Application of Santulli enterostomy in the treatment of neonatal necrotizing enterocolitis: a retrospective cohort study

doi:10.21203/rs.3.rs-4908166/v1

The Santulli enterostomy (SE) has been used as a clinical surgical treatment of necrotizing enterocolitis (NEC) in few studies which enrolled small number cases or lacked control group. Our study aimed to compare the clinical safety and efficacy of Santulli enterostomy with single- or double-lumen enterostomy in neonatal NEC through a retrospective cohort study. 110 patients met the criteria were divided into the SE group with 64 cases and the conventional enterostomy group with 46 cases who underwent single- or double-lumen enterostomy. There were no significant differences in complications and prognoses between the two groups after enterostomy. The stoma location in the SE group was higher (20 [11,37] cm vs 10 [4.5,15,5] cm), but the unused small intestine (USI) length was not significantly different (13 [5,20] cm vs 10 [4.5,15,5] cm). Multivariate analysis showed that USI length was the influence factor of malnutritional status after enterostomy (OR=1.103, P<0.001). The operation time, intestinal recovery time, fasting time, hospitalization time and intraoperative blood loss were all significantly less and the incidence of complications was lower in the SE group after stoma closure. Multivariate analysis showed that SE was a protective factor for complications after stoma closure (OR=0.036, P=0.006). Santulli enterostomy is a safe treatment option for NEC and can increase the effective utilization length of the small intestine after enterostomy, thereby improving the postoperative nutritional status. In addition, it enhances the recovery process and reduces the incidence of complications after stoma closure.

Health sciences/Diseases/Gastrointestinal diseases

Health sciences/Gastroenterology/Gastrointestinal diseases

Neonate

Necrotizing enterocolitis

Santulli enterostomy

Nutritional status

Complications

Neonatal necrotizing enterocolitis (NEC) is the most prevalent gastrointestinal emergency during the neonatal period. It can lead to intestinal perforation, multiple organ failure, and even fatality.^[1] The condition primarily affects preterm infants, accounting for approximately 90% of cases, with approximately 50% of NEC patients requiring surgical intervention.^[2] The mortality rate following surgical treatment ranges from 20% to 67%.^[3] Common surgical approaches include peritoneal drainage, primary anastomosis, and enterostomy⁴, of which enterostomy is widely used in NEC treatment. Currently employed enterostomy surgical techniques in clinical practice include single-lumen enterostomy, double-lumen enterostomy, Bishop enterostomy, Santulli enterostomy.^[5-7]

Santulli enterostomy was initially performed in 1961 for the management of congenital intestinal atresia. Subsequently, it was adapted for the treatment of NEC in 1975, a total of five cases were examined and two survived.⁸ In recent years, research on Santulli enterostomy has been expanded to conditions such as Hirschsprung’s disease, midgut volvulus and so on. Despite an increase in the variety of diseases studied, there remains a lack of research on the application of Santulli enterostomy in NEC. Furthermore, relevant studies were limited or lacked control groups. ^[7,9,10]

Our center has observed that Santulli enterostomy can provide more clinical benefits in the treatment of NEC than traditional single- or double-lumen enterostomy. This study further evaluated and compared the clinical safety and efficacy of Santulli enterostomy with single- or double-lumen enterostomy to provide a reference for surgeons to choose the surgical approach for the treatment of NEC.

1. Inclusion and exclusion criteria

The inclusion criteria were as follows: (1) neonates with NEC presenting clear indications for surgical intervention; (2) neonates who underwent enterostomy.

The exclusion criteria were as follows: neonates who: (1) received colostomy; (2) received Bishop enterostomy; (3) received small bowel arrangement surgery simultaneously; (4) had lesions affected the transverse colon or its distal portion and Santulli enterostomy couldn't be applied.(5) had severe intestinal malformations and severe developmental malformations, such as biliary atresia, diaphragmatic hernia, and severe congenital heart disease; (6) lost to follow-up after enterostomy surgery or discharged automatically only due to family reasons.

2. Research object

A total of 110 neonates with NEC admitted to the Third Affiliated Hospital of Zhengzhou University between January 2017 and January 2024 were retrospectively analyzed. The neonates were categorized into the Santulli enterostomy (SE) group and conventional enterostomy (CE) group including single-lumen enterostomy and double-lumen enterostomy. Enterostomy surgery was conducted by a deputy chief physician or higher, and the choice of surgical procedure was based on specific conditions as well as personal experience and habits. This study was approved by the hospital's Ethics Committee (approval number: 2024-126-01).

3. Data collection

The clinical data of the neonates were collected and recorded through the medical record system, including: (1) demographic information during enterostomy surgery such as gender, gestational age (GA) at birth, birth weight, age at operation, ventilator use, white blood cell (WBC) count, platelet (PLT) count, C-reactive protein (CRP) level, intraoperative details such as extent of lesion, colon involvement or not and perforation or not; (2) clinical outcomes after enterostomy surgery: postoperative hospital stay time, postoperative parenteral nutrition (PN) time and prognoses including successful closure of stoma, death or abandonment and closure of stoma after unplanned relaparotomy; postoperative gastrointestinal complications and stoma-related complications.

Further clinical data were collected from neonates who underwent successful stoma closure surgery. The contents are as follows:(1) General information, intraoperative details, stoma height, and length of unused small intestine (USI) during the enterostomy surgery. (2) Weight-for-age Z score (WAZ) for nutritional status assessment after enterostomy and clinical outcomes after stoma closure surgery included operation time, postoperative intestinal recovery time, postoperative fasting time, postoperative hospitalization time, intraoperative blood loss, presence of intestinal stenosis during the operation and complications within one month.

4. Related definitions:

WAZ= (Measured weight - average weight for the age of the gender)/Standard deviation of weight for the age of the gender, the result can be 0, positive or negative. WAZ score is normal in the range of -2~2.Unused small intestine (USI): The USI in the CE group refers to either the surgically removed part or the distal part of the stoma, whereas it only refers to the surgically removed small intestine because the intestinal continuity can be maintained in the SE group. Extent of NEC lesion: Focal: lesion accumulated in a single intestinal segment; multifocal: lesions accumulated in two or more segments of the intestine, but more than 50% of the healthy small intestine was still retained; pan-intestinal: lesions extensively involved the small intestine and colon, and the remaining healthy intestines accounted for less than 25% of the total length of the intestines.^[11,12]In this study, only extensive small intestine involvement, but no more than 50% of the healthy small intestine was also classified as extensive lesions. Short bowel syndrome (SBS): The absorption capacity of the small intestine is limited due to resection, exclusion, congenital short bowel, etc., which cannot meet the needs of normal growth and development of children and requires parenteral nutrition support more than 42d. ^[13] High-output stoma: The volume of defecation at the stoma was >40ml/ (kg · d), accompanied by severe water and electrolyte disturbance requiring correction by intravenous fluid replacement.^[14]

5. Statistical analysis

SPSS 25.0 statistical software was used for data analysis. Student’s t-test or the rank-sum test was used to compare the continuous variables between the two groups. The chi-square test was used to compare categorical variables. Multivariate analysis models were used to analyze the influencing factors of nutritional status after enterostomy and complications within one month after stoma closure. We drew a directed acyclic graph (DAG) to identify possible confounders that may induce a non-causal association between the enterostomy method and WAZ, the enterostomy method and complications after stoma closure. The DAG was used for the selection of covariates and is shown in Figure 1, P<0.05 was considered statistically significant.

1. Baseline data on patients undergoing enterostomy surgery

Based on the predefined inclusion and exclusion criteria, 110 neonates with NEC were enrolled in this study. They were categorized into two groups based on different enterostomy methods: the CE group (46 cases) and the SE group (64 cases). There were no significant differences in gender, GA, birth weight, age, ventilator use, WBC count, PLT count, CRP level, intraoperative details between the two groups. (Table 1)

2. Postoperative outcome data following enterostomy surgery

There were no significant differences in postoperative hospital stay time, postoperative PN time, gastrointestinal complications or stoma-related complications between the CE and SE groups. A total of ten cases underwent unplanned relaparotomy, including three cases in the CE group and seven cases in the SE group. The prognoses included successful closure of stoma, death or abandonment and closure of the stoma after relaparotomy. There were no significant differences in the prognoses between the two groups. (Table 2)

3. Baseline data on patients undergoing stoma closure surgery successfully

According to the prognoses, we further compiled the data of 91 neonates who successfully closed the stoma without relaparotomy and added the data of stoma height and length of USI during the enterostomy operation. After analysis, there were no significant differences in the general data of the patients in the two groups. Marked by the ileocecal valve, the median stoma height in the SE group was 20 cm compared to 10 cm in the CE group, which was significantly different (P = 0.002), but there was no significant difference in the length of the USI (P = 0.713). (Table 3)

4. Nutritional status at stoma closure and postoperative outcome data after stoma closure procedure

There was no significant difference in the WAZ which represented nutritional status between the two groups (P = 0.537). The operation time, postoperative intestinal recovery time, postoperative fasting time, postoperative hospitalization time and intraoperative blood loss were significantly less in the SE group than in the CE group. Thirteen cases of distal intestinal stenosis were identified in both groups, with an overall incidence rate of 14.29% (13/91). Specifically, there were seven cases in the CE group and six cases in the SE group, demonstrating no significant difference in the incidence of intestinal stenosis between the two groups (P = 0.309). Within one month after stoma closure surgery, there was only one case of intestinal obstruction in the SE group; however, complications occurred in seven cases in the CE group including two cases of anastomotic leak, three cases of intestinal obstruction, one case of abdominal hemorrhage and three cases of poor incision healing. The incidence of complications differed significantly between the two groups (P = 0.007). (Table 4)

5. Multivariate analyses to identify risk factors of nutritional status at stoma closure and the complications within 1 month after stoma closure

Utilizing a directed acyclic graph, we identified confounding variables and integrated them into our analysis (Fig. 1). The values of enterostomy methods are as follows: conventional enterostomy = 0, Santulli enterostomy = 1.Multivariate analyses showed that PLT count and USI length were the risk factors of malnutrition with ORs of 0.994 (P = 0.049, 95%CI, 0.989-1) and 1.103 (P < 0.001, 95%CI, 1.051,1.158) (Table 5) and Santulli enterostomy played a significant role in the occurrence of complications after stoma closure surgery, with an OR of 0.036 (P = 0.006,95%CI,0.003–0.38) compared with single-lumen or double-lumen enterostomy (Table 6).

Neonates with NEC often suffer from poor overall health, rapid disease progression, and critical conditions. The timing and method of surgery are closely linked to the prognosis of these patients. Santulli enterostomy involves end-to-side anastomosis of the distal and proximal intestinal tubes at the stoma opening, resembling a surgical approach between primary anastomosis and single-lumen enterostomy. The intestinal inflammation in NEC is evident, often accompanied by intestinal perforation and significant intraperitoneal contamination which can increase the risk of intestinal suture leakage and affect the surgical prognosis. ^[15] Therefore, the application of primary anastomosis requires careful consideration and Santulli enterostomy is not recommended for routine use for children with NEC due to the presence of anastomosis in this enterostomy method. ^[16–18] However, Ming Yue et al. ^[7] performed Santulli enterostomy in 33 cases diagnosed as NEC, congenital Megacolon, intestinal atresia and other diseases and no anastomotic leakage occurred. In comparison, there were four cases of anastomotic leakage in the control group, therefore Santulli enterostomy was considered safe and feasible. However, only 26 children with NEC participated in the study, and their intraoperative conditions were not described in detail. In our study, we incorporated intraoperative conditions such as the extent of lesion, colon involvement or not, perforation or not as variables into the baseline data to more accurately characterize the fundamental conditions of the two groups. The SE group experienced anastomotic leakage in one case which occurred since the stoma was plugged for examining the distal bowel movement and in the CE group there was only one intestinal leakage case as well. There were no significant differences in the postoperative complications, prognoses or unplanned relaparotomies between the two groups. The comparable incidence of complications and prognoses suggest that Santulli enterostomy is a safe treatment for NEC.

NEC patients with stomas are often at risk of malnutrition. Malnutrition not only affects the prognosis of the disease, but also affects the physical and cognitive development of children. ^[19] Chong et al. ^[20] observed that the WAZ at stoma closure was lower than that at the time of ostomy operation in 89% of cases, with 42% of them meeting the criteria for severe malnutrition (WAZ<-3). In the present study, the malnutrition rate was 24.2%. Multivariate analysis showed that the length of USI and PLT count were independent influencing factors of nutritional status. The Santulli enterostomy operation can maintain intestinal continuity and the remaining small intestine at the distal end of the stoma can be utilized, especially the ileum, which plays an important role in absorbing nutrition. ^[21,22] We found that the median distance between the location of the stoma and the ileocecal part was 20 (11,37) cm in the SE group and 10(4.5,15.5)cm in the CE group. This difference was statistically significant (P = 0.002), suggesting that the stoma location was higher in the SE group. However, there was no significant difference in the length of the USI between the two groups (P > 0.05). It is suggested that Santulli enterostomy could increase the length of the available small intestine and improve the nutritional status of children after NEC stoma if intraoperative conditions are allowed. According to a previous study reduced PLT levels suggest intestinal necrosis during the onset of NEC, and the degree of reduction is related to the incidence of rapid progression of NEC and intestinal failure, which was also verified in our study. ^[23]

If children with stoma are malnourished, stoma closure surgery is needed to improve nutritional status, but the timing of stoma closure remains controversial. ^[24–26] In Santulli enterostomy cases, plugging the stoma through a sealing device, such as catheter balloon, can achieve the same effect as stoma closure. There are two opportunities for stoma plugging in cases of Santulli enterostomy case. The first opportunity arises when severe malnutrition occurs, allowing observation of nutritional status after plugging the stoma and it is noted that the initial stoma plug should be performed under close medical supervision to avoid harmful consequences. The second opportunity is to optimize distal bowel function prior to stoma closure and to identify postoperative intestinal stenosis combined with routine contrast enema. Intestinal stenosis is a common complication in children with NEC. Regardless of conservative or surgical treatment, intestinal stenosis develops at different times, mostly within three months after NEC. For surgically treated children with NEC, Intestinal stenosis mainly occurs in the ascending colon, considering the anatomical location and functional particularity of the ileocecal region. ^[27] In this study, a total of 13 cases were found to have intestinal stenosis during stoma closure, with an incidence of 14.29%, which was consistent with the literature. ^[28] Six of these cases occurred in the SE group and the incidence of the two group was not significantly different.

In the CE group, it was necessary to fully free the proximal and distal enterotomy tube of the stoma during the stoma closure operation and then perform anastomosis, which could increase the risk of intraperitoneal adherence and anastomotic leakage theoretically. Besides, after single-lumen ostomy, the distal intestinal tube is disused and the diameter of the proximal intestinal tube is significantly different from that of the proximal intestinal tube, which is prone to anastomotic stenosis, anastomotic proximal intestinal tube expansion and torsion. ^[29] Double-lumen ostomy can solve the disuse of the distal intestinal tube, but the nursing operation is complicated. In Santulli enterostomy, it is only necessary to identify the presence of distal intestinal stenosis and adhesive intestinal obstruction prior to stoma closure. If these conditions are not found, the intestinal tube used for the stoma only needs to be dissociated and removed during the operation, which is simpler. Multivariate analysis showed that Santulli enterostomy could reduce the incidence of postoperative complications. In addition, we found that intestinal function of the children after stoma closure recovered more rapidly in the SE group because the Santulli enterostomy could maintain the continuity of the intestine and the distal intestinal tube of the stoma got functional exercise.

Our study was retrospective in nature and may introduce bias into the research data. Furthermore, there is currently no objective index reflecting the degree of intestinal inflammation to guide surgical decisions for Santulli enterostomy, particularly when considering the risk of intestinal leakage. Therefore, doctors may rely on their experience when making such decisions.

Santulli enterostomy is a safe treatment option for NEC, even in cases involving intestinal tube necrosis or perforation and can increase the effective utilization length of the small intestine, thereby improving the postoperative nutritional status in children. Additionally, it has the potential to yield greater benefits in terms of stoma closure, particularly by reducing the occurrence of postoperative complications.

Data availability

The data presented in the study are included in the article/Supplementary Material, and further inquiries can be directed to the corresponding author.

Author contributions

Z.F. and H.S. provided the study conception and design, data collection and writing first draft and revised versions. Z. F. and J. Z. provided statistical analysis and writing-editing and revision. F.Q., X.W., H.H., H.H., M.Z., P.W., and W.Z. provided study conception and design and revised versions. All authors reviewed the manuscript and approved the submitted version.

Additional information

Funding

This study was supported by the Medical Science and Technology Project from the Health Commission of Henan Province. NO: LHGJ20230393 and NO: LHGJ20210465.

Ethics statement

The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. This retrospective study was approved by the Ethics Committee of Third Affiliated Hospital of Zhengzhou University (2024-126-01).

Consent statement

Due to the retrospective nature of the study, the Ethics Committee of Third Affiliated Hospital of Zhengzhou University waived the need of obtaining informed consent.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Table 1 Baseline data on patients undergoing enterostomy surgery

Characteristics	CE group		SE group	χ²/Z/t	P value
Case number		46	64
Gender				0.716	0.397
Female		13(28.3）	23(35.9)
male		33(71.7)	41(64.1)
GA (w)		31.64（29.46，35）	31.57（28.89，34.29）	-0.497	0.619
Birth weight				5.667	0.129
NWI^a		8（17.4）	4（6.3）
LBWI^b		14（30.4）	31（48.4）
VLBWI^c		18（39.1）	20（31.3）
ELBWI^d		6（9.52）	9（14.1）
Age（d）		13.5（7.75,21）	13.5（7,21）	-0.227	0.820
Ventilator use				0.007	0.933
Yes		14（30.4）	19（29.7）
No		32（69.6）	45（70.3）
WBC count (10⁹/L)		7.16（4.70,14.75）	6.86（4.10,10.25）	-1.067	0.286
PLT count(10⁹/L)		224.35±122.32	226.92±114.45	-0.111	0.912
CRP (mg/L)		46.65(4.95,116.25)	48.71(9.38,93.95)	-0.015	0.988
Extent of lesion				0.404	0.922
Focal		29(63)	39(60.9)
Multi-focal		16(34.8)	24(37.5)
Pan-intestinal		1(2.2)	1(1.6)
Colon involved or not				0.025	0.875
Yes		18(39.1)	26(40.6)
No		28(60.9)	38(59.4)
Perforation or not				3.28	0.070
Yes		19(41.3)	16(25)
No		27(58.7)	48(75)

^anormal-weight infant;^blow-birth-weight infant;^c very-low-birth-weight infant;^d extremely-low-birth- weight infant

Table 2 Postoperative outcome data following enterostomy surgery

	CE group		SE group	χ²/Z	P value
Case number		46	64
Postoperative hospital stay time(d）		23.5 (18.75,49.25)	28 (16.25,46.75)	0.968	0.887
Postoperative PN time (d)		19.5 (12.75,33)	18.5 (13,32.75)	0.762	0.964
Postoperative gastrointestinal complications		19（41.3）	34（53.1）	1.498	0.221
Anastomotic leak		1（2.2）	1（1.6）	0.000	1
Intestinal obstruction		4（8.7）	7（10.9）	0.004	0.949
High-output stoma		2（4.3）	0（0.00）	-	0.173
Necrotizing enterocolitis		1（2.2）	3（4.7）	0.032	0.858
Cholestasis		12（26.1）	20（31.3）	0.346	0.556
SBS		7（15.2）	7（10.9）	0.441	0.506
Malnutrition		8（17.4）	19（29.7）	2.185	0.139
Stoma-related complications		1 11（23.9）	17（26.6）	0.099	0.753
Stoma prolapse		4（7.94）	4（5.66）	0.013	0.908
Stoma retraction		1（2.2）	5（7.8）	0.738	0.390
Stoma stenosis		2（4.3）	1（1.6）	0.085	0.771
Poor incision healing		4（8.7）	8（12.5）	0.399	0.528
Skin damage around stoma		1（1.59）	2（3.77）	0.000	1
Relaparotomy		3（6.5）	7（10.9）	0.21	0.647
Prognosis				4.878	0.076
Successful closure of stoma		34（74.60）	57（89.1）
Death or abandonment		9（19.6）	4（6.1）
Stoma closure after unplanned relaparotomy		3（6.5）	3（4.3）

Table 3 Baseline data on patients undergoing stoma closure surgery successfully.

Characteristics	CE group	SE group	χ²/Z	P value
Case number	34	57
Gender			0.728	0.393
Female	9（26.5）	20（35.1）
male	25（73.5）	37（64.9）
GA (w)	32 (29.57,35.82)	31.71 (29.14,34.36)	-0.677	0.498
Birth weight			6.309	0.093
NWI	7（20.6）	3（5.3）
LBWI	12（35.3）	31（54.4）
VLBWI	11（32.4）	15（26.3）
ELBWI	4（11.8）	8（14）
Age（d）	15 (7.75,22.25)	13 (6.5,21)	-0.558	0.577
Ventilator use			0.117	0.732
Yes	9（26.5）	17（29.8）
No	25（73.5）	40（70.2）
WBC count (10⁹/L)	7.02 (4.93,15.47)	6.88 (4.05,10.23)	-1.181	0.237
PLT count (10⁹/L)	217.5 (152.75,316.25)	207 (150，269)	-0.324	0.746
CRP (mg/L)	61.93 (6.98,123.08)	47.87 (9.67,92.91)	-1.153	0.249
Extent of lesion			0.71	0.890
Focal	20（58.8）	35（61.4）
Multi-focal	14（41.2）	21（36.8）
Pan-intestinal	0（0）	1（1.8）
Colon involved or not			0.627	0.428
Yes	16	22
No	18	35
Perforation or not			3.444	0.063
Yes	14（41.2）	13（22.8）
No	20（58.8）	44（77.2）
Stoma height(cm)	10（4.5,15.5）	20(11,37）	-3.055	0.002
Length of USI (cm)	10(4.5,15.5)	13(5,20)	-0.367	0.713

Table 4 WAZ at stoma closure and postoperative outcome data following stoma closure procedure.

	CE group	SE group	χ²/Z	P value
WAZ at stoma closure			0.381	0.537
Abnormal	7（20.6）	15（26.3）
Normal	27 (79.4)	42（73.7）
Operation time（min）	99 (69.5,110)	77 (60,96.5)	-2.118	0.034
Postoperative intestinal recovery time（d）	2 (1.375,2.5)	1 (0.5,1.75)	-3.442	0.001
Postoperative fasting time（d）	5(4,7)	4(2,5)	-4.024	<0.001
Postoperative hospitalization time (d)	20(14,25.5)	13(11,16)	-3.743	<0.001
Blood loss (ml）	5 (4.5,10)	3 (2,5)	-2.98	0.003
Intestinal stenosis			1.035	0.309
Yes	7（20.6）	6（10.5）
No	27（79.4）	51 (89.5)
Complications in one month after stoma closure	7（20.6）	1（1.8）	7.219	0.007
Anastomotic leak	2（5.9）	0（0.00）	-	0.137
Intestinal obstruction	3（8.8）	1（1.8）	1.13	0.288
Abdominal hemorrhage	1（2.9）	0（0.00）	-	0.374
Poor incision healing	1（2.9）	0（0.00）	-	0.374

Table 5 Multivariate analysis to identify the risk factors of malnutrition at stoma closure.

Variables	P value	OR	95%CI
Enterostomy method	0.607	1.377	0.406	4.671
GA (w)	0.936	1.007	0.842	1.205
PLT count(10⁹/L)	0.049	0.994	0.989	1
Extent of lesion	0.588	1.368	0.44	4.25
Length of USI (cm)	<0.001	1.103	1.051	1.158

Table 6 Multivariate analysis to identify the risk factors of complications within one month after stoma closure.

Variables	P value	OR	95%CI
Enterostomy method^*	0.006	0.036	0.003	0.38
GA (w)	0.552	1.071	0.854	1.345
PLT count(10⁹/L)	0.086	0.992	0.983	1.001
Extent of lesion	0.960	0.898	0.014	58.29
colon involved or not	0.278	0.082	0.001	7.512
Perforation or not	0.864	0.834	0.104	6.694

No competing interests reported.

SupplementarymaterialRawdata.xlsx

Application of Santulli enterostomy in the treatment of neonatal necrotizing enterocolitis: a retrospective cohort study

Status:

Version 1

Abstract

Figures

Introduction

Methods

Results

1. Baseline data on patients undergoing enterostomy surgery

2. Postoperative outcome data following enterostomy surgery

3. Baseline data on patients undergoing stoma closure surgery successfully

4. Nutritional status at stoma closure and postoperative outcome data after stoma closure procedure

Discussion

Conclusion

Declarations

References

Tables

Additional Declarations

Supplementary Files

Status:

Version 1