The safety and efficacy of clipping the staple line in laparoscopic sleeve gastrectomy: A retrospective cohort study

Sulaiman Alshammari; AbdulAziz Al Mulhem; Abdullah Al Jafar; Hesham AlGhofili; Doaa Maher; Elham Alobaid; Abdullah Aldohayan

doi:10.4103/sjl.sjl_2_22

ORIGINAL ARTICLE

Year : 2022 | Volume : 7 | Issue : 1 | Page : 7-11

The safety and efficacy of clipping the staple line in laparoscopic sleeve gastrectomy: A retrospective cohort study

Sulaiman Alshammari, AbdulAziz Al Mulhem, Abdullah Al Jafar, Hesham AlGhofili, Doaa Maher, Elham Alobaid, Abdullah Aldohayan
Department of Surgery, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia

Date of Submission	23-Jan-2022
Date of Acceptance	23-Jan-2022
Date of Web Publication	16-Nov-2022

Correspondence Address:
Dr. Sulaiman Alshammari
Department of Surgery, College of Medicine, King Saud University, P O Box 242069, Riyadh 11461
Saudi Arabia

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/sjl.sjl_2_22

Abstract

Background: Obesity is a worldwide health problem and is of particular importance in Saudi Arabia, where there is a high incidence of the disease. There are many surgical procedures for its management, including laparoscopic sleeve gastrectomy (LSG). However, this procedure has postoperative complications such as bleeding and leakage.
Patients and Methods: This retrospective cohort study included all patients who underwent LSG at King Khalid University Hospital under one surgeon from July 2015 to May 2018. The 146 patients were divided into a clipping group (n = 72) who underwent LSG with clipping of the staple line, and a nonclipping group (n = 74) who underwent LSG without clipping of the staple line. The incidence of postoperative complications, including bleeding and leak, was compared in the two groups.
Results: There was no statistically significant difference between the two groups regarding patient demographic criteria or risk factors for postoperative complications. In addition, there was no statistically significant difference between the two groups in postoperative bleeding (P = 1) or leak (P = 0.324).
Conclusion: Clipping the staple line in LSG does not affect the rate of postoperative leaking or bleeding.

Keywords: Bariatric surgery, bleeding, laparoscopic sleeve gastrectomy, leaks, staple line clipping

How to cite this article:
Alshammari S, Mulhem AA, Jafar AA, AlGhofili H, Maher D, Alobaid E, Aldohayan A. The safety and efficacy of clipping the staple line in laparoscopic sleeve gastrectomy: A retrospective cohort study. Saudi J Laparosc 2022;7:7-11

How to cite this URL:
Alshammari S, Mulhem AA, Jafar AA, AlGhofili H, Maher D, Alobaid E, Aldohayan A. The safety and efficacy of clipping the staple line in laparoscopic sleeve gastrectomy: A retrospective cohort study. Saudi J Laparosc [serial online] 2022 [cited 2023 Jun 9];7:7-11. Available from: https://www.saudijl.org/text.asp?2022/7/1/7/361354

Introduction

Obesity is a worldwide health problem. In Saudi Arabia, 35.4% of the population has a body mass index (BMI) of more than 30.^[1] Obesity is a risk factor for many diseases, including hypertension, coronary heart disease, diabetes mellitus type 2, and metabolic syndrome.^[2],[3] Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric surgical procedure that has proven excellent short, intermediate, and long-term results for weight loss and reduction of associated diseases.^{[4],[5],[6],[7],[8]} One study demonstrated significant improvement of comorbidities 6 months after surgery, with pre-existing diabetes mellitus, hypertension, and bronchial asthma completely resolved in 73%, 74%, and 100% of patients, respectively.^[9]

The percentage of LSG complications is not more than 15% in large medical centers.^[10] The most common short-term complications are gastric leaks because of staple line failure and bleeding from the staple line.^[11],[12] The incidence of staple line leaks is 5% in patients undergoing LSG.^[13],[14] Bleeding from any source occurs in 1%–6% of the patients.^[13],[15] Intraluminal bleeding from the staple line presents as upper gastrointestinal bleeding. These complications can lead to significantly poor outcomes, ranging from a prolonged hospital stay to the need for total gastrectomy.^[11],[12] Moreover, if these complications are not detected and managed promptly, they may cause abdominal sepsis that can proceed to either chronic gastric fistula or multi-organ failure.^{[16],[17],[18],[19],[20]} The percentage of deaths from these complications is 0.3%, 0.1% of which result from a staple line leak.^[4] Clinical manifestations such as fever, increased heart rate, and pain can provide a strong confirmation of leakage and help in its early detection and management.^[21]

One common method to avoid these complications is staple line reinforcement, which can be performed by various techniques.^{[22],[23],[24]} Methods include continuous serosal sutures, over-sewing, V-loc™ sutures (Medtronic Ltd., Watford, UK), and fibrin tissue sealant applied throughout the staple line.^[25],[26] However, a systematic review has shown no statistical difference in the rate of staple line leaks or other complications in LSG with or without reinforcement.^[27] On the other hand, over-sewing can prolong the operation time and therefore increase the risk for complications.^[28],[29]

This study explores a new reinforcement technique, clipping of the staple line, to prevent complications. Clipping has been used previously in other forms of surgery, such as in colorectal polyps, where clipping of resection sites can reduce the risk of bleeding and perforation.^[30],[31] It is a safe technique that is faster than the usual suturing of the stomach. Therefore, it may decrease the operation time. There are few studies involving the staple line clipping technique in LSG. This study assesses the safety and efficacy of clipping the staple line in patients undergoing LSG.

Patients and Methods

Patients and ethical approval

This retrospective cohort study involved all 146 patients who underwent LSG at King Khalid University Hospital under a single surgeon from July 2015 to May 2018. Patients were divided into two groups. The first group underwent LSG between July 2015 and January 2017 without clipping of the staple line (n = 74). The second group underwent LSG with clipping of the staple line after this new technique was implemented in February 2017 (n = 72). Demographic data including age, sex, BMI, and risk factors for bleeding or leak, including steroid use, diabetes mellitus, smoking, bleeding tendency, and antiplatelet and anticoagulant administration were collected for all patients. The two groups were compared for postoperative complications including bleeding or leaks. The data were collected prospectively from the patients' history and examination and during follow-up in our clinic for at least 4 weeks after the operations. All procedures were performed after patients provided written informed consent. The study was approved by the King Saud University Institutional Review Board (approval number E-18-3416) and was conducted in accordance with international research ethics standards.

Laparoscopic sleeve gastrectomy procedure

LSG was performed using the same technique in each group. The greater omentum and the gastro-colic ligaments were dissected with bipolar cautery until the fundus and the greater curvature of the stomach was freely mobilized. A 40 French blunt bougie was used trans-orally. The stomach incision was started approximately 2–3 cm from the pylorus toward the angle of His, while a bougie was pushed toward the pylorus so that the sleeve was created parallel to the pylorus. In the clipping group, a reinforced stapler followed by staple-line reinforcement clips was used to secure the sleeve. In the nonclipping group, only the reinforced stapler was used. After sleeve completion, 100 cc of methylene blue was pushed in the stomach via the bougie to check for leaks of the staple line via camera observation. The excised stomach specimen was extracted through a 12 mm trocar site.

Statistical measures

Each participant was assigned a code number to maintain confidentiality, and the coding numbers were retained by the principal investigator. Data were collected in Microsoft Excel (Microsoft Corporation, Redmond, WA, USA) and converted to SPSS version 22.0 (SPSS Inc., Chicago, IL, USA). Frequencies and percentages were calculated for all nominal variables and the mean ± standard deviation was calculated for all numerical variables (measurable variables). The Student's t-test was used for comparisons between the clipping and nonclipping groups with respect to all numerical variables (measurable variables), while the Chi-square test was used for all nominal variables. A P < 0.05 was considered statistically significant.

Results

Technically, LSG procedures were successful for all enrolled patients (n = 146). The average age of the patients was 36 years. The clipping group (n = 72, 49.3%) and the nonclipping group (n = 74, 50.6%) had no significant differences in demographics or risk factors [Table 1].

Table 1: Patient demographics (n=146)

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[Table 2] shows the difference between the two groups in terms of postoperative bleeding and leakage. Bleeding and leaks were evaluated for 4 weeks from the operation day. None of the patients in either group experienced bleeding after surgery. Only one patient in the clipping group (0.8%) experienced leakage in the 1^st week after surgery. The difference between the groups was not statistically significant (P = 0.324).

Table 2: Comparison of postoperative bleeding and leakage in clipping and nonclipping groups

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Discussion

Staple line reinforcement in sleeve gastrectomy is an approach to decrease postoperative bleeding and leak.^[32] Various techniques have shown good results, but others show no differences compared to nonreinforcement, and there is no consensus regarding the best technique. Clipping was hypothesized to be a preferable technique for reinforcement of the staple line. However, this study showed no statistically significant differences in the incidence of leaks and postoperative bleeding between patients who underwent LSG with or without staple line reinforcement by clipping. Patients were followed for 4 weeks after LSG. There was no postoperative bleeding in either group, and only one patient had a leak in the clipping group (0.8%). The patient did not comply with postsurgical advice, and he smoked one pack of tobacco. However, the leak was successfully treated with an endoscopic stent and peritoneal drainage.

These results agree with those of Kwiatkowski et al.^[28] who also found an insignificant difference with the clipping technique as compared to no reinforcement. However, in their study postoperative bleeding and leaks occurred at a slightly higher rate in patients who underwent clipping (4.6% and 2.3%, respectively). This may be explained by the difference in the operators' experience. As another example of operator related factors, Major et al.^[29] showed that an increased number of stapler firings was related to an increase in leaks and bleeding.

Several studies have assessed other reinforcement methods. Bülbüller et al.^[25] compared nonreinforcement of the staple line to continuous serosal 3-0 Prolene^® sutures (Ethicon, Somerville, NJ, USA), V-loc™ sutures, and Tisseel fibrin sealant (Baxter, Deerfield, IL, USA) applied throughout the staple line. Their study results showed no statistically significant differences between nonreinforcement and the other three reinforcement methods. However, Hany and Ibrahim^[33] showed a significant decrease in the incidence of leaks with reinforcement using the V-loc™ technique (0%) as compared to no reinforcement (1.7%). Consten et al.^[23] demonstrated that buttressing with an absorbable polymer membrane, Seamguard^® (Gore Medical, Newark, DE, USA), showed a significant decline in the risk of bleeding in the short term after operation. However, studies by Dapri et al.^[24] and Guerrier et al.^[34] showed no differences in the reduction of leaks in buttressing with Seamguard^® in comparison with nonreinforcement, but both studies showed significantly decreased intraoperative staple line bleeding.

Results also vary for evaluation of over-sewing of the staple line. Siddiq et al.^[35] showed that there was no statistically significant difference in the incidence of bleeding or leakage between patients who underwent over-sewing of the staple line and the nonreinforcement group. Their results showed a single leak (1.36%) in the over-sewing group and none in the nonreinforcement group. Bleeding occurred in 5 cases in the over-sewing group (2.38% in males, 5.48% in females) and only 3 cases in the nonreinforcement group (2.77% in males and 2.70% in females). In contrast, Taha et al.^[36] showed that over-sewing of the staple line during LSG is an inexpensive and simple method to decrease the incidence and severity of postoperative bleeding. The staple-line bleeding rate was significantly lower in patients who had over-sewing of the staple line during LSG (P < 0.05). Furthermore, Varban et al.^[37] also showed that over-sewing of the staple line was associated with fewer leaks and lower overall complication rates (4.81% vs. 7.95%, P = 0.0027) in comparison to other methods.

Mercier et al.^[38] compared surgical glue to a nonreinforcement group and showed that there was no significant difference in complications, but leaks in the nonreinforcement group were more severe. The surgical glue group was also associated with a reduced initial length of hospital stay (4.8 vs. 5.2 days, P = 0.01). Therefore, surgical glue might be a safe and cost-effective intervention in LSG.

Most of these studies reveal a similar incidence in postoperative bleeding and leaks with different reinforcement methods and nonreinforcement. In our opinion, the level of surgical experience and the quality of the staple line, bougie size, and the method used in clipping could be important factors. These could be areas for further study. This study was limited by the small sample size, which was reflected in the low statistical power. A study with a larger sample size might show more conclusive evidence for the benefits of staple line clipping.

Conclusion

There was no significant difference in LSG postoperative leak and bleeding with or without clip reinforcement of the staple line. Studies with larger sample sizes as well as consideration of the surgeons' experience and other variables are recommended.

Ethical approval

The study was approved by the King Saud University Institutional Review Board (approval number is E-18-3416) and was conducted in accordance with international research ethics standards.

Informed consent

All patients provided written informed consent before participation in the study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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