The short-term clinical outcomes of endoscopic rubber band ligation for grade I~III internal hemorrhoids

doi:10.21203/rs.3.rs-4620732/v1

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The short-term clinical outcomes of endoscopic rubber band ligation for grade I~III internal hemorrhoids

https://doi.org/10.21203/rs.3.rs-4620732/v1

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Background To investigate the short-term safety and efficacy of endoscopic rubber band ligation (ERBL) for grade I~III internal hemorrhoids, and to analyze the related factors of adverse events after ERBL.

Methods The clinical data of 266 patients with grade I~III internal hemorrhoids treated by ERBL in Henan Provincial People's Hospital from January 2021 to June 2023 were retrospectively analyzed. According to the Goligher’s grading of internal hemorrhoids, the patients were divided into three groups: grade I (98 patients), grade II (56 patients) and grade III internal hemorrhoids (112 patients). The clinical efficacy and adverse events (AEs) 24h after ERBL of the three groups were compared and analyzed.

Results The effectiveness rate of grade I, II and III internal hemorrhoids were 88.8%, 87.5% and 86.6%, respectively, with no statistical difference (p>0.05). A total of 107 (40.2%) patients had AEs 24h after ERBL, of which 11 (4.1%) had postoperative bleeding, 48 (18.0%) had anal pain, 80 (30.1%) had sense of anal sagging, and 15 (5.6%) had urinary retention. The postoperative adverse events of grade I, II and III internal hemorrhoids were 42.9% (42/98), 51.8% (29/ 56) and 32.1% (36/112), respectively, and the difference was statistically significant (p<0.05). Univariate and multivariate analysis showed that the suspension ligation was the protective factor for postoperative AEs [OR (95%CI): 9.64 (2.124,43.79), p=0.04].

Conclusions ERBL is effective for grade I~III internal hemorrhoids, but it is safer for grade III internal hemorrhoids. Suspension ligation can reduce postoperative adverse reactions. Multicenter, prospective studies are needed to verify our conclusion.

endoscopic rubber band ligation

suspension ligation

internal hemorrhoids

Goligher’s grading

clinical outcomes

Hemorrhoids is one of the common anorectal diseases in the world. The prevalence of hemorrhoids is higher than 50% in the United States, and it is common in people aged 45–65 years old [1–3]. The latest Chinese study showed that 50.1% of the population have anorectal diseases, more than 95% of which are hemorrhoids, and internal hemorrhoids are the most common, accounting for about 60% of the number of hemorrhoids patients [4]. The main clinical symptoms of internal hemorrhoids are bleeding, prolapse, pain, anal itching, increased secretions, and difficult defecation [5, 6], these symptoms seriously affect the life quality of patients.

In the 1950s, Blaisdell [7] first proposed the concept of ligation in the treatment of internal hemorrhoidal bleeding, which was later modified and simplified using rubber bands by Barron in the 1960s [8]. This technique is to attract the mucosa, connective tissue and blood vessels in the internal hemorrhoids through the ligation bands, resulting in ischemic necrosis, fibrosis of hemorrhoids nuclear tissue and retraction of the prolapsed internal hemorrhoids. Rubber band ligation (RBL) was initially performed under rigid proctoscopy, but its main disadvantages are limited working space and narrow field of vision, as well as the inability to record video and pictures of the procedure. In addition, only one or two ligations can be performed in every operation. The rapid development of endoscopic technology can overcome the above shortcomings of rectal endoscopy. At present, endoscopic rubber band ligation (ERBL) has become one of the commonly used methods in the treatment of internal hemorrhoids, which has the advantages of minimally invasiveness, low cost, good visual field and easy operation.

Goligher’s grading [4] is a commonly used classification of internal hemorrhoids. According to the degree of prolapse, internal hemorrhoids are divided into I ~ IV grades. ERBL is suitable for grade I ~ III internal hemorrhoids with related symptoms. However, there are few studies to compare the safety and efficacy of ERBL in the treatment of grade Ⅰ ~ III internal hemorrhoids. This study aimed to investigate these problems through retrospective analysis.

Patients

266 patients with grade I ~ III internal hemorrhoids were retrospectively included in this study. All these patients were treated with ERBL from January 2021 to June 2023 in Henan Provincial People’s Hospital. Before ERBL, all patients signed informed consent.

The inclusion criteria were (1) patients with symptomatic grade I ~ III internal hemorrhoids and ineffective conservative treatment such as diet and drugs; (2) patients who were unable or unwilling to undergo surgery due to advanced age, hypertension, heart disease and other reasons; (3) patients who were willing to undergo endoscopic treatment and sign informed consent form. The exclusion criteria were (1) patients with grade IV internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids; (2) grade I ~ III internal hemorrhoids with complications such as chimerism, thrombosis, infection, and so on; (3) patients who were unable or unwilling to undergo ERBL due to various reasons; (4) patients with colorectal tumors, anal fissures, fistulas, et al; (5) patients with previous history of anorectal surgery, multiple treatment of internal hemorrhoids and pelvic radiotherapy.

The medical records and endoscopic records were collected. This study was approved by the Hospital Ethics Committee.

ERBL procedure

All patients were advised to have a low-residue diet 2 days before ERBL, fast on the morning of ERBL, and take 2000mL polyethylene glycol electrolyte solution (PEG) orally 4–6 h before surgery for bowel preparation. Then, routine coloscopy were performed to observe all colorectum and to exclude anal bleeding caused by diseases other than hemorrhoids. If there were colorectal polyps or submucosal tumors, endoscopic resection was performed simultaneously. After coloscopy, gastroscope was used to observe the internal hemorrhoids, including the size, quantity and surface condition of internal hemorrhoids, so as to judge the risk of bleeding and prolapse, and confirm the position of dentate line and anorectal line. According to the above observation, the ligation site, the number of ligation bands and the sequence of ligation were determined.

Then, ERBL was performed using gastroscope, the procedure of ERBL refers to previous study of our team [9]. (1) a band ligator was fixed on the front end of the gastroscopy; (2) the endoscope was reversed to identify hemorrhoids, anorectal line and dentate lines again; (3) the band ligator was pushed onto the top of the hemorrhoids, avoiding the dentate line, and the hemorrhoid was sucked into the transparent cap by negative pressure suction, and then the band ligator handle was turned clockwise to release the first band. (4) repeat above step until an appropriate number of bands were ligated depending on the severity of the hemorrhoids; (5) Finally, the ligation device was removed after observation and confirmation of no bleeding.

If there is serious prolapse or high risk of bleeding, the suspension ligation was used, that is the first ligation was performed in the position away from the anorectal line then close to the anorectal line (Fig. 1). Multiple ligation points on the same horizontal plane were avoided.

Postoperative management and follow up

After ERBL, patients were fasted for 6 hours. If other treatments were performed at the same time, the fasting time would be prolonged accordingly. sedentary, standing and forced defecation should be avoided within 24 hours after operation, smooth defecation should be ensured, lactulose should be used if necessary. Spicy food, alcohol, overwork, and so on, were avoided within 1 week after operation.

Within 24 hours after ERBL, the patients were asked if there were any adverse events, such as pain, bleeding, anal distension, urinary retention, and so on. The effectiveness rate were evaluated 6 months after ERBL. The follow-up methods included outpatient or medical records in our hospital. Patients who did not come to our hospital for review were followed up by phone, text message, Wechat or email.

Definitions

Goligher’s grading [4]: grade I, hemorrhoids with bleeding, no prolapse; grade II, hemorrhoids with bleeding and spontaneous reduction of prolapse; grade III, hemorrhoids with bleeding and prolapse requiring manual reduction; and grade IV, irreducible prolapse of hemorrhoids.

Clinical efficacy: (1) cure: symptoms such as hematochezia and prolapse disappear completely after operation; (2) effective: symptoms are not disappear completely, but frequency reduce; (3) ineffective: symptoms were not significantly change compared with that before treatment. Effectiveness rate = number of (cured cases + effective cases) / total number of cases × 100%.

According to NGS score [10], pain was divided into no pain (score 0), mild pain (score 1–3), moderate pain (score 4–6) and severe pain (score 7–10).

Statistical analysis

Continuous variables were presented as the mean ± standard deviation (SD) and analyzed by the Student’s t-test or Mann-Whitney test. Categorical variables were presented as numbers (percentage) and analyzed by the χ2 test or the Fisher exact test. Multivariate analysis was performed with the multivariate logistic regression model. A P value < 0.05 was considered to be statistically different. Data were analyzed using the SPSS 25.0 (IBM, Corp., Armonk, NY, USA version 3.4.3).

1. Baseline characteristics of the enrolled patients

As shown in Table 1, a total of 266 patients (185 males and 81 females) with a mean age of 48.1 (24–79) years old were enrolled, including 98 patients with grade I internal hemorrhoids (36.8%), 56 patients with grade II internal hemorrhoids (21.1%) and 112 patients with grade III internal hemorrhoids (42.1%). There were more male patients in grade I internal hemorrhoid group (77.6%) and grade II internal hemorrhoid group (73.2%) than in grade III internal hemorrhoid group (60.7%), and the difference was statistically significant (p = 0.024). In addition, the proportion of preoperative severe effect on life of patients with grade II (12.4%) and grade III internal hemorrhoids (15.2%) was significantly higher than that of grade I internal hemorrhoids (4.1%) (p < 0.05). There were no statistical differences in age, hypertension, diabetes and preoperative symptoms among the three groups (p > 0.05).

Table 1

Baseline characteristics of the enrolled 266 patients
Characteristics	Grade I (n = 98)	Grade II (n = 56)	Grade III (n = 112)	P value
Sex, n (%)				0.024
male	76 (77.6)	41 (73.2)	68 (60.7)
female	22 (22.4)	15 (26.8)	44 (39.3)
Age, years, Mean ± SD	46.8 ± 11.3	46.7 ± 11.1	49.8 ± 10.9	0.081
Hypertension, n (%)	22 (22.4)	9 (16.1)	28 (25)	0.421
Diabetes, n (%)	6 (6.1)	2 (3.6)	9 (8)	0.592
Preoperative symptoms, n (%)
bleeding, n (%)				0.741
no	27 (27.6)	12 (21.4)	35 (31.2)
small	63 (64.3)	38 (67.9)	67 (59.8)
massive	8 (8.2)	6 (10.7)	10 (8.9)
anal discomfort	9 (9.2)	6 (10.7)	17 (15.2)	0.388
anal swelling	3 (3.1)	3 (5.4)	7 (6.2)	0.581
anal itching	14 (14.3)	9 (16.1)	23 (20.5)	0.472
anal pain	20 (20.4)	10 (17.9)	25 (22.3)	0.794
difficult defecation	5 (5.1)	5 (8.9)	16 (14.3)	0.080
Preoperative effect on life, n (%)				0.001
no	48 (49.0)	17 (30.4)	65 (58.0)
mild	41 (41.8)	29 (51.8)	25 (22.3)
moderate	5 (5.1)	3 (5.4)	5 (4.5)
severe	4 (4.1)	7 (12.4)	17 (15.2)

2. Procedure-related outcomes

The procedure-related results are shown in Table 2. All patients successfully underwent ERBL. 162 patients (60.9%) had concomitant colorectal lesions, including colorectal polyps, rectal neuroendocrine tumors, laterally spreading tumor and underwent simultaneous treatment with endoscopic mucosal resection or endoscopic submucosal dissection, respectively. No complications related to endoscopic resection occurred. There was no statistical difference in simultaneous treatment and whether ERBL was based on anal line among the three groups.

The number of patients who underwent suspension ligation in grade III internal hemorrhoids group (17.0%) was significantly more than that in the grade I (4.1%) and grade II groups (3.6%) (p < 0.05). The mean ligation bands in grade I, grade II and grade III internal hemorrhoids group was 3.5 ± 0.9, 3.7 ± 0.6, and 4.3 ± 1.2, respectively, the difference was statistically significant (p < 0.05). In addition, with the increase of the grade of internal hemorrhoids, the proportion of multi-band ligation (4–7 bands) gradually increased, the difference was also statistically significant (p < 0.05).

Table 2

Procedurerelated characteristics of the 266 patients
Characteristics	Grade I (n = 98)	Grade II (n = 56)	Grade III (n = 112)	P value
Simultaneous treatment, n (%)				0.609
yes	58 (59.2)	32 (57.1)	72 (64.3)
no	40 (40.8)	24 (42.9)	40 (35.7)
ERBL based on the anorectal line, n (%)				0.312
yes	43 (43.9)	30 (53.6)	60 (53.6)
no	55 (56.1)	26 (46.4)	52 (46.4)
Suspension ligation, n (%)				0.001
yes	4 (4.1)	2 (3.6)	19 (17.0)
no	94 (95.9)	54 (96.4)	93 (83.0)
Number of bands, Mean ± SD	3.5 ± 0.9	3.7 ± 0.6	4.3 ± 1.2	< 0.001
2–3, n (%)	50 (51.0)	17 (30.4)	25 (22.3)	< 0.001
4–7, n (%)	48 (49.0)	39 (69.6)	87 (77.7)
ERBL: endoscopic rubber band ligation

3. Follow-up outcomes

All patients were followed up successfully for 6 months. 78.2% of the patients were satisfied with ERBL. Among them, the satisfaction rate of grade I internal hemorrhoids group is the highest (86.7%), followed by grade II group (82.1%), and grade III group was the lowest (68.7%), the difference was statistically significant (p < 0.05). The effect of internal hemorrhoids on daily life after ERBL was significantly better than that before operation, and there was no significant difference among the three groups (p > 0.05).

A total of 107 patients (40.2%) had adverse events 24h after ERBL, of which, the grade II internal hemorrhoids group was the most (51.8%), and the grade III internal hemorrhoids group was the least (32.1%), the difference was significant (p < 0.05). Postoperative bleeding occurred in 11 patients (11/266, 4.1%), which resolved spontaneously without any treatment, no massive bleeding was observed. 48 patients (48/266, 18.0%) experienced anal pain, of which, 33 patients (12.4%) were mild and relieved without medication, 15 patients (5.6%) had moderate/severe pain and were relieved by the use of painkillers. 15 patients (5.6%) developed urinary retention 24 hours after ERBL and were relieved after hot compress in the bladder region or catheterization (Table 3).

Table 3

Follow-up outcomes of enrolled 266 patients
Characteristics	Grade I (n = 98)	Grade II (n = 56)	Grade III (n = 112)	P value
Adverse events, n (%)	42 (42.9)	29 (51.8)	36 (32.1)	0.040
bleeding	6 (6.1)	2 (3.6)	3 (2.7)	0.509
anal pain	18 (18.4)	14 (25)	16 (14.3)	0.234
mild	11 (11.2)	11 (19.6)	11 (9.8)	0.374
Moderate/severe	7 (7.1)	3 (5.4)	5 (4.5)
sense of anal sagging, n(%)	31 (31.6)	21 (37.5)	28 (25)	0.228
urinary retention, n(%)	5 (5.1)	2 (3.6)	8 (7.1)	0.663
Clinical efficacy, n (%)				0.728
cure	35 (35.7)	22 (39.3)	36 (32.1)
effective	52 (53.1)	27 (48.2)	61 (54.5)
ineffective	11 (11.2)	7 (12.5)	15 (13.4)
Satisfactions of ERBL, n(%)				< 0.001
yes	85 (86.7)	46 (82.1)	77 (68.7)
no	13 (13.3)	10 (17.9)	35 (31.3)
Postoperative effect on life				0.742
no	94 (95.9)	55 (98.2)	108 (96.4)
mild	4 (4.1)	1 (1.8)	4 (3.6)
ERBL: endoscopic rubber band ligation

Univariate and multivariate analysis showed that non-suspension ligation was an independent risk factor for postoperative adverse events (OR [95%CI]: 9.64 [2.12–43.79], p = 0.003] (Table 4).

The clinical efficacy was evaluated 6 months after ERBL (Table 3), and the results showed that the curation rates of grade I, grade II degree and grade III internal hemorrhoids group were 39.8%, 35.7% and 37.5%, respectively, and the effective rates were 49.0%, 51.8% and 49.1%, respectively. The total clinical effectiveness rates of the three groups were 88.8%, 87.5% and 86.6%, respectively. There was no statistical difference (p = 0.715).

Table 4

Univariate and multivariate analysis of risk factors for postoperative adverse events
	No AE	AE
Characteristics	(n = 159)	(n = 107)	p1	OR (95%CI)	p2
Sex, n (%)			0.700	1.38 (0.78 ~ 2.43)	0.272
male	112 (70.4)	73 (68.2)
female	47 (29.6)	34 (31.8)
Age, years, Mean ± SD	49.0 ± 10.8	46.6 ± 11.6	0.086	0.89 (0.42 ~ 1.88)	0.756
<60, n (%)	135(84.9)	93(86.9)	0.646
≥60, n (%)	24(15.1)	17(13.1)
Simultaneous resection, n (%)			0.579	0.9 (0.53 ~ 1.54)	0.712
yes	99 (62.3)	63 (58.9)
no	60 (37.7)	44 (41.1)
ERBL based on the anorectalal line, n (%)			0.900	0.74 (0.43 ~ 1.26)	0.265
yes	79 (49.7)	54 (50.5)
no	80 (50.3)	53 (49.5)
Suspension ligation, n (%)			< 0.001	9.64 (2.12 ~ 43.79)	0.003
yes	23 (14.5)	2 (1.9)
no	136 (85.5)	105 (98.1)
Goligher’s grading, n (%)			0.040
grade I	56 (35.2)	42 (39.3)
grade II	27 (17)	29 (27.1)		1.34 (0.68 ~ 2.65)	0.399
grade III	76 (47.8)	36 (33.6)		0.69 (0.37 ~ 1.27)	0.231
Number of bands, Mean ± SD	3.9 ± 1.1	3.9 ± 1.0	0.918
No. of bands, n (%)			0.794	1.1 (0.63 ~ 1.92)	0.738
2–3	54(34.0)	38(35.5)
4–7	105(66.0)	69(64.5)
AE: adverse events; ERBL: endoscopic rubber band ligation

Internal hemorrhoids are common anorectal diseases, which is clinically characterized by painless rectal bleeding with or without prolapse. Most patients still occur repeatedly after dietary, lifestyle changes or drug treatment, which seriously affect their quality of life. Minimally invasive or even surgical treatment is needed eventually.

With the rapid development of endoscopy, endoscopic treatment has become one of the main treatments of internal hemorrhoids, of which, endoscopic injection sclerotherapy (EIS) and ERBL are the most commonly used. A meta-analysis of 18 related articles conducted by MacRae et al. [11] found that the therapeutic effect of ERBL was significantly better than that of EIS in grade I ~ III internal hemorrhoids, especially for grade III internal hemorrhoids with severe prolapse (grade I and grade II: p = 0.007, grade III: p = 0.042), and there was no significant difference in the incidence of postoperative complications (p = 0.350). In this article, ERBL was recommended as the initial treatment of grade I to III internal hemorrhoids. Coughlin et al [12] conducted a cost-benefit analysis for 2026 patients who received surgical or ERBL treatment, and found that ERBL had lower cost and higher postoperative quality of life than surgical treatment. In addition, ERBL had a significantly higher success rate for the solution of anal prolapse than EIS [13].

Regarding the mechanism of hemorrhoids, the theory of "anal cushion sliding downward” proposed by Loder [14] is popularly recognized at present. This theory refers that the supporting tissue of the anal cushion, which is composed of venous plexus, smooth muscle and connective tissue, is damaged, thus the anal cushion slides downward, leading to the dilation and deformation of hemorrhoid blood vessels. The suspension ligation mentioned in this paper is a new ligation method based on above theory. By ligating the mucous membrane above the dentate line, the prolapsed anal cushion can move upward, as a result, the prolapse degree of internal hemorrhoids can be relieved and the incidence of postoperative adverse events such as bleeding, edema and pain et al, can be reduced [15]. In this study, we found that the proportion of using suspension ligation in grade III internal hemorrhoids group was significantly higher than that in grade I and II internal hemorrhoids groups, the postoperative adverse events was significantly lower than that in other two groups. Multivariate analysis also found that suspension ligation was the protective factor for postoperative adverse events. These results are consistent with previous studies [15]. Therefore, suspension ligation can reduce the occurrence of postoperative adverse events, especially for severe prolapse of internal hemorrhoids.

Postoperative anal pain is one of the main adverse events of ERBL. Previous studies have reported that the incidence of anal pain after ERBL is 13.3%-55.2% [3, 16, 17]. In this study, the incidence of anal pain after ERBL was 18%, and the incidence of moderate and severe pain was only 5.6%, which was lower than that of previous studies. Most patients' pain can be relieved by warm sits bath or oral painkillers. There are great differences among different studies, which may be related to factors such as the different definitions of pain and treatments among different studies.

We think that the possible factors associated with anal pain after ERBL are as follows: first, increasing number of ligation bands may lead to excessive traction and increased tension of the local mucosa, thus resulting in traction pain. Schleinstein et al [3] found that the incidence of anal pain in patients with ligation bands ≥ 3 was significantly higher than that in patients with < 3 bands. However, the study performed by Tian et al [18] found that there was no significant correlation between postoperative adverse events and the number of ligation bands, which is consistent with our results. Second, regarding the location of ligation, some studies recommend ligation at the 0.5 ~ 1.5cm above the dentate line during ERBL [19], while some studies only emphasize that the ligation site should be located in the insensitive area above the dentate line. At present, the diameter and length of the suction cap of the ligator are both 1cm. In addition, it is difficult to identify of the dentate line because of its zigzag distribution, which both lead to a higher risk of accidental injury to the dentate line. This may be the reason for the high incidence of anal pain after ERBL in some studies. The anorectal line is the upper edge of the anal cushion, which is easy to identify. The site of 1-2cm above the anorectal line is away from the dentate line, ligation in this site can reduce the occurrence of postoperative anal pain. A previous study of our team also showed that ligation with reference to the anorectal line can reduce the incidence of postoperative pain [20]. In this study, 50% of the cases were ligated with reference to the anorectal line, which may also be the reason for the low pain rate in this study. Third, the bad visual field may also be a factor of anal pain. Both the expert opinions and guidelines for the internal hemorrhoids recommend ligation with inverted endoscope [4, 9], because the visual field is wide when the endoscope is reversed, so the anatomical marks of hemorrhoid nucleus and anal canal can be clearly observed and the appropriate ligation site can be determined.

Postoperative bleeding is another common adverse event after ERBL, with an incidence ranging from 8.3% [11] to 62.1% [21]. In our study, its incidence was 4.1%, which was lower than that in previous studies. Most of the bleeding is a small amount, which can be stopped by conservative treatment. Schleinstein et al [22] reported that 29.3% of patients had mild bleeding at 2h post-ERBL and the rate declined to 10.3% at 10–14 d with observation or symptomatic treatment. However, a small number of patients with massive bleeding caused by bands loss may need emergency endoscopic hemostasis or even surgery. Therefore, the tension of the ligature site can be reduced by root supplementary ligation and series ligation during ligation, so as to reduce the possibility of band removal. In addition, coagulation disorders [23], taking anti-platelet and/or acetylsalicylic acid [24] can increase the risk of bleeding related to ERBL. It is routinely recommended that patients should stop this medication for at least 1 week prior to, and 2 weeks post ERBL [25]. The risk of the hemorrhoidal bleeding against the risk of thrombotic events must be balanced.

There are some limitations in this study. First, this is a retrospective and single-center study, which meant that some data, such as the body mass index, type of endoscope, could not be collected. Second, the data in this study is from a tertiary medical center, and the level of operation may be different from that of other hospitals. Third, the follow-up time of this study is short, only 6 months. Therefore, prospective, multicenter, long follow-up studies are warranted in the future to validate our results.

In conclusion, this study found that ERBL was effective for grade I ~ III internal hemorrhoids and there was no significant difference in the effectiveness rate between them. However, the adverse events (including anal pain, bleeding, urinary retention, et al) 24h after ERBL of grade I and II internal hemorrhoids were significantly higher than those of grade III internal hemorrhoids. Univariate and multivariate analysis showed that the non-suspension ligation was an independent risk factor for postoperative adverse events. In the future, prospective, multicenter, long follow-up studies are warranted in the future to validate our results.

Disclosures:

Shanshan Xu, Zhenjuan Li, Hui Ding, Hao Zhang, and Xiuling Li have no conflicts of interest or financial ties to disclose

Author Contribution

X.SS wrote the main manuscript text, L.ZJ prepared figures A-E, Z.H collected data and followed up patients. All authors reviewed the manuscript.

Acknowledgement:

Conflict of Interest Disclosure：The authors declare that they have no conflict of interest

Funding Information: No

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The short-term clinical outcomes of endoscopic rubber band ligation for grade I~III internal hemorrhoids

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Abstract

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Introduction

Materials and Methods

Patients

ERBL procedure

Postoperative management and follow up

Definitions

Statistical analysis

Results

1. Baseline characteristics of the enrolled patients

2. Procedure-related outcomes

3. Follow-up outcomes

Discussion

Declarations

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Author Contribution

Acknowledgement:

References

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