Management of Leak after Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy

Abstract

The single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been introduced in the past few years for the treatment of morbid obesity. SADI-S has shown good results in terms of long-term results and short-term complications. However, the management of patients undergoing SADI-S and suffering from a leak is a great challenge for surgeons. We present an extensive review of the currently available literature on the management of leak after SADI in morbid obese (MO) patients. We aim at providing objective information regarding the optimal management, including diagnosis, technical options for the different strategies that have been proposed, to facilitate the selection of the best individual approach for each MO patient.

Introduction

Bariatric surgery has been proved to reduce the risk for the development of medical complications such as diabetes mellitus, cardiovascular diseases, or even cancer.^1,2 Further, morbid obese (MO) patients associate a myriad of metabolic derangements, such as type 2 diabetes mellitus, which could also justify some of the postoperative complications seen in this kind of patients, including the gastrointestinal leak.³ Metabolic and bariatric surgery (MBS) has proved to be successful in the treatment of obesity and associated diabetes, leading to a decrease in the levels of inflammatory markers.⁴ However, postoperative complications remain. Thus, anastomotic leak (AL) treatment during the postoperative period in MO patients can be challenging, even in expert hands, and yield high complication and mortality rates. Nowadays, the main MBS primary techniques are sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB).⁵ However, in recent times, single anastomosis procedures have experienced an extraordinary increase, including mini-gastric bypass (MGB)-one-anastomosis gastric bypass (OAGB), SADI-S or stomach intestinal pylorus sparing surgery (SIPS), intestinal bipartition, etc.^6,7 These procedures, compared with standard RYGB or SG, apparently offer some advantages such as a reduction in the risk of internal hernia formation and also the operative time. However, the discussion remains open regarding whether the procedures are more or less effective and which type of patients they should be offered to, as suggested by Lee et al.⁸

The duodenal-ileal bypass with single anastomosis and associated with gastric sleeve (SADI-S) was first described in 2007 by Sánchez-Pernaute et al. as a simplified evolution of the duodenal switch (DS), offering better results in terms of postoperative complications.⁹ One of the main advantages of this technique is the reduction of the number of anastomosis, which clinically implies an increase in weight loss, higher rates in resolution of comorbidities, and a reduction in AL or stenosis rates, as well as similar incidences of postoperative complications compared with the DS technique. Should any occur, the diagnosis can be challenging, and the treatment ranges from conservative (non-invasive) measures to reoperation.⁹ In this article, we aim at reviewing the impact of leak on SADI-S and at describing the technical options to treat the AL.

Materials and Methods

A literature review was conducted to evaluate the evidence supporting the different treatment approaches for MO patients with a leak after SADI-S. We carried out (A.C.de.T. and R.V.) a systematic research of the following metasearch engines, including the period from the platform inception through September 2020: PubMed, MEDLINE, Cochrane Central Register of Controlled Trials, Embase, and the main clinical trial databases (the International Clinical Trials Registry Platform Search Portal and ClinicalTrials.gov) for ongoing studies. The search strategy included keywords such as “bariatric surgery,” “obesity surgery,” “SADI,” “SIPS,” “SADI-S,” and “COMPLICATIONS.” To ensure not missing relevant articles, we also searched gray literature, as well as looked at the references named in the published studies. Discrimination by language was not conducted. Finally, the following data were deduced from the included articles: study main features (author, journal, and year of publication), demographic characteristics (number of patients included, age, gender, baseline body mass index [BMI]), number and types of complications, management to treat complications, and final outcomes.

Results

In our review, 53 papers were screened for review by 2 authors (A.C.de.T. and R.V.). After applying our inclusion and exclusion criteria, 15 of them were finally analyzed to obtain information about complications after SADI-S procedure (Table 1). Having a total number of 2138 patients, the overall complication rate was 3.23%, with the AL being the most common one (1% of cases). Other postoperative complications that must be considered in this surgery are bleeding/hematoma, especially around the anastomosis and the staple line, as well as incisional hernias. Results are shown in Table 1.

Table 1.

Table Summarizing All the Literature Reporting Complications after Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy

Study	Year	Number of patients	Mean age	Gender	Type of surgery	Complication rate	Number and types of complications	Management of complications
Ceha et al.¹⁰	2018	32 SADI-S 32 RYGB	46.9 (21–66)	26 ♀ 6 ♂	Second stage SADI-S	6.2%	1 AL 1 intraluminal bleeding	Not specifically mentioned. Reoperation in the case of the AL
Zaveri et al.¹¹	2019	96 SADI-S	44.8 years ±11.3	Not mentioned	Second stage SADI-S	5.3% early 6.4% late	0 ALs 3 wound infections 1 abdominal sepsis	Wound infections were treated with intravenous antibiotics. The patient with sepsis needed reoperation
De la Cruz et al.¹²	2020	42 SADI-S 42 OAGB	45.1 years ±11.1	31 ♀ 11 ♂	Second stage SADI-S	7.1%	1 duodenal stump leak 1 AL 1 small bowel perforation caused by an incarcerated internal hernia	The first 2 complications needed laparoscopic reoperation. The small bowel perforation required multiple surgical revisions
Finno et al.¹³	2020	181 SADI-S 259 DS	50.8 years	126 ♀ 55 ♂	DS versus SADI-S single center	6.7%	1 duodeno-ileal anastomosis leak 2 duodenal stump leaks 7 hemoperitoneum 2 intraluminal bleeding	Not specifically mentioned: reoperation in all cases
Moon et al.¹⁴	2019	9 SADI 6 RYGB 6 DS	41.1 years ±6.4	5 ♀ 4 ♂	Second stage SADI-S	0%	None	Not applicable
Surve et al.¹⁵	2020	91 SADI-S	43 years	67 ♀ 32 ♂	PRIMARY SADI-S	1.1%	1 case of bleeding of the anastomosis	1 volume of blood and intravenous iron infusion
Surve et al.¹⁶	2018	27 SADI-S	47.7 years ±11.2	23 ♀ 4 ♂	22 primary stage SADI-S and 5 second stage SADI	7.40%	ALL FIRST STAGE 1 gastric staple line leak 1 hematoma	Not specifically mentioned: reoperation
Sánchez-Pernaute et al.¹⁷	2013	100 SADI-S	47 years (22–71)	63 ♀ 37 ♂	93 primary stage SADI-S and 7 second stage SADI	0%	None	Not applicable
Dijkhorst et al.¹⁸	2018	66 SADI-S 74 RYGB	43.3 years ±11.0	55 ♀ 10 ♂	Second stage SADI-S	16.7%	2 ALs 2 resleeves 7 others
Wu et al.¹⁹	2018	22 SADI-S	16–75 years	17 ♀5 ♂	Second stage SADI	4.45%	1 incisional hernia	Surgical repair of the incisional hernia
Pereira et al.²⁰	2019	9 BPD-DS9 SADI-S	36 ± 12 years	13 ♀5 ♂	BPD-DS versus SADI-S	0% in BPD-DS15.8% in SADI-S	1 duodenal fistula1 hemoperitoneum1 gastric tube fistula	Not mentioned
De la Cruz et al.¹²	2020	51 SADI-S	42 years (18–62)	35 ♀16 ♂	Second stage SADI-S	0%	None	Not applicable
Sánchez-Pernaute et al.²¹	2010	50 SADI-S	46 years (22–71)	32 ♀18 ♂	50 primary stage SADI-S	8%	1 bleeding (staple line)1 early trocar orifice herniation2 gastric leaks	- Endoscopic hemostasis.- Surgical correction of the hernia.- No specific treatment was required for the gastric leaks
Grueneberger et al.⁷	2014	9 SADI-S7 SADJ-S	49 years	12 ♀4 ♂	SADI-S versus SADJ-S	0% in SADI-S	1 trocar perforation in SADJ-S	Not applicable
Balibrea et al.²²	2017	30 SADI-S	47.8 years (30–59)	22 ♀8 ♂	Second stage SADI-S	13.33%	1 pulmonary atelectasis1 parietal hematoma2 ALs	Parietal hematoma was treated with percutaneous embolization. Early resuture of the ALs
Surve et al.²³	2018	1328 SADI-S	Not mentioned	903 ♀425 ♂	1328 primary stage SADI-S (multicenter)	1.36%	9 ALs5 strictures at the duodeno-ileostomy2 anastomotic ulcers2 bile refluxes	- Reintervention in all ALs.- Pneumatic balloon dilation in anastomotic strictures.- PPI for anastomotic ulcers.- Post-pyloric reconstruction of the single anastomosis in bile reflux

AL, anastomotic leak; BPD-DS, biliopancreatic diversion with duodenal switch; DS, duodenal switch; OAGB, one-anastomosis gastric bypass; PPI, proton pump inhibitors; RYGB, Roux-en-Y gastric bypass; SADI-S, single anastomosis duodeno-ileal bypass with sleeve gastrectomy; SADJ-S, single anastomosis duodeno-jejunal bypass with sleeve gastrectomy.

General complications of SADI-S

All surgical procedures have a probability of complications. SADIS-S has a low rate of complications, the most frequent being the leak from the anastomosis, which can be in the duodeno-ileal segment or in the gastric tube. The early complications that occur are postoperative hemorrhage and acute trocar site hernia, which may need reoperation. In addition, some patients can develop severe gastroesophageal reflux disease (GERD). Hypoalbuminemia is another particularly important complication that justifies the need for postoperative monitoring.²²

General considerations regarding clinical presentation and diagnosis of an AL after SADI-S

Despite the low complication rate for SADI-S, some patients may develop a leak from the duodeno-ileal anastomosis or within the gastric tube; hence, early diagnosis with an adequate clinical evaluation and complementary tests such as blood analysis, PCR, and imaging studies with contrast medium can help us to give effective and early treatment. Conservative treatment with broad-spectrum antibiotics, gastric rest, and total parenteral nutrition with electrolyte replacement has provided good results to treat leaks, aiming at avoiding reoperation as long as the patient is hemodynamically stable and constantly evaluating the patient.^24–28

We identify as “acute” leaks those that appear within the first 7 postoperative days (PODs). Their etiology is multifactorial, usually secondary to ischemia or technical surgical problems, and they generally require early reoperation.

Clinical findings, patient's status, and POD considerations

Hypertension, tachypnea, fever, malaise, and progressive abdominal pain are the most frequent signs and symptoms, as shown in the study by Csendes et al.²⁵ regarding bypass, but they can be extended to digestive leaks following any technique. The most frequent clinical sign was fever (higher than 37.5°C), which can occur even from the first POD. However, it is important to suspect a hypothetical leak when there is early tachycardia (higher than 100 bpm) regardless of the presence of fever. Sepsis, seen less frequently, is defined as temperature >38°C with an increased white cell count. In addition, corroborating evidence included tachycardia and elevated levels of C-reactive protein (CRP) in blood. Finally, the management of leaks farther divides as to whether they were early or late and whether sepsis was well controlled or not.²⁵

Csendes's trial proposes the classification of leaks according to the POD of appearance, which is useful to be practical in their management: early leaks (1–4 POD) corresponding to 28.3% and, with a similar incidence, late leaks (>10 POD), 25%; intermediate leaks (5–9 POD) were the most frequent ones (46.7%). In their study, they show that leaks can occur as late as 59 days after surgery.²⁵

As previously said, the early and initial suspicion of AL should be based on clinical parameters such as fever (>38°C) on the second and third POD without other explanation, tachycardia (>100 bpm), and upper abdominal pain without peritoneal signs, in the absence of other clinical parameters.

Drain output

Another important sign in leak's diagnosis is the increase of the daily output through the drain:

- Early leaks are characterized by a high output, ranging from 500 to 1.2 L per day, usually with the presence of pus or gastrointestinal content. This quantity decreases gradually over the next PODs. They usually present with a sudden onset of severe left upper quadrant pain radiating to the left shoulder. Fever, nausea, and vomiting are other main symptoms.

- Clinical presentation of late leaks is more insidious, also with the presence of nausea, fever, but abdominal pain has a gradual onset. The average output initially ranges from 50 to 300 mL per day, being reduced over the next few days.

When the aspect of the drainage fluid changes from serous-hematic to bilious, a leak from the duodenal stump must be suspected. Rarely, there was the appearance of food through the drain (5% of cases of leak), in this case from the duodenal-ileal anastomosis.²⁵

Laboratory

The enhanced recovery after surgery protocols include a CRP-based diagnostic algorithm as a complementary tool to help in the diagnosis of intestinal leaks, which can improve outcomes as well as reduce costs.²⁴ In fact, CRP was elevated in 100% of the patients in the published series who had a leak. However, there are also cases of false positives, because it increases up to 5 days after surgery in non-complicated patients. Thus, with the presence of the previously mentioned clinical signs, combined with a CRP value higher than 6.1 mg/dL on the first POD, it is mandatory to rule out a leak after SADI-S.²⁴

CRP is an acute phase reactant that is synthesized within the first 6 hours after surgery. Usually, the peak in serum is obtained after 48 hours, the absolute value of which reflects the intensity of the inflammatory stimulus. Interestingly, this occurs even before the appearance of clinical symptoms. For all these reasons, in addition to its low cost, CRP has become a highly reliable marker in the daily clinical practice of gastrointestinal surgery.²⁶

In a morbidly obese patient without clinical signs and symptoms, a negative test on the first POD (CRP <6.1 mg/dL) means a chance of developing an early leak <2%. Supported by an area under the curve (AUC) receiver operating characteristic (ROC) curve of 0.92, the sensitivity and specificity of this cut-off value is 0–82 and 0.92, respectively.²⁷

The ability of CRP to predict a postoperative leak and other intra-abdominal infectious complications has been previously demonstrated in the fields of esophageal and colorectal surgery in many meta-analyses. What is important to consider is that CRP has a great negative predictive value, which means that it is safe to rule out the event after a negative test.²⁷

Radiology in AL

The first-line radiological test is the abdomen computed tomography (CT) scan, which is more useful in the early stages. In case of a sleeve leak, it is typical to find locules of free air and a fluid collection surrounding the gastric staple line, often extending around the spleen. One of the main advantages of this technique is the ability to identify and drain intra-abdominal collections. In the majority of cases, leaks produce an inflammatory response but collections have an insignificant size. Therefore, there is enough with intravenous antibiotics, nil by mouth and placement of a nasogastric or nasojejunal tube. For more complicated cases, invasive procedures can be useful, such as tube feeding (jejunostomy), placement of covered stents plus CT scan or ultrasound-guided percutaneous drainage.²⁸

On the other hand, contrast swallow is more useful in follow-up to monitor the progression of the fistula. This technique is useful to establish those leaks from the staple line that may not be obvious on CT scan.

In those cases where an abdominal drain might be placed, we can take advantage of it through the administration of methylene blue orally (5 mL dissolved in 250 mL of water). In the presence of this dye in the drain, a leak must be considered.²⁵ Alternatively, it is possible to diagnose in the opposite direction by injecting a radio-opaque contrast into the drain as a tubegram. The presence of this contrast within the gastrointestinal tract would confirm the surgical complication.

Finally, as a confirmation, the gastrointestinal defect can be confirmed directly through an upper gastrointestinal (GI) endoscopy only if an endoscopic procedure is planned, such as a covered stent insertion or a nasojejunal tube insertion.²⁸

Csendes et al.²⁵ suggest that the first method for the diagnosis of an early fistula, maximum on the 4th day, would be with a gastroduodenal transit with barium and not with Gastrografin^®, which only presents a 17%–22% positivity, especially in small fistulas, whereas barium detects 100% positivity. It is important to note that they do not find any peritonitis complication associated with it, simply remaining encapsulated, which is seen in successive radiological tests.²⁵

In the fistulas that appear after the 4th POD, from the 5th, the abdominal CT scan indicates their detection to the greatest extent, where a collection with air and liquid can be visualized around the surgical site.²⁵

Current status to treat the AL

Unstable patients, those with tachycardia, fever, and signs of peritoneal irritation should undergo a revisional procedure. Depending on the place where the leak appears, different approaches and treatments should be considered. Treatment will depend on its site (duodeno-ileal anastomosis or duodenal stump), and the general aspect of the leak and the tissue. Green indocyanine could be helpful to consider in different approaches, but there are no data available nowadays for the SADI-S procedure. Nevertheless, some data are arising for pancreatic and bariatric surgery.^29,30 Depending on these aspects (degree of ischemia of the tissue, size of the leak, and final aspect before repair), other strategies could also be considered, including conversion to another bariatric procedure.

Leak at the duodenal's stub

The leak at the the duodenal's stub has not been described yet in published literature for SADI-S. However, in other general surgery procedures, including gastric surgery for cancer, leak mortality accounts for 16%–20% (Ref.³¹). Its management could be conservative, percutaneous, endoscopic, and surgical (including duodenostomy in Fig. 1 and duodeno-jejunostomy). The laparoscopic approach should be acceptable. Percutaneous drainage should be taken into account as another option depending on the patient's clinical condition, as well as the severity of his condition. In most cases, conservative treatment is preferred.³²

FIG. 1.

The placement of a Foley probe to treat leak from the duodenal stump.

Leak of the duodeno-ileal anastomosis

Simple suturing of the anastomosis should be considered when the leak is small, and the overall aspect of the anastomosis is acceptable (Fig. 2). A drain placement should be considered.

FIG. 2.

A leak at the level of the duodeno-ileal anastomosis. Treatment is performed by a single stick suture.

T-tube placement

A T-tube placement through the hole and simple suturing of the anastomosis should be considered when the leak is also small and the overall aspect of the anastomosis is acceptable, but the surgeon dares to make a new leak (Fig. 3). This is a described strategy in sleeve leak.³³

FIG. 3.

A T-tube placement through the hole and simple suturing of the anastomosis.

Conversion to DS and stent placement

Some surgeons would consider, according to their standard practice and previous experience, the conversion of the SADI-S to a DS, including a stent placement (Fig. 4b). A transection of the efferent loop must be done, including a Roux-en-Y at 1 meter from the ileocecal valve (Fig. 4a). Enteric defects should be closed according to the standard DS technique. This conversion from a one-anastomosis technique to a Roux-en-Y allows stent placement, and it excludes bile passage through the anastomosis. The anterior defect of the leak should also be closed accordingly.

FIG. 4.

The conversion of the single anastomosis duodeno-ileal bypass (A, B) with sleeve gastrectomy to a duodenal switch (a), including a stent (A) placement (b).

Conversion to DS and stent placement with resection of the anastomosis

This approach can be considered in case the anastomosis is not convenient, there is enough place at the level of the duodenum for another anastomosis, and the surgeon still considers a malabsorptive procedure for the patient. A complete resection of the anastomosis should be performed (Fig. 5a). A complete DS confection should be done (Fig. 5b), including a Roux-en-Y at 1 meter from the ileocecal valve. Enteric defects should be closed according to the standard DS technique. This conversion allows a stent placement (Fig. 5c).

FIG. 5.

A conversion to DS and a stent placement with resection of the anastomosis. A complete resection of the anastomosis (A, B, C) should be performed (a). A complete DS confection (A) is done (b). This conversion allows a stent (A) placement (c). DS, duodenal switch.

Conversion to distal Roux-en-Y gastric bypass

When it is impossible to use the duodenum and even the antrum to configure the new anastomosis, distal gastric bypass should be considered as a solution with resection of the previous one and recalibrating the gastric pouch (Fig. 6a). Petersen's space and the enteric defect should be done accordingly (Fig. 6b). The alimentary limb should be at least 100 cm, with a common handle of at least 2 m. Although everything depends on the length of this common loop in the first SADI-S, the surgeon must decide the best form of reconstruction.

FIG. 6.

A conversion to distal Roux-en-Y gastric bypass (A, B), including a complete resection of the anastomosis and gastric pouch sizing (a). A reconstruction with a Roux-en-Y (A, B) should then be performed (b).

Discussion

Although the published cases of anastomotic fistula in SADI-S are very few, it is true that when there is one, it entails very severe complications.

The average published incidence is 2.4%. The key to therapeutic success is early diagnosis and proper management.³⁴

Sánchez-Pernaute et al. only describe 1 case of AL in their first 100 cases of SADI-S, which was treated conservatively.¹⁷ Other studies such as that of Nelson et al.³⁴ present the same incidence of AL as Sánchez-Pernaute et al. in their first 69 cases. This time he treated it with a conversion to MGB.²³

In their SADI-S paper, Zaveri et al. describe an early and late complication rate of 7.7% and 10.9%, respectively.³⁵ The most common early complications were nausea (2.2%) and wound infection (2.2%): 1.3% were grade I, 4.2% were grade II, 0.4% were grade IIIa, 1.3% were grade IIIb, and 0.2% were grade V. The complication consisted of a leak of the intestinal suture not reflected in CT imaging tests, since it poured into the mesentery and no air outside or contrast extravasation was visible. It triggered respiratory distress and kidney failure.

It must be taken into account that in SADI-S only one anastomosis is performed, which in experienced hands has a very low failure rate, and, in turn, decreases the probability of AL compared with procedures with two anastomoses.

As previously mentioned, according to our review, the overall complication rate in SADI-S is 3.23%, ranging from 16.7% to 0% in different series. We have seen some qualitative differences in complication rates between primary and second stages of SADI-S (1.55% versus 8.38%, respectively). Although we do not have statistical analysis to prove whether it is a true difference between both approaches in terms of complications, these data suggest the need for future prospective studies.

One of the main problems with the practice of one anastomosis raised, especially since endoscopy has become a clear potential solution for leaks, was the impossibility to treat the AL in a more conservative manner, with stent placement. Thus, conversion to another procedure such as DS was needed. This same approach is encountered in other one-anastomosis procedures such as MGB-OAGB.

We also specifically emphasize the peristalsis of the efferent loop whenever conversion to another procedure should apply. In fact, the SADI-S afferent loop (biliary) should never be converted to an alimentary limb when converting the SADI-S to a DS, to avoid peristaltic problems related to food passage.

This article has some limitations, such as the lack of literature of a phenomenon (AL), which, fortunately appears to be uncommon. Also, the best surgical approach is not clear as it will depend on the surgeon's experience, previous management, and the patient's situation. Although AL remains an unusual condition after SADI-S once the learning curve has been reached, surgical management should be considered.

Conclusions

SADI-S is a safe procedure that offers different possibilities after AL. Surgical management should be the basis of AL after SADI-S. Early stage diagnosis is mandatory to avoid major and serious complications. However, endoscopy and radiology should also be considered depending on the type of leak and clinical presentation.

Footnotes

Acknowledgments

The authors would like to acknowledge Dr. Marius Nedelcu ICYLS (International Club of Young Laparoscopic Surgeons) for the invitation.

Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this work.

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