Evaluation of the safety and effectiveness of the disposable endoscope for endoscopic rubber band ligation of internal hemorrhoids: A prospective randomised controlled trial

doi:10.21203/rs.3.rs-2439306/v1

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Evaluation of the safety and effectiveness of the disposable endoscope for endoscopic rubber band ligation of internal hemorrhoids: A prospective randomised controlled trial

https://doi.org/10.21203/rs.3.rs-2439306/v1

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Purpose

We aimed to compare not only the safety and effectiveness of endoscopic rubber band ligation (ERBL) for treating grade II-III internal hemorrhoids using disposable endoscopes versus reusable endoscopes, but also maintenance cost of them.

Method

This was a prospective randomised controlled trial with 42 patients who underwent ERBL for grade II-III internal hemorrhoids using either a disposable endoscope (n = 21) or a reusable endoscope (n = 21). Safety was assessed by postoperative infection rate, in-procedure vital stability, and incidence of device-related adverse events. Effectiveness was assessed by endoscopic image clarity, flexibility, matching between the endoscope and surgical instrument, and therapeutic effect. Cost accounting of maintenance was also estimated.

Results

In terms of safety, although neutrophil count on a postoperative day (POD) 1 in the disposable endoscope group was significantly higher than in the reusable endoscope group (P = 0.008), no patients in either group had a postoperative infection. No life-threatening events, equipment failure or device-related adverse effects occurred during the procedures in either group. In terms of effectiveness, image clarity (P = 0.599) and endoscopic flexibility (P = 0.057) were mildly inferior in disposable endoscope group, but no significant differences were found. Matching between the endoscope and ligating device was 100% in both groups. The therapeutic effects on POD 30 were similar in both groups (P = 0.611). The maintenance cost of reusable endoscope was 214.74RMB per case when disposable endoscope was 0.

Conclusion

Compared with reusable endoscopes, disposable endoscopes are equally safe, feasible, and reliable in ERBL for internal hemorrhoids, and maintenance cost can be totally saved.

Clinical trial registration was completed (ChiCTR2200060014) on May 14, 2022.

Endoscopes

Ligation

Hemorrhoids

Safety

Effectiveness

The common endoscope is repeatedly utilized in modern times. After each use, it needs to be cleaned and sterilised before being used again, which is a complicated and time-consuming process. Concerns have been raised over the possibility that reusable endoscopes cannot be fully sterilised [1, 2]. Previous reports regarding antibiotic-resistant bacteria transmitted through gastroscopes have also attracted the attention of endoscopists [3]. The EndoFresh® disposable endoscope (XZING-W200B, HuiZhou Xzing Technology Co., Ltd., China) has been developed to reduce the risk of hospital infection and avoid cleaning and sterilising procedures, especially during the COVID-19 pandemic. The safety and technical performance of the disposable endoscope are comparable with reusable endoscopes used in routine examinations [4, 5]. However, minimally invasive gastrointestinal treatment using disposable endoscopes has not been reported yet.

Treatment of minimally invasive internal hemorrhoids using endoscopes has proven effective and safe for patients with grade I-III symptomatic internal hemorrhoids [6]. Patients with grade II and III internal hemorrhoids with prolapse are mainly treated with endoscopic rubber band ligation (ERBL) [7]. As early as 2002, ERBL performed in the retroflexed position has been proven to be easily available, safe, and effective in treating symptomatic hemorrhoids [8, 9]. However, whether disposable endoscope-guided ERBL is equally feasible as ERBL using traditional reusable endoscopes has not been explored yet.

In this study, we randomly used disposable or reusable endoscopes for ERBL in patients with grade II-III internal hemorrhoids. This study aimed to compare the incidence of postoperative infection, endoscopic flexibility, image clarity, device-related adverse events, clinical effects and maintenance cost of these two types of endoscopes.

2.1 Study population

We recruited patients with symptomatic internal hemorrhoids diagnosed at Shenzhen Hospital of Southern Medical University between May 14, 2022, and June 7, 2022. On July 7, 2022, the trial stopped with the end of follow-up of the last recruited patient. This study was conducted in accordance with the Ethical Guidelines of the Declaration of Helsinki. The Medical Ethics Committee of Shenzhen Hospital of Southern Medical University approved this prospective cohort study (NYSZYYEC20210034) on April 20, 2022. Clinical trial registration was completed (ChiCTR2200060014) on May 14, 2022. Internal hemorrhoids were graded according to Goligher's classification [10] (Table 1). The inclusion criteria are as follows[11]: (1) Age of 18 to 75 years, with no limitation according to sex; (2) grade II-III internal haemorrhoids with accompanying symptoms, such as bleeding, prolapse, or itching; (3) conservative treatment for grade II-III internal haemorrhoids such as diet regulation and drugs has proven ineffective; (4) patients unwilling to undergo haemorrhoidectomy. The exclusion criteria are as follows[12]: (1) Grade IV haemorrhoids, mixed haemorrhoids, or external haemorrhoids; (2) internal haemorrhoids accompanied by incarceration, thrombosis, erosion, or infection; (3) patients with severe systemic diseases who cannot tolerate endoscopic treatment; (4) patients with perianal infectious diseases or anal fistulae; (5) patients with active inflammatory bowel disease; (6) patients with coagulation dysfunction or using anticoagulants; (7) pregnant women.

Table 1

Goligher’ s Classification
Grade	Degree of Prolapse
I	No prolapse
II	Prolapse on defecation with spontaneous reduction
III	Prolapse on defecation requiring manual reduction
IV	Irreducible prolapse

According to the estimation formula of test sample content of single-group target value method, when the significance level is 0.05 and the test efficiency (1-β) = 0.8, the estimated sample size is: N = 21, therefore, a total of 42 patients were recruited. The random numbers were generated by computer, and the patients were assigned to either the disposable endoscope group (n = 21, EndoFresh®, XZING-W200B, HuiZhou Xzing Technology Co., Ltd) or the reusable endoscope group (n = 21, EG-600WR, Fuji Film Co., Ltd) orderly according to random numbers. All patients were evaluated before treatment with a medical history review, laboratory examination (blood tests, hypersensitive C-reactive protein (hs-CRP), coagulation function, and infectious diseases), and electrocardiography (ECG). All patients signed informed consent forms for the treatment and were informed of the risks associated with the treatment. All patients underwent whole bowel preparation before ERBL.

2.2 Endoscopic rubber band ligation (ERBL)

Patients were treated with ERBL. After the multiple band ligation device (Speedband®, M00542251, Boston Scientific Co., Ltd, USA) was attached to the endoscope, hemorrhoids were suctioned into the ligating device, and then an elastic band was released. The above steps were repeated until the prolapsed hemorrhoids were relieved, and no more than seven ligations in total were performed per patient (Fig. 1, Supplementary Material, Video 1 and 2).

2.3 Evaluation measures

Follow-up visits were performed on postoperative day (POD) 1, POD 7, and POD 30, and the follow-up items are listed below.

2.3.1 Safety measures

(1) Primary outcome measures: Postoperative infection

The primary outcome measure was the postoperative infection rate. Blood tests, hs-CRP, temperature, and anal pain were measured on POD 1 and POD 7. We mainly focused on white blood cell (WBC) and neutrophil (NEUT) counts among the blood tests. Anal pain intensity was quantified by the Visual Analogue Scale (VAS), with scores on a scale of 0–10, where 0–3 indicates mild pain, 4–6 indicates moderate pain, 7–9 indicates severe pain, and 10 indicates excruciating pain [12].

Evaluation criteria were formulated referring to the CDC definitions of nosocomial surgical site infections [13]: (1) WBC count > 10×10⁹/L, (2) NEUT count > 6.3×10⁹/L, (3) hs-CRP > 10 mg/L, (4) temperature > 38°C, and (5) VAS of anal pain continuously > 4 with suppuration. Additionally, pathogens were cultured. Patients who met all five items above were considered to have a postoperative infection.

(2) Secondary outcome measures: Trends of WBC count, NEUT count, and hs-CRP level

WBC count, NEUT count, and hs-CRP levels measured before the operation, on POD 1, and POD 7 were compared within and between groups.

In-procedure stability

In-procedure vital sign stability was evaluated based on the changes in blood pressure and heart rate measured before anaesthesia, during ERBL, and 10 ± 5 minutes after the procedure. Subjects whose blood pressure and heart rate changed more than 20% from baseline were defined as 'unstable' [14].

Incidence of equipment failure and device-related adverse events

Equipment failure, such as image interruption, water delivery blockage, or leakage, and adverse events during or within 1 hour after the operation, such as mucosa damage, bowel perforation, massive haemorrhage, or instability of vital signs, were recorded.

2.3.2 Effectiveness measures

(1) Primary outcome measures: ERBL feasibility

Evaluation method: The operator evaluated endoscopic image clarity, flexibility, clinical operability, and matching between the endoscope and surgical instrument.

Evaluation criteria:

(1) Image clarity was graded as follows: (A) Good brightness, contrast, and clarity: accurate identification of the anal and dentate lines was possible, and internal hemorrhoids could be clearly identified. (B) Fair brightness, contrast, and clarity: rough identification of the anal and dentate lines was possible, and internal hemorrhoids could be roughly identified. (C) Poor brightness, contrast, and clarity: identification of the anal and dentate lines was not possible, and internal hemorrhoids could not be identified.

(2) Endoscopic flexibility was graded as follows: (A) The endoscope could be easily retroflexed from the forward position. (B) The endoscope could be roughly retroflexed from the forward position. (C) The endoscope failed to be retroflexed from the forward position.

(3) Matching between the endoscope and ligating device was graded as follows: (A) The endoscope and ligating device matched perfectly, and the operation went smoothly. (B) The endoscope and ligating device matched roughly, and the operation procedure was slightly affected. (C) The endoscope and ligating device could not match, and the operation failed to proceed.

ERBL feasibility was considered 'qualified' if all items were graded 'A' or 'B'. If any one item was graded 'C', ERBL feasibility was considered 'unqualified'. The qualification rate of ERBL feasibility = (the number of 'qualified' cases/the number of subjects in each group) × 100.

(2) Secondary outcome measures: Postoperative follow-up

Evaluation method: All subjects underwent outpatient follow-up on POD 30 after ERBL to assess the therapeutic efficacy.

Evaluation criteria: (1) Cured: haematochezia and prolapse symptoms disappeared completely, and wounds healed completely. (2) Effective: haematochezia and prolapse symptoms were improved, hemorrhoids were reduced or displayed incomplete atrophy, and wounds healed well. (3) Invalid: haematochezia and prolapse symptoms were not alleviated or were aggravated.

2.3.3 Cost accounting

The cost of maintenance for each endoscope was estimated, including sterilization, repair and storage costs.

2.4 Statistical analyses

Data were analysed using Statistical Product and Service Solutions Version 26.0 (SPSS, International Business Machines Corporation). Since there was no loss of follow-up in this trial, the protocol set population was consistent with the full analysis set population. Measurement data were analysed using the paired t-test or Wilcoxon rank sum test between the two groups. The variance of repeated measurement analysis was performed for intragroup and intergroup comparisons. Count data were summarised by frequency and percentage (n [%]) and compared using the Chi-square test or Fisher's exact test. A P-value of < 0.05 was considered statistically significant.

3.1 General information

No significant between-group differences were observed for sex, age, grading of internal hemorrhoids, pre-operation WBC and NEUT counts, hs-CRP, blood pressure, or heart rate (Table 2).

Table 2

Baseline Characteristics of the Patients
	Disposable Endoscope Group (n = 21)	Reusable Endoscope Group (n = 21)	P-Value
Age (years)	39.81 ± 7.17	41.48 ± 9.17	0.330
Gender, n (%)
Male	9 (42.86%)	9 (42.86%)	1.000
Female	12 (57.14%)	12 (57.14%)	1.000
Classification of Internal Haemorrhoids, n (%)
III	12 (57.14%)	14 (66.67%)	0.525
II	9 (42.86%)	7 (33.33%)	0.525

3.2 Safety measures

(1) Primary outcome measures: Postoperative infection

NEUT count > 6.3×10^9/L was 66.67% in the disposable endoscope group and 19.05% in the reusable endoscope group on POD 1, which were significantly different (P = 0.002). However, NEUT count > 6.3×10^9/L on POD 7, WBC count > 10×10^9/L and hs-CRP > 10 mg/L on POD 1 and POD 7 were not significantly different between the groups. The mean temperature (°C) on POD 1 and POD 7 was 36.42 ± 0.33 and 36.30 ± 0.20 respectively in the disposable endoscope group and 36.45 ± 0.21 and 36.40 ± 0.21 respectively in the reusable endoscope group. The mean VAS on POD 1 and POD 7 was 0.95 ± 1.02 and 0.10 ± 0.44 respectively in the disposable endoscope group and 0.71 ± 0.85 and 0.24 ± 0.70 respectively in the reusable endoscope group. No patients in either group suffered from suppuration. In summary, no patients in either group suffered from postoperative infection (Table 3).

Table 3

Comparisons of Postoperative Infection between Groups
	Disposable Endoscope Group (N = 21)	Reusable Endoscope Group (N = 21)	P-Value
WBC POD 1, n (%)
> 10×10⁹/L	7 (33.33%)	2 (9.52%)	0.133
≤ 10×10⁹/L	14 (66.67%)	19 (90.48%)	0.133
WBC POD 7, n (%)
> 10×10⁹/L	1 (4.76%)	0 (0%)	1.000
≤ 10×10⁹/L	20 (95.24%)	21 (100%)	1.000
NEUT POD 1, n (%)
> 6.3×10⁹/L	14 (66.67%)	4 (19.05%)	0.002
≤ 6.3×10⁹/L	7 (33.33%)	17 (80.95%)	0.002
NEUT POD 7, n (%)
> 6.3×10⁹/L	3 (14.29%)	0 (0%)	0.231
≤ 6.3×10⁹/L	18 (85.71%)	21 (100%)	0.231
hs-CRP POD 1, n (%)
> 10 mg/L	0 (0%)	0 (0%)	-
≤ 10 mg/L	21 (100%)	21 (100%)	-
hs-CRP POD 7, n (%)
> 10 mg/L	0 (0%)	2 (9.52%)	0.469
≤ 10 mg/L	21 (100%)	19 (90.48%)	0.469
Temperature, n (%)
> 38℃	0 (0.0%)	0 (0.0%)	-
≤ 38℃	21 (100.0%)	21 (100.0%)	-
VAS, n (%)
>4	0 (0.0%)	0 (0.0%)	-
≤ 4	21 (100.0%)	21 (100.0%)	-
Suppuration, n (%)
Yes	0 (0.0%)	0 (0.0%)	-
No	21 (100.0%)	21 (100.0%)	-
Postoperative Infection, n (%)
Yes	0 (0.0%)	0 (0.0%)	-
No	21 (100.0%)	21 (100.0%)	-
WBC, white blood cell count; POD, postoperative day; NEUT, neutrophil

(2) Secondary outcome measures: Trends of WBC count, NEUT count, and hs-CRP level (Fig. 2)

(1) WBC counts: The mean WBC counts (×10^9/L) before the operation, on POD 1, and POD 7 were 6.66 ± 1.42, 8.44 ± 2.65, and 7.32 ± 1.44, respectively, in the disposable endoscope group, and 6.01 ± 1.32, 7.37 ± 2.32, and 6.81 ± 1.36 respectively in the reusable endoscope group. There was no interaction in WBC counts between the groups at different measurement times, and no significant difference in WBC counts was found between the groups (P = 0.087). Significant differences were observed in WBC counts at different measurement times (P = 0.000).

(2) NEUT counts: The mean NEUT counts (×10^9/L) before the operation, on POD 1, and POD 7 were 3.93 ± 1.14, 6.74 ± 2.03, and 4.78 ± 1.37, respectively, in the disposable endoscope group and 3.33 ± 1.17, 5.24 ± 1.89, and 4.28 ± 1.06, respectively, in the reusable endoscope group. There was no interaction in NEUT counts between the groups at different measurement times. Significant differences were observed in NEUT counts between the groups (P = 0.008). Significant differences were also observed in NEUT counts at the different measurement times (P = 0.000).

(3) Hs-CRP: The mean hs-CRP levels (mg/L) before the operation, on POD 1, and POD 7 were 1.10 ± 1.43, 1.50 ± 1.83, and 3.93 ± 3.18, respectively, in the disposable endoscope group and 1.08 ± 0.83, 1.49 ± 1.47, and 7.49 ± 15.86, respectively, in the reusable endoscope group. No interaction of hs-CRP level between the groups was observed at different measurement times. There was no significant difference in hs-CRP levels between the groups (P = 0.342). A significant difference in hs-CRP levels was observed at the different measurement times (P = 0.016).

In-procedure stability

(1) In-procedure vital sign stability

During ERBL, systolic pressure stability, diastolic pressure stability, and heart rate stability were 85.71%, 66.67%, and 90.48%, respectively, in the disposable endoscope group, and 95.24%, 95.24%, and 90.48% in the reusable endoscope group, respectively. Only diastolic pressures were statistically different between the two groups (P = 0.049).

After the procedure (10 ± 5 minutes), systolic pressure stability, diastolic pressure stability, and heart rate stability were 80.95%, 80.95%, and 85.71%, respectively, in the disposable endoscope group, and 90.48%, 80.95%, and 80.95%, respectively, in the reusable endoscope group. The difference between the two groups was not statistically significant.

(2) Incidence of equipment failure and operation-related adverse events

No equipment failure or operation-related adverse events occurred in either the disposable or the reusable endoscope groups.

3.3 Effectiveness measures

(1) Primary outcome measures: ERBL feasibility

Image clarity: Grade A was assigned to 18 operations (85.71%), and grade B was assigned to 3 (14.29%) in the disposable endoscope group. Grade A was assigned to 20 operations (95.24%), and grade B was assigned to 1 (4.76%) in the reusable endoscope group. The difference between the two groups was not statistically significant (P = 0.599).

Endoscopic flexibility: Grade A was assigned to 16 operations (76.19%), and grade B was assigned to 5 (23.81%) in the disposable endoscope group. Grade A was assigned to 21 operations (100.00%), and grade B was assigned to 0 (0%) in the reusable endoscope group. The difference between the two groups was not statistically significant (P = 0.057).

Matching between endoscope and ligating device: Grade A was assigned to 21 operations (100.00%), and grade B was assigned to 0 (0%) in both groups. The difference between the two groups was not statistically significant.

Qualified ERBL feasibility (grade A and B) was 100% in both groups (Table 4).

Table 4

Comparisons of ERBL Feasibility between Groups
	Disposable Endoscope Group (n = 21)	Reusable Endoscope Group (n = 21)	P-Value
Endoscopic flexibility, n (%)
A	16 (76.19%)	21 (100.0%)	0.057
B	5 (23.81%)	0 (0.0%)	0.057
Matching between endoscope and ligating device, n (%)
A	21 (100.0%)	21 (100.0%)	-
B	0 (0.0%)	0 (0.0%)	-
Acceptable clinical operability, n (%)
A	18 (85.71%)	21 (100.0%)	0.231
B	3 (14.29%)	0 (0.0%)	0.231
Image clarity, n (%)
A	18 (85.71%)	20 (95.24%)	0.599
B	3 (14.29%)	1 (4.76%)	0.599
Qualified ERBL feasibility, n (%)
Yes	21 (100.0%)	21 (100.0%)	-
No	0 (0.0%)	0 (0.0%)	-
ERBL, endoscopic rubber band ligation

(2) Secondary outcome measures: Postoperative follow-up of therapeutic effect

In the disposable endoscope group, the number of cases regarded as 'cured' was 12 (57.1%), 'effective' was 9 (42.9%), and 'invalid' was 0 (0%). In the reusable endoscope group, the number of cases regarded as 'cured' was 13 (61.9%), 'effective' was 7 (33.3%), and 'invalid' was 1 (4.8%). The difference in therapeutic effects between the two groups was not statistically significant (P = 0.611).

3.4 Cost counting

The total maintenance cost of reusable endoscope was 214.74RMB/case, including the cost of endoscopic sterilization (183.15 ± 0.00) RMB, the cost of endoscopic repair (25.30 ± 0.00) RMB, and the cost of endoscopic storage (6.29 ± 0.00) RMB, when the maintenance cost of disposable endoscope was 0.

Internal hemorrhoids are a group of soft veins formed by congestion in the varicose venous plexus above the dentate line under the mucosa and anal skin at the lower end of the rectum [15]. Symptomatic internal hemorrhoids mainly present as prolapse, bleeding, itching, and pain [16]. ERBL refers to endoscopic-assisted ligation of hemorrhoids to create fibrosis of the rectal wall, which can prevent prolapse and bleeding by reducing the blood flow into the haemorrhoidal venous plexus [17]. Guidelines for the treatment of hemorrhoids in France [18] in 2016 and in America [18] in 2018 indicated that for patients with grade I and II internal hemorrhoids and grade III internal hemorrhoids with mucosal prolapse, ERBL is the first choice of treatment. This study is the first prospective randomised controlled trial comparing the safety and clinical feasibility of disposable endoscope- and reusable endoscope-guided ERBL of internal hemorrhoids.

Regarding safety, although the NEUT count on POD 1 in the disposable endoscope group (6.74 ± 2.03×10^9/L) was higher than in the reusable endoscope group and mildly exceeded the upper limit of the normal range (6.3×10^9/L), the count returned to normal levels on POD 7, and no postoperative infection was diagnosed in either group. While in-procedure stability of diastolic blood pressure in the disposable endoscope group was slightly worse than in the reusable endoscope group, no life-threatening events happened. These results suggest that the overall safety of disposable endoscopes is guaranteed. It is worth mentioning that the hs-CRP level in one patient in the reusable endoscope group was extremely high (75.68 mg/L) on POD 7, but no fever or severe anal pain were reported, and WBC and NEUT counts were within normal ranges. This abnormal elevation of hs-CRP level may be due to the patient's history of uraemia. The patient had a satisfactory therapeutic effect without adverse events, which implies ERBL may be a good alternative for patients who cannot tolerate haemorrhoidectomy.

Although the gradings of image clarity and endoscopic flexibility of the disposable endoscopes were lower than the reusable endoscopes (manifesting as a higher-grade B rate in the disposable endoscope group), all patients in both groups underwent ERBL successfully. The feasibility rate of the disposable endoscope was 100%. Additionally, follow-up on POD 30 revealed that more than half of subjects in both groups reported that their symptoms of hemorrhoids were completely alleviated. These results indicate that disposable endoscopes can provide a promising alternative for ERBL. However, image brightness, sharpness, and contrast, as well as the curvature of the disposable endoscope, may require improvement to meet the needs of accurate diagnosis and complex operation.

In this study, the EndoFresh® disposable endoscopes (XZING-W200B, HuiZhou Xzing Technology Co., Ltd) used with ERBL have two light-emitting diodes (LEDs) and a 110° view angle, which can clearly identify the anorectal and dentate lines to confirm the location of ligation [16]. Additionally, the 10.8 mm outer diameter insertion tube and 3.00 mm diameter instrument channel can fit with the Speedband® multiple band ligation device. Moreover, ERBL is always performed when the endoscope is in a retroflexed position [9, 19], and a 180° upwards bending angle is adequate for the ligation device to reach the hemorrhoids.

Disposable endoscopes can be used directly after they are removed from the packaging and discarded following the medical waste management principles after use [20], which can completely prevent cross-contamination among patients especially amid the COVID-19 pandemic.

Compared with the reusable endoscope, the disposable endoscope does not need sterilization and repair and is discarded after use, which saves the sterilization, repairing and storage cost for 214.74RMB/case. The development history of disposable endoscopes shows that the product cost of disposable endoscopes should be further reduced with the increase of production capacity in the future.

In conclusion, disposable endoscope can be an appropriate alternative in the ERBL of internal hemorrhoids for similar safety and effectiveness to reusable endoscope. It can also save cost and time for maintenance and storage. However, as this was a single-centre study, the number of patients was small. The purpose of this study is to obtain real clinical use data through small sample of clinical use, which can be used to guide large-scale clinical application of the product after marketing. A multi-centre study with more patients and a longer period of follow-up are required in the future to guarantee the feasibility of disposable endoscope use.

Competing Interests: The authors have no relevant financial or non-financial interests to disclose.

Authors' contributions:

All authors contributed to the study conception and design. Wen Xu drafted the article, Guili Xia and Laihe Li analysed and interpreted the data, Ge Cao and Xianhuan Yan put forward the conception, Ling Dong designed the protocol, Ying Zhu was responsible for critical revision of the article for important intellectual content and final approval of the article. All authors read and approved the final manuscript.

Acknowledgments

We thank Elsevier Language Editing Services for editing a draft of this manuscript.

Funding

No funding was received for conducting this study.

Conflict of interest

The authors have no relevant financial or non-financial interests to disclose.

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No competing interests reported.

video1withnarration.mp4
Video 1. The procedure for endoscopic rubber band ligation for internal hemorrhoids using a disposable endoscope.
video2withnarration.mp4
Video 2. The procedure for endoscopic rubber band ligation for internal hemorrhoids using a reusable endoscope.

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Evaluation of the safety and effectiveness of the disposable endoscope for endoscopic rubber band ligation of internal hemorrhoids: A prospective randomised controlled trial

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Abstract

Purpose

Method

Results

Conclusion

Figures

1 Introduction

2 Patients And Methods

2.1 Study population

2.2 Endoscopic rubber band ligation (ERBL)

2.3 Evaluation measures

2.3.1 Safety measures

2.3.2 Effectiveness measures

2.3.3 Cost accounting

2.4 Statistical analyses

3. Results

3.1 General information

3.2 Safety measures

3.3 Effectiveness measures

3.4 Cost counting

4. Discussion

5. Conclusion

Declarations

References

Additional Declarations

Supplementary Files

Status:

Version 1