Updates Surg DOI 10.1007/s13304-014-0257-0
ORIGINAL ARTICLE
Laparoscopic sleeve gastrectomy: efficacy of fibrin sealant in reducing postoperative bleeding. A randomized controlled trial Mario Musella • Marco Milone • Paola Maietta Paolo Bianco • Anna Pisapia • Dario Gaudioso
•
Received: 11 November 2013 / Accepted: 9 June 2014 Ó Springer-Verlag Italia 2014
Abstract Staple line leakage and bleeding are worrisome complications of laparoscopic sleeve gastrectomy (LSG). Solutions such as buttressing, oversewing or roofing the staple line with gelatin matrix have been proposed with controversial results. Because the use of fibrin sealant has shown a possible benefit in reducing the reoperation rate due to early complication in patients (pts) undergoing laparoscopic Roux-en-Y gastric bypass (LRYGBP), this solution has been tested in 100 consecutive pts undergoing LSG. A clinical trial has been performed on 100 consecutive pts. Exclusion criteria from the study were considered ASA IV pts, treated or untreated malignancies at any stage, steroids or FANS assumption, previous sovramesocolic surgery and conversion to open surgery. All pts were randomized to receive (group A, 50 pts) or to not receive (group B, 50 pts) 4 ml of human fibrin sealant (TisseelTM, BaxterÒ Deerfield, IL, USA) sprayed along the suture line. Primary endpoint was the incidence of postoperative complications: leaks, bleeding of the staple line or stenosis of the gastric remnant. Significance was assigned at a p level \0.05. By considering pts in group A vs. pts in group B our results shown no significant difference in fistulas or strictures occurrence (p = 0.2). Bleeding was significantly higher in patients not sprayed with sealant (group A vs. group B, 1/7, p = 0.03). This randomized trial has so far shown the use of fibrin sealant in LSG to significantly reduce postoperative bleeding. Although a trend
M. Musella (&) M. Milone P. Maietta P. Bianco A. Pisapia D. Gaudioso General Surgery, Department of Advanced Biomedical Sciences, Naples ‘‘Federico II’’ University, Via S. Pansini, 5 Building 12, 80131 Naples, Italy e-mail: [email protected]
in reducing leak occurrence emerges, it does not reach statistical significance. Keywords Sleeve gastrectomy Bariatric surgery Fibrin sealant Postoperative complications Leaks Bleeding
Introduction Laparoscopic sleeve gastrectomy (LSG) is to date one of the most frequently performed bariatric interventions in Italy. According to the Italian Society for Bariatric Surgery (SICOB), in 2012 it has been the first choice for bariatric surgeons, counting 1,231 recorded procedures (31.9 % of all interventions), followed by adjustable gastric banding (LAGB) and Roux-en-Y gastric bypass (LRYGBP) [1]. It was originally conceived as a first step approach followed by either laparoscopic LRYGBP or biliopancreatic diversion with duodenal switch (BPD-DS) [2] to decrease operative risks, especially in super obesity [3]. Later, the good results reported in terms of excess weight loss rate (EWL %) and comorbidities resolution in the long term [4, 5], have led a qualified number of authors to reach consensus in considering LSG as a stand-alone procedure to treat morbid obesity [6]. Despite of the satisfactory results provided, leak and bleeding remain worrisome complications following LSG and although different solutions such as buttressing, oversewing or roofing the entire staple line with gelatin matrix have been proposed [7, 8], the results remain controversial [2, 9, 10]. The use of fibrin sealant has been already suggested in bariatric surgery, and, the use of this support during LRYGBP has shown a possible benefit in reducing the reoperation rate due to early complications [11]. Moreover, fibrin sealant has shown
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some efficacy in healing leaks in a non-operative setting in both LRYGBP and LSG [12, 13]. Aim of this randomized trial is to assess the efficacy of a fibrin sealant in reducing postoperative complications in patients undergoing LSG.
(TisseelTM - BaxterÒ Deerfield, IL, USA) is sprayed along the suture line through a dedicated laparoscopic set (EasysprayTM—BaxterÒ Deerfield, IL, USA). The procedure finishes with the placement of a drain along the suture line and the extraction of the resected stomach. A swallow GastrographinÒ X-ray control is not routinely performed postoperatively.
Patients and methods Outcome measures A prospective, randomized clinical trial was designed to assess the efficacy of human fibrin sealant (TisseelTM— BaxterÒ Deerfield, IL, USA) in the prevention of specific complications following LSG for the treatment of morbid obesity. The study protocol was approved by the ‘‘Federico II’’ University ethical committee (code 215/08). Starting from January 2009, one hundred morbidly obese patients, scheduled to LSG, were recruited from our outpatient obesity unit and randomized (1:1) to two treatment groups: fibrin sealant (group A) and control (no fibrin sealant, group B). Patients included men and women aged 18–65 years with a body mass index (BMI) ranging from 40 to 55 kg/m2, undergoing LSG. All patients in both groups received a preoperative esophago-gastroscopy (EGDS) to rule out gastric lesions. An informed consent form following SICOB guidelines [1] was filled and received from all patients. All patients were prepared to surgery by a standard prophylaxis to prevent pulmonary embolism according to the same guidelines [1]. A computerized randomization was obtained the day prior to surgery. Criteria of exclusion from the study included previous sovramesocolic surgery, ASA 4 patients, treated or untreated malignancies at any stage, and conversion to open surgery.
Data collected were demographics, surgery (technique, time, conversion, methylene-blue test, fibrin sealant usage, and time to oral diet initiation), hospital stay, and complications. The primary endpoint was the occurrence of complications (suture line leak, significant bleeding, stenosis) occurring during the first 30 days from surgery. By a significant bleeding, a blood loss originating from the staple line, higher than 300 ml during the first postoperative day, is meant. Secondary endpoints were the operative time in minutes, the length of hospital stay (LOS) in days, the time to oral diet initiation in days and the adverse effects directly related to fibrin sealant application. A staff surgeon not participating in surgery, and blinded to the procedure used, was responsible to record the endpoints. Statistical analysis was performed with S.P.S.S. 14, 0. Where requested values are expressed as mean ± standard deviation. The Yatescorrected v2 test was used as a means of evaluating differences in categoric variables, and the Mann–Whitney U test was used for continuous variables. Statistical significance was accepted when the p value was lesser than 0.05.
Surgical technique Results The surgical procedure begins with the vascular preparation of the greater gastric curvature starting 5–6 cm proximal to the pylorus and going up to the gastro-esophageal junction. In all cases a 5 mm radiofrequency device (LigasureTM, CovidienÒ Mansfield, MA, USA) is used. Later, following a 36-Fr bougie placed transorally down to the pyloric channel, a vertical gastrectomy is performed by a linear stapler (Echelon FlexTM 60 EndopathÒ, EthiconÒ Cincinnati, OH, USA). Routinely, a ‘‘green’’ cartridge (4.1 mm staple height) is used for the first firing followed by two ‘‘gold’’ cartridges (3.8 mm staple height). The last two firings are performed by a couple of ‘‘blue’’ cartridges (3.5 mm staple height). All the sleeved stomachs are tested intraoperatively by methylene-blue injection through the bougie. A naso-gastric tube is routinely placed and removed on first postoperative day. In the fibrin sealant group, following these steps, 4 ml of human fibrin sealant
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By evaluating preoperative general demographics features and preoperative comorbidities, between group A and group B, no statistical difference was observed (Table 1, 2). Mean operative time was 82.8 ± 5.2 min for group B while it was 84.3 ± 6.2 min for group A patients (p = 0.2). One death occurred in group A due to a pulmonary embolism on second postoperative day. Primary endpoint outcome is reported in Table 3. No significant difference was observed in leak occurrence (p = 0.2). Two fistulas in group B developed on the second postoperative day. They were well drained by the tube and were managed by parenteral nutrition and fasting. The last one developed on seventh postoperative day. Revision surgery was requested in that case due to a sovramesocolic septic collection. The patient was later managed by esophageal stenting but recovery required 96 days. No
Updates Surg
0.1
bleeding in both groups required revision surgery. They all presented within the first 6 h from surgery and, if needed, were managed by transfusion of one or more blood red cell unit. Hemorrhages in group A were significantly lower than in group B (7 vs. 1, p = 0.03). No significant strictures were observed in both groups. If we consider the reintervention rate for leaks, bleeding and strictures, only one patient in group B (2 %, p = 0.9) needed revision surgery. Secondary endpoint outcomes are reported in Table 4. No adverse effect related to the sealant use was observed.
0.2
Discussion
Table 1 Demographic data of groups Group A
Group B
Statistical significance (P)
0.2
Sex Men (N)
36
29
Women (N)
14
21
Age Mean
32.3
33.2
Std Deviation
±9.9
±7.9
0.5
BMI Mean
43.6
44.8
Std Deviation
±4.4
±8.5
26 24
33 17
ASA ASA 2 (N) ASA 3 (N)
Table 2 Preoperative comorbidities in the groups
Hypertension
Group A
Group B
Statistical significance (P)
27
31
0.5
Diabetes II
17
12
0.3
Dyslipidemia
8
5
0.5
Mild gastritis at preoperative EGDS
28
32
0.5
Orthopaedic impairment
11
9
0.6
Sat O2
95.0 ± 1.4
95.1 ± 1.5
0.6
Sleep apnea
12
8
0.3
Tab. 3 Primary endpoint outcomes Group A
Group B
Statistical significance (P)
Fistulas
0 (0 %)
3a (6 %)
0.2
Bleeding
1 (2 %)
7 (14 %)
0.03
Stricture
0 (0 %)
0 (0 %)
–
a
One patients requiring revision surgery
Tab. 4 Secondary endpoint outcomes
Operative time
Group A
Group B
Statistical significance (P)
82.8 ± 5.2 min
84.3 ± 6.2 min
0.2
LOS
5.1 ± 1.1
5.2 ± 1.2
1
Time to oral liquid diet
3.2 ± 1
3.1 ± 1.1
1
LSG is gaining worldwide popularity as a single-step procedure in the treatment of morbidly obese patient [14]. Although it is usually considered as a restrictive procedure some other advantages have been observed when compared to other interventions. Furthermore, the hormonal effect produced by the ghrelin and the glucagon-like peptide 1 (GLP-1) decrease [15], the accelerated gastric emptying [16], the absence of implanted material, the persistence of normal gastrointestinal continuity, the avoidance of malabsorption and the opportunity to convert LSG into both a LRYGBP or a BPD-DS [17] if needed, has led many experts to reach a wide consensus in considering LSG as a valid stand-alone procedure [6]. Two recent meta-analyses [9, 18] describe an overall leak rate ranging from 2.2 to 2.4 % in LSG patients. Conversely, staple line bleeding has been reported to range from 0 to 8 % [2, 17, 19]. Several authors have attempted to solve these complications by suggesting oversewing or buttressing of the staple line, but despite that, the matter remains controversial. If we consider Choi [2] and Glaysher [20] meta-analysis, the authors, reporting the results on 1,345 and 3,175 patients, respectively, concludes that reinforcing the staple line during LSG may lead to decreased incidence of postoperative leak and overall complications. Nevertheless, if we consider a subgroup analysis in the first article [2], it is remarked how reinforcing the staple line with a buttress may decrease the risk of staple line hemorrhage and overall complications, but it is not clear whether it decreases the risk of staple line leak after LSG. Equally, reinforcing the staple line with oversewing did not show any advantage compared with the control group in leak, hemorrhage, and overall complications. Conversely, in the second paper [20], it is suggested that staple-line reinforcement reduces the incidence of leakage and postoperative complications than non-reinforcement, but does not significantly reduce bleeding complications. Finally in both articles no specific
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conclusion about the efficacy of fibrin glue is suggested. In this light both studies, however, conclude that prospective studies with better evidence are needed. Nevertheless, as experience and numbers grow, some exhaustive and updated reports appear to provide clearer indications. Parikh [9] in an analysis involving 8922 LSG patients has in fact demonstrated the onset of 198 postoperative leaks being influenced by the reduced caliber of the bougie and not by the use of buttressing material, whereas Aurora [18], studying 4,888 LSG patients, found a 2.4 % of postoperative leaks being not affected by the use of buttressing material. Under this view, if we consider these metaanalyses the wider source of data concerning LSG postoperative complications, it might be concluded that larger numbers show the use of buttressing material or oversewing of the staple line, being significantly useless in leak prevention. Expert consensus goes in that direction. Most authors seem in fact to agree about the utility of buttressing material only to prevent postoperative staple line bleeding [6, 17]. Although previously described in LRYGBP patients [11], a randomized controlled trial defining the use of fibrin sealant in LSG has been not reported. The results of our study seem, however, to confirm previously cited articles and consensus conferences conclusions. No significant evidence has shown fibrin sealant being useful in preventing postoperative leaks (group A vs. group B 0/3, 0 % vs 6 %, p = 0.2), although a favorable trend was observed in treated patients. Conversely, the same product has shown to be significantly useful in preventing bleeding from the staple line (group A vs. group B 1/7, 2 % vs. 14 %, p = 0.03). Furthermore, fibrin glue has demonstrated no significant impact on secondary endpoint outcome (Table 4). According to published data, a low leak rate should probably be explained by a correct surgical technique more than by the use of any material able to reinforce the staple line. As suggested, firing the last cartridge about 2 cm distal from the incisura angularis and holding the stapler compression for about 20 s before using it, remain points of pivotal importance [6, 9, 21, 22]. If we therefore consider buttressing material or fibrin sealant significantly effective in reducing postoperative bleeding, costs seem however different. A 4 ml human fibrin sealant set costs in fact about 180€, whereas the expenses for the use of buttressing material, as reported [20], may range from 640 to 2,400 € per single intervention. We consider this one other important point to be carefully evaluated. This study has a major limitation. It was in fact designed as a concept study, and therefore we did not estimate the required sample size specifically requested for each endpoint. Larger studies are therefore required to reach a definitive conclusion about the utility of fibrin sealant in
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LSG patients. To date, according to our data, fibrin sealant appears useful in significantly reducing staple line postoperative bleeding, with acceptable expense and without producing any adverse effect. No evidence is provided that fibrin sealant may significantly reduce postoperative leaks, strictures, LOS or early reintervention rate. Conflict of interest
None.
References 1. http://www.sicob.org 2. Choi YY, Bae J, Hur KY, Choi D, Kim YJ (2012) Reinforcing the staple line during laparoscopic sleeve gastrectomy: does it have advantages? A meta-analysis. Obes Surg 22:1206–1213 3. Regan JP, Inabnet WB, Gagner M et al (2003) Early experience with two- staged laparoscopic Roux-en-Y gastric bypass as an alternative in the super–super obese. Obes Surg 13:861–864 4. Braghetto I, Csendes A, Lanzarini E, Papapietro K, Ca´rcamo C, Molina JC (2012) Is laparoscopic sleeve gastrectomy an acceptable primary bariatric procedure in obese patients? Early and 5-year postoperative results. Surg Laparosc Endosc Percutan Tech 22:479–486 5. Musella M, Milone M, Bellini M, Sosa Fernandez LM, Leongito M, Milone F (2012) Effect of bariatric surgery on obesity-related infertility. Surg Obes Relat Dis 8:445–449 6. Rosenthal RJ (2012) International sleeve gastrectomy expert panel. International sleeve gastrectomy expert panel consensus statement: best practice guidelines based on experience of [12,000 cases. Surg Obes Relat Dis 8:8–19 7. Dapri G, Cadie`re GB, Himpens J (2010) Reinforcing the staple line during laparoscopic sleeve gastrectomy: prospective randomized clinical study comparing three different techniques. Obes Surg 20:462–467 8. Gentileschi P, Camperchioli I, D’Ugo S, Benavoli D, Gaspari AL (2012) Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc 26:2623–2629 9. Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M (2013) Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy. A systematic review and metaanalysis of 9991 cases. Ann Surg 257:231–237 10. Musella M, Milone M, Bellini M, Leongito M, Guarino R, Milone F (2011) Laparoscopic sleeve gastrectomy. Do we need to oversew the staple line? Ann Ital Chir 82:273–277 11. Silecchia G, Boru CE, Mouiel J, Rossi M, Anselmino M, Morino M, Toppino M, Gaspari A, Gentileschi P, Tacchino R, Basso N (2008) The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial. Surg Endosc 22:2492–2497 12. Brolin RE, Lin JM (2013) Treatment of gastric leaks after Rouxen-Y gastric bypass: a paradigm shift. Surg Obes Rel Dis 9:229–233 13. Casella G, Soricelli E, Rizzello M, Trentino P, Fiocca F, Fantini A, Salvatori FM, Basso N (2009) Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg 19:821–826 14. Hutter MM, Schirmer BD, Jones DB, Ko CY, Cohen ME, Merkow RP, Nguyen NT (2011) First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg 254:410–422
Updates Surg 15. Pereferrer FS, Gonzalez MH, Rovira FA et al (2008) Influence of sleeve gastrectomy on several experimental models of obesity: metabolic and hormonal implications. Obes Surg 18:97–108 16. Melissas J, Koukouraki S, Askoxylakis J et al (2007) Sleeve gastrectomy—a restrictive procedure? Obes Surg 17:57–62 17. Gagner M, Deitel M, Kalberer TL, Erickson AL, Crosby RD (2009) The second international consensus summit for sleeve gastrectomy, March 19–21, 2009. Surg Obes Rel Dis 5:476–485 18. Aurora AL, Khaitan L, Saber AA (2012) Sleeve gastrectomy and the risk of leak: a systematic analysis of 4,888 patients. Surg Endosc 26:1509–1515 19. Deitel M, Gagner M, Erickson AL, Crosby RD (2011) Third International Summit: Current status of sleeve gastrectomy. Surg Obes Relat Dis 7:749–759
20. Glaysher M, Khan OM, Mabvuure NT, Wan A, Reddy M, Vasilikostas G (2013) Staple line reinforcement during laparoscopic sleeve gastrectomy: Does it affect clinical outcomes? Int J Surg 11:286–289 21. Ballanger DE, Greenway FL (2011) Laparoscopic sleeve gastrectomy, 529 cases without a leak: short-term results and technical considerations. Obes Surg 21:146–150 22. Baker RS, Foote J, Kemmeter P et al (2004) The science of stapling and leaks. Obes Surg 14:1290–1298
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ORIGINAL ARTICLE
Laparoscopic sleeve gastrectomy: efficacy of fibrin sealant in reducing postoperative bleeding. A randomized controlled trial Mario Musella • Marco Milone • Paola Maietta Paolo Bianco • Anna Pisapia • Dario Gaudioso
•
Received: 11 November 2013 / Accepted: 9 June 2014 Ó Springer-Verlag Italia 2014
Abstract Staple line leakage and bleeding are worrisome complications of laparoscopic sleeve gastrectomy (LSG). Solutions such as buttressing, oversewing or roofing the staple line with gelatin matrix have been proposed with controversial results. Because the use of fibrin sealant has shown a possible benefit in reducing the reoperation rate due to early complication in patients (pts) undergoing laparoscopic Roux-en-Y gastric bypass (LRYGBP), this solution has been tested in 100 consecutive pts undergoing LSG. A clinical trial has been performed on 100 consecutive pts. Exclusion criteria from the study were considered ASA IV pts, treated or untreated malignancies at any stage, steroids or FANS assumption, previous sovramesocolic surgery and conversion to open surgery. All pts were randomized to receive (group A, 50 pts) or to not receive (group B, 50 pts) 4 ml of human fibrin sealant (TisseelTM, BaxterÒ Deerfield, IL, USA) sprayed along the suture line. Primary endpoint was the incidence of postoperative complications: leaks, bleeding of the staple line or stenosis of the gastric remnant. Significance was assigned at a p level \0.05. By considering pts in group A vs. pts in group B our results shown no significant difference in fistulas or strictures occurrence (p = 0.2). Bleeding was significantly higher in patients not sprayed with sealant (group A vs. group B, 1/7, p = 0.03). This randomized trial has so far shown the use of fibrin sealant in LSG to significantly reduce postoperative bleeding. Although a trend
M. Musella (&) M. Milone P. Maietta P. Bianco A. Pisapia D. Gaudioso General Surgery, Department of Advanced Biomedical Sciences, Naples ‘‘Federico II’’ University, Via S. Pansini, 5 Building 12, 80131 Naples, Italy e-mail: [email protected]
in reducing leak occurrence emerges, it does not reach statistical significance. Keywords Sleeve gastrectomy Bariatric surgery Fibrin sealant Postoperative complications Leaks Bleeding
Introduction Laparoscopic sleeve gastrectomy (LSG) is to date one of the most frequently performed bariatric interventions in Italy. According to the Italian Society for Bariatric Surgery (SICOB), in 2012 it has been the first choice for bariatric surgeons, counting 1,231 recorded procedures (31.9 % of all interventions), followed by adjustable gastric banding (LAGB) and Roux-en-Y gastric bypass (LRYGBP) [1]. It was originally conceived as a first step approach followed by either laparoscopic LRYGBP or biliopancreatic diversion with duodenal switch (BPD-DS) [2] to decrease operative risks, especially in super obesity [3]. Later, the good results reported in terms of excess weight loss rate (EWL %) and comorbidities resolution in the long term [4, 5], have led a qualified number of authors to reach consensus in considering LSG as a stand-alone procedure to treat morbid obesity [6]. Despite of the satisfactory results provided, leak and bleeding remain worrisome complications following LSG and although different solutions such as buttressing, oversewing or roofing the entire staple line with gelatin matrix have been proposed [7, 8], the results remain controversial [2, 9, 10]. The use of fibrin sealant has been already suggested in bariatric surgery, and, the use of this support during LRYGBP has shown a possible benefit in reducing the reoperation rate due to early complications [11]. Moreover, fibrin sealant has shown
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some efficacy in healing leaks in a non-operative setting in both LRYGBP and LSG [12, 13]. Aim of this randomized trial is to assess the efficacy of a fibrin sealant in reducing postoperative complications in patients undergoing LSG.
(TisseelTM - BaxterÒ Deerfield, IL, USA) is sprayed along the suture line through a dedicated laparoscopic set (EasysprayTM—BaxterÒ Deerfield, IL, USA). The procedure finishes with the placement of a drain along the suture line and the extraction of the resected stomach. A swallow GastrographinÒ X-ray control is not routinely performed postoperatively.
Patients and methods Outcome measures A prospective, randomized clinical trial was designed to assess the efficacy of human fibrin sealant (TisseelTM— BaxterÒ Deerfield, IL, USA) in the prevention of specific complications following LSG for the treatment of morbid obesity. The study protocol was approved by the ‘‘Federico II’’ University ethical committee (code 215/08). Starting from January 2009, one hundred morbidly obese patients, scheduled to LSG, were recruited from our outpatient obesity unit and randomized (1:1) to two treatment groups: fibrin sealant (group A) and control (no fibrin sealant, group B). Patients included men and women aged 18–65 years with a body mass index (BMI) ranging from 40 to 55 kg/m2, undergoing LSG. All patients in both groups received a preoperative esophago-gastroscopy (EGDS) to rule out gastric lesions. An informed consent form following SICOB guidelines [1] was filled and received from all patients. All patients were prepared to surgery by a standard prophylaxis to prevent pulmonary embolism according to the same guidelines [1]. A computerized randomization was obtained the day prior to surgery. Criteria of exclusion from the study included previous sovramesocolic surgery, ASA 4 patients, treated or untreated malignancies at any stage, and conversion to open surgery.
Data collected were demographics, surgery (technique, time, conversion, methylene-blue test, fibrin sealant usage, and time to oral diet initiation), hospital stay, and complications. The primary endpoint was the occurrence of complications (suture line leak, significant bleeding, stenosis) occurring during the first 30 days from surgery. By a significant bleeding, a blood loss originating from the staple line, higher than 300 ml during the first postoperative day, is meant. Secondary endpoints were the operative time in minutes, the length of hospital stay (LOS) in days, the time to oral diet initiation in days and the adverse effects directly related to fibrin sealant application. A staff surgeon not participating in surgery, and blinded to the procedure used, was responsible to record the endpoints. Statistical analysis was performed with S.P.S.S. 14, 0. Where requested values are expressed as mean ± standard deviation. The Yatescorrected v2 test was used as a means of evaluating differences in categoric variables, and the Mann–Whitney U test was used for continuous variables. Statistical significance was accepted when the p value was lesser than 0.05.
Surgical technique Results The surgical procedure begins with the vascular preparation of the greater gastric curvature starting 5–6 cm proximal to the pylorus and going up to the gastro-esophageal junction. In all cases a 5 mm radiofrequency device (LigasureTM, CovidienÒ Mansfield, MA, USA) is used. Later, following a 36-Fr bougie placed transorally down to the pyloric channel, a vertical gastrectomy is performed by a linear stapler (Echelon FlexTM 60 EndopathÒ, EthiconÒ Cincinnati, OH, USA). Routinely, a ‘‘green’’ cartridge (4.1 mm staple height) is used for the first firing followed by two ‘‘gold’’ cartridges (3.8 mm staple height). The last two firings are performed by a couple of ‘‘blue’’ cartridges (3.5 mm staple height). All the sleeved stomachs are tested intraoperatively by methylene-blue injection through the bougie. A naso-gastric tube is routinely placed and removed on first postoperative day. In the fibrin sealant group, following these steps, 4 ml of human fibrin sealant
123
By evaluating preoperative general demographics features and preoperative comorbidities, between group A and group B, no statistical difference was observed (Table 1, 2). Mean operative time was 82.8 ± 5.2 min for group B while it was 84.3 ± 6.2 min for group A patients (p = 0.2). One death occurred in group A due to a pulmonary embolism on second postoperative day. Primary endpoint outcome is reported in Table 3. No significant difference was observed in leak occurrence (p = 0.2). Two fistulas in group B developed on the second postoperative day. They were well drained by the tube and were managed by parenteral nutrition and fasting. The last one developed on seventh postoperative day. Revision surgery was requested in that case due to a sovramesocolic septic collection. The patient was later managed by esophageal stenting but recovery required 96 days. No
Updates Surg
0.1
bleeding in both groups required revision surgery. They all presented within the first 6 h from surgery and, if needed, were managed by transfusion of one or more blood red cell unit. Hemorrhages in group A were significantly lower than in group B (7 vs. 1, p = 0.03). No significant strictures were observed in both groups. If we consider the reintervention rate for leaks, bleeding and strictures, only one patient in group B (2 %, p = 0.9) needed revision surgery. Secondary endpoint outcomes are reported in Table 4. No adverse effect related to the sealant use was observed.
0.2
Discussion
Table 1 Demographic data of groups Group A
Group B
Statistical significance (P)
0.2
Sex Men (N)
36
29
Women (N)
14
21
Age Mean
32.3
33.2
Std Deviation
±9.9
±7.9
0.5
BMI Mean
43.6
44.8
Std Deviation
±4.4
±8.5
26 24
33 17
ASA ASA 2 (N) ASA 3 (N)
Table 2 Preoperative comorbidities in the groups
Hypertension
Group A
Group B
Statistical significance (P)
27
31
0.5
Diabetes II
17
12
0.3
Dyslipidemia
8
5
0.5
Mild gastritis at preoperative EGDS
28
32
0.5
Orthopaedic impairment
11
9
0.6
Sat O2
95.0 ± 1.4
95.1 ± 1.5
0.6
Sleep apnea
12
8
0.3
Tab. 3 Primary endpoint outcomes Group A
Group B
Statistical significance (P)
Fistulas
0 (0 %)
3a (6 %)
0.2
Bleeding
1 (2 %)
7 (14 %)
0.03
Stricture
0 (0 %)
0 (0 %)
–
a
One patients requiring revision surgery
Tab. 4 Secondary endpoint outcomes
Operative time
Group A
Group B
Statistical significance (P)
82.8 ± 5.2 min
84.3 ± 6.2 min
0.2
LOS
5.1 ± 1.1
5.2 ± 1.2
1
Time to oral liquid diet
3.2 ± 1
3.1 ± 1.1
1
LSG is gaining worldwide popularity as a single-step procedure in the treatment of morbidly obese patient [14]. Although it is usually considered as a restrictive procedure some other advantages have been observed when compared to other interventions. Furthermore, the hormonal effect produced by the ghrelin and the glucagon-like peptide 1 (GLP-1) decrease [15], the accelerated gastric emptying [16], the absence of implanted material, the persistence of normal gastrointestinal continuity, the avoidance of malabsorption and the opportunity to convert LSG into both a LRYGBP or a BPD-DS [17] if needed, has led many experts to reach a wide consensus in considering LSG as a valid stand-alone procedure [6]. Two recent meta-analyses [9, 18] describe an overall leak rate ranging from 2.2 to 2.4 % in LSG patients. Conversely, staple line bleeding has been reported to range from 0 to 8 % [2, 17, 19]. Several authors have attempted to solve these complications by suggesting oversewing or buttressing of the staple line, but despite that, the matter remains controversial. If we consider Choi [2] and Glaysher [20] meta-analysis, the authors, reporting the results on 1,345 and 3,175 patients, respectively, concludes that reinforcing the staple line during LSG may lead to decreased incidence of postoperative leak and overall complications. Nevertheless, if we consider a subgroup analysis in the first article [2], it is remarked how reinforcing the staple line with a buttress may decrease the risk of staple line hemorrhage and overall complications, but it is not clear whether it decreases the risk of staple line leak after LSG. Equally, reinforcing the staple line with oversewing did not show any advantage compared with the control group in leak, hemorrhage, and overall complications. Conversely, in the second paper [20], it is suggested that staple-line reinforcement reduces the incidence of leakage and postoperative complications than non-reinforcement, but does not significantly reduce bleeding complications. Finally in both articles no specific
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conclusion about the efficacy of fibrin glue is suggested. In this light both studies, however, conclude that prospective studies with better evidence are needed. Nevertheless, as experience and numbers grow, some exhaustive and updated reports appear to provide clearer indications. Parikh [9] in an analysis involving 8922 LSG patients has in fact demonstrated the onset of 198 postoperative leaks being influenced by the reduced caliber of the bougie and not by the use of buttressing material, whereas Aurora [18], studying 4,888 LSG patients, found a 2.4 % of postoperative leaks being not affected by the use of buttressing material. Under this view, if we consider these metaanalyses the wider source of data concerning LSG postoperative complications, it might be concluded that larger numbers show the use of buttressing material or oversewing of the staple line, being significantly useless in leak prevention. Expert consensus goes in that direction. Most authors seem in fact to agree about the utility of buttressing material only to prevent postoperative staple line bleeding [6, 17]. Although previously described in LRYGBP patients [11], a randomized controlled trial defining the use of fibrin sealant in LSG has been not reported. The results of our study seem, however, to confirm previously cited articles and consensus conferences conclusions. No significant evidence has shown fibrin sealant being useful in preventing postoperative leaks (group A vs. group B 0/3, 0 % vs 6 %, p = 0.2), although a favorable trend was observed in treated patients. Conversely, the same product has shown to be significantly useful in preventing bleeding from the staple line (group A vs. group B 1/7, 2 % vs. 14 %, p = 0.03). Furthermore, fibrin glue has demonstrated no significant impact on secondary endpoint outcome (Table 4). According to published data, a low leak rate should probably be explained by a correct surgical technique more than by the use of any material able to reinforce the staple line. As suggested, firing the last cartridge about 2 cm distal from the incisura angularis and holding the stapler compression for about 20 s before using it, remain points of pivotal importance [6, 9, 21, 22]. If we therefore consider buttressing material or fibrin sealant significantly effective in reducing postoperative bleeding, costs seem however different. A 4 ml human fibrin sealant set costs in fact about 180€, whereas the expenses for the use of buttressing material, as reported [20], may range from 640 to 2,400 € per single intervention. We consider this one other important point to be carefully evaluated. This study has a major limitation. It was in fact designed as a concept study, and therefore we did not estimate the required sample size specifically requested for each endpoint. Larger studies are therefore required to reach a definitive conclusion about the utility of fibrin sealant in
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LSG patients. To date, according to our data, fibrin sealant appears useful in significantly reducing staple line postoperative bleeding, with acceptable expense and without producing any adverse effect. No evidence is provided that fibrin sealant may significantly reduce postoperative leaks, strictures, LOS or early reintervention rate. Conflict of interest
None.
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