A Study of effectiveness of Glyceryl Trinitrate Ointment versus Surgical Management of patients with Chronic Anal Fissure at tertiary health care center

 

Sanjay Prabu Warad¹, Shirish Maskepatil^2*

 

Abstract              Background: Anal fissure consists essentially of crack in the skin-lined part of anal canal which often shows a considerable reluctance to heal Aims and Objectives: To Study effectiveness of Glyceryl Trinitrate Ointment versus Surgical Management of patients with Chronic Anal Fissure at tertiary health care center. Methodology: This was a cross-sectional study carried out in the patients of Anal fissure in the department of Surgery at tertiary health care centre during the one year period i.e. January 2017 to January 2018. In the one year period there were 70 patients with Anal fissure diagnosed clinically were with the written and explained consent were included into study. Out of the 70 patients 35 patients enrolled to Group A - treated with local glyceryl trinitrate ointment 0.2% (liposomal base) applied twice daily for 6 weeks and Group B included 35 patients managed by lateral internal sphincterotomy. All patients were treated by using a uniform method in the lithotomy position with the same technique of sphincterotomy. Statistical analysis was Chi-square test, unpaired t-test analyzed by SPSS 19 version software. Result: In our study we have seen that the average Age in Group A was 48±1.92 yrs. and 48±1.92 yrs. in Group B was comparable (p>0.05; t=1.56; df=68). The sex ratio in Group A was 1.05 and 1.50 was comparable (p>0.05, X2=0.92, df=1). The Bleeding during Procedure in Group A was 5 ± 3.52ml and 48 ±3.12 ml was significantly higher in Group B (P< 0.0001 ; t =52.12 ;df=68); Time to first bowel movement (hr) was 15±3.25 hrs and 28±4.12 hrs (P<0.001; t = 11.82;df=68); Average hospital stay (Days)-1.5 ±1.23 days, 3.52± 2.12 days (P<0.001; t= 13.12, df=68); Pain after 24 hrs. of procedure (VAS Score) was 3± 2.43 and 6±3.45 (P<0.0001;t=21.23 ;df=68); Average Wound healing time (Days)- 19±2.92 days and 32±4.34 days (P<0.001;t=23.15 ,df=68) respectively higher in Group B as compared to Group A. The various complications were Retention of Urine - 0% ,11.43%; Bleeding-2.86%, 14.29%; Incontinence of flatus -2.86%, 20.00%; Recurrence- 8.57%, 14.29%; Perianal abscess -0.00%, 8.57%; Anal stenosis - 0.00%, 11.43% respectively in Group A and Group B. Over all the complications were common were very common in Group B as compared to Group A (Z=2.41, p<0.01) Conclusion: It can be concluded from our study that Glyceryl Trinitrate treatment group was superior as compared to Surgical method with respect to less Procedural bleeding, less time for the first bowel movement with less analgesic were better in Glyceryl Trinitrate treatment group and overall complications were less in Glyceryl Trinitrate treatment group compared to conventional surgical sphincterotomy group .

Key Word: Glyceryl Trinitrate Ointment, Chronic Anal Fissure, Sphincterotomy group

 

INTRODUCTION

Anal fissure consists essentially of crack in the skin-lined part of anal canal which often shows a considerable reluctance to heal¹. Chronic anal fissure (CAF) is common perineal condition and well known painful entity. Standard surgical treatment even though is not expensive may require long hospital stay and sometimes have worrying complications like anal incontinence. So non surgical treatment for this ailment is much needed². Following the recent demonstration of nitric oxide as most important biological mediator of recto anal inhibitory reflex, it has been shown that topical application of nitric oxide donor, such as Glyceryl Trinitrate can lower the sphincter pressure and heal anal fissure. Glyceryl Trinitrate has been shown to be an effective treatment for chronic anal fissure. It decreases anal tone and ultimately heals the anal fissure^1,2. Glyceryl Trinitrate is a cost effective first line treatment strategy for the management of chronic anal fissure³. The commonly accepted definition of anal fissure is: ‘‘A linear ulcer of the anoderm, distal to the dentate line, generally located in the posterior midline’’^4,8. Anal fissure is very painful, because it affects the multilayer squamous epithelium of the anoderm, which is richly innervated with pain fibers. During defecation, the lesion is stretched with consequent painful symptomatology, which can persist for a certain amount of time⁹ and be accompanied by slight bleeding. The pain can be so intense as to induce the patient to avoid defecation with consequent hardening of the feces and exacerbation of the problem^{4, 9}. So we have studied effectiveness of Glyceryl Trinitrate Ointment versus Surgical Management of patients with Chronic Anal Fissure at tertiary health care center.

 

METHODOLOGY

This was a cross-sectional study carried out in the patients of Anal fissure in the department of Surgery at tertiary health care centre during the one year period i.e. January 2017 to January 2018. In the one year period there were 70 patients with Anal fissure diagnosed clinically were with the written and explained consent were included into study. Out of the 70 patients 35 patients enrolled to Group A - treated with local glyceryl trinitrate ointment 0.2% (liposomal base) applied twice daily for 6 weeks and Group B included 35 patients managed by lateral internal sphincterotomy. All patients were treated by the same surgeons using a uniform method in the lithotomy position with the same technique of sphincterotomy. Statistical analysis was Chi-square test, unpaired t-test analyzed by SPSS 19 version software.

(Z=2.41, p<0.01) The various complications were Retention of Urine - 0%, 11.43%; Bleeding-2.86%, 14.29%; Incontinence of flatus -2.86%, 20.00%; Recurrence- 8.57%, 14.29%; Perianal abscess -0.00%, 8.57%; Anal stenosis - 0.00%, 11.43% respectively in Group A and Group B. Over all the complications were common were very common in Group B as compared to Group A (Z=2.41, p<0.01)

 

DISCUSSION

Improving diet and defecation habits is a good long-term strategy for reducing gastrointestinal problems. Therefore, patients with primary chronic anal fissures are advised to assume liquids and fiber supplements as well as bulk-forming emollient laxatives and to use warm sitz baths. The amount of fiber should be increased gradually to avoid problems of flatulence. These simple measures are able to reduce the pain and should be recommended to all patients. If bulk-forming laxatives are not sufficient, osmotic laxatives can be tried. To reduce the pain, local anesthetics can be used as additional measures but only for short periods of time due to the risk of skin sensitization^{10, 11, 12}. It is important to emphasize that, in the case of acute anal fissures, conservative treatment can provide a cure in 87% of the cases, while in chronic forms this figure is 50%^13–15 A small lump or skin tag on the skin near the anal fissure (more common when chronic). Treatment includes a high-fibre diet and over-the-counter fibre supplements (25-35 grams of fibre/day) to make stools soft, formed, and bulky Over-the-counter stool softeners to make stools easier to pass. Drinking more water to help prevent hard stools and aid in healing. Warm tub baths (sitz baths) for 10 to 20 minutes, a few times per day (especially after bowel movements to soothe the area and help relax anal sphincter muscles). This is thought to help the healing process. Medications, such as lidocaine, that can be applied to the skin around the anus for pain relief. Medications such as diltiazam, nifedipine, or nitroglycerin ointment to relax the anal sphincter muscles which helps the healing process. Narcotic pain medications are avoided because they can cause constipation which could make the situation worse. Although most anal fissures do not require surgery, chronic fissures are harder to treat and surgery may be the best option. The goal of surgery is to help the anal sphincter muscle relax which reduces pain and spasms, allowing the fissure to heal. Surgical options include Botulinum toxin (Botox®) injection into the anal sphincter or surgical division of an inner part of the anal sphincter (lateral internal sphincterotomy) ¹⁶. Your colon and rectal surgeon will find the best treatment for you and discuss the risks of surgery. Both types of surgery are typically done as same-day outpatient procedures. Glyceryl trinitrate lowers the sphincter pressure and heals the anal fissure¹⁷.In our study we have seen that the average Age in Group A was 48±1.92 yrs. and 48±1.92 yrs. in Group B was comparable (p>0.05; t=1.56; df=68). The sex ratio in Group A was 1.05 and 1.50 was comparable (p>0.05, X²=0.92, df=1). The Bleeding during Procedure in Group A was 5 ± 3.52ml and 48 ±3.12 ml was significantly higher in Group B (P< 0.0001; t =52.12 ;df=68); Time to first bowel movement (hr) was 15±3.25 hrs and 28±4.12 hrs (P<0.001; t = 11.82;df=68); Average hospital stay (Days)-1.5 ±1.23 days , 3.52± 2.12 days (P<0.001; t=13.12 , df=68); Pain after 24 hrs. of procedure (VAS Score) was 3± 2.43 and 6±3.45 (P<0.0001;t=21.23 ;df=68); Average Wound healing time (Days)- 19±2.92 days and 32±4.34 days (P<0.001;t=23.15 ,df=68) respectively higher in Group B as compared to Group A The various complications were Retention of Urine -0% , 11.43%; Bleeding-2.86%, 14.29%; Incontinence of flatus -2.86%, 20.00%; Recurrence- 8.57%, 14.29%; Perianal abscess -0.00%, 8.57%; Anal stenosis - 0.00%, 11.43% respectively in Group A and Group B. Over all the complications were common were very common in Group B as compared to Group A (Z=2.41, p<0.01) These findings are similar to Awais Ghori et al¹⁸ they found the mean duration of symptoms Constipation was present in 27 patients i.e. 67% in glyceryl trinitrate (Group A) ointment and it was present in 31 patients i.e. 77% in Sphincterotomy group(Group B) . The VAS score in both the groups decreased gradually but the decrease was more in group B compared to group A at the end of 7th week which was statistically significant (p<0.05). At the end of the 1st week, none of the patients were healed completely. But at the end of the 4th, in group A, only 14 patients were completely healed, 38 patients were completely healed in group B. At the end of the 7th week, all patients in group B were healed i.e. 100% were healed and in group A, 32 patients were healed completely.

 

CONCLUSION

It can be concluded from our study that Glyceryl Trinitrate treatment group was superior as compared to Surgical method with respect to less Procedural bleeding, less time for the first bowel movement with less analgesic were better in Glyceryl Trinitrate treatment group and overall complications were less in Glyceryl Trinitrate treatment group compared to conventional surgical sphincterotomy group.

 

 

REFERENCES

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