Hetal L Nakrani¹, Tukaram Sambhaji Dudhamal^2
1 JS Ayurved Mahavidyalaya and PD Patel Ayurved Hospital, Nadiad, India
² Department of Shalya Tantra, I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar, Gujarat, India

Introduction

In the present era, due to changing lifestyle such as sedentary lifestyle, increased stress, improper dietary and sleep habits, the incidences of lifestyle disorders are increasing continuously. This also leads to constipation which is the main causative factor for Parikartika. Parikartika can be compared with fissure-in-ano which is one of the common disorder among the anorectal disorders and is painful condition. It is common entity among the people and affects a large percentage of population at least once in their life.

Acharya Sushruta has described the term “Parikartika” as a condition of anus in which cutting and burning type of pain occurs. Acharya Kashyapa has described three types of Parikartika, namely, Vataja, Pittaja, and Kaphaja.^[1] According to classic, the factors responsible for the Parikartika are similar to cause of the complications of Basti (enema) and Virechana (purgation) procedure, Arsha (haemorrhoids), Atisara (diarrhoea), and Udavarta (severe constipation).^[2],[3]

Sushruta has described a number of surgical and para-surgical procedures such as Ksharakarma (chemical cauterization), Agnikarma (thermal cauterization), and Raktamokshana (therapeutic blood letting). Among xsthem, Ksharakarma has multitherapeutic uses and has pharmacological and surgico-medicament action.

The contemporary surgical treatments such as Lord’s anal dilatation, fissurectomy, and sphincterotomy for the anal fissure are available with their own advantages and disadvantages like recurrence, incontinence or hemorrhage. These disadvantages can be overcomed by Ayurveda with the help of para surgical measures like Ksharasutra, which is well established in the management of fistula^[4], piles^[5] and chronic fissure in ano.^[6]At present, open lateral internal sphincterotomy (OLIS) is considered the gold standard treatment for chronic fissure-in-ano.^[7] Hence, in this study, evaluation of the Ksharasutra application as an important para-surgical tool by transfixation technique for surgical management of Parikartika (chronic fissure-in-ano) was planned. Ksharasutra application was compared with modern surgical process of OLIS in the management of Parikartika. OLIS is outpatient department (OPD) procedure with minimum complication. Hence, this intervention has been taken as control group. This study was planned with an aim to evaluate and compare the role of Ksharasutra ligation and OLIS in the management of Parikartika (chronic fissure-in-ano).

Materials and Methods

Selection of patients

Patients of Parikartika (chronic fissure-in-ano) having signs and symptoms like, pain in ano, bleeding per rectum and constipation, were selected from the OPD/IPD of Shalya Tantra, IPGT&RA hospital, Jamnagar irrespective of gender, occupation and religion. The registered patients were randomly allocated into two groups by computer randomization method (www.randomization.com). The study was approved by the Institutional Ethics Committee, vide letter no. PGT/7/-A/Ethics/2016-17/2675 dated 16.11.2016. The study was also registered in the Clinical Trial Registry of India, vide registration number: CTRI/2017/04/008388 retrospectively.

Diagnostic criteria

The patients were diagnosed on the basis of signs and symptoms like burning pain after defecation, dropwise bleeding after defecation, swelling at anal region.

Examination

On local examination chronic fissure with skintag and on per rectum digital examination spasm of sphincter was noted. Proctoscopy examination was done after giving suitable anaesthesia at the time of operation to exclude other anorectal pathologies such as piles, polyp, and any other growth.

Inclusion criteria

Patients of Parikartika (chronic fissure-in-ano) having chronicity more than 6 months and age between 18 years and 60 years were selected. Patients of Parikartika associated with Arsha (piles) and Bhagandara (fistula-in-ano) were also included in this study.

Exclusion criteria

Fissure-in-ano having chronicity of <6 months and patient suffering from malignancy of any organs were excluded. The patients who were suffering from acute fissure-in-ano, congenital anal stricture or carcinoma of ano-rectum were excluded from study. Positive cases of human immunodeficiency virus (HIV), venereal disease research laboratory (VDRL) and hepatitis-B were excluded. In this trial, uncontrolled cases of diabetes mellitus, uncontrolled hypertension and patients of tuberculosis were also excluded.

Laboratory investigations

Routine hemogram such as Hb%, total leukocyte count, differential leukocyte count, bleeding time, clotting time and erythrocyte sedimentation rate were done. Biochemical investigations such as fasting blood sugar, postprandial blood sugar, kidney function test (blood urea and serum creatinine) and liver function test (total serum bilirubin, serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase) were performed in all registered patients. Human immunodeficiency virus (HIV), Venereal Disease Research Laboratory (VDRL) and hepatitis-B (HBsAg), urine analysis for albumin, sugar, and microscopy was also performed. Stool examination for routine and microscopic was also done. These investigations were done only before treatment for fitness of patients for anaesthesia and surgery point of view.

Methods

Group A: Apamarga Ksharasutra application with transfixation of sentinel tag was done under suitable anesthesia.

Group B: OLIS followed by excision of sentinel tag was done under suitable anesthesia.

Operative procedure

Common preoperative procedures adopted for both the groups

Written informed consent was taken from every patient at the time of registration. Written informed consent for operation was also taken. Fitness tests, including laboratory tests and physical examination of all patients were done for anesthesia as well as surgery point of view. Injection tetanus toxoid, 0.5 ml intramuscular (IM), was given before surgery. Intradermal injection of xylocaine 2% sensitivity test was done before surgery. The patient was kept nil orally at least 6 h before surgery. Preparation of parts, i.e., shaving of perineal area, was done. Soap water enema at 10 pm at the day before surgery and proctoclysis enema at 7 am on the day of operation was given.

Procedure of Ksharasutra transfixation in Group A

The patient was taken in the lithotomy position. Painting and draping of perianal region was done. Injection xylocaine 2% with adrenaline was given for the purpose of local anaesthesia. With two fingers, anal sphincters was dilated in controlled manner. The whole fissure bed including of fibrous tissue was incised by tissue cutting scissor and fibers of internal anal sphincter were separated by blunt dissection by gauze piece from fissure bed till anoderm. After that transfixation of sentinel tag was done by Ksharasutra with the help of round body curved needle. After achieving haemostasis, ‘T’ bandage was applied and the patient was shifted to the ward in stable condition.

Procedure of open lateral internal sphincterotomy

The patient was taken in lithotomy position. Painting and draping was done. Local anesthesia was given with injection xylocaine 2% with adrenaline. Anal dilatation was done as mentioned in Group A. Intersphincteric groove was palpated with the index finger and 1 cm incision was taken at 5 O’clock at perianal skin through the intersphincteric groove. The lateral side of internal anal sphincter was dissected and a segment of it was withdrawn outside using curved artery forceps and then divided completely with electric cautery. Pressure packing was done for 5 min to reduce the chances of hematoma. The wound was left open to heal by secondary intension. The whole fissure bed including fibrous tissue and sentinel tag was excised with the help of scissor. Sterilized dressing was carried out. After hemostasis, ‘T’ bandage was applied and the patient was shifted to the ward in stable condition.

Postoperative procedures

The same procedure was adopted in both the groups. After surgery head low position was given till the complete recovery from the anesthesia. Appropriate intravenous (IV) fluids were used as per the need. Suitable antibiotic coverage was given for 5 days. Suitable analgesics were used as per the requirement. From next day of surgery onward, sitz bath with Panchawalkala decoctionmixed with warm water was advised two times a day. Avipatikara powder 5 g two times before meal with luke warm water was prescribed for soften the stool. 10 ml of Matra Basti (enema with oil) with Jatyadi oil was given once daily after sitz bath. 1 g (500mgx2) of Triphala Guggulu Vati three times a day with warm water after meal was prescribed in all patients.

Assessment criteria

Assessment was carried out on the basis of post-operative status of pain, swelling and oozing by adopting the gradation depicted in [Table 1] and overall assessment was carried out on the basis of post-operative pain, swelling, oozing and wound healing as depicted in [Table 2].

Duration of treatment and follow-up

Patients were assessed on weekly interval up to 4 weeks and thereafter, till 1 month to observe recurrence and any untoward effects of the treatment.

Statistical test

For the assessment of result by statistical analysis, the Wilcoxon signed-rank test was applied on subjective criteria like pain, swelling, oozing and wound healing in intragroup and the Mann–Whitney rank sum test was used for intergroup comparison.

Observations

Total 30 patients of fissure in ano were registered, among them 15 patients in group A and 15 patients in group B. The maximum patients belonged to 18–30 years (38.71%), male (61.29%), Hindu religion (96.77%) had Krura Koshtha (54.84%). The maximum patients reported complaint of passing hard stool (96.77%). 45.16% of patients were found to have Vatakaphaja Prakriti. The symptoms of Parikartika observed among the patients of both the groups were pain in ano in 100% (moderate 48.39%), constipation in 96.77% with irregular bowel in 60% and bleeding per rectumin 90.32% of patients (dropping type in 67.86%, mild in 64.29%, after defecation in 50% and occasional in nature in 82.14%). On local examination, 3.23% patients had unhealthy pri-anal skin and 96.77% patients had discharge from anal canal. Maximum patients (51.61%) had chronic fissure with sentinel tag at 6 O’clock position. Sphincter spasm was found in 74.19% and anal papilla was observed in 41.94% of the patients.

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