Is Gastro-Gastric Fixation Suture Necessary in Laparoscopic Adjustable Gastric Banding? A Prospective Randomized Study

Abstract

Background:

The reason for gastro-gastric suture (GGS) in laparoscopic adjustable gastric banding (LAGB) is to prevent migration, slippage, and pouch dilatation. Despite various suturing techniques, these complications are still quite common. In our study, we prospectively randomized patients for GGS and analyzed outcome.

Methods:

Between September 2006 and February 2008, eighty patients were randomized before LAGB procedure with pars flaccida technique. Forty patients had GGS for band fixation (Group 1), and 40 patients did not (Group 2). Groups were compared for length of surgery (LOS), length of hospital stay (LOHS), early and late complications, and percent of excess weight loss (%EWL). Mann–Whitney U test was used to define statistical differences between groups. P<.05 was accepted as significant.

Results:

Mean body mass index (BMI) of groups 1 and 2 were 43.3±4.9 and 42.2±4.3 kg/m², respectively. Mean LOHS was 29.2±9.3 and 25.2±10.5 hours in groups 1 and 2, respectively. There was no statistically significant difference between groups 1 and 2 in comparison of %EWL (P=.344 and P=.132, respectively). There was a significant difference in LOS between groups, and it was shorter in group 2 (P<.05). In terms of complications, slippage rate was higher, migration and port complications were lower in group 2 although not statistically significant (P>.05). Pouch dilatation rate was similar in both groups.

Conclusions:

LOS is shorter without GGS. There is no difference in rates of slippage, migration, pouch dilatation complications, and %EWL between either approach. In light of our findings, we think that routine use of GGSs should be revisited.

Introduction

Laparoscopic adjustable gastric banding (LAGB) is the most commonly applied bariatric procedure in Europe since the 1990s.¹ LAGB provides effective and sustained weight loss. Band migration, pouch dilatation, and slippage are the main drawbacks of LAGB.

Various techniques were defined to fix the band on the stomach. Suturing of lesser curvature to right crus (Zappa)² or left crus (Signhal),³ anterior 3 or 4 gastro-gastric suture (GGS) fixation (Parikh, Chevallier, Ponce, Martikainen)^4–7 are examples of these techniques.⁸ Despite these methods, in LAGB, slippage rate is between 1.4% and 24%, migration rate is between 0.5% and 3.8%, and pouch dilatation rate is between 1% and 25%.^9,10 It was Frydenberg¹¹ who first showed that when the band was sutured to the gastric fundus, an angle of His is reconstructed, thus slippage rate decreased.

In our study, we prospectively randomized patients who had planned to undergo LAGB and performed GGS in one group. We assessed outcomes of either technique and neccessity of GGS.

Materials and Methods

Between September 2006 and February 2008, eighty patients were randomized before LAGB procedure. Forty patients had GGS for band fixation (Group 1), and 40 patients did not (Group 2) after pars flaccida technique. Details of pars flaccida technique are described elsewhere.¹² Randomization was carried out with computerized selection. All subjects were included in the study after informed consent procedures. The study was approved by the hospital ethics committee, and Helsinki declaration was fulfilled.

Patient selection was done according to International Federation for the Surgery of Obesity and Metabolic Disorders criteria (BMI>40 or BMI 35–40 with comorbidity). Enoxaparin sodium 40mg/0.4mL was subcutaneously administered 12 hours preoperatively and on the first postoperative day. Compression stockings were applied after anesthesia induction.

Surgical procedure was started with 5 trocars. Pars flaccida technique was used for LAGB. A port was placed on rectus muscle fascia on left hypochondrium. Isotonic saline was used to adjust the band.

All operations were done by the same team. To standardize the fine surgical techniques, all surgeries were performed by the same surgeon for the patients enrolled in the study. In operations Lap-band^® (Inamed Health, Santa Barbara, CA), AMI (AMI, GmbH, Feldkirch, Austria) bands were used. In group 1, three 3/0 silk GGS were placed between anterior fundus and proximal pouch above the gastric band. Attention was paid not to constrict the band between sutures. Patients in group 2 had band placement without GGS. All patients in both groups had a 3 mL isotonic sodium injection into the port at the end of the surgery. Patients were mobilized, and oral liquids were started on the same day. Patients were discharged on the first postoperative day. Follow-up and diet for both groups were the same. Follow-up was scheduled for 1st, 3rd, 6th, and 12th months in 1st year and every 6 months thereafter. Weight loss, improvement of comorbidities, and complications were monitored, and percent of excess weight loss (%EWL) was analyzed.

Mann–Whitney U test was used to define statistical differences between groups. Chi-square test was used for variables without normal distribution. P<.05 was accepted as significant.

Results

Twenty eight out of 108 patients were excluded from the study. Reasons for exclusion were psychological adjustment failure (n=11), inflammatory bowel disease (n=4), history of previous gastrointestinal (n=4) or bariatric surgery (n=6), and concurrent cholecystectomy (n=3). The remaining 80 patients were randomized and included in the study. Two patients in group 1 and one patient in group 2 were excluded from the study secondary to failure to adhere with follow-up schedule. Characteristics of groups are given in Table 1. There was a significant difference in length of surgery (LOS) between groups, and it was shorter in group 2 (P<.05). Differences in rest of the variables were not statistically significant.

Table 1.

Comparison of Basic Variables

	Group 1 (n=38)	Group 2 (n=39)
	Mean±SD	Mean±SD	P value
Age (years)	30.6±7.7	30.2±7.4	.788
Gender
F	31 (81.6%)	30 (76.9%)
M	7 (18.4%)	9 (23.1%)	.336
Weight (kg)	127.5±15.3	124.5±15.5	.442
Excess weight (kg)	58.6±9.8	56.3±9.3	.356
BMI (kg/m²)	43.3±4.9	42.2±4.3	.222
LOS (minutes)	81.5±15.5	55.4±11.4	.001
LOHS (hours)	29.2±9.3	25.2±10.5	.078
Band volume (mL)^a	4.7±1.8	5.4±1.9	.156

Band volume 2 years after laparoscopic adjustable gastric banding procedure.

BMI, body mass index; LOS, length of surgery; LOHS, length of hospital stay; SD, standard deviation.

Table 2 shows %EWL at the end of 1st, 2nd, and 3rd years in both groups. % EWL was higher in 2 and 3 years in both groups, when compared with the 1st year, and this was statistically significant (P=.001). In terms of postoperative weight loss, when the 2nd and 3rd years were compared, then there were no statistically significant differences (P=.069, P=.122, respectively). There was no statistically significant differences between groups 1 and 2 in comparison of %EWL (P=.344 and P=.132, respectively).

Table 2.

Comparison of Percent Loss of Excess Weight

	1st year	2nd year		3rd year
	Mean±SD	Mean±SD	P value^a	Mean±SD	P value^b	P value^c
Group 1 (n=38)	27.4±8.8	47.2±11.0	0.001	53.7±12.4	.001	.069
Group 2 (n=39)	28.2±8.5	51.8±11.5	0.001	55.8±12.9	.001	.122
P value^d	.344	.132		0.87

P value: significance of difference of weight loss between the groups to 1st and 2nd years.

P value: significance of difference of weight loss between the groups to 1st and 3rd years.

P value: significance of difference of weight loss between the groups to 2nd and 3rd years.

P value: comparison of weight losses in different years of the 1st and 2nd groups.

Complications (slippage, pouch dilatation, and port complications) are shown in Table 3. Slippage rate was higher, migration and port complications were lower in group 2, but these were not statistically significant (P=.500, P=.500, P=.356). Pouch dilatation rates were similar in both groups (P=.692).

Table 3.

Comparison of Groups with Regard to Complications

	Group 1 (%)	Group 2 (%)	P value
Slippage	2 (5.3)	3 (7.7)	.500
Migration	2 (5.3)	1 (2.6)	.500
Pouch dilatation	2 (5.3)	2 (5.1)	.692
Port complications^a	5 (13.2)	3 (7.7)	.356

That is port rotation, infection, detachment of calibration tube, and leakage from port.

Discussion

We have been performing LAGB for morbid obesity since 2006. Initially, we had been using GGS for all patients. In reoperation of these patients for various reasons, we observed that GGS sutures induced an inflammatory reaction.¹³ Our observations also showed that GGS did not decrease incidence of slippage or pouch dilatation. Our experience supports findings of Fried et al.,¹⁴ who said that GGS induced microtrauma increases infection rate. Infection weakens stomach wall resistance and disrupts tissue consistency, which prevents dislocation of band into gastric lumen.¹⁵ Mizrazi et al.¹⁶ had similar findings. Steffen et al.¹⁷ further stated in their study enrolling 824 patients with LAGB in 5 years that GGS causes traction on gastric pouch and increases tendency to form ventral slippage.

GGS does not decrease complications related to gastric band but rather increases LOS and risks of anesthesia. GGS fixes a part of the band, whereas the remaining part is still mobile. Changes in pouch pressure and gastric contractions cause movement of this mobile part of the band. This imbalanced movement adds up to trauma caused by GGS, which further increases the risk of migration.¹³ Our experience in gastroscopy of patients with LAGB who show posterior migration support this hypothesis.

Gastric slippage can be anterior or posterior. Anterior slippage gives the stomach an hour-glass shape, and the upper pouch folds downward. This causes vomiting and distension. In pars flaccida technique, a retrogastric tunnel is created, and the band is not fixed with sutures. Posterior slippage is smaller and rare.¹⁸ Ramos et al.¹⁹ compared 70 patients with GGS and186 patients without GGS and showed that there was no difference between two groups in weight loss, improvement in comorbid diseases, slippage, or migration. LOS was shorter in the group without fixation sutures.

Slippage, migration, and pouch dilatation affect the success of banding procedure. Signhal et al.⁴ reported better results in 1140 patients after suturing the fundus to the left diaphragmatic crus. In this study, 3 patients had slippage, 6 had pouch dilatation, and 4 had malpositioning. In a retrospective analysis of 3584 patients with LAGB by Frering and Fontaumard,²⁰ slippage rate was 3% in patients with GGS, whereas it was 1% in those without GGS. In a prospective randomized study of 100 patients by Fried et al.¹⁴ slippage rate was 2.2% in the GGS group but 2.0% in the group without GGS. Migration rate and LOS were also higher in the GGS group. In our previous study with 127 patients who had 3 GGS sutures placed to fix the band, migration rate was 1.6%, and slippage rate was 3.9%.²¹ A similar retrospective study by Lantsberg et al.²² analyzing 784 patients with GGS and 1494 without GGS showed lower slippage but higher migration rate in the latter group. Shashidhar et al.²³ did a survey with 29 British surgeons who used different band brands to assess effects of GGS on slippage. This study had 6990 patients with GGS, and slippage rate changed between 0.5% and 12%, whereas those without GGS (n=1370) had slippage rate between 1.0% and 2.5%. In our study, slippage rates were 5.3% versus 7.7%; migration rates were 5.3% versus 2.6%; and pouch dilatation rates were 5.3% versus 5.1% in groups 1 and 2, respectively. However, the differences in these variables were not statistically significant. The incidences of band migration, slippage, and pouch dilation change according to time of follow-up. Stroh et al. cited in their article that although band migration and pouch dilatation increased with time; slippage decreased in follow-up in their study. The authors attributed the latter to a shift in surgical technique to pars flaccida from perigastric approach.²⁴ Likewise, data in the literature evaluating the incidence of pouch dilatation and band migration are heterogeneous, because most studies include different approaches and techniques. However, almost all studies state that these complications occur at least 2 years from the time of primary surgery.^1,25

Major drawbacks of our study are the low number of patients enrolled and short term follow-up. Future studies can focus on comparing different types of suturing techniques and can enroll more patients with longer follow-up.

As conclusion, our study showed that in patients with LAGB, GGS does not decrease slippage, migration, or pouch dilatation but increases duration of surgery. Surgeons should also keep in mind that occurence of these three complications has a tendency to increase with time after the first operation. In light of our findings we think that routine use of GGSs should be revisited.

Disclosure Statement

No competing financial interests exist.

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