Preliminary Safety Evaluation of the Bendos Q Powered Stapling System in Laparoscopic Sleeve Gastrectomy

Abstract

Purpose

Laparoscopic sleeve gastrectomy (LSG) is the most commonly performed bariatric procedure worldwide, but staple-line complications remain among the most feared adverse events, with leaks reported in approximately 1–5% of cases. The Bendos Q powered stapling system is a new device designed to improve tissue compression and staple-line consistency.

Materials and Methods

We retrospectively analyzed a prospectively maintained database at a single bariatric center (July–December 2025), including the first consecutive series of patients who underwent primary LSG with the Bendos Q system. Primary outcomes were staple-line bleeding, staple-line leak, and major complications according to the Clavien–Dindo classification.

Results

Twenty-four consecutive patients (58.3% women) underwent LSG. Mean age was 39.8±10.2 years and mean body mass index was 37.6±4.9 kg/m². Gastric transection was performed exclusively with green cartridges. Mean operative time was 65±10 minutes, with 5.1±0.7 stapler firings. No intraoperative complications occurred, and hemoglobin remained stable (13.0±0.6 g/dL at discharge). No staple-line bleeding, leaks, major complications, or reoperations were observed. Mean hospital stay was 2 days (range, 1–3).

Conclusion

In this preliminary series, the Bendos Q powered stapling system was associated with favorable short-term perioperative outcomes in LSG, with no staple-line complications or major postoperative events observed. Although these findings are promising, the small sample size, single-center design, and absence of a comparator group warrant caution; larger comparative studies with longer follow-up are needed to confirm the safety of this device.

INTRODUCTION

Obesity is one of the most important global public health challenges. According to the World Health Organization, the prevalence of obesity has increased dramatically over the past decades, with more than 650 million adults worldwide currently affected. Bariatric surgery remains the most effective treatment for severe obesity, providing durable weight loss and improvement or remission of obesity-related comorbidities such as type 2 diabetes, hypertension, and obstructive sleep apnea.

Among bariatric procedures, laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed metabolic and bariatric operation worldwide. Global registry data from the International Federation for the Surgery of Obesity and Metabolic Disorders indicate that sleeve gastrectomy accounts for more than half of all bariatric procedures performed globally [1,2]. The popularity of LSG is largely attributable to its relative technical simplicity, favorable metabolic outcomes, and acceptable safety profile compared with other bariatric procedures [3,4].

Despite these advantages, complications related to the gastric staple line remain a major concern. Staple-line bleeding and staple-line leak are the most clinically significant adverse events, both of which may significantly increase morbidity and prolong hospital stay [5]. Staple-line leaks are particularly feared due to their potential severity and the complexity of their management; large systematic analyses and multicenter registry studies have reported leak rates ranging between 1% and 5% following sleeve gastrectomy [6,7]. Several factors contribute to staple-line complications, including patient-related variables such as obesity severity and tissue characteristics, and technical aspects such as bougie size, distance from the pylorus, tissue ischemia, and the performance of the stapling device [8,9]. The reliability of the stapling mechanism is therefore a critical factor in preventing complications during sleeve gastrectomy.

Technological advances in surgical stapling have aimed to improve the reproducibility of staple formation and tissue compression. Powered stapling systems have been developed to reduce the variability associated with manual firing and to provide controlled and consistent tissue compression during stapler activation. In a large real-world analysis of laparoscopic bariatric surgery, the use of powered stapling systems was associated with a lower rate of bleeding-related complications than manual staplers [9]; the more consistent staple formation proposed as a mechanism for this benefit has been supported mainly by preclinical and benchtop testing.

The Bendos Q powered stapling system (B. Braun, Melsungen, Germany) is a powered endoscopic linear stapler based on a modular three-component architecture: a reusable battery-powered universal handle, an interchangeable single-use reload, and a single-use staple cartridge. The system incorporates powered jaw control, allowing gradual, motorized closure and opening of the jaws, which facilitates atraumatic tissue manipulation and controlled pre-compression prior to firing. Firing is governed by a tissue-sensing adaptive technology that continuously adjusts firing speed according to tissue thickness and resistance, with the aim of achieving consistent staple formation across heterogeneous tissue. The cartridges feature staples of three different heights within a single staple line, designed to provide graduated compression, and the articulating shaft allows stepwise angulation of up to 45°. A range of reload lengths and cartridge configurations is available, enabling the surgeon to tailor staple height and staple line length to the target tissue and procedure. Audible feedback confirms completion of each phase of the operating cycle. However, clinical data regarding its performance in bariatric surgery remain limited, particularly during the early phase of clinical use.

The aim of the present study was therefore to evaluate the early safety and perioperative outcomes of LSG performed using the Bendos Q powered stapling system in a consecutive preliminary series of patients treated at a single bariatric center.

MATERIALS AND METHODS

1. Study design

We performed a retrospective analysis of a prospectively maintained bariatric surgery database. The study included the first consecutive series of patients undergoing primary LSG using the Bendos Q powered stapling system between July 2025 and December 2025. All procedures were performed at a single bariatric center.

2. Patient population

All adult patients undergoing primary LSG with the Bendos Q powered stapling system during the study period were included. Indications for surgery followed current international guidelines for metabolic and bariatric surgery. At our institution, surgery was indicated in patients with a body mass index (BMI) ≥35 kg/m² regardless of the presence, absence, or severity of comorbidities, and was also considered in individuals with a BMI of 30–34.9 kg/m² in the presence of relevant metabolic comorbidities, including type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, and non-alcoholic steatohepatitis. Patients undergoing revisional procedures were not included in the present analysis. Baseline variables recorded for each patient included age, sex, BMI and obesity class, American Society of Anesthesiologists physical status, relevant comorbidities (type 2 diabetes, hypertension, and obstructive sleep apnea), smoking status, anticoagulant or antiplatelet use, and prior abdominal or bariatric surgery. Baseline characteristics of the study population are summarized in Table 1.

Table 1. Preoperative characteristics of the study population.

Characteristic		Value
Patients		24
Female sex		14 (58.3)
Male sex		10 (41.7)
Age (years)		39.8±10.2
Age range (years)		19–58
BMI (kg/m2)		37.6±4.9
BMI range (kg/m2)		32.1–47.2
Obesity class
	Class I (BMI 30–34.9)	6 (25.0)
	Class II (BMI 35–39.9)	12 (50.0)
	Class III (BMI ≥40)	6 (25.0)
ASA classification
	ASA I	12 (50.0)
	ASA II	11 (45.8)
	ASA III	1 (4.2)
Comorbidities
	Type 2 diabetes	10 (41.7)
	Hypertension	8 (33.3)
	Obstructive sleep apnea	6 (25.0)
Current smoking		2 (8.3)
Anticoagulant/antiplatelet use		2 (8.3)
Prior abdominal/bariatric surgery		0 (0)

Values are presented as number (%) or mean ± standard deviation.

ASA = American Society of Anesthesiologists, BMI = body mass index.

3. Surgical technique

All procedures were performed laparoscopically by an experienced bariatric surgical team. After standard laparoscopic access and mobilization of the greater curvature, gastric calibration was performed using a 36-French bougie positioned along the lesser curvature. Gastric transection began 6 cm proximal to the pylorus and was performed with the Bendos Q powered stapling system, using green cartridges (open staple heights, 3.5/3.8/4.2 mm) exclusively for all firings. This cartridge was selected because its staple height range was considered appropriate for the anticipated thickness of the gastric wall along the entire sleeve staple line, in line with the manufacturer’s recommendations for gastric tissue. A single cartridge type was used throughout in combination with the graduated compression provided by the three staple heights within each staple line and with the tissue-sensing adaptive firing technology, which adjusts firing speed to local tissue thickness and resistance, thereby avoiding the need to change cartridge height between the antrum and the fundus. Staple-line reinforcement was not routinely employed. After completion of the sleeve, an intraoperative leak test was systematically performed using a pneumatic air test.

4. Outcome measures

Primary outcomes were staple-line bleeding, staple-line leak, and major postoperative complications according to the Clavien–Dindo classification (grade ≥II). Secondary outcomes included operative time, number of stapler firings, intraoperative complications, hemoglobin at discharge (postoperative day 2), length of hospital stay, 30-day readmission, reoperation, and mortality.

5. Statistical analysis

Continuous variables are reported as mean ± standard deviation with ranges where appropriate. Categorical variables are presented as absolute frequencies and percentages. Descriptive statistical analyses were performed using Microsoft Excel version 16 (Microsoft Corporation, Redmond, WA, USA). Given the descriptive nature of this preliminary case series, no formal hypothesis testing was performed.

6. Ethics statement

All procedures performed in this study were conducted in accordance with the ethical standards of our institution and with the principles of the Declaration of Helsinki (1964) and its subsequent amendments. The study was approved by the accredited Research Ethics Committee (Comité de Ética de la Investigación con medicamentos, CEIm; approval No. 24/571, dated 15 March 2026) for this retrospective analysis of routinely collected clinical data. Written informed consent was obtained from each patient for the surgical procedure and for the use of anonymized clinical data for research and publication purposes.

RESULTS

1. Patient characteristics

A total of 24 patients underwent LSG with the Bendos Q powered stapling system during the study period. Fourteen patients (58.3%) were female and ten (41.7%) were male. The mean age was 39.8±10.2 years (range, 19–58) and the mean BMI was 37.6±4.9 kg/m² (range, 32.1–47.2). Detailed baseline characteristics are presented in Table 1.

2. Operative outcomes

All procedures were completed laparoscopically without conversion. Gastric transection was performed exclusively with the Bendos Q powered stapling system using green cartridges, with a mean of 5.1±0.7 firings per case (range, 4–6). Staple-line reinforcement was not used in any patient. The mean operative time was 65±10 minutes (range, 50–85). No intraoperative complications were observed.

3. Postoperative outcomes

Postoperative hemoglobin levels remained stable, with a mean preoperative value of 13.2±0.5 g/dL and a mean value of 13.0±0.6 g/dL on postoperative day 2, corresponding to a minimal mean decrease of 0.2 g/dL. No cases of staple-line bleeding, staple-line leak, or Clavien–Dindo ≥II complications were observed. The mean length of hospital stay was 2 days (range, 1–3). One patient (4.2%) required readmission within 30 days because of dehydration, which resolved with conservative management. No reoperations or mortality occurred. The postoperative course, stratified by obesity class, is shown in Table 2. Operative time and the number of stapler firings increased progressively with obesity class (58±9, 65±9, and 72±9 minutes, and 4.6±0.5, 5.1±0.5, and 5.6±0.5 firings for Class I, II, and III, respectively), consistent with the greater technical demand associated with a higher BMI. No staple-line bleeding, staple-line leak, or Clavien–Dindo ≥II complication occurred in any obesity class, and the single 30-day readmission occurred in a Class II patient. Hemoglobin at discharge and length of hospital stay were not available disaggregated by obesity class and are therefore reported for the overall cohort only; both were similar across obesity classes.

Table 2. Postoperative course at 30 days, stratified by obesity class.

Variable	Class I (n=6)	Class II (n=12)	Class III (n=6)	Total (n=24)
Operative time (minutes)	58±9	65±9	72±9	65±10
Stapler firings	4.6±0.5	5.1±0.5	5.6±0.5	5.1±0.7
Hemoglobin at discharge (POD 2; g/dL)a	-	-	-	13.0±0.6
Length of hospital stay (days)a	-	-	-	2 (1–3)
Staple-line bleeding	0	0	0	0
Staple-line leak or dehiscence	0	0	0	0
Clavien–Dindo complications ≥II	0	0	0	0
30-day readmission	0	1	0	1
Reoperation	0	0	0	0
Mortality	0	0	0	0

Values are presented as mean ± standard deviation or median (range).

POD = postoperative day.

^aHemoglobin at discharge and length of hospital stay were not available disaggregated by obesity class and are therefore reported for the overall cohort only; both were similar across obesity classes. Obesity class defined by body mass index: Class I, 30–34.9 kg/m²; Class II, 35–39.9 kg/m²; Class III, ≥40 kg/m².

DISCUSSION

In this preliminary clinical series, LSG performed using the Bendos Q powered stapling system was associated with favorable short-term perioperative outcomes, with no staple-line bleeding, staple-line leak, or major postoperative complications observed. To our knowledge, this is among the first clinical reports describing the use of this powered stapling platform in bariatric surgery.

Staple-line complications remain among the most feared adverse events following sleeve gastrectomy. Large systematic analyses and multicenter registry studies have reported leak rates ranging between 1% and 5% [6,7], whereas bleeding rates have been reported between 1% and 6% [10]. The clinical and economic impact of these complications is substantial, as they often require reoperation, prolonged hospitalization, or readmission. Improving the consistency of staple formation has therefore been a major focus of device development.

Powered stapling systems have been introduced to improve the reproducibility of staple formation and to reduce variability associated with manual firing. A large real-world analysis of laparoscopic bariatric surgery reported a lower rate of bleeding-related complications with powered staplers than with manual staplers [9], whereas the more consistent staple formation proposed as the underlying mechanism has been demonstrated mainly in preclinical and benchtop studies rather than in comparative clinical outcomes. In the present series, no staple-line bleeding or leak was observed during gastric transection with the Bendos Q powered stapler, a finding that is consistent with acceptable performance of the stapler in this early series. However, given the small sample size and the absence of a comparator group, these observations should be regarded as preliminary and do not establish the reliability of this device relative to existing stapling platforms.

Our findings are also consistent with recent data on other alternate stapling platforms in sleeve gastrectomy. In a recent single-center retrospective series of 100 primary sleeve gastrectomies performed with the iREACH OMNIA alternate linear stapler, no staple-line bleeding or leaks were observed across all BMI categories, with a reported 95% confidence interval of 0–3.7% [11]. The 0% complication rate observed in our series should likewise be interpreted with caution, as rare events cannot be reliably excluded in such a small sample: the exact (Clopper–Pearson) 95% confidence interval for 0 events in 24 patients ranges from 0% to 14.2%, which remains fully compatible with the 1–5% leak rates reported in the literature, and, assuming a true leak rate of 1%, the probability of observing zero leaks in 24 patients is approximately 79%. Our 0% complication rate should therefore be regarded as encouraging but preliminary, rather than as evidence of the absence of risk. Taken together, these non-randomized, single-arm retrospective cohorts suggest that staple-line complication rates can be kept very low across various contemporary stapling systems; however, in the absence of direct comparative data, such findings do not provide evidence of the superiority of any specific device over others. It should also be acknowledged that part of this comparative and supporting evidence, including the iREACH OMNIA series [11] and the real-world powered- versus manual-stapler analysis [9], derives from studies funded or conducted by the respective device manufacturers, and should therefore be interpreted with that potential for bias in mind.

Another notable feature of this study is that staple-line reinforcement was not used in any patient. The role of reinforcement in sleeve gastrectomy remains controversial. Some meta-analyses have demonstrated reductions in bleeding rates with reinforcement techniques, while others have not shown significant differences in leak rates [12,13]. Although the present study was not designed to evaluate reinforcement strategies, no staple-line complications were observed with the Bendos Q system even without reinforcement; however, in the absence of a comparator group, this observation cannot be specifically attributed to the staple formation provided by this device.

This study has several limitations that should be acknowledged. First, this is a small preliminary series of 24 consecutive patients, which limits the statistical power to detect rare complications such as staple-line leak. Second, the analysis was conducted at a single center by a high-volume bariatric team, which may limit the generalizability of the findings to other settings. Third, the study focuses on short-term, 30-day perioperative outcomes; long-term safety, weight loss, and metabolic outcomes remain to be evaluated. In addition, hemoglobin at discharge and length of hospital stay could not be retrieved disaggregated by obesity class from the study database and are therefore reported for the overall cohort only. In particular, weight loss outcomes were not analyzed as a formal endpoint, because postoperative weight was not recorded at a standardized time point in this retrospective series and follow-up visits occurred with considerable variability in timing; the study was designed to evaluate device safety rather than weight loss efficacy, and the sample size is insufficient to draw meaningful conclusions regarding differences in weight loss across obesity classes. A prospective study with standardized follow-up is currently underway to assess weight loss and metabolic outcomes in a larger cohort. Fourth, the absence of a comparator group precludes any conclusion regarding the superiority of the Bendos Q system over existing manual or powered stapling devices. Despite these limitations, the present series provides initial real-world clinical data on the safety profile of this new powered stapling platform in LSG. Larger multicenter studies and prospective comparative trials with longer follow-up are needed to confirm and extend these preliminary findings.

CONCLUSION

LSG performed using the Bendos Q powered stapling system was associated with favorable short-term perioperative outcomes in this small preliminary single-center series, with no staple-line bleeding, staple-line leak, or major postoperative complications observed. These preliminary findings suggest that this powered stapling device is feasible for use in bariatric surgery; however, given the small sample size, single-center design, and absence of a comparator group, they do not establish the superiority or a safety advantage of this device over existing stapling systems. Larger comparative studies with longer follow-up are required to confirm these results.