A prospective, randomize study of comparison of lateral internal sphincterotomy versus Lord’s anal dilatation in chronic anal fissure

INTRODUCTION

Chronic anal fissure (CAF) is a linear tear in the anoderm extending proximally from anal verge to the dentate line.¹ It presents as pain, bleeding during defecation and constipation and is the most commonly encountered problem in proctology.² Hard stools and internal sphincter hypertonia are some of the main etiological factors.³

Management ranges from medical to surgical, but medical applications do not achieve satisfactory results while surgical techniques have their own advantages and disadvantages.

Two widely performed surgeries include Lord’s anal dilatation (LAD) and Lateral internal sphincterotomy (LIS). LAD is one of the ancient and simple surgical techniques, but with high incidence of recurrence and incontienence.⁴ LIS is the preferred surgical technique these days, but again with high incidence of incontinence.² Aim of this study was done to compare LAD with LIS in the treatment of anal fissure with regard to symptoms, post-operative complications and recurrence.

METHODS

The study design was a prospective, randomized, single blinded trial done in department of General Surgery of a tertiary care hospital from June 2016 to May 2017. All patients with anal pain for ≥8 weeks with induration of the edges of the fissure and exposure of the fibers of the internal sphincter in the floor of the fissure with sentinel tag were defined as having CAF.⁵

Inclusion criteria

• • Age between 18-50 years.
• • Having CAF
• • Failed medical management6 (Not responded to medical management of CAF for ≥6 weeks).

Patients were randomly assigned to either group; randomization was done by computer generated random table.

Exclusion criteria

• • Patients with inflammatory bowel disease, AIDS, tuberculosis, Sexually transmitted diseases
• • Pregnancy/ Puerperium
• • Patients on anticoagulation/immunosuppression medications
• • Patients with other conditions affecting anal canal (tumours, Incontinence, abscess, fistulas, hemorrhoids, stenosis)
• • Any previous anorectal surgery
• • Obstetric trauma.
• • Critically ill or moribund patient
• • Consent not obtained

Data collection

Written informed consent was obtained in the language understood by the patient, after approval from institutional ethical committee. Patient’s particular, clinical details and examination findings were recorded on standardized proforma. Pre and post-operative pain was accessed using Wong-baker faces pain rating scale.⁷ Constipation was accessed by modified Longo score.⁸ Incontinence was accessed by scoring system reported by Wexner.⁹

Surgical procedure

Second generation cephalosporin, metronidazole and amikacin were administered before surgery as prophylactic antibiotics in stat doses. Both procedures were carried out in spinal anaesthesia with patient in lithotomy position. After cleaning of the surgical field with Povidone-iodine, draping of the field was done.

Lord’s anal dilatation

Anal dilatation was performed as described by Watts et al.¹⁰ First digital rectal examination, and proctoscopy was performed to confirm clinical findings, and to rule out other causes of bleeding. Thereafter fully lubricated index finger of right hand was introduced, and constriction band was palpated which corresponds to anorectal line. After palpating the constriction band, fully lubricated index finger of each hand was introduced in the anal canal and continuous gentle outward pressure was applied, till the constriction overcame. During this procedure hand repeatedly moved all around in order to relax all the segment. The procedure was stopped till the anal canal was relaxed enough to accept four fingers (two of each hand) at a time without much force.

Lateral internal sphincterotomy

First digital rectal examination followed by proctoscopy was done. After proctoscopy bivalve type of anal speculum was inserted, the tight distal internal sphincter was palpated as a tight band within the canal. The Intersphincteric groove, which marks the distal end of the internal sphincter, was palpated. A Vongraefe knife was introduced through the perianal skin at the left lateral aspect of the canal sandwiched parallel between the anoderm and the internal sphincter, when the tip reached the dentate line, the blade was turned outwards and the internal sphincter muscle divided with the blade till the give way feeling was appreciated, this give marked that fibers had been divided, and this ends the sphincterotomy, thereafter the blade was removed, and gentle pressure was applied to control bleeding. Skin tag was removed if any.

Post-operative management

Post-operatively patient was given oral second-generation cephalosporin and metronidazole and discharged on same for one week. Injectables NSAIDs were administered the following evening and oral NSAIDs were started from the next day.

Patients resumed eating after four hours of surgery. Sitz bath and laxatives were advised from the first post-operative day and continued for one week.

Patients were discharged on third post-operative day, and any delay along with reason for the same, was noted. Patients were followed up to assess any complications of the procedure (pain, incontinence, abscess formation, hematoma, recurrence) initially in surgical OPD on weekly basis for four consecutive weeks. They were subsequently followed up monthly, telephonically and examined, if required in subsequent OPD in the third month and six months respectively.

Statistical analysis

Data were entered into MS-EXCEL 2010 spread sheet and analyzed using statistical software SPSS 20.

RESULTS

Majority of the population consisted of male (65%), with male to female ratio 1.7:1. The mean age of the entire study population was 42.13±12.32 years with mean age of men being 38.42±12.32 years and of women 40.12±11.33 years.

Pre-operative findings

Patients had complaints of pain, bleeding per rectum, constipation and itching on presentation. Pain was the most common presenting complaint and was present in 96% of patients. On Wong bakers faces pain score 71% had grade IV and 29% had grade V pain score on presentation. Bleeding per rectum was second most presenting complaints in 83% patients. Average Modified Longo score for constipation was 15 (10-18) in pre-operative period. In 31% cases, itching was associated with one or two of the above complaints, but not as a sole complaint. No patient was incontinent in pre-operative period.

On examination sentinel tag was present in all the cases out of which 93% was posterior (6 o’clock), 5% anterior (12 o clock) and multiple in 2% cases.

Post-operative findings

Post-operative complaints were pain, bleeding per rectum, mucous discharge and incontinence. A comparison between pain scores at different points of evaluation is shown in Table 1. Maximum pain score at 24 hours of operation was seen in significantly less numbers of patients in the LIS group compared to LAD group (p value-0.0118, or 5.5045, 95% CI- 1.4598-20.7557). However, there was no significant difference in the pain score between the two groups when evaluated subsequently i.e. before discharge, 1 month, 3 month and 6 months (p value- 0.1388, 0.6176, 0.4655) respectively.

n= Number of patients with the maximum pain score in LAD group (n1*) and LIS group (n2**)

A comparison between the number of patients having bleeding per rectum, post operatively, is shown in Table 2. Thirty-seven patients (74%) in LAD and 41 (82%) in LIS group observed bleeding in first 24 hours post operatively, which was clinically not bothering and subsided in subsequent days and were not found to be statistically significant (p value 0.3364) (Table 2).

Mucous discharge was present in 7 patients (14%) of LAD group, which resolved in due course within weeks, but persisted in 2 patients (4%) for one month; whereas in LIS group it was present in 3 patients (6%), which persisted for one month in only one patient (2%). In both the cases difference was statistically not significant at the time of discharge and after one month of treatment p value being 0.1945 and 0.5653 respectively.

In both group, no patient had complete incontinence at any point of time, but 4 patient had incontinence for liquid and for gas in LAD group, only for 3-4 days, while in LIS group 3 patient had such complaints which also persisted for 3-4 days. No intervention was required for this complaint in any group.

Post-operative hospital stay in LAD group is comparable to LIS group i.e. mean 3.4±0.6701 days (minimum 3 days and maximum 5 days) and mean 3.5 days (minimum 3 and maximum 5 days) respectively.

Follow-up

After three months of treatment complete healing was observed in 48 patients and incomplete in rest of the two patients in LAD group, whereas in LIS group complete healing was observed in 49 patients and incomplete in one patient. The difference in wound healing was statistically not significant (p value 0.565, or 2.0417, 95% CI 0.1792-23.2672).

Recurrence was observed in 2 patients (4%) in LAD group, whereas in 1 patient (2%) in LIS group. This again was statistically insignificant (p value 0.5653).

DISCUSSION

LAD had similar post-operative symptoms, complications and recurrence rate, when compared with LIS, in this study. The ratio of male and female (1.7:1) in this study is comparable to other studies as of Nahas et al (2.3: 1) and Gupta V et al (1.4: 1).^6,11

In this study pain was main presenting complaint, followed by associated bleeding per rectum and constipation, this was in accordance to results by Mapel et al.¹²

On examination posterior anal fissure (6 O’ Clock) was most common finding, followed by anterior (12 O’ Clock) and mixed. These observations were in accordance with observations of previous studies.^6,13-17

In this study, pain score in first 24 hours was significantly higher in LAD group as compared to LIS group reason might be due to inter-individual difference in the application of force in anal dilatation, intra-operatively.⁴ This difference was negated in subsequent days and difference at the time of discharge was non-significant.

Incontinence is one of the complications of surgeries around anal canal. In this study also, author had such incidences but were temporary and subsided in due course of time. At the end of three months complete healing occurred in 96-98% cases in both the group which were in accordance to other studies conducted Gupta V et al.^6,11 Recurrence rate in this study was 2-4%, although it was statistically insignificant, but still higher in LAD group (OR:2.0417) which was in accordance to Arroyo et al.^10,18

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

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