Two-year outcomes from a randomised controlled trial that compared the outcomes between revisional banded laparoscopic sleeve gastrectomy (BLSG) and revisional non-banded laparoscopic sleeve gastrectomy (NBLSG) after weight recurrence, has reported that BLSG tends to have a more stable weight loss with a significantly lower BMI, lower stomach volume and less weight regain. The findings were featured in the paper, ‘Two-Year Results of the Banded Versus Non-banded Re-sleeve Gastrectomy as a Secondary Weight Loss Procedure After the Failure of Primary Sleeve Gastrectomy: a Randomized Controlled Trial’, published in Obesity Surgery.
The authors stated that although LSG is the most common bariatric metabolic surgery procedure worldwide, insufficient weight loss or weight recurrence has been reported in up to 30% of patients after LSG. Indeed, the incidence of revisional surgery after weight regain has been reported to be 13% more frequent after LSG than after RYGB. The reasons for weight recurrence or insufficient weight loss include hormonal/metabolic, dietary non-adherence, physical inactivity, anatomical surgical failure and mental health.
In particular, the study’s authors from the Medical Research Institute, Alexandria University, Alexandria, Egypt, highlighted that sleeve dilatation could be an essential cause of weight recurrence because of the loss of restriction over time, which allows more food intake. They noted approximately 4.5% of patients undergo revisional LSG because of a dilated sleeve with more than 61% of patients presenting with a dilated sleeve one year after primary LSG.
There are several surgical options available after post-LSG weight recurrence including conversion to RYGB, conversion to biliopancreatic diversion with duodenal switch or conversion to single anastomosis duodenal-ileal bypass. However, according to the authors revisional LSG after weight recurrence following primary LSG is a good option that may achieve effective sufficient weight loss and improve associated medical problems.
To stimulate weight loss after bariatric-metabolic surgery, BLSG can be performed, which involves inserting a band around the upper part of the sleeve pouch to prevent its expansion and maintain better weight loss. Previous studies have reported significantly higher weight loss in the BLSG cohort vs. NBLSG cohort, other studies have reported no significant differences between BLSG and LSG regarding weight loss. Moreover, patients who underwent BLSG are reported to have a higher incidence of eating problems with more regurgitation, vomiting and dysphagia than those who underwent NBLSG because of the restrictive function of the band.
To investigate the effectiveness of revision LSG with BLSG and NBLSG, the authors designed a randomised controlled trial to compare the outcomes and two-year follow-up results of BLSG and NBLSG after weight regain following primary LSG. Specifically, the primary endpoints were percentage excess body weight loss (%EWL), percentage total weight loss (%TWL), change in BMI, and associated medical problems after the weight loss at one and two years postoperatively.
Secondary endpoints were gastric volume measurement and esophagogastroduodenal (EGD) transit gastroscopy one year postoperatively. The sleeve volume was assessed preoperatively and two years after surgery using multi-detector computed tomography (MDCT) virtual gastroscopy and 3D reconstruction.
The study included 82 patients - four patients were excluded for being older than 60 years, ten for suffering from GERD, seven for refusing a revision LSG procedure and two for a history of a previous leak after LSG. After one year, two patients were lost to follow-up in the BLSG group and two in the NBLSG group; in year two, 25 patients were left in each group and this was the total number of patients analysed.
For patients in the BLSG group, a peri-gastric dissection was performed 4-5cm from the gastroesophageal junction and a size 7.5cm (1.75 cm internal diameter) MiniMizer Gastric Ring (Bariatric Solutions International) was placed loosely around the pouch. Non-absorbable sutures were used to fix the MiniMizer Ring to the stomach passing through the built-in holes in the Ring.
Outcomes
The authors reported that there were no significant differences in baseline characteristics between the two groups. The two groups achieved similar %EWL and %TWL at six months, one year and two years postoperatively (%EWL 46.9 vs. 43.6, 83.7 vs. 86.3, and 85.7 vs. 83.9, p=>0.151; %TWL 23.9 vs.21.8, 43.1 vs.43.3, 44.2 vs. 42.2, p=>0.342). However, BMI was significantly lower at two years in the BLSG group (24.9 vs. 26.9) compared to the NBLSG group (p=0.045). Overall, the BMI was significantly reduced two years postoperatively in both groups compared to pre-revisional surgery (47.7 to 24.9 in BLSG and 46.9 to 26.0kg/m2 in NBLSG; p=<0.001). In addition, between years one and two in the NBLSG cohort, 20 patients (80%) had a 2kg increase in weight (0.5–5 kg), compared with only six patients (24.0%) in the BLSG cohort.
Food tolerance was significantly lower with BLSG with an average of -1.1 points (p= < 0.001) vs. NBLSG. However, the reduced postoperative stomach volume significantly reduced the food tolerance score in both groups (p=<0.001). Indeed, the new stomach volume was significantly smaller in the BLSG group vs. NBLSG group by 34.6mL on average (159.6 vs. 194.2 mL, p=<0.001), and both groups showed a significant reduction in volume after two years (-248.4 mL vs. -215.8 mL, p=<0.001) in the BLSG and NBLSG groups, respectively). After two years, the volume above the band in the BLSG was 72.4±16.5 mL (Figure 1). Improvements in hypertension, type 2 diabetes and dyslipidaemia were reported in both groups.
Postoperative complications were not significantly different between BLSG and NBLSG (84.0 vs. 88.0%, p=1.00). One patient (4%, p=0.784) in the BLSG group had the Ring removed after two years at the end of the study because of persistent complaints of GERD C and dysphagia and was converted to an RYGB operation. No leaks, abscesses, 30-day post-op interventions, band erosions, or band slippages were reported during the study period.
After one year, during the endoscopic procedure, 28.0% in the BLSG group and 24.0% in the NBLSG group were free from complications. However, 8.0% of the BLSG group had constriction at the ringside, and 48.0 vs. 60.0% had asymptomatic GERD A de Novo in the BLSG and NBLSG groups, respectively. Moreover, 4% had GERD B de Novo in the BLSG group, compared to 0% in the NBLSG group. GERD B + hiatal hernia de Novo was present in 8.0% of the BLSG and 16.0% of the NBLSG groups.
After two years, no significant differences in nutritional deficiencies (p ≥ 0.110) were found between both groups. The most prevalent deficiencies were calcium < 8.6 mg/dL (28.0% in the BLSG group and 48.0% in the NBLSG group), vitamin D < 20 ng/mL (24.0 vs 20.0%), and haemoglobin < 11mg/dL (40.0 vs 36.0%).
“We recommend studying the effect of successful or failed LSG on stomach volume in future cohorts, focusing on the cut-off values for dilatation vs. volume vs. weight regain,” they concluded. “After a 2-year follow-up, both procedures were considered safe, with no significant differences in the occurrence of complications and nutritional deficits.”
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