A Single-Institution 5-Year Retrospective Analysis of Laparoscopic Sleeve Gastrectomy Staple-Line Reinforcement: Bioabsorbable Mesh Versus Oversewing

Abstract

Background:

Staple-line reinforcement has been used to decrease complications such as staple-line bleeding (SLB) and staple-line leaks (SLLs) in patients undergoing laparoscopic sleeve gastrectomy (SG). There is little data comparing bioabsorbable mesh reinforcement (BMR) with oversewing the staple line (OSL). The aim of our study was to compare BMR with OSL in SG.

Materials and Methods:

This is a single-institution retrospective analysis comparing risks and benefits of BMR (group a) with those of OSL (group b) for SG staple-line reinforcement between 2015 and 2020.

Results:

In total, 857 patients were identified. There were 452 (52.74%) in group a and 405 (47.26%) in group b. SLB requiring transfusion occurred in 6 (1.32%) patients in group a and 6 (1.48%) patients in group b, NS (P = .848). Zero SLL was identified in either group. One-year mean direct cost of SG in group a was $7881 compared with $6677 in group b.

Conclusion:

This retrospective study showed that there was low risk of bleeding or leak with either technique of staple-line reinforcement and there was no significant difference in SLB or leak rate with bioabsorbable mesh versus oversewing. The use of bioabsorbable mesh was more expensive than oversewing.

Introduction

In the United States, obesity represents the largest share of health care-related expenditure.¹ According to the CDC, 42.4% of adults in the United States have a body mass index (BMI) ≥30 kg/m².² Over a decade ago, obesity-related comorbidities such as hypertension (HTN), type 2 diabetes mellitus (DM2), cardiovascular disease, dyslipidemia, degenerative joint disease, and obstructive sleep apnea (OSA) were estimated to cost the health care system $147 billion per year, with today's estimates up to $210 billion.^2,3 To date, bariatric surgery has been proven to be more effective in losing excess weight compared with diet and exercise in morbidly obese patients.^4,5 Of the available surgical options, sleeve gastrectomy (SG) is the most commonly performed operation for weight loss in the United States.⁶

Although SG continues to be an effective treatment for morbid obesity, complications such as staple-line leaks (SLLs) and staple-line bleeding (SLB) carry a significant morbidity and mortality. In a systematic review including studies from 2010 to 2017, the incidence of SLB occurred in 1%–6% of all cases, and SLLs in 2%–6% of all cases^6,7 Staple-line reinforcement devices or oversewing the staple line (OSL) are techniques used to minimize the incidence of these complications, although the comparative outcomes are inconclusive.

The use of bioabsorbable mesh reinforcement (BMR) devices such as GORE^® SEAMGUARD^® (W.L. Gore & Associates, Flagstaff, AZ) is commonly used as a buttressing device, designed to distribute the pressure exerted on the staples onto a larger area on the gastric tissue, aiming to decrease bleeding and leaks.⁸ A recent systematic review analyzing 148 studies and 40,653 patients found significantly lower rates of SLLs using mesh reinforcement (0.73%) compared with oversewing (1.21%), or no reinforcement (1.89%; P = .027).⁹ Meanwhile, multiple prospective studies in the literature show no significant leak reduction when comparing the use of mesh, oversewing, or no reinforcement technique at all.^10,11

Moreover, in a study that compared the outcomes in 89,477 cases of SG between 2012 and 2014, SLR was associated with higher leak rates (0.96% versus 0.65%; odds ratio [OR] 1.20; 95% confidence interval [CI] 1.00 to 1.43) and lower bleeding (0.75% versus 1.00%; OR 0.74; 95% CI 0.63 to 0.86) when compared with not performing SLR.¹² The lack of consistency in SLR outcomes in SG emphasizes the need of further data contribution to the literature.

This retrospective chart review evaluated the rates of SLB and SLLs in two reinforcement techniques during SG: bioabsorbable mesh versus oversewing.

Materials and Methods

This study was conducted at Ochsner Medical Center in New Orleans LA and was approved by the institutional review board. The inclusion criterion was set for patients age ≥18 years, who underwent laparoscopic SG with current procedural terminology code 43775, between January 2015 and December 2019. No exclusion criterion was set for this study. All patients met the National Institutes of Health consensus criteria for bariatric surgery.

Patients who underwent staple-line reinforcement with use of a bioabsorbable mesh were placed in group a, and patients who underwent oversewing for staple-line reinforcement were placed in group b.

All patient data were collected from the electronic medical record software system EPIC. Unidentifiable patient data including demographic information, age, weight, BMI, diagnosis of HTN, DM, hyperlipidemia (HLD), OSA, gastroparesis, gastroesophageal reflux disease (GERD), liver steatosis, nonalcoholic steatohepatitis (NASH), cirrhosis, chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), surgical history, number of prior surgeries, operative time, hospital length of stay, event of return to emergency room (ER) within 30 days, hospital readmission within 30 days, requirement of outpatient intravenous (IV) hydration, weight loss at 6 months, bioabsorbable mesh use, oversew use, and presence of SLB, SLL, and event of deep wound infection were collected and stored into a secure computer database.

We defined SLB as acute postoperative blood loss requiring transfusion or return to operating room. SLL was defined as any fluid collection or presence of air adjacent to the line.

Surgical technique

For both groups a and b, access to peritoneum is gained through a standard five- or six-port technique. A liver retractor was placed. The greater curve of the stomach is taken down starting 6 cm from the pylorus going all the way to the base of the left crus taking all posterior gastric attachments with the harmonic scalpel. A 40- to 42-French bougie was passed toward the pylorus to guide resection.

In group b (OSL), an endoscopic GIA stapler (Ethicon Endosurgery; J and J, Cincinnati, OH) was used to resect the stomach along the bougie, starting ∼6 cm from the pylorus and ending just to the left of the angle of His. The staple line was reinforced with the oversewing technique, using a running absorbable double-ended 2-0 Quill stitch starting at the middle of the staple line and going up to the proximal staple line and distally to near but not always all the way to the distal staple line (Stratafix; Ethicon, Cincinnati, OH).

In group a (BMR), the bioabsorbable mesh (Seamguard; WL Gore, Newark, DE) is placed on the GIA stapler and used to resect the stomach and reinforce the staple line. The device is supplied with two sleeves: one onto the cartridge jaw and the other onto the anvil jaw of the endoscopic stapler. After proper positioning, and locking of the stapler, the thread attached to the reinforcement sleeves is removed, which fires the stapler. The stomach is divided as in group b otherwise.

In both groups, after gastric resection, the bougie was removed, and endoscopy was performed to check for leak. After a negative test for air leaks, the endoscope was withdrawn. The gastrectomy was removed through the primary trocar site, and all trocar sites were closed. No postoperative leak testing was done routinely. Patients are followed up at 1 week with a nursing phone call and at 2 weeks in clinic.

Statistical analysis

The results for patient data including age, weight, and BMI are expressed as mean ± standard deviation and range. Statistical evaluations for SLB and SLL were performed by chi-square analysis. Statistical significance was accepted at P < .05.

Results

We identified 857 patients for our study: 452 in group a and 405 in group b. Demographics are depicted in Table 1 and patient obesity-related comorbidities are depicted in Table 2.

Table 1.

Demographic Data

Demographic and clinical characteristics	All (n = 857), N (%)	Group a: bioabsorbable mesh (n = 452), N (%)	Group b: oversew (n = 405), N (%)	P
Gender				.019
Female	689 (80.4)	377 (83.4)	312 (77.0)
Male	168 (19.6)	75 (16.6)	93 (23)
Age, mean ± SD (range)	47.6 ± 12.2 (20–76)	45.0 ± 11.9 (20–73)	50.5 ± 11.9 (21–76)	<.001
Weight, lbs, mean ± SD (range)	124.6 ± 24.9	125.7 ± 27.2	123.3 ± 24.4	.158
BMI, mean ± SD (range)	44.6 ± 7.13 (29–77)	45.0 ± 7.1 (32–77)	44.1 ± 7.2 (29–77)	.059

Bold indicates statistical significance.

BMI, body mass index; SD, standard deviation.

Table 2.

Patient Obesity-Related Comorbidities

Medical history	All (n = 857), N (%)	Group a: bioabsorbable mesh (n = 452), N (%)	Group b: oversew (n = 405), N (%)	P
HTN	567 (66.3)	284 (63.1)	283 (69.6)	.037
DM2	283 (33.1)	126 (28)	157 (38.8)	<.001
HLD	384 (44.9)	176 (39.1)	208 (51.4)	<.001
OSA	406 (47.5)	185 (41.1)	221 (54.6)	<.001
Gastroparesis	12 (1.4)	2 (0.4)	10 (2.5)	.012
GERD	467 (54.6)	254 (56.4)	213 (52.6)	.259
Liver steatosis	101 (11.8)	47 (10.4)	54 (13.3)	.191
NASH	41 (4.8)	18 (4)	23 (5.7)	.251
Cirrhosis	47 (5.5)	22 (4.9)	25 (6.2)	.411
COPD	49 (5.7)	16 (3.6)	33 (8.1)	.004
CKD	79 (9.2)	33 (7.3)	46 (11.4)	.042

Bold indicates statistical significance.

CKD, chronic kidney disease; COPD, chronic obstructive pulmonary disease; DM2, type 2 diabetes mellitus; GERD, gastroesophageal reflux disease; HLD, hyperlipidemia; HTN, hypertension; NASH, nonalcoholic steatohepatitis; OSA, obstructive sleep apnea.

Patient demographics

No significant differences in BMI were found between either group. Group a had a significantly younger mean age (45.0 versus 50.5 years, P < .001), and higher percentage of female patients (83.4% versus 77.0%, P = .019) compared with group b.

Patient obesity-related comorbidities

Significant differences in presence of comorbidities between group a and group b included DM2 (group a: 28%, group b: 38.8%, P < .001), HLD (group a: 39.1%, group b: 51.4%, P < .001), OSA (group a: 41.1%, group b: 54.6%, P = <.001), gastroparesis (group a: 0.4%, group b: 2.5%, P < .001), and COPD (group a: 3.6% group b: 8.1%, P = .004). The prevalence of HTN, GERD, liver steatosis, NASH, cirrhosis, and CKD was not found to be significantly different between groups a and b.

Patient surgical history

Significant differences in surgical history between group a and group b included history of fundoplication (group a: 0.66%, group b: 4.9%, P = .001) and laparoscopic gastric band (group a: 2.9%, group b: 7.2%, P < .001), history of two previous surgeries (group a: 1.6%, group b: 5.7%, P = .001), and history of only one surgery (group a: 17%, group b: 13.1%, P = .023). Detailed patient surgical history is summarized in Tables 3 and 4.

Table 3.

Patient Surgical History

Surgical history	All (n = 857), N (%)	Group a: bioabsorbable mesh (n = 452), N (%)	Group b: oversew (n = 405), N (%)	P
Laparoscopic cholecystectomy	32 (3.7)	15 (3.3)	17 (4.2)	.498
Laparoscopic hiatal hernia repair	3 (0.35)	1 (0.22)	2 (0.49)	.499
Fundoplication	29 (3.4)	3 (0.66)	20 (4.9)	.001
Laparoscopic gastric band	42 (4.9)	13 (2.9)	29 (7.2)	<.001
Ventral hernia (mid or upper)	10 (1.2)	5 (1.1)	5 (1.2)	.861

Bold indicates statistical significance.

Table 4.

Rates of Patients with Prior Surgeries

Number of prior surgeries	All (n = 857), N (%)	Group a: bioabsorbable mesh (n = 452), N (%)	Group b: oversew (n = 405), N (%)	P
0	693 (80.9)	368 (81.4)	325 (80.2)	.664
1	130 (15.2)	77 (17.0)	53 (13.1)	.023
2	30 (3.5)	7 (1.6)	23 (5.7)	.001
≥3	4 (0.5)	0	4 (1.0)	−

Bold indicates statistical significance.

Primary endpoint data

The incidence of SLB occurred in 12 (1.40%) of all SG procedures: 6 (1.32%) in group a and 6 (1.48%) in group b, which was not statistically significant (P = .848). One case of SLLs was identified in group a (0.22%) and zero cases of SLLs identified in group b.

Postoperative infection occurred in 3 (0.35%) of all SG cases: 0 cases in group a and 3 (0.74%) cases in group b. The results are summarized in Table 5.

Table 5.

Primary Endpoint Data by Group

Postoperative complication	All (n = 857), N (%)	Group a: bioabsorbable mesh (n = 452), N (%)	Group b: oversew (n = 405), N (%)	P	Odds ratio
Postoperative complication	All (n = 857), N (%)	Group a: bioabsorbable mesh (n = 452), N (%)	Group b: oversew (n = 405), N (%)	P	Estimate	95% CI
Staple-line bleeding	12 (1.40)	6 (1.32)	6 (1.48)	.848	1.12	(0.36 to 3.49)
Staple-line leak	1 (0.11)	1 (0.22)	0	—	—	—
Deep wound infection	3 (0.35)	0	3 (0.74)	—	—	—

CI, confidence interval.

Secondary endpoint data

There were no significant differences in operative time, hospital length of stay, rates of return to ER within 30 days, hospital readmission within 30 days, use of outpatient IV hydration, and total weight loss at 6 months between groups a and b. Detailed secondary endpoint data by group are summarized in Table 6.

Table 6.

Secondary Endpoint Data by Group

	All (n = 857)	Group a: bioabsorbable mesh (n = 452)	Group b: oversew (n = 405)	P	Odds ratio
	Mean ± SD (range)			P	Estimate	95% CI
Operative time, minutes	65.6 ± 20.7 (31–216)	64.6 ± 22.9 (34–216)	66.8 ± 17.81 (31–185)	.111	−2.2	−4.9 to 0.7
Hospital length of stay, days	1.5 ± 1.60 (0–22)	1.5 ± 1.89 (0–22)	1.5 ± 1.20 (0–17)	.597	0.06	−0.14 to 0.27

	N (%)	N (%)	N (%)
Return to ER within 30 days	73 (8.5)	39 (8.6)	34 (8.4)	.902	0.97	(0.60 to 1.57)
Hospital readmission within 30 days	24 (2.8)	13 (2.9)	11 (2.7)	.887	0.94	(0.41 to 2.13)
Outpatient IV hydration	24 (2.8)	16 (3.5)	8 (2.0)	.168	0.55	(0.23 to1.30)
Weight loss at 6 months	846 (98.7)	447 (98.9)	399 (98.5)	.626	1.32	(0.42 to 4.16)

CI, confidence interval; ER, emergency room; IV, intravenous; SD, standard deviation.

Monetary data

In 2020, the average direct cost (USD) of SG for group a was $7820 and that for group b was $6677. Detailed monetary data are outlined in Table 7.

Table 7.

Monetary Data for Sleeve Gastrectomy in 2020

Staple-line reinforcement groups	Average direct cost	Average total OR supply cost	Average cost of staple-line reinforcement device
a	$7881	$2820	$767.5
b	$6677	$2223	$0

Cost measured in USD from 2020 not adjusted for inflation.

Discussion

Over time reported rates of bleeds have fallen from upward of 10% in 2007 to recent studies ranging between 0% and 3%. Early leak rates have similarly fallen from upward of 8% to recent studies reporting 1.1%–2.4%.^13,14 It is unclear whether this reduction is due to increased surgical experience in SG or by use of reinforcement techniques. It should be noted that several prospective studies have showed no significant reduction in bleeds or leaks with SLR compared with the use of no reinforcement methods.^11,15

In our study, both reinforcement techniques revealed low rates of SLB (BMR: 1.32%, OSL: 1.48%) and leaks (BMR: 0.22%, OSL: 0%) compared with the recent literature (1%–6%) and (2%–6%), and no significant differences were found in primary and secondary outcomes. The 1 case of SLL presented as a fluid collection adjacent to gastric staple line on post operative day 6. Normal endoscopic findings and no extravasation of oral contrast were found on upper gastrointestinal films. The patient was managed successfully through drainage with pig-tail catheterization. The 3 patients who developed postoperative infection were treated successfully with nonoperative inpatient antibiotic therapy.

This review may highlight the need for evidence-based methods to determine the comparative value of surgical devices, such as those used for staple-line reinforcement in SG. In a recent study published in 2021, which analyzed 346,530 patient charts, reinforced stapling was shown to reduce minor postoperative bleeding, but not major bleeding or leaks, and is not cost-effective if routinely used in SG. This conclusion was arrived after calculating the mean incremental cost of reinforced stapling ($819.60 per surgery), and the net quality adjusted life years (QALY) gain (decreased rate of minor bleeding) equaling 0.00002, thus yielding an incremental cost-effectiveness ratio at $40,553,000/QALY.¹⁶

It is worth noting that at our institution, the incremental cost of reinforced stapling averages to $1,204 per surgery, yet a direct comparison with cost-effectiveness ratio/QALY may not be applicable due to our current study not finding a decreased rate of minor bleeding associated with BMR use.

Although this study does not make comments or investigate directly on the requirement for staple-line reinforcement, it does add to the current literature that severe postoperative complication rates are lower in our study than the national average using these reinforcement techniques. There are limitations to this study in that it is a single-institution retrospective study of moderate size and, therefore, could have the presence of bias. Future study direction can be placed into a multisystem across alternative or similar patient populations to further validate these findings.

Conclusion

This retrospective study of 857 patients who underwent laparoscopic SG showed there was low risk of bleeding or leak with either technique of staple-line reinforcement, and there was no significant difference in SLB or leak rate with bioabsorbable mesh versus oversewing. The use of bioabsorbable mesh was more expensive than oversewing, with no significant difference in primary or secondary outcomes.

Footnotes

Acknowledgment

The authors specially thank Dr. Malika Mora, MD, for her efforts in data collection.

Authors' Contributions

Each author has participated sufficiently in the study to take public responsibility for appropriate portions of the article contents. J.S.P. contributed to writing—original draft, data curation, investigation, resources, and project administration. H.H.H. was involved in writing—original draft, data curation, investigation, and resources. C.V. carried out formal analysis and software. J.G. took care of writing review and editing and resources. J.W. took care of writing review and editing and resources. W.S.R. was in charge of conceptualization, methodology, resources, writing review and editing, supervision, and project administration.

Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

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