To the best of our knowledge, there is a paucity of studies in literature comparing these three bariatric techniques, and that represents a strength point of our study.
In our study, operative time showed significant difference between the three study groups (p < 0.001). It was significantly prolonged in the SASJ group (106.75 minutes), compared to the other two groups (81.0 and 104.0 minutes in LSG and OAGB groups respectively).
This prolonged operative time of SASJ could be attributed to its relative novelty and complexity as it comprises creation of a gastric sleeve, counting 2 meters of the jejunum and performing a GJ anastomosis afterwards. However, our results are within the normal limits reported in the literature. Khalaf and Hamed reported that the mean operative time of the SASI procedure was 98.8 minutes . Romero et al. reported that operative time had a mean value of 116.3 minutes (range, 60–270 minutes) . Another study reported much prolonged operative time for the SASJ procedure, which had a mean value of 192.8 minutes .
Regarding postoperative complications, we didn’t find any significant difference among the 3 study groups. Our study reported the safety of the SASJ procedure regarding the early post-operative course, as no cases with leakage, peritonitis or bleeding were encountered. In another study, bleeding was encountered in 3.7% of cases while staple line leakage occurred in 0.3% of cases .
Our findings showed that SASJ succeeded to achieve 6 and 12-month EWL of 53.47 and 77.61% respectively, and that was not significantly different from either OAGB or LSG (p > 0.05). In the same SASJ group, %TWL had mean values of 39.4 and 56.85% at the same time points respectively. Regarding % EWL in other studies, Sewefy and Saleh reported that the included cases achieved 85% EWL at one-year follow up . Additionally, Alamo et al. presented significant weight loss amounts in their assessment as 31.9%, 56.9%, and 76.1% of weight loss, were achieved during 3, 6, and 12 months after the surgery, respectively .
Sayadishahraki and his colleagues also confirmed our findings, as they reported no significant difference between different bariatric procedures regarding 3- and 6- month %EWL. Of note, these authors added an additional group the included patients undergoing RYGB. At 3-month follow up visit, patients had mean %EWL of 33.01, 41.24, 33.50, and 33.92% in the RYGB, SASJ, OAGB, and LSG groups respectively. Six-month visit readings were as follows; 50.54, 54.54, 52.48, and 50.70% in the same four groups respectively . Not only do these authors confirmed the comparable effects of these different procedures on short term weight loss, but they also reported weight loss results near to ours.
Furthermore, Khalaf and Hamed reported that % EWL had mean values of 58.7 and 86.9%, while %TWL had mean values of 29.5 and 44.2% at 6-and 12-month follow up visits respectively .
Regarding resolution of diabetes in our study, only two out of the eleven cases diagnosed with DM in the SASJ group showed no resolution at one-month follow up. All of these eleven cases showed complete resolution at 3-month follow up, and remained with the same condition during the study period. Remission of T2DM after the SASJ procedure could be explained by both decreased calorie intake along with rapid delivery of the food elements to the distal bowel leading to early satiety and release of antihyperglycemic hormones .
This rapid improvement of diabetes was also confirmed by the study of Sayadishahraki and his coworkers who reported that all of the patients showed improved diabetes mellitus during the 6-month study and ceased medication, and also insulin therapy. These authors tested the same three procedures of ours along with RYGB .
Moreover, Mahdy et al. conducted their research on 61 patients, who have undergone SASI (single-anastomosis sleeve ileal) procedure, which has the same principle as SASJ, in order to assess its results on diabetic mellitus type 2 patients. Study follow up period was one year. Eventually, they presented marvelous short-term outcomes as all patients had complete resolution of diabetes in the first month postoperatively except five patients who had resolution after 3 months and required the gradual withdrawal of insulin and hypoglycemic drugs . In the same context, other authors reported that normalization of blood glucose occurred within two months after surgery in all diabetic patients , and this confirms the efficacy of this procedure in such cases.
Arslan et al. reported also a dramatic decrease in glycosylated hemoglobin levels from 9.58 down to 6.56% three months following surgery . All these previously mentioned studies confirmed our findings regarding the effectiveness of SASJ procedure in improving diabetes on the short-term outcome.
In the current study, all cases diagnosed with OSAS before operation showed complete resolution within 6 months after operation. Khalaf and Hamed reported that patients with OSAS showed improvement in 33.3%, while the remaining cases showed complete resolution .
In contrary to LSG, no single patient had de novo GERD after SASJ procedure. This observation may be explained by the impact of adding an anastomosis between the distal gastric sleeve and the ileum which may reduce the intragastric pressure, thus decreasing the risk of GERD. However, 20% of our cases developed GERD in the LSG group. There is an ongoing debate whether sleeve gastrectomy may worsen GERD if present pre-operatively, develops de novo GERD or improves it . In a large study from Italy with a 5-year follow-up, postoperatively erosive esophagitis was detected in 21% of patients, while Barrett’s metaplasia was encountered in 17%. Interestingly, GERD symptoms were experienced only by 33% of patients with grade C esophagitis, and by 57% of patients with grade D esophagitis . Others have shown different results. For example, in a prospective study, Rebecchi et al. showed that the SG improved reflux symptoms in most of patients with morbid obesity with pre-operative GERD, while de novo reflux was uncommon .
Apart from this ongoing debate, reported low incidence of postoperative GERD after SASJ represents a major merit of this new procedure over LSG.
We reported no significant difference between the three groups regarding post-operative laboratory parameters; neither after 6 months nor after 12 months.
Conversely, other authors reported significant difference between different bariatric surgeries regarding post-operative serum albumin (p < 0.001). The included cases had mean albumin levels of 4.14, 4.1, 4.52, and 4.86 gm/dl in the RYGB, SASJ, OAGB, and LSG groups respectively . Although statistical analysis showed a significant difference regarding that parameter, all values were within the normal limits, and we think these differences are clinically irrelevant.
When it comes to the manifestations of malnutrition associated with bariatric procedures, it is really important to analyze if there is an obvious difference in the nutritional status among all study groups. Our results didn’t show significant difference between 3 bariatric procedures in terms of Iron deficiency anemia, hair loss, neuropathy, vitamin D deficiency and hypocalcemia. This indicates that all of the three procedure have comparable nutritional complication profile.
Nevertheless, apparently, SASJ is not an innocent procedure, and the presence of two pathways does not necessarily mean to wean cases from multivitamin and mineral supplementation. This was also confirmed by Sayadishahraki et al. who reported that vitamin D deficiency was detected in 76% of SASJ cases, while zinc deficiency was detected in 12% of cases. Additionally, vitamin B12 was present in 20% of cases, whereas ferritin deficiency was diagnosed in 24% of cases . Romero et al. reported that one out of 83 cases had dropped in hemoglobin at 11 months post-surgery due to iron deficiency and hypermenorrhea and therefore required blood transfusion. Another patient had hypoalbuminemia . Kermansaravi et al. revised SASI bypass to SG in 2/24 patients (8.3%) due to excessive weight loss and hypoalbuminemia .
The presence of a double-outlet for the gastric content can be a blessing or a curse for the SASJ procedure. Double-outlet provides a credit over malabsorptive procedures by preserving easy endoscopic access to the duodenum and biliary system. Contrarily, one cannot precisely estimate the ratio of fluid passing through either pathways. The distribution of fluid passing through multiple outlets is ruled by many factors, including intraluminal pressure, velocity of the contents, its density, outlet spacing, diameter ratio, and frictional forces .
In contrast to our findings, other authors reported that after six months of surgery, 95.3% of all patients had stopped taking oral supplements and multivitamins with no significant postoperative nutritional complications at one year follow up . Additionally, others reported vitamin and mineral deficiency, and anemia were not observed after SASJ during the short follow up period (3 months) .
Post-operative health related quality of life showed no significant difference between the three study groups (p > 0.05). The success of a bariatric intervention does not only relate to weight loss, but is also determined by its effect on quality of life, behaviors of eating disorders, food tolerance, and resolution of co-morbidities. It is expected that after bariatric surgery quality of life improves due to weight loss, better function, and resolution of co-morbidities, however, the occurrence of side effects may hinder that. Such side effects include recurrent vomiting, regurgitation, or poor postoperative nutrient absorption [34, 35]. As we reported comparable outcomes between the three procedures, it would be expected to have comparable quality of life reported by our patients.
Our study has some limitations; firstly, it is a single center study that included a relatively small sample size. However, given the fact that SASJ bypass procedure is a relatively new technique with very few published data supporting its beneficial outcomes, it was really difficult to convince our patients to participate in our randomized controlled trial. Given their popularity and well established outcomes, most of our patients requested to have either LSG or OAGB and not SASJ bypass which is not familiar to them. Thus, Randomization and preoperative patient consent (both approved and revised by IRB) couldn’t help us to increase sample size and include more patients within our study. Secondly, relative short term follow up period (one year) which may not be long enough to evoke significant difference between study groups in terms of weight loss, improvement of comorbidities and development of long-term complications especially nutritional ones. We assumed that follow up for the first postoperative year represents preliminary results that may give an idea about early outcomes of a relatively new procedure like SASJ bypass in comparison to LSG and OAGB. Results of our pilot study may represent a starting point that encourages us and maybe other authors to further research with larger sample size and a longer follow up.