This study was a pilot study conducted to compare rubber band ligation with kshara sutra karma to treat patients of hemorrhoids, using various subjective and objective methods for comparison.
Rubber Band Ligation relies on the principle of 'Mucosal Fixation'. The mucosa and the submucosal vascular cushions are fixed to the underlying muscle coat by creating scarring after full thickness ulceration. Kashara sutra transfixation and ligation leads to strangulation of the hemorrhoidal tissue.
By virtue of its penetrating and 'Ksharan' properties, the kshara induces a sterile inflammatory response in hemorrhoidal tissue and neighboring tissue leading to scarring and mucosal fixation. Guggul, by virtue of its soothing action, prevents harm to delicate anal canal tissue by the irritant action of Kshar. Haridra by virtue of its antiseptic, varnya (wound healing) and krimighna (antimicrobial) properties promotes wound healing as well.
Since hemorrhoids is, primarily, a subjective disease presenting with a distressing symptom complex of pain, bleeding, prolapsed piles, discharge per anum, it is important that treatment is targeted at elimination of symptoms, improvement of quality of life and hence patient satisfaction. KSL scored higher on this parameter as compared to RBL. On the objective parameter of prolapse of internal hemorrhoids (treatment outcome) Group II gave better treatment outcome than group I. Since the difference in treatment outcome was insignificant statistically, we concluded that the two forms of treatment were comparable on this aspect .
In group I, all the patients underwent RBL without any anesthetic requirement. This was possible because RBL is done about 1 cm above dentate line in the base of hemorrhoids, strangulating rectal mucosa or upper anal canal mucosa, which is pain insensitive due to autonomic innervation. In group II, all the patients required local hemorrhoidal and/or pudendal block along with sedation. This facilitated Recamier's digital anal dilatation up to maximum of six fingers. Also pain sensitive external part of hemorrhoids could be dealt with as effectively as internal hemorrhoids.
In group II, statistically significantly higher pain score was observed as incorporation of external hemorrhoidal tissue within Kshar Sutra ligature caused pain after effect of local anesthesia and sedation had worn off. This pain responded well to simple analgesics like paracetamol, warm sitz bath, and ensuring that first bowel movement after ksharasutra ligation was soft and smooth. On the other hand, RBL produced less pain as RBL was done 1 cm above dentate line in pain insensitive mucosa, banding only the internal hemorrhoids.
The observed gradual control of bleeding in RBL as compared to KSL can be accounted for by the different principles of both these treatments. RBL reduces bleeding by producing mucosal fixation and submucosal fibrosis.[12
] This process of submucosal fibrosis is completed by three weeks. Therefore, proctorrhagia is controlled by the end of three weeks. KSL reduces or cures proctorrhagia by ligation and phytochemical cauterization of hemorrhoidal mass or vascular cushions at the time of operation and so cure of proctorrhagia is evident soon after KSL.
KSL is an operative technique attended to by greater postoperative pain. Higher postoperative pain combined with factors like perfusion volumes over 1000 ml, use of pentazocine, multi-pedicular hemorrhoidectomy and neurotonic susceptibility of the patient resulted in postoperative urinary complaints. However, this complication was completely prevented after first two cases by taking precautions such as encouraging immediate preoperative urination, restricting perfusion volume to not more that 500 ml, avoiding large intracanal dressings or packings, hot fomentation and warm sitz bath (between 40° and 50°C), which have been shown to induce lowering of urethral pressure and micturition,[12
] avoiding opioid analgesics in postoperative phase, and excluding patients with obstructive uropathies for KSL treatment RBL resulted in reduction of internal hemorrhoidal prolapse but not its complete cure in 2 patients. External hemorrhoidal plexus engorgement remained unchanged after RBL. Persistent internal hemorrhoidal prolapse and external hemorrhoidal plexus engorgement interfering with anal hygiene were the causes of per anal discharge. Helminthic infestation was also suspected for which deworming was done.
The average period of anal stenosis is six weeks, although it can be detected at four weeks. No incidence of anal stenosis was observed in either group in the present study. In Group II being the following precautions were taken to prevent anal stenosis, minimizing tissue dissection (in the form of semi-circular groove) thus safely preventing circumferential loss of anal canal mucosa, maintenance of normal intestinal transit by use of bulk evacuant postoperatively, regular monitoring of wound healing in order to avoid any wound stickiness, and single digital dilatation P/A starting from seventh postoperative day, until complete scarring.
In KSL, external hemorrhoidal plexus or dermal component was included in the ligature besides internal part of hemorrhoids. On the contrary, in RBL, only a part of internal hemorrhoidal tissue was included in elastic band ligature, the strangulated tissue mass being about 1 cm. Small tissue mass held in elastic ligature resulted in formation of a smaller wound by rapid sloughing off in group I as compared to group II.
Since RBL causes necrosis of only a small nub of internal pile, it was found to be ineffective in relieving or curing external hemorrhoidal plexus engorgement. KSL dealt with external hemorrhoidal plexus engorgement at the time of operation by including it in the transfixation ligature and thus resulting in its complete cure in all the patients.
In the present study, anal incontinence of any type (feces, flatus, both) was not encountered in any patient of group I and group II. Anal incontinence after KSL was prevented by taking following precautions: digital dilatation of only six (3+3) fingers was done by applying gentle, steady and continuous pressure in all directions and making circular finger movements for about 10 min,[8
] internal anal sphincter was carefully prevented from being injured or included in Kshar Sutra
ligature, sphincterotomy was not performed in any case,[13
] wide retractors like Park's retractor or Ferguson's
retractor were not used during surgery[14
] and patients with history of obstetric anal trauma and neuropathic irritable bowel syndrome were excluded from the study.
This study had some limitations including the fact that this is not randomized study as two groups were treated in two different hospitals. Ten consecutive patients fulfilling inclusion criteria were included in each group. The sample size was small, but homogeneity was maintained in terms of demographic features, clinical features of patients and the team performing procedures. Follow-up of patients could have been longer than 04 weeks, but for the limitations imposed by time period within which this study was to be completed. However, this is the first study of its kind comparing KSL for hemorrhoids with a conventional technique like RBL, albeit in a small sample of patients. Guggul has sticking property. It also has Vranashodhana, Vranaropana, Putihara, Jantughna and Vedanasthapana properties. Due to the above facts, Guggul was used in the present study in place of Snuhi latex for making Kshar Sutra. Use of Guggul-based Apamarga Kshar Sutra in treating hemorrhoids grades II and III is new.
We have also modified the technique of KSL such as gentle anal stretching and three fingers Recamier's anal dilatation instead of the more traumatic Lord's procedure to prevent injury to internal anal sphincter, minimal tissue dissection in the form of semi-circular groove on anal skin, crushing and thinning of pile mass pedicle using specially improvised pile mass crushing forceps leading to less tissue trauma and negligible blood loss during the procedure, minimal tissue dissection saving circumferential loss of anal mucosa, andtight, secure ligature as Kshar Sutra is made from linen thread. We did not rely on Kshar Sutra procured from market. Apamarga Kshar, fully equipped Kshar Sutra Cabinet and Guggul-based Apamarga Kshar Sutra were manufactured in the department itself using standard techniques. This has helped us achieve better quality of cost effective Kshar Sutras.
One Kshar Sutra from the batch was subjected to culture and sensitivity test to rule out contamination. Physicochemical analysis of one Kshar Sutra was also performed to see that pH of Kshar Sutra was within standard range (pH was 10.6).