislocation) (personal experience with standard laparoscopy, data not published). In our center, HALS in indicated also if anesthesiologists required less surgical time (patients with other medical problems).

Specifically talking about obesity in difficult patients (i.e., those with an abundant layer of visceral fat at observation), the tactile feedback facilitates the immediate recognition of the anatomical structures to be dissected, resulting in increased safety of the procedure, shorter operating time, and faster emergency response in case of complications such as bleeding since the surgeon can readily use his/her fingers to stop the blood loss. The latest studies on this topic report that surgically treated patients show reduced mortality rates, lower risk of developing other pathologies related to weight loss therapeutic treatments, and inferior direct and indirect social costs. Assisted laparoscopy is a procedure with a good cost–benefit ratio for the traditional surgeon who wants to start approaching the laparoscopic technique for more complex surgeries.

Surgical management is currently the best treatment providing long-term resolution of obesity and superobesity in a high number of cases.^13–15

The long-term results of a recent randomized trial for LAGB using two different bands showed that long-term weight loss was similar (Lapband^® vs. SAGB^®) in patients who retained their band. It was also reported that the use of bands is associated with high long-term complication and reoperation rates and that gastric banding (with either band) has a significant long-term failure rate.¹⁶

It is clear that restrictive procedures should result in a combination of acceptable weight loss, resolution/improvement of comorbidities, and improvement of quality of life without complications; as for laparoscopic gastric banding, a reported high rate of long-term complications is of great concern, with a 50–60% failure rate observed at 10-year follow-up.^17–22

Severe and morbid obesity is a chronic and evolving disease for which one single surgical intervention is unlikely to provide definitive relief for all the patients who, in any case, are exposed to the risk of developing surgery-related complications.

Gastric band implantation techniques range from the originally described perigastric technique to the now widely (but not yet uniformly) accepted pars flaccida technique. The main advantage of this latter technique seems to be a marked reduction in the rates of posterior pouch dilatation/slippage. All published series of laparoscopic gastric banding regard morbid obesity, including a cohort of patients, variable in size, with excellent results both in terms of weight loss and overall quality of life. This study focuses on a specific cohort of patients. Gastric banding, although successful, has known complications; in literature, many studies about laparoscopic banding reported a different percentage for each complication and, for this reason, it is difficult to obtain comparable data. Band slippage rates usually range from 2% to 24%, but with the pars flaccida technique, they reduce to between 2% and 12.8%. In the study series, it was possible to observe that a very low slippage rate (2%) correlated with the technique used and with the assistance of the surgeon's hand when positioning the band. Band erosion: erosion of the gastric band through the stomach wall is one of the most serious complications associated with gastric banding with an occurrence rate ranging from 1% to 3%. It was reported in literature that the pars flaccida technique could minimize the incidence of band slippage and reduce the incidence of band erosion. In the study, there were no cases of band erosion; this was probably due to the technique used.^17–26

Port and tubing problems also seem to be common; there is no overall consensus as to the preferred site to place the port, which often depends entirely on the surgeon's preference, or to the best method of preventing port complications such as rotation with consequent difficult access, subcutaneous erosion, and port site infection. In published studies, the rate of port site complications ranged from 7% to 14%, although it was not possible to correlate this result with port site, type of anchoring to the band, or type of sutures used. In this study, only two cases had a flipped port, but the study surgeons did not use a technique different from the ones used by other surgeons in their studies; this finding should be therefore considered as a casual event.^23–30

Tube leakage, disconnection, and infection are other complications requiring reoperation since any fluid leak from the tube would cause the band to deflate. No such complications to the connection tube could be observed in our study.

Gastric banding quotes the lowest mortality rate (<1%) among the more commonly performed bariatric procedures,^18,19 with most case series reporting 0%.^26–28

During the study, there was only one postoperative death: during skin closure, a patient had a cardiac arrest and died. Autopsy confirmed sclerotic cardiomyopathy caused by cocaine abuse. Specifically, the patient had omitted this detail to the study staff during the preoperative assessment and it was later discovered that this previous condition was precisely the cause of the cardiac arrest.

Conclusion

Hand-assisted LAGB is a safe and well-tolerated bariatric procedure (especially for severe obesity), which can sometimes be used initially to improve the surgeon's skills in bariatric surgeries. This procedure does not affect the postoperative hospital length of stay and reduced rates of intraoperative and postoperative complications, reducing the slippage rate with respect to conventional laparoscopy, and reduced band erosion; this procedure could be considered an alternative to standard laparoscopy.

Footnotes

Author Disclosure Statement

No competing financial interests exist.

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