Laser Hemorrhoidoplasty Procedure for Grade Two and Three Hemorrhoidal Disease. A Retrospectively prospective study, analysis of forty-seven patients

Ferhatoglu MF

Istanbul Okan University, Faculty of Medicine, Department of General Surgery, Istanbul, Turkey

Kartal A

Istanbul Okan University, Faculty of Medicine, Department of General Surgery, Istanbul, Turkey

Kıvılcım T

Istanbul Okan University, Faculty of Medicine, Department of General Surgery, Istanbul, Turkey

Ekici U

Istanbul Gelisim University, Istanbul, Turkey

Kebudi A

Istanbul Okan University, Faculty of Medicine, Department of General Surgery, Istanbul, Turkey

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Abstract

Background: Laser Hemorrhoidoplasty (LH) is a novel minimally invasive technique to treat symptomatic hemorrhoids. The purpose of this study was to evaluate clinical outcomes and patients' satisfaction treated with the LH.

Methods: Indications for LH included patients with symptomatic grade 2-3 hemorrhoids resistant to medical therapy, with low-grade prolapse. Clinical efficiency was evaluated assessing the resolution of symptoms and patient satisfaction. The anal margin edema, pain, recurrence of the symptoms was also evaluated.

Results: Forty-seven patients included in the study. At 3-month follow-up, symptoms had completely resolved in 78.7% of patients. There was a statistically significant improvement in pain. When patients were asked in the evaluation on third postoperative month how they were compared to your preoperative condition 78.7% had a better condition.

Conclusions: The LH is simple, minimally invasive, and almost pain-free. It may be considered as "first-line treatment" in all patients having grade two /three hemorrhoidal diseases and without significant anal prolapse.

Key words

Laser; hemorrhoidoplasty; hemorrhoid; pain; edema; mucosal prolapsus

Introduction

Hemorrhoidal disease is a widespread anorectal disease having a lifetime risk of up to 5% and causes remarkable disability [1]. Whereas Lee JH et al. [2] from South Korea and Riss W et al. [3]   from Austria said the prevalence of hemorrhoidal disease in the adult population of 14.4% and 38.9%, respectively.

The most typical signs include rectal bleeding, pain, anal irritation, and prolapse [4]. Nearly 50% of individuals suffering from hemorrhoidal disease need treatment, and up to 20% of individuals having need treatment because of hemorrhoidal disease require a surgical procedure [5-7].

Many methods have been identified to treat hemorrhoidal disease. However, there are still doubts about the ideal approach which should be an effective procedure and without discomfort for the patient [1].

Treatment choices are determined by type/ severity of the disease, patient's preference and the expertise of the surgeon. Dietary and lifestyle modification can be useful on low-graded internal hemorrhoids, [8] but high-grade, strangulated or thrombosed hemorrhoids or hemorrhoids refractory to non-surgical treatment strategies should be treated surgically [9].  Morigana et al.  first described the ligation of the hemorrhoidal artery in the last decade of the twentieth century [10]. Dearterialization of hemorrhoidal plexus is the primary mechanism of this non-excisional technique which results in shrinkage of the hemorrhoidal cushions [11,12].

Our study aimed to summarize the results of Laser Hemorrhoidoplasty Procedures (HeLP) performed in patients with symptomatic second- and third-degree hemorrhoids with absent or minimal internal mucosal prolapse.

Materials and Methods

This retrospectively prospective study was performed on Istanbul Okan University Health Application and Research Center on 56 individuals between January 2017- January 2018. All individuals’ preoperative medical history was taken, and routine physical examination including digital rectal examination and blood test (liver and kidney functions, counter blood count, coagulation parameters) was performed. 

All patients had second and third-degree hemorrhoids with or without minimal rectal mucosal prolapse, and all patients did not benefit from medical treatment having second-degree hemorrhoids included to study. Exclusion criteria are fourth-degree hemorrhoids (Goligher’s classification) [13], severe mucosal prolapse (Not reducted manually), previous surgery for hemorrhoid disease, acute complications (thrombosis, fecal incontinence), previous rectal anastomosis, anal stenosis, concomitant anal pathology (anal fissure or fistula, inflammatory bowel disease, and ongoing anticoagulant therapy), age <18 and >70.

Two sodium dihydrogen phosphate + disodium hydrogen phosphate enema (135 ml) were administrated one hour before the procedure. Antibiotic prophylaxis with 500 mg metronidazole + 1 gr cefazolin sodium was routinely given three before the induction of anesthesia.

Surgical technique: All patients were sedated with sedoanalgisia by an anesthesiology, medical doctor (PROPOFOL %1 10gr/20 ml, Midazolam 50mg/10ml) and placed on lithotomy position. The HeLP kit: Neo V Laser (Ha’Eshel St. 7, 3088900 Caesarea, Israel), Using a 1470 nm diode laser optic fiber, power: 6-watt pulses of 1 second with a 1 second pause, size: probe: 600 microns, Corona crystal hemorrhoid probe (MEDNET GmbH, Borkstr10, 48163, Munster, Germany).  Through the following steps, HeLP was performed above 2.5 cm of the dentate line of anus under direct vision of the red light on the tip of the laser probe (Figure 1), six pulses per one hemorrhoid was made and, an absorbable, cylindrical, hemostatic gelatin sponge was administrated to the anal canal at the end of the procedure. 

Figure 1. Application of laser, red light on the tip of the applicator is shown (Red arrow).

Paracetamol 1000mg (IV) + Tramadol HCl 50 mg (IV) was used for postoperative analgesia, and oral liquid diet was given two hours after the procedure and patients with no evidence of bleeding were discharged. All patients have invited the out-patient clinic on the second and seventh day and the first month of the HeLP procedure and physically examined by the primary surgeon (MFF, TK, AK, AIF, AG). The occurrence of postoperative pain, edema and bleeding was checked up and asked the patient in every out-patient clinic visit.

Follow-up: All patients were admitted for follow-up on postoperative day 2,7 and 30.

Evaluation of edema: The degree of anal margin edema was classified into: grade 0: no edema; grade 1: minimal local edema, without affecting regular activity; grade 2: mild local edema, without affecting regular activity; grade 3: severe edema of all anus; grade 4: edema closing anal orifice fully.

Evaluation of pain: Wong-Baker FACESÒ pain scale of 0-10 was used. (0= No pain,10=The worst possible pain).

All patients were called by telephone or e-mail in the third month of the HeLP procedure, and the following questions were asked.

  1. Is there evidence of bleeding?
  2. Is there pain in defecation?
  3. Have symptoms and complaints regressed?
  4. When you compare your current status according to pre-operation, give a score between 1-3 (three-point verbal rating scale (VRS) 1: bad, 2: same, 3: good).

Recurrence was defined as any symptom which healed after the HeLP procedure, but which occurred during follow-up and caused discomfort.

If symptoms or complains recurred after HeLP procedure during follow-up was defined as recurrence of the disease.

Statistical analysis: For statistical analysis, the NCSS (Number Cruncher Statistical System) 2007 (Kaysville, Utah, USA) program was used. Descriptive statistical methods (mean, standard deviation, median, frequency, ratio, minimum, maximum) were used to evaluate the study data. The normal distribution of quantitative data was tested with Kolmogorov-Smirnov, Shapiro-Wilk test and graphical evaluations. The Mann Whitney U test was used to compare two groups of data that were not normally distributed. Kruskal Wallis test and double comparison were performed by Dunn-Bonferroni test in a comparison of groups of three and more who did not show normal distribution. Pearson's chi-square test and Fisher Exact test were used to comparing the qualitative data. Spearman dağılıms Correlation Analysis was used in the variables that did not show the normal distribution in the evaluation of the relationships between the variables. In the assessment of the follow-up of the variables that did not show normal distribution, the Wilcoxon Signed Ranks test was used to evaluate the Friedman test and the paired comparisons. Significance was at least p <0.05.

Ethical Approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the Helsinki declaration and its later amendments or comparable ethical standards. Ethic committee of Istanbul Okan University also approved the study protocol (13.03.2019/ 104).

Informed Consent: Informed consent was obtained from all individual participants included in the study.

Results

The study was conducted with a total of 47 cases. The ages of the cases ranged from 24 to 79 years, and the mean age was 40.30 ± 12.12 years. The operation time ranged from 5 to 35 minutes, with a mean of 22.13 ± 14.73 minutes; The duration of discharge ranged from 7 to 91 hours, with an average of 23.62 ± 14.36 hours and a follow-up period of 14 to 150 days, with an average of 43.04 ± 29.28 days. While 17.0% (n = 8) of the cases had grade 2 hemorrhoidal disease, 83.0% (n = 39) had grade 3 hemorrhoidal disease and 36.2% (n = 17) of the cases had one dilated hemorrhoidal plexus, 23.4% (n = 11) had two, 40.4% (n = 19) had three dilated hemorrhoidal plexuses. Before the operation, mild mucosal prolapse was observed in 14.9% (n = 7) of the cases.

Long-term postoperative bleeding was observed in 14.9% (n = 7), recurrence of the disease after the procedure in 21.3% (n = 10) of the cases, and complication was observed in 5 cases (Anal stenosis: 1, Abscess formation: 1, hemorrhage (Short-term): 2, thrombosis: 1). In the evaluation on the third postoperative month, 12.8% of the cases had bleeding, 10.6% had pain, 23.4% had non-specific postoperative complaints. When patients were asked in the evaluation on third postoperative month how they were compared to your preoperative condition; 17.0% (n = 8) had the same status after the operation, while 78.7% (n = 37) had better and 4.3% (n = 2) worse.

As a result of bilateral comparisons of the postoperative sixth hour, postoperative day 2, postoperative day 7 and postoperative day 30 pain measurements; the decrease in pain measurements was found to be statistically significant (p = 0.001; p = 0.001; p = 0.001, respectively) (Table 1).

Table 1. Evaluation of Pain Measurements in Follow-up

 

Pain

 

Min-Max (Median)

Mean± SD

 

Postoperative sixth hour

2-8 (5)

4,55±1,32

 

Postoperative day 2

0-5 (3)

2,85±1,33

 

Postoperative day 7

0-6 (1)

1,40±1,55

 

Postoperative day 30

0-5 (0)

0,53±1,18

 

 

ap 0,001**

 

 

Bilateral comparation; bp

Postoperative sixth hour- Postoperative day 2

0,001**

 

 

Postoperative sixth hour- Postoperative day 7

0,001**

 

 

Postoperative sixth hour- Postoperative day 30

0,001**

 

 

Postoperative day 2- Postoperative day 7

0,001**

 

 

Postoperative day 2- Postoperative day 30

0,001**

 

 

Postoperative day 7- Postoperative day 30

0,001**

 

 

aFriedman Test

 

bWilcoxon Signed Ranks Test

**p<0.01

The change in edema levels was statistically significant (p = 0.001) on postoperative day 2, postoperative day 7 and postoperative 30 days. As a result of bilateral comparisons according to the postoperative day, the decrease in the day 7 and day 30, the reduction of edema levels was statistically significant (p = 0.001; p = 0.001; p <0.01, respectively). The decrease in the edema levels at day 30 according to postoperative day 7 was also statistically significant (p = 0.001; p <0.01) (Table 2).

Table 2. Evaluation of Edema Level in Follow-up

   

Edema; n (%)

Min-Max (Median)

No

Minimal (1)

Mild

Severe (3)

Completely closing anal orifice (4)

0

-2

Mean± SD

n (%)

n (%)

n (%)

n (%)

n (%)

Postoperative day 2

2-4 (3)

0 (0)

0 (0)

14 (29,8)

20 (42,5)

13 (27,7)

2,98±0,77

Postoperative day 7

0-3 (2)

6 (12,8)

15 (31,9)

16 (34,0)

10 (21,3)

0 (0)

1,64±0,96

Postoperative day 30

0-2 (0)

37 (78,7)

9 (19,1)

1 (2,1)

0 (0)

0 (0)

0,23±0,48

ap

0,001**

         

Bilateral comparation; bp

Postoperative day 2- Postoperative day 7

0,001**

         

Postoperative day 2- Postoperative day 30

0,001**

         

Postoperative day 7- Postoperative day 30

0,001**

         

aFriedman Test

 

bWilcoxon Signed Ranks Test

**p<0.01

     

There was a statistically significant relationship between pain and edema on postoperative day 2, 7 and 30, as the edema increases, the pain increases (p=0.001).

There was no statistically significant difference between the recurrence rates of the patients according to the hemorrhoid grade and number (p> 0.05).

There was a statistically significant difference between the rates of recurrence in patients with preoperative mucosal prolapse (p = 0.001); The incidence of recurrence was higher in patients with mucosal prolapse before surgery.

The postoperative pain levels of the cases according to the number of hemorrhoids were statistically significant (p = 0.001). As a result of bilateral comparisons; sixth postoperative hour pain levels of patients with two hemorrhoids and three hemorrhoids were higher than those with one hemorrhoid (p = 0.040; p = 0.001, respectively). No significant difference was found between the postoperative pain levels of the patients with hemorrhoids two and three hemorrhoids (p> 0.05).

According to the number of hemorrhoids, postoperative day two edema levels of the cases were statistically significant (p = 0.001). As a result of bilateral comparisons; the postoperative day two edema levels of the patients with three hemorrhoids were higher than those with one hemorrhoid (p = 0.002). No significant difference was found between the postoperative day two edema levels of the other groups (p> 0.05). Postoperative day 7 and postoperative day 30 edema levels did not show statistically significant difference according to hemorrhoid numbers (p> 0.05).

According to the number of hemorrhoids, the changes in the edema levels at day 30 according to postoperative day 2 showed a statistically significant difference (p = 0.001). As a result of bilateral comparisons; the decrease in the day 30 edema levels of the patients with two hemorrhoids and three hemorrhoids was higher than the ones with one hemorrhoid (p = 0.004; p = 0.003, respectively).

Postoperative day 7 and 30 pain levels did not show statistically significant difference according to hemorrhoid grade (p> 0.05). Statistically, a significant difference was found between the postoperative day two pain levels; grade 3 cases had higher postoperative pain levels than grade 2 cases (p = 0.045).

The postoperative day 2 and 7 edema levels were statistically significant (p = 0.014; p = 0.011, respectively); grade 3 cases had higher postoperative edema levels than grade 2 cases.

Postoperative sixth hour, postoperative day 2, 7 and 30 pain levels were higher than those without mucosal prolapse (p = 0.022; p = 0.003; p = 0.003; p = 0.002, respectively). Also, postoperative day 2, 7 and 30 edema levels of patients with mucosal prolapse were higher than those without mucosal prolapse (p = 0.001; p = 0.001; p = 0.001, respectively).

Discussion

The primary aim of a colorectal surgeon when managing patients experiencing symptoms of the hemorrhoidal disease should be to cure symptoms and improve the life quality of the patient.

Many surgical modalities exist to treat hemorrhoidal disease; optimal surgical procedures should provide low levels of pain, low morbidity, and preservation of the anatomy of the anal canal.  Doppler-guided laser appears as an adequate and painless method for the treatment of symptomatic second and third-grade hemorrhoids including moderate anal mucosal prolapse [14].

Traditional hemorrhoidectomy may become a painful/distributing procedure for benign disease [15]. Short-term complications of traditional hemorrhoidectomy involve urinary retention (20.1%), bleeding (2.4%-6%), and abscesses formation (0.5%). Long- term complications include formation of anal fissure (1%-2.6%), anal stenosis (1%), anal fistula (0.5%) and incontinence (0.4%), repetitive hemorrhoidal symptoms (20%) [14,15]. In the presented study recurrence of the symptoms were 21.3%, short-term bleeding 4.2%, abscess formation 2.1%, thrombosis 2.1% and anal stenosis 2.1%.  Our complications are very similar to literature subjecting traditional hemorrhoid surgery [14-17] A systematic review of Giordano et al. [18] evaluated seventeen reports including 1996 cases reporting overall outcomes in grade 2 and three hemorrhoidal diseases with mean recurrence rates of 11% for prolapse, 9% for pain at defecation, and 10% for bleeding at an average of 1-year follow-up after HeLP procedure. In another recent review published by Pucher et al. [19], 2904 cases from 28 researchers were evaluated, and overall recurrence was a rate of 17.5%. We believe the reason for our high complication rate is to start a newer procedure in the treatment of this disease. Also, complications are usually seen in the first 30 cases, suggesting that this procedure has a non-short learning curve.

Lowering the arterial stream of the hemorrhoidal plexus diminishes the symptoms with minimal discomfort, and pain.10 Dearterialization has the advantage over traditional surgical methods as the preservation of the anatomy and physiology of the anal canal [20], thus better quality of life. In the presented study, 78.7% of the patients stated that according to the preoperative status in better condition. In the study of Giordano et al. [21], he noted that laser dearterialization procedure improves quality of life after the postoperative period. Ratto et al. [22] also pointed out HeLP procedure have no negative impact on quality of life, unlike other techniques.

The gold standard surgical technique for the hemorrhoidal disease is still Milligan-Morgan and Ferguson hemorrhoidectomies. Postoperative pain is the most significant complication of these techniques [22] But HeLP technique has possible benefits over these gold standard techniques.  First, the patient can be operated under sedoanalgesia. And, it is nearly a painless procedure because the laser shots are applied almost 2.5 cm over the dentate line where the mucosa is practically insensitive, but most of the patients describe a mild discomfort because of the anoscope. The laser shots which has a maximal effect depth of 4 mm create an insignificant injury on the mucosa and submucosa. In our cases, the pain on the sixth postoperative hour was 4.55 ± 1.32 (over 10) and 1.40 ± 1.55 (over 10) on the postoperative 7th day. We think minimal incision length/depth and insensitive characteristic of mucose above dentate line causes this comfort after surgery.

Adequate collagen bridges are needed connecting adjacent incision walls to avoid the formation of a collagen/healing tissue bands, which may lead to shrinkage of the anal canal and anal stenosis. The increased pain of anal mucosa after surgery activates internal sphincter spasms which creates a problematic cycle between pain and edema [23]. In the presented study, there was a statistically significant relationship between pain, as the edema increases the pain increases. Our cases had severe edema on postoperative day 2, but we think, the performing the HeLP procedure from a minimal incision, and since the surgical approach to anal mucosa surgery is not performed, the pain is less serious, although the edema is severe. Other advantages which have been reported that laser technology provides tissue vaporization and hemostasis, prevents thermal injury of the surrounding tissue, accelerates recovery time, has bactericidal properties and reduces postoperative pain [24,25].

The HuBble trial examined the cost-effectiveness of dearterialization procedure, and after 0ne-year follow-up, since its low recurrence rate, this procedure seems to be cost-effective in the treatment of hemorrhoidal disease [17]. Cost-effectivity is another advantage of the process as being performed without less pain and no need for general anesthesia.

Since few studies in the literature can be used in comparing the data of the present study, the retrospective nature and short follow-up period of the present study are the primary limitations.

The fact that we did not randomize patients who underwent traditional hemorrhoid surgery with the patient having HeLP procedure could be seen as a limitation of this paper, but in this paper, we aimed to evaluate only the possible benefits and characteristics of the HeLP procedure. And, although not to use of Doppler ultrasonography in the HeLP procedure seems to be another limitation of the study, there are studies in the literature showing that there is no significant statistical difference compared to used and not used Doppler ultrasonography while HeLP procedure.

Conclusion

The HeLP technique attracts attention with a high treatment success rate and provides an essential quality of life benefits like conserving the anatomy and physiology of the anal canal when compared to other traditional surgical treatment techniques. It also has a low recurrence rate and superior long-term outcome. HeLP, therefore, seems a valid therapeutic alternative for primary hemorrhoidal disease and maybe for selected repetitive cases. The benefits of this procedure cannot be underappreciated as avoiding from an impaired anal function, including fecal incontinence and different defecation disorders, which may occur following surgical treatment for the hemorrhoidal disease.

Competing interests

No conflict of interest was declared by the authors.

Funding

There is no funding related to this article.

Authors’ contributions

MFF, TK and AK, collected the information, reviewed the literature. MFF and UE wrote the manuscript. AK critically reviewed the manuscript and approved the final form. All authors read and approved the final manuscript.

References

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Editorial Information

Article Type

Research Article

Publication history

Received date: May 08, 2019
Accepted date: July 25, 2019
Published date: July 31, 2019

Copyright

© 2019 Ferhatoglu MF. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Citation

Ferhatoglu MF, Kartal A, Kıvılcım T, Ekici U, Kebudi A (2019) Laser Hemorrhoidoplasty Procedure for Grade Two and Three Hemorrhoidal Disease. A Retrospectively prospective study, analysis of forty-seven patients Membranes. OSP J Surg 1. JOS-1-101

Corresponding author

Murat Ferhat Ferhatoglu

Okan University, Faculty of Medicine, Department of General Surgery, Aydinli yolu cd. No:2 Icmeler, Tuzla, Istanbul, Turkey.
  ferhat.ferhatoglu@okan.edu.tr

E-mail : bhuvaneswari.bibleraaj@uhsm.nhs.uk

Figure 1. Application of laser, red light on the tip of the applicator is shown (Red arrow).

Table 1. Evaluation of Pain Measurements in Follow-up

 

Pain

 

Min-Max (Median)

Mean± SD

 

Postoperative sixth hour

2-8 (5)

4,55±1,32

 

Postoperative day 2

0-5 (3)

2,85±1,33

 

Postoperative day 7

0-6 (1)

1,40±1,55

 

Postoperative day 30

0-5 (0)

0,53±1,18

 

 

ap 0,001**

 

 

Bilateral comparation; bp

Postoperative sixth hour- Postoperative day 2

0,001**

 

 

Postoperative sixth hour- Postoperative day 7

0,001**

 

 

Postoperative sixth hour- Postoperative day 30

0,001**

 

 

Postoperative day 2- Postoperative day 7

0,001**

 

 

Postoperative day 2- Postoperative day 30

0,001**

 

 

Postoperative day 7- Postoperative day 30

0,001**

 

 

aFriedman Test

 

bWilcoxon Signed Ranks Test

**p<0.01

Table 2. Evaluation of Edema Level in Follow-up

   

Edema; n (%)

Min-Max (Median)

No

Minimal (1)

Mild

Severe (3)

Completely closing anal orifice (4)

0

-2

Mean± SD

n (%)

n (%)

n (%)

n (%)

n (%)

Postoperative day 2

2-4 (3)

0 (0)

0 (0)

14 (29,8)

20 (42,5)

13 (27,7)

2,98±0,77

Postoperative day 7

0-3 (2)

6 (12,8)

15 (31,9)

16 (34,0)

10 (21,3)

0 (0)

1,64±0,96

Postoperative day 30

0-2 (0)

37 (78,7)

9 (19,1)

1 (2,1)

0 (0)

0 (0)

0,23±0,48

ap

0,001**

         

Bilateral comparation; bp

Postoperative day 2- Postoperative day 7

0,001**

         

Postoperative day 2- Postoperative day 30

0,001**

         

Postoperative day 7- Postoperative day 30

0,001**

         

aFriedman Test

 

bWilcoxon Signed Ranks Test

**p<0.01