Resected Gastric Volume / Number of Staplers Fired Ratio as a Tool in Predicting Complication and Midterm Results in Sleeve Gastrectomy

doi:10.21203/rs.3.rs-4719001/v1

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Resected Gastric Volume / Number of Staplers Fired Ratio as a Tool in Predicting Complication and Midterm Results in Sleeve Gastrectomy

https://doi.org/10.21203/rs.3.rs-4719001/v1

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Background

Laparoscopic sleeve gastrectomy is a restrictive surgery that aims to decrease the patients’ gastric volume. This study hypothesized that increased resected gastric volume/number of staplers fired ratio is associated with better postoperative 12th -month outcomes.

Objectives

To analyze the effects of resected gastric volume/number of staplers fired ratio on postoperative results of patients with sleeve gastrectomy.

Setting:

University Hospital, Istanbul, Türkiye

Methods

We analyzed the data of 407 patients who underwent laparoscopic sleeve gastrectomy between 2018–2022. The primary outcome was the effect of resected gastric volume/number ratio on postoperative 12th -month excess weight loss.

Results

A total of 407 patients were included in the study. The higher resected gastric volume/number of staplers fired ratio was associated with higher excess weight loss in the postoperative 12th -month, and no effect was found in complications (p = 0.001 and p = 0.785, respectively).

Conclusion

This study revealed that resected gastric volume/number of staplers fired could be used to predict weight loss. Further studies should inspect the effect of resected gastric volume/number of staplers fired on complications.

Health sciences/Health care/Weight management

Health sciences/Diseases/Endocrine system and metabolic diseases/Obesity

Health sciences/Diseases/Gastrointestinal diseases/Nutrition disorders/Obesity

Laparoscopic sleeve gastrectomy

resected gastric volume

staple firing number

ratio

complications

Obesity is a common disease responsible for different systemic disorders [1]. Bariatric surgery is an end-resort treatment option in patients with obesity, refractory to medical modalities, and laparoscopic sleeve gastrectomy (LSG) is the most applied bariatric surgery[2]. Although its benefits are testified, it’s not a magical touch without any failures or complications. It’s said that > 25% of patients regain weight, and up to 5% experience operative complications, including stapler line leakage (SLL), hemorrhage, or gastric stricture[3, 4].

Since weight loss is a multifactorial process including metabolic, psychological, and surgical factors, it’s challenging to predict the outcome of the surgery. Thus, different elements are widely researched to predict outcomes[5–7]. LSG is a surgery defined under the umbrella term of restrictive surgery. The initial theory behind the operation is decreasing the gastric volume. Therefore, resected gastric volume (RGV) is a crucial factor affecting the outcome of the surgery[8].

The number of staplers fired (SF) is an operative parameter directly affected by the patient characteristics, dimensions of the stomach, and the surgeon. Its relationship with short-term complications is reported, but no significant data on its midterm bariatric results[9, 10].

It’s the most extensive data of the patients in a single center and operated by the same surgeon. Our study reveals the relationship between the ratio of RGV/SF and clinical outcomes.

Data from the patients who underwent LSG between 2018–2022 in our hospital were recorded prospectively and collected retrospectively following the institutional board approval from Kanuni Sultan Süleyman Training and Research Hospital Ethics Committee (KAEK/2023.03.06). The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request. Consent forms were taken from the institution and the patients according to the editorial and publishing policies. All methods were performed in accordance with the relevant guidelines and regulations. 407 patients operated by the same surgeon who completed 12 months of follow-up and gave written consent to participate in the study were included in the study. Three-port LSG was applied, and 38 Fr bougie guided the sleeve line. Purple staplers were used for the gastric transection. In case of a hemorrhage, titanium clips were used for hemostasis, and the methylene blue test was used for the leakage control following the transection. An insufflation was inserted through the antrum, and the specimen was filled with CO₂ gas until the internal pressure was measured at 10 mmHg. The amount of gas used was recorded as mL and regarded as RGV.

Patients were divided into groups according to the RGV, SF, and RGV/SF ratio. Percent excess weight loss (%EWL) indicated treatment success. It was calculated by [(Preoperative Weight-Postoperative Weight)/(Preoperative Weight-Ideal Body Weight)]x100. Patients with ≥%50 EWL were regarded as efficaciously treated. Receiver operator characteristics (ROC) analysis was performed to determine the optimal RGV and RGV/SF cut-off values. 725 mL and 103.57 mL/n were determined, respectively.

The Fisher’s exact test and chi-square (x²) test were used to compare the categorical variables between the two groups. Kolmogorov Smirnov and Shapiro-Wilk tests were performed to analyze the normal distribution of the data. Independent samples T-test and analysis of variance were performed to investigate the normal distributing data, and Mann Whitney-U and Kruskal Wallis tests were performed to compare the non-normal distributing data. Univariate and multivariate regression analyses were performed to analyze the %EWL and complication indicators. p < 0.05 was assumed to be statistically significant.

Baseline Characteristics

A total of 407 patients were included in this study. 391 (96.1%) patients were female. The rate of female patients was significantly higher in the < 725mL RGV group and the < 123.57 RGV/SF group (p = 0.042 and p = 0.022, respectively).

The mean age was 35.29. The patients with > 725mL RGV, > 123.57 RGV/SF, and ≥ 50% %EWL had a higher mean age (p < 0.001, p = 0.002, and p = 0.008, respectively). The mean age of patients in the 5 SF group was lower than 6 SF and > 6 SF groups (p = 0.018).

The mean preoperative BMI was 45.57 kg/m². Patients with < 50% %EWL and < 725mL RGV had higher BMI (p = 0.009 and p = 0.002, respectively). On the first preoperative visit, 230 (56.5%) patients had at least one obesity-related comorbidity.

The rate of patients with comorbidities was higher in those with ≥ 50% %EWL and who experienced any complications (p = 0.01 and p = 0.002, respectively). The rate of any obesity-related disease was lower in the 5 SF group (p < 0.001). The baseline characteristics of the patients and the relationship between the groups are outlined in Table 1.

Table 1

The baseline characteristics of the patients and the relationship between the groups
	Female, n(%)	Age, mean ± SD	Initial BMI mean ± SD	Comorbidity, n(%)
RGV < 725 ml (203)	199 (98.1)	33,42 ± 10,09	46,23 ± 4,72	106 (52,2)
RGV > 725ml (204)	192 (94.1)	37,16 ± 11,01	44,92 ± 5,27	124 (60,8)
p-value	0,042^a	< 0,001^b	0,009^b	0,081^a
RGV/SF < 103,57 (163)	161 (98.8)	33,29 ± 10,99	45,76 ± 4,76	99 (60,7)
RGV/SF > 103,57 (244)	230 (94.3)	36,64 ± 10,33	45,45 ± 5,22	131 (53,7)
p-value	0,022^a	0,002^b	0,539^b	0,160^a
< 50% %EWL (36)	34 (94.4)	30,75 ± 10,48	48,69 ± 5,88	13 (36,1)
≥ 50% %EWL (371)	357 (96.2)	35,74 ± 10,65	45,27 ± 4,85	217 (58,5)
p-value	0,422^c	0,008^b	0,002^b	0,010^a
No Complication (365)	350 (95.9)	35,35 ± 10,69	45,68 ± 5,10	197 (54)
Had Complication (42)	41 (97.6)	34,86 ± 11,03	44,62 ± 4,40	33 (78,6)
p-value	0,494^c	0,780^b	0,151^b	0,002^a
SF = 5 (95)	91 (95.8)	32,58 ± 10,59	44,56 ± 4,45	39 (41,1)
SF = 6 (202)	195 (96.5)	36,10 ± 11,36	45,85 ± 4,92	115 (56,9)
SF > 6 (110)	105 (95.5)	36,15 ± 9,19	45,93 ± 5,63	76 (69,1)
p-value	0,884^a	0,018^d	0,080^d	< 0,001^a
RGV: Resected gastric volume; SF: Staplers fired; SD: Standard deviation; EWL: Excess weight loss; BMI: Body mass index. ^a: Pearson's chi-squared test; ^b: Independent t-test for two samples; ^c: Fisher's exact test; ^d: Analysis of variance.

Operative and Complication Outcomes

The mean RGV was 766mL. Higher RGV/SF ratio, experiencing complication, and > 6 SF were associated with increased RGV (p < 0.001, p = 0.031, and p < 0.001, respectively).

The mean SF was 6.05. There was a statistically significant but clinically insignificant increase in SF in patients with < 50% %EWL and experienced complications (p < 0.001, and p < 0.001, respectively).

The mean RGV/SF ratio was 127.46. Patients with > 725mL RGV and ≥ 50% %EWL were prone to have an increased RGV/SF ratio (p < 0.001 and p < 0.001, respectively).

Forty-two (10.3%) patients experienced complications in total. 24 (57.1%) of these were bleeding, 15 (35.7%) were nausea-vomiting, and 3 (7.2%) were gastric twists or stenosis. The details of operative and complication outcomes are outlined in Table 2.

Table 2

Operative and complication outcomes
	RGV(mL), mean ± SD	SF, mean ± SD	RGV/SF, mean ± SD	Complications, n(%)	Bleeding, n(%)	Nausea, n(%)	Twist, n(%)
RGV < 725 ml (203)		6 ± 0,67	91,34 ± 17,14	18 (8,9)	2 (1)	13 (6,4)	3 (1,5)
RGV > 725ml (204)		6,11 ± 0,80	163,41 ± 46,92	24 (11,8)	22 (10,8)	2 (1)	0 (0)
p-value		0,124^b	< 0,001^b	0,337^a	< 0,001^a	0,004^a	0,123^c
RGV/SF < 103,57 (163)	525,46 ± 110,05	6,11 ± 0,66		16 (9,8)	0 (0)	13 (8)	3 (1,8)
RGV/SF > 103,57 (244)	927,46 ± 285,60	6,01 ± 0,79		26 (10,7)	24 (9,8)	2 (0,8)	0 (0)
p-value	< 0,001^b	0,190^b		0,785^a	< 0,001^a	< 0,001^a	0,064^c
< 50% %EWL (36)	686,11 ± 191,09	6,64 ± 0,49	103,84 ± 28,51	3 (8,3)	2 (5,6)	0 (0)	1 (2,8)
≥ 50% %EWL (371)	774,26 ± 312,11	5,99 ± 0,74	129,75 ± 51,57	39 (10,5)	22 (5,9)	15 (4)	2 (0,5)
p-value	0,097^b	< 0,001^b	< 0,001^a	0,477^c	0,642^c	0,243^c	0,243^c
No Complication (365)	753,42 ± 295,75	5,99 ± 0,74	126,84 ± 50,72
Had Complication (42)	879,76 ± 353,91	6,57 ± 0,55	132,91 ± 48,61
p-value	0,031^b	< 0,001^b	0,461^b
SF = 5 (95)	735,26 ± 320,89		147,05 ± 64,18	0 (0)	0 (0)	0 (0)	0 (0)
SF = 6 (202)	715,84 ± 234,41		119,31 ± 39,07	19 (9,4)	6 (3)	13 (6,4)	0 (0)
SF > 6 (110)	886,36 ± 366,73		125,52 ± 51,61	23 (20,9)	18 (16,4)	2 (1,8)	3 (2,7)
p-value	< 0,001^b		< 0,001^d	< 0,001^a	< 0,001^a	0,011^a	0,017^a
RGV: Resected gastric volume; SF: Staplers fired; SD: Standard deviation; EWL: Excess weight loss. ^a: Pearson's chi-squared test; ^b: Independent t-test for two samples; ^c: Fisher's exact test; ^d: Analysis of variance.

Weight Loss Outcomes

The mean BMI in the postoperative 6th -month was 33.53 kg/m^2, and the mean BMI loss (%BMIL) since the operation was 26.42%. There was no significant difference in the 6th -month %BMIL. Patients with < 725mL RGV were prone to have a higher 6th -month BMI, but there was no difference in %BMIL (p = 0.017 and p = 0.615, respectively).

In the postoperative 12th -month, the mean BMI was 28.76 kg/m^2, and the mean %BMIL since the operation was 36.74%. Patients with > 103.57 RGV/SF ratio were prone to have an increased %BMIL (p = 0.001). A < 725mL RGV and a < 103.57 RGV/SF ratio were associated with higher BMI in the 12th -month follow-up (p = 0.003 and p = 0.002, respectively).

In the postoperative 12th -month follow-up, the mean %EWL was 68.6%. Having < 725mL RGV and > 103.57 RGV/SF ratio were favorable prognostic factors in achieving %EWL (p = 0.01 and p < 0.001, respectively). The details of weight loss outcomes are outlined in Table 3.

Table 3

Weight loss outcomes
	6th -Month BMI, mean ± SD	12th -Month BMI, mean ± SD	6th -Month %BMIL, mean ± SD	12th -Month %BMIL, mean ± SD	%EWL, mean ± SD
RGV < 725 ml (203)	34,10 ± 5,23	29,35 ± 4,10	26,24 ± 8,19	36,41 ± 6,92	66,99 ± 13,03
RGV > 725ml (204)	32,96 ± 4,38	28,18 ± 3,61	26,59 ± 5,52	37,07 ± 6,15	70,21 ± 12,12
p-value	0,017^a	0,003^a	0,615^a	0,312^a	0,01^a
RGV/SF < 103,57 (163)	34 ± 5,44	29,50 ± 4,24	25,76 ± 8,24	35,48 ± 6,73	65,91 ± 13,15
RGV/SF > 103,57 (244)	33,22 ± 4,40	28,27 ± 3,59	26,85 ± 5,95	37,59 ± 6,29	70,40 ± 12,02
p-value	0,125^a	0,002^a	0,146^a	0,001^a	< 0,001^a
No Complication (365)	33,54 ± 4,91	28,74 ± 3,94	26,57 ± 7,06	36,93 ± 6,67	68,77 ± 12,76
Had Complication (42)	33,46 ± 4,35	28,96 ± 3,65	25,02 ± 6,06	35,10 ± 5,08	67,15 ± 11,88
p-value	0,926^a	0,724^a	0,170^a	0,086^a	0,434^a
SF = 5 (95)	32,83 ± 4,01	28,14 ± 3,32	26,12 ± 8,04	36,63 ± 7,01	69,83 ± 13,60
SF = 6 (202)	33,67 ± 4,60	29,08 ± 3,59	26,60 ± 5,98	36,44 ± 5,59	67,72 ± 9,95
SF > 6 (110)	33,88 ± 5,85	28,73 ± 4,79	26,33 ± 7,69	37,40 ± 7,67	69,17 ± 15,88
p-value	0,256^b	0,153^b	0,159^b	0,459^b	0,352^b
RGV: Resected gastric volume; SF: Staplers fired; SD: Standard deviation; EWL: Excess weight loss; BMIL: BMI loss. ^a: Independent t-test for two samples; ^b: Analysis of variance.

A significant negative and weak correlation exists between the initial BMI and %EWL (r=-0.301, p < 0.001). A significant positive and weak correlation was also between RGV and RGV/SF and %EWL (r = 0.128, p = 0.01 and r = 0.152, p = 0.002, respectively). While there was a significant negative correlation between the 6th -month BMI and %EWL, there was a positive relationship between the %EWL and the 6th -month %BMIL (r=-0.612, p < 0.001 and r = 0.581, p < 0.001, respectively). We reported that %EWL had a negative correlation with the 12th -month BMI and a positive correlation with the 12th -month %BMIL (r=-0.893, p = < 0.001 and r = 0.85, p < 0.001, respectively).

Predictive Factors of %EWL and Complications

In achieving the target %EWL, decreased baseline BMI, decreased SF, increased age, and increased RGV/SF ratio were associated with increased achievement. Each increase in the SF reduces the probability of reaching the target %EWL by 72.6%. The details of the analyses are outlined in Table 4.

Table 4

Predictive Factors of %EWL
	Univariate			Multivariate
	B	OR (%95 CI)	p-value	B	OR (%95 CI)	p-value
Age	0,052	1,053 (1,013 − 1,095)	0,009	0,056	1,058 (1,011 − 1,107)	0,015
Gender (F)	0,405	1,500 (0,327-6,877)	0,602
BMI	-0,125	0,883 (0,827-0,942)	0,000	-0,086	0,918 (0,856-0,984)	0,015
RGV	0,001	1,001 (1,000–1,003)	0,099
SF	-1,263	0,283 (0,167-0,479)	0,000	-1,295	0,274 (0,153-0,490)	0,000
RGV/SF	0,015	1,015 (1,005 − 1,025)	0,004	0,016	1,016 (1,004 − 1,028)	0,009
F: Female; BMI: Body mass index; RGV: Resected gastric volume; SF: Staplers fired.

The results of the regression analysis for the complication experience are summarized in Table 5. In the univariate analysis, RGV and SF were found to be independent factors that affect the complication rate [OR = 1,001 (1,000–1,002), p = 0.012 and [OR = 3,067 (1,898-4,956), p < 0.001, respectively]. In multivariant analyses of RGV and SF, SF was found to be the most decisive factor affecting the rate of complication [OR = 2,820 (1,725-4,610), p < 0.001).

Table 5

Predictive Factors of Complications
	Univariate			Multivariate
	B	OR (%95 CI)	p	B	OR (%95 CI)	p
Age	-,004	0,996 (0,966-1,026)	0,780
Gender (F)	,564	1,757 (0,226-13-648)	0,590
BMI	-,044	0,957 (0,894-1,023)	0,198
RGV	,001	1,001 (1,000–1,002)	0,012	0,001	1,001 (1,000–1,002)	0,198
SF	1,121	3,067 (1,898-4,956)	< 0.001	1,037	2,820 (1,725-4,610)	< 0.001
RGV/SF	,002	1,002 (0,996-1,008)	0,461
F: Female; BMI: Body mass index; RGV: Resected gastric volume; SF: Staplers fired.

Obesity is a global problem that is becoming more common every decade. In 2022, more than 300.000 patients underwent a bariatric operation, and more than 61% were LSG[11]. %EWL is one of the most recognized parameters in the literature for the follow-up of patients in the postoperative period.

A study by Abdallah et al. [6] stated that patients lose 63.8% of their extensive weight in one year following the LSG. In our research, the %EWL was higher than in the beforementioned study in all groups, and there was a significant difference between the RGV and RGV/SF subgroups. In addition to postoperative 12th -month %EWL, 6th, and 12th -month %BMIL were analyzed to monitor the total weight loss and change in the obesity grade of the patients. We reported that the 6th -month %BMIL wasn’t associated with the RGV, RGV/SF ratio, or SF.

SLL and hemorrhage are the most common complications of LSG, with a higher risk of mortality. It’s reported that SLL is seen in 0–3% of the patients, and hemorrhage is seen in 0–8%[12]. SF is noted as one of the significant factors of SLL[13]. The significance of SF is controversial in predicting complications. Major et al. [9]said that with every increase in SF, the risk of complication is multiplied by 1.91 (95% CI: 1.09–3.33, p = 0.023). In a study by Penna et al. [10], ≥ 7 SF was associated with increased postoperative bleeding and reoperation rates (10.4%, p = 0.0042, and 10%, p = 0.033, respectively). We reported that SF was the most contributing factor to the rate of complications. Every increase in SF multiplied the overall complication risk by 2.82 (95% CI:1.73–4.61, p < 0.001). In our study, the range of the SF was narrower, and the complication rate was higher with more minor Clavien-Dindo scales compared to the study by Major et al.

The RGV and sleeve size volume are other factors affecting the surgery results. Since volume restriction is the primary rationale of the LSG, postoperative sleeve size and RGV are essential factors affecting the treatment results [8]. Obeidat et al. [14] reported that > 500mL RGV was associated with ≥ 50% %EWL. Since the same approach was performed in the operations, RGV was only affected by patient characteristics. In different studies, GRV was not a predictive factor of weight loss in long-term follow-up[10, 15, 16]. In our research, > 725mL RGV was associated with a higher %EWL in postoperative 12th -month follow-up.

A study presented by Penna et al. [10] reported the RGV/SF as a more predictive factor in identifying patients at higher risk of postoperative complications and inadequate weight loss than RGV alone. The < 140 RGV/SF ratio was associated with increased intraoperative bleeding, prolonged ICU, and total length of stay. In comparison, the > 212 RGV/SF ratio positively affected BMI loss and %EWL in the post-operative 12th -month follow-up. In our study, patients were grouped as low (RGV/SF, < 103.57) and high (RGV/SF, > 103.57) according to the RGV/SF ratio. No significant relationship was reported. In the subgroup analyses, a higher ratio was associated with decreased nausea-vomiting and increased hemorrhage. We also found that male and older patients were prone to have significantly increased RGV/SF ratio. Thus, the surgeon must be more alert regarding bleeding in male and elderly patients.

Limitations

Since there was no SLL in our series, prospective studies with a higher sample size are needed to evaluate the significance of the RGV/SF ratio in predicting SLL.

This is the most extensive single-center series evaluating the predictive significance of the RGV/SF ratio on postoperative complications and weight loss. Our study showed that RGV/SF could be a predictive parameter in predicting the midterm results of the surgery.

Conflict of Interest:

The authors declared no conflict of interest.

Author Contribution

Study conception and design: M.C.K.; Acquisition of data: C.B., M.C.K. ; Analysis and interpretation of data: M.C.K., C.B., U.M.K., Critical revision of manuscript: M.C.K., A.U.M., C.S., E.A. ; Approval of the final manuscript: All authors.

Data Availability

The datasets used and/or analyzed during the current study available from the corresponding author.

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No competing interests reported.

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Resected Gastric Volume / Number of Staplers Fired Ratio as a Tool in Predicting Complication and Midterm Results in Sleeve Gastrectomy

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Abstract

Background

Objectives

Setting:

Methods

Results

Conclusion

INTRODUCTION

MATERIALS AND METHODS

RESULTS

Baseline Characteristics

Operative and Complication Outcomes

Weight Loss Outcomes

Predictive Factors of %EWL and Complications

DISCUSSION

CONCLUSION

Declarations

Conflict of Interest:

Author Contribution

Data Availability

References

Additional Declarations

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