Laser Therapy in Perianal Fistulas

Abstract

(1) Background: Perianal fistula represents a chronic local suppuration, and recurrent or incorrectly treated, this pathology has a negative effect on the life of patients. (2) Methods: A 12-month prospective study was conducted with a study group (patients at the second presentation) and a control group (patients at the first presentation). The BTL-6000 brand laser has 50 times the maximum power of conventional laser devices with an unmatched wavelength of 1064 nm and a tissue penetration power of up to 10 cm. It is highly effective in speeding up healing and pain management (3) Results: Transcutaneous high-intensity laser therapy of perianal fistulas proved effective with a promising positive impact on both symptomatology and local signs in the study group. As for the patients in the control group, 37 of them required a second hospitalization due to the recurrence of symptoms and to whom the same laser therapy was applied. (4) Conclusions: A beneficial and positive effect was observed in our study, mainly on the symptoms determined by the appearance of the perianal fistula, both in the short- and long-term. High-frequency laser therapy is of major importance, considering the lower costs compared to surgery as well as the discomfort created during local treatments.

1. Introduction

One of the most well-known gastrointestinal diseases is the perianal fistula. Perianal fistula is a local chronic suppuration and contains a fistulous path which forms when a chronic process becomes acute at the anal region, which can be recurrent or treated incorrectly [1,2]. Therefore, this is not a disease on its own but an evolutionary complication of a perianal abscess or phlegmon. The term ‘fistula’ is a non-anatomical communication between two epithelial surfaces, which is usually straight, but the perianal fistula has a sinuous path—thus, spontaneous drainage is almost never possible [2].

The main reason a patient with an anal fistula is seeking medical help is the persistent purulent discharge at the anal level, which stains the lingerie. This pathology has a negative effect on the patient’s life and mostly on sexual activity as the patient is inhibited by the suppurations from the fistula. The anal fistula has a chronic evolution, being the most common form of perianal sepsis. The diagnosis is based on the careful physical examination of the local area and also on paraclinical examinations, such as fistulography or even anoscopy using instillations of blue methylene [3,4]. The treatment of perianal fistula is dependent on the location of its path. The objective of the treatment is to eradicate the infection and prevent the deterioration of the sphincter muscle, which can lead to fecal incontinence. At the present time, surgery is the only definitive treatment, with the main goal being the complete cure of anal fistulas. However, the success of the intervention is influenced by some factors, one of them being the experience of the surgeon [5]. It is of great importance to evaluate and study new procedures that aid the surgeon and primarily the easiest ways for the patient to recover from invasive and also non-invasive methods [6].

The laser treatment uses infrared light on the damaged areas. The goal is to aid the healing of the soft tissues, which improves acute and chronic conditions [7,8]. The High-Intensity Laser stimulates microcirculation in the local area and aids lymphatic drainage in the affected zone. By combining bio-stimulation with photo-mechanic stimulation, the laser treatment cures the tissue and offers a strong and non-dependent form of pain management at the same time. Thus, the High-Intensity Laser System offers a powerful and efficient treatment for a large range of clinical indications [9].

This research aims to provide information on the healing process of the laser treatment application on wounds.

2. Materials and Methods

2.1. Aim of the Study

This study aims to demonstrate that this laser therapy approach offers an advantage in terms of reduced discomfort created during therapy as well as post-therapy complications. The study is an observational, longitudinal case study wherein we collected data from the control and study groups on the 5th and the 7th days after treatment.

2.2. Materials

The outlook study was conducted during a 12-month period, from 1 June 2020 to 1 June 2021. Of the 100 patients, 50 were on their second time seeking medical help and were included in the study group, and 50 were on their first time and were included in the control group. The patients were admitted to the CF Oradea Clinical Hospital with the diagnosis of an anorectal fistula. The patients included were between 32 and 58 years old. This study was approved by the local ethical committee of the institution in which the study was conducted. The brand of the laser used was BTL-6000 (Figure 1A) with a 12 watts laser probe using a program that emits 1064 nm with a penetration power of the tissue at nearly 10 cm [10].

2.3. Methods

Patients in the control and study groups were given conservative treatment consisting of anti-analgesic treatment and broad-spectrum antibiotics until the result of the antibiogram, after which targeted antibiotic therapy and local treatments were applied. For the study group patients, laser treatment was also applied in addition to the aforementioned treatments.

The high-intensity laser treatment was applied to the external orifice of the fistula and transcutaneously following the fistula’s path (Figure 1B). Local laser treatment was performed after a preliminary preparation with antiseptic solutions of the fistulous path for 7 days straight (Figure 1C–E). Both short- and long-term (3–6 months after treatment) results were evaluated. Pain scale, local complications, defecation discomfort and the time to return to daily activities were also evaluated on these patients. Patients had to complete questionnaires both on admission day and daily after the surgery was performed; In this way, their local discomfort and general wellbeing were evaluated. We also introduced the numerical scales to highlight the subjective evolution and impact of the high-intensity laser on the patient. The evolution questionnaire included frequent signs and symptoms of the illness, such as local pain and perianal discomfort during defecation, pathological drainages and the discomfort made by the laser treatment.

Inclusion criteria for these two groups were: For the study group, patients with a history of surgical examination for this illness, which was separate from the patients with the first surgical examination, who were included in the control group. The exclusion criteria were ages under 30 and over 60 and complex path fistulas.

Based on the knowledge gathered from interpreting the data, we can conclude that there are patients who developed this illness long before going to see a doctor because of the ‘embarrassing’ location of it, which is a drawback for the patient as it leads to the delay of treatment approaches as well as starting early conservative treatment. The selected patients previously received a local treatment, local cleaning and lavage of the fistula’s path with antiseptic solutions, and medical treatment with antibiotics. The evolution was favorable in the short term, but they came back with the same symptoms.

3. Results

3.1. Characteristics of the Population (Age, Sex and Environment)

Of a total of fifty patients that entered the study, 39 were men (78%), and 11 were women (22%). For environmental characteristics, 37 patients were from urban areas, while only 13 were from rural areas. The analyzed sample was formed equally from two lots: 50 being treated patients and 50 being the control group, so the total size of the sample was 100 patients. In terms of the sexes, the control group consisted of 44% women and 56% men, while the study group consisted of 22% women and 78% men. At the same time, 30% of the control group came from rural areas and 70% from urban areas, similar to the study group with 26% from rural and 74% from urban area provenances.

The average age of the control group was 42.68 years old, with a deviation of 8.42 and a median of 41 (aged between 27 and 55 years old). The average age of the patients treated with laser was 40.2 years, with a 7.45 deviation and a median of 39 (aged between 28 and 50 years old). The differences between these two groups were statistically insignificant (

Table 1. Characteristics of the population.

Baseline Characteristics of the Study and Control Groups	Study Group MD ± DS		Control Group MD ± DS		p-Value
Age (years)	40.2 ± 7.45		42.68 ± 8.42		<0.00001
Sex		Percentage (%)		Percentage (%)	0.261
Women	11	22	22	44
Men	39	78	28	56
Environment					0.423
Urban	37	26	13	70
Rural	13	74	15	30

).

In the first stage, these two lots were analyzed and compared to see the differences over a period of time. The results show significant differences in local pain on the 7th day, discomfort during defecation on the 3rd day, perianal discomfort on the 5th and 7th days, local suppuration at the end of treatment compared with the beginning and reported general wellbeing compared with admission day.

3.2. Impact of Laser Therapy on Suppurations in the Fistula

The statistical 95% confidence interval value was 12.98, and the β coefficient with standard error (SE) was −1. From the graph, we can see the increase in the number of patients in whom the fistula disappears. The laser treatment proved to be effective and statistically significant (p < 0.001), Figure 2.

Local pain was present in only 17 patients with a perianal fistula on admission day. On the numerical scale of the questionnaire, this was evaluated with patients rating pain from 1 to 10, with 1 meaning the absence of pain and 10 meaning high-intensity pain that needed painkiller medicine. Only two patients gave 10 points on admission day; later on, after the laser treatment, they no longer needed painkillers by the 3rd day. On the 4th day of treatment, eleven of the other patients gave 2 points on the numerical scale; these same patients gave 3, 5 and 6 points on admission day. The last four patients gave 2 points on admission, meaning that the pain was almost nonexistent. On the 7th day (discharge day), these four patients mentioned that they had no local pain. The decrease in local pain was significant (p < 0.001). In conclusion, we can easily observe the positive painkilling impact of high-intensity laser treatment (Figure 3).

3.3. The Discomfort Created by the Laser Treatment

The local burning sensation was present in every patient at the moment of admission, persisting throughout the 5th day, when amelioration on the skin level was observed. On discharge day, only 20 patients had evidenced remission of major local burning sensation. At the 3-week medical check-up, this burning sensation disappeared in six of these patients, and in twelve patients, there was a slight observable coloration of the skin and the persistence of the burning sensation in others. At the 3-month check-up, the perifistular burning sensation could be seen in five patients, and at the 6-month follow-up, it disappeared, with the exception of two cases in which the fistula reappeared (Figure 4). The decrease in the perifistular burning sensation was significant (p > 0.05).

The high-intensity laser treatment of the perianal fistulas, in all 50 cases, was proven to be efficient with a positive and promising impact both on the local signs and symptoms and also on the persistence of the external orifice of the fistula. This was evident given the fact that 44 out of 50 patients’ check-ups were made every three weeks, and after twelve weeks, they did not need the fifth check-up anymore due to the fact that they had favorable evolution post-treatment, or they went to another medical center for diagnosis and treatment. As we mentioned earlier, two of the women needed readmission into the hospital, and the laser treatment was repeated. Regarding the control group, 37 of them needed a second admission to the hospital after six months of check-ups due to the recurrence of the fistula, to which we applied the same laser treatment mentioned in the previously presented study. Thirteen patients did not show up at their regular check-ups, probably because of the absence of the recurrence of the symptoms, or maybe they presented to another medical facility.

3.4. Statistical Analyses

Through repeated-measures ANOVA and testing the assumption of sphericity, we analyzed data from our study, where the requirement was to assess the effect of the passage of time after laser treatment on the control and study groups.

The test results shown in the Within-Groups Effects table show us where there was an overall significant difference between the means at the different time points.

The test results shown in the Between-Groups Effects table show us the differences in conditions that occur between the groups of subjects.

In

Table 2. Within-Group Effects (repeated measures or intra-group effects).

Measure: Day
Source		Type III Sum of Squares	df	Mean Squared	F	Sig.
Day	Sphericity assumed	27.525	3	9.175	7.783	0.000
	Greenhouse–Geisser	27.525	2.055	13.392	7.783	0.001
	Huynh–Feldt	27.525	2.288	12.029	7.783	0.000
	Lower-bound	27.525	1.000	27.525	7.783	0.006
Day × Age	Sphericity assumed	3.167	3	1.056	0.895	0.444
	Greenhouse–Geisser	3.167	2.055	1.541	0.895	0.413
	Huynh–Feldt	3.167	2.288	1.384	0.895	0.422
	Lower-bound	3.167	1.000	3.167	0.895	0.347
Day × Sex	Sphericity assumed	3.858	3	1.286	1.091	0.353
	Greenhouse–Geisser	3.858	2.055	1.877	1.091	0.339
	Huynh–Feldt	3.858	2.288	1.686	1.091	0.344
	Lower-bound	3.858	1.000	3.858	1.091	0.299
Day × Environmental Provenance	Sphericity assumed	9.513	3	3.171	2.690	0.047
	Greenhouse–Geisser	9.513	2.055	4.628	2.690	0.069
	Huynh–Feldt	9.513	2.288	4.157	2.690	0.063
	Lower-bound	9.513	1.000	9.513	2.690	0.104
Environmental Provenance	Sphericity assumed	6.211	3	2.070	1.756	0.156
	Greenhouse–Geisser	6.211	2.055	3.022	1.756	0.175
	Huynh–Feldt	6.211	2.288	2.714	1.756	0.170
	Lower-bound	6.211	1.000	6.211	1.756	0.188
Day × Sex × Environmental Provenance	Sphericity assumed	3.148	3	1.049	0.890	0.447
	Greenhouse–Geisser	3.148	2.055	1.532	0.890	0.415
	Huynh–Feldt	3.148	2.288	1.376	0.890	0.424
	Lower-bound	3.148	1.000	3.148	0.890	0.348
Day × Sex	Sphericity assumed	0.654	3	0.218	0.185	0.907
	Greenhouse–Geisser	0.654	2.055	0.318	0.185	0.837
	Huynh–Feldt	0.654	2.288	0.286	0.185	0.859
	Lower-bound	0.654	1.000	0.654	0.185	0.668
Day × Environmental Provenance	Sphericity assumed	2.139	3	0.713	0.605	0.612
	Greenhouse–Geisser	2.139	2.055	1.041	0.605	0.552
	Huynh–Feldt	2.139	2.288	0.935	0.605	0.569
	Lower-bound	2.139	1.000	2.139	0.605	0.439
Day × Sex × Environmental Provenance	Sphericity assumed	4.385	3	1.462	1.240	0.296
	Greenhouse–Geisser	4.385	2.055	2.133	1.240	0.292
	Huynh–Feldt	4.385	2.288	1.916	1.240	0.294
	Lower-bound	4.385	1.000	4.385	1.240	0.268
Error (Day)	Sphericity assumed	321.836	273	1.179
	Greenhouse–Geisser	321.836	187.034	1.721
	Huynh–Feldt	321.836	208.235	1.546
	Lower-bound	321.836	91.000	3.537

, significant changes are observed in the local pain scores within the groups. Significant changes in local pain scores were observed only with the passage of time (day). No changes were observed related to the rest of the parameters.

Regarding the effects between groups, significant changes in local pain scores given can be observed between groups across the passage of time, as well as a significant interaction between sex and the environment of origin (

Table 3. Between-Group Effects.

Measure: Day
Transformed Variable: Average
Source	Type III Sum of Squares	df	Mean Squared	F	Sig.
Intercept	75.077	1	75.077	11.252	0.001
Age	25.021	1	25.021	3.750	0.056
Sex	17.664	1	17.664	2.647	0.107
Environmental Provenance	1.765	1	1.765	0.265	0.608
Groups	33.031	1	33.031	4.951	0.029
Sex × Environmental Provenance	26.957	1	26.957	4.040	0.047
Sex	7.522	1	7.522	1.127	0.291
Environmental Provenance	18.960	1	18.960	2.842	0.095
Sex × Environmental Provenance	0.178	1	0.178	0.027	0.871
Error	607.153	91	6.672

).

Table 4. Descriptive statistics on the control and study groups.

		N	Minimum	Maximum
Local pain on day 0	Control group	50	2	10
	Study group	50	2	10
	Total	100	2	10
Local pain on day 3	Control group	50	2	9
	Study group	50	2	8
	Total	100	2	9
Local pain on day 5	Control group	50	0	7
	Study group	50	0	5
	Total	100	0	7
Local pain on day 5	Control group	50	0	5
	Study group	50	0	3
	Total	100	0	5
Discomfort in defecation on day 0	Control group	50	5	5
	Study group	50	5	5
	Total	100	5	5
Discomfort in defecation on day 3	Control group	50	2	5
	Study group	50	2	5
	Total	100	2	5
Discomfort in defecation on day 5	Control group	50	2	4
	Study group	50	2	4
	Total	100	2	4
Discomfort in defecation on day 7	Control group	50	1	4
	Study group	50	1	3
	Total	100	1	4
Local suppuration on day 0/7	Control group	50	1	2
	Study group	50	1	2
	Total	100	1	2
General condition reported on the day of admission vs. day 3	Control group	50	2	3
	Study group	50	2	3
	Total	100	2	3
General condition reported on the day of admission vs. day 5	Control group	50	2	3
	Study group	50	2	3
	Total	100	2	3
General condition reported on the day of admission vs. day 7	Control group	50	2	4
	Study group	50	3	4
	Total	100	2	4
Perianal discomfort on day 0	Control group	50	2	5
	Study group	50	2	5
	Total	100	2	5
Perianal discomfort on day 3	Control group	50	2	5
	Study group	50	3	5
	Total	100	2	5
Perianal discomfort on day 5	Control group	50	1	4
	Study group	50	2	5
	Total	100	1	5
Perianal discomfort on day 7	Control group	50	0	4
	Study group	50	0	5
	Total	100	0	5

shows that, regardless of the sample or group on which the comparisons were made, there are significant differences in local pain scores between the measurements at various times for ratings of 10 from day zero to five and 2 on day seven.

In the case of local suppuration, 24 of the controls (48%) did not have suppuration on day seven, while the remaining 52% did. Most patients did not have suppurations on the seventh day (74%), and only a small percentage (26%) still presented suppurations on the seventh day.

Regarding the long-term effect of the applied treatment on the two lots at three and six months from discharge, a beneficial effect was observed in the patients from the study group; However, 22 of these patients presented with the reoccurrence of the fistula and symptoms after six months, compared to the control group where 37 patients returned with the same problems. Although reoccurrence is present in most patients, we can observe the beneficial effects of this treatment since the number of reoccurrences in those with the laser treatment was much lower than in the controls.

4. Discussion

Anal fistulas continue to be a problem for patients and surgeons, despite scientific advances [1,7]. New biological products, cell-based treatments, endoscopy and surgical techniques have been introduced, which raises the hope that results can be improved [8,9]. The treatment for fistulas changed over the years from surgical management to multidisciplinary management when it comes to gastroenterologists’ approach to inflammatory bowel disease or other specialties, such as radiology or surgery [10,11,12].

We attempted to evaluate the patients with the mentioned diseases with the aim of reducing surgical interventions. However, in some cases, the persistence of unwanted complications, such as urinary incontinence, which can, of course, be bothersome for the patients and badly influence their daily lives [8,9].

Following one year, the healing rate of the fistulas was 50% for the 1-step surgical treatment and 60% for the 2-step surgical treatment (drainage plus medical treatment and then surgical intervention in the 2nd stage with curative intention). In general, 19.2% of the patients developed postoperative fecal incontinence [2].

In our study, we observed a 56% healing rate without surgical treatment due to the fact that only 28 patients returned for the 12-month medical check-up, probably because of either healing, going to another medical center, or personal reasons. Of the 28 patients who had local stimulation treatment, neither presented fecal incontinence compared with surgical treatment outcomes [13,14,15].

Transcutaneous laser therapy is a new technique that has an excellent success rate, thus avoiding surgical intervention [16]. To reduce possible postoperative complications, such as discomfort created by the initial treatment used, we chose the laser treatment approach, wherein we observed an advantage regarding the discomfort created during the execution of this intervention and also fewer postoperative complications [17,18,19].

The study showed that the male sex is predominant in this disease; Specifically, 78% in our study are male, and only 22% are female. In our study’s time frame, the predominant environment of origin was urban (74%) and fewer were from rural areas (26%), probably because of sedentariness. The main symptom, discomfort in defecation, was always present when the patient was admitted to the hospital; thus, in these conditions, we can say that 100% of people had it on the first day. On the third 3rd postoperative day, this symptom was present in 72% of the patients, and on the sixth post-treatment day, only 24% still reported discomfort.

A positive impact was also observed on the perianal suppurations with a considerably reduced number of cases. On admission to the hospital, 100% of patients had pathological secretions on the fistula’s external orifice, but on the seventh day after the laser treatment, only 13 patients still had suppurations. A positive impact was also obtained in perianal discomfort and local pain on the last day of treatment, where only one person still mentioned the discomfort. The biggest influence was tracked in the case of local pain, where the pain disappeared on the third and fourth days post-local laser stimulation.

Depending on the type and extension of the fistula, the surgical approach can vary from simple drainage to more complex techniques and should always be combined with medical therapy [20,21]. Our study shows the benefits and positive effects of transcutaneous laser therapy in perianal fistulas, especially regarding the symptoms and healing of the perianal fistula both in the short- and long-term (up to 12 months) [22,23].

The laser treatment was also effective in reducing the post-treatment complications over a period from 3 to 12 months, compared with some studies on the surgical treatment of the fistula, obtaining a healing rate of 56% without surgical intervention compared with the estimated percent of 50 to 60% with diverse surgical techniques [24,25].

5. Conclusions

Transcutaneous laser therapy in perianal fistulas is a new, efficient method that ensures increased psychological comfort for patients versus previously or minimally invasive surgical methods. We consider that this therapy is of major importance with respect to the reduced costs to which both the patient and the medical unit are subjected. The discomfort created by laser therapy is zero after 6 days of treatment, which increases the quality of life compared with the condition of patients who underwent the surgical method. The effectiveness of the method can be seen in our study with the improvement of symptoms during treatment as well as the disappearance of symptoms both in the immediate post-therapy period and in the long term.