The efficacy of endoscopic sphincterotomy after cholecystectomy in patients with sphincter-of-Oddi dysfunction. Manometry based randomised trial of endoscopic sphincterotomy for sphincter of Oddi dysfunction. Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function? Unilateral versus bilateral lateral internal sphincterotomy: a randomized controlled trial for chronic fissure in ano. Anal sphincter function after treatment of fissure-in-ano by lateral subcutaneous sphincterotomy versus anal dilatation. A randomized study. Open versus closed lateral sphincterotomy performed as an outpatient procedure under local anesthesia for chronic anal fissure: prospective randomized study of clinical and manometric longterm results. Topical nitroglycerin versus lateral internal sphincterotomy for chronic anal fissure: prospective, randomized trial. Internal sphincterotomy is superior to topical nitroglycerin in the treatment of chronic anal fissure: results of a randomized, controlled trial by the Canadian Colorectal Surgical Trials Group. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones.
Forty-seven patients thought to have dysfunction of the sphincter of Oddi were randomly assigned to undergo endoscopic sphincterotomy or sham sphincterotomy in a prospective double-blind study. All the patients had pain resembling biliary pain, had previously undergone a cholecystectomy, and had clinical characteristics suggesting biliary obstruction. The patients were randomly assigned to the treatment (n = 23) or nontreatment (n = 24) group before manometric examination of the sphincter of Oddi was performed. Sphincterotomy resulted in improvement in pain scores at one-year follow-up in 10 of 11 patients with elevated sphincter pressure. In contrast, there was improvement in only 3 of 12 patients with elevated basal sphincter pressures who underwent the sham procedure. In patients with normal sphincter pressure, pain scores were similar regardless of treatment. After one year, sphincterotomy was performed in 12 symptomatic patients who had undergone the sham procedure--7 with elevated sphincter pressures and 5 with normal sphincter pressures. Forty patients were followed for four years. Of the 23 patients with increased sphincter pressure, 10 of the original 11 who underwent sphincterotomy remained virtually free of pain; 7 others who subsequently underwent sphincterotomy also benefited from it. Thus, 17 of 18 patients with sphincter-of-Oddi dysfunction verified by manometry benefited from sphincterotomy. In patients with normal sphincter pressure, sphincterotomy was no more beneficial than sham therapy. Our observations suggest that endoscopic sphincterotomy offers long-term relief of pain in a group of patients with verified sphincter-of-Oddi dysfunction. Endoscopic sphincterotomy for biliary-type pain after cholecystectomy remains controversial despite evidence of efficacy in some patients with a high sphincter of Oddi (SO) basal pressure (SO stenosis).
                To evaluate the effects of sphincterotomy in patients randomised on the basis of results from endoscopic biliary manometry.
                Endoscopic biliary manometry was performed in 81 patients with biliary-type pain after cholecystectomy who had a dilated bile duct on retrograde cholangiography, transient increases in liver enzymes after episodes of pain, or positive responses to challenge with morphine/neostigmine. The manometric record was categorised as SO stenosis, SO dyskinesia, or normal, after which the patient was randomised in each category to sphincterotomy or to a sham procedure in a prospective double blind study. Symptoms were assessed at intervals of three months for 24 months by an independent observer, and the effects of sphincterotomy on sphincter function were monitored by repeat manometry after three and 24 months.
                In the SO stenosis group, symptoms improved in 11 of 13 patients treated by sphincterotomy and in five of 13 subjected to a sham procedure (p = 0.041). When manometric records were categorised as dyskinesia or normal, results from sphincterotomy and sham procedures did not differ. Complications were rare, but included mild pancreatitis in seven patients (14 episodes) and a collection in the right upper quadrant, presumably related to a minor perforation. At three months, the endoscopic incision was extended in 19 patients because of manometric evidence of incomplete division of the sphincter.
                In patients with presumed SO dysfunction, endoscopic sphincterotomy is helpful in those with manometric features of SO stenosis. Endoscopic papillary balloon dilation (EPBD) is assumed to preserve sphincter of Oddi function because it causes little trauma to the papilla. However, few studies have addressed this issue specifically. In this study, we investigated whether EPBD can preserve sphincter function, and evaluated whether or not such preservation has clinical significance.
                Seventy patients with common bile duct (CBD) stones were randomly assigned to EPBD or endoscopic sphincterotomy (EST). Sphincter of Oddi (SO) function was measured by endoscopic manometry before, one week after, and one year after treatment. Incidence of pneumobilia and later complications were compared between the two groups at one year. Series manometric data were compared within each group and between the two groups. For a more detailed analysis of the cumulative incidence of later complications, retrospective cohorts were added to the study groups, giving a total number of 235 patients in the EPBD group and 126 in the EST group.
                Baseline characteristics did not differ significantly between the 35 EPBD and 35 EST patients. CBD stones were discharged successfully in all cases. CBD pressure, SO basal and peak pressures, and contraction frequency decreased significantly at one week in both groups. The damage was more severe in the EST group, and SO contraction completely disappeared in 23 patients in this group. The incidence of pneumobilia was significantly lower in the EPBD group than in the EST group (p<0.01) whereas CBD stones recurred and cholecystitis appeared at a similar rate in both groups at one year. A complete series of manometric data up to one year was obtained in 55 patients; 28 in the post-EPBD and 27 in post-EST groups. In the post-EPBD group, SO basal and peak pressures significantly recovered at one year compared with data at one week but these measures still remained significantly lower than those before EPBD (p< 0.01). In the post-EST group, SO contraction did not recover even after one year. A Kaplan-Meier analysis of 235 EPBD and 126 EST patients for a median follow up of 37 months revealed significantly lower incidences of biliary complications such as recurrent CBD stones and cholangitis, and cholecystitis in the EPBD group than in the EST group (p<0.05). The risk of pneumobilia was also significantly lower in the EPBD group (p<0.01).
                Preservation of papillary function after EPBD was not complete but remained somewhat reduced. However, preservation was more successful with EPBD than with EST. Such preservation may be clinically beneficial for the prevention of later complications. Standard treatment for Chronic Anal Fissure (CAF) is unilateral Internal Sphincterotomy (UIS). Still there is recurrence and the risk of of incontinence. Bilateral Internal Sphincterotomy (BIS) as a treatment for CAF has not been adequately evaluated.
                A prospective randomized controlled trial of UIS at 3 o'clock compared with BIS at 3 and 9 'O' clocks. The outcome variables were: post operative pain, recurrence and incontinence.
                There was 104 and 107 cases in UIS and BIS group respectively with similar age and sex. There were 12 recurrences in UIS and only one in the BIS group (p < 0.001) with no change in the continence. BIS group had less pain (p < 0.001).
                BIS for CAF resulted in less postoperative pain, lower recurrence with no increase in the incontinence. However, further study is required with pre and post operative anal manometry. Twenty patients with chronic anal fissure were randomized into two groups. Ten patients were treated with lateral subcutaneous sphincterotomy and 10 with anal dilatation. Anal dilatation was carried out preoperatively, and at 1 and 3 months after the operation in all patients. Preoperatively there was a significantly increased maximal resting pressure in the 20 fissure patients (80 mmHg median) compared with 20 control subjects (50 mmHg median). Postoperatively a significant decrease in pressure occurred in the dilated group (49 mmHg median p less than 0.05), whereas the pressure was not significantly reduced in the group that underwent sphincterotomy (65 mmHg median p less than 0.05). At 1 year three patients complained of recurrent symptoms of anal fissure in the dilated group compared with one in the sphincterotomy group. Minor continence disturbance was noted in two patients in both groups. The aim of this prospective randomized trial was to compare the effectiveness and morbidity of open and closed sphincterotomy performed as an outpatient procedure under local anesthesia in the treatment of chronic anal fissure.
                Eighty patients with chronic anal fissure were treated by open (group 1) or closed lateral internal sphincterotomy (group 2). Clinical and manometric results were recorded at the time of admission and at 1-week, 2-month, 6-month, 1-year, and 2-year followup visits.
                Overall healing after 2 years was 92.5% in the open sphincterotomy group and 90% in the closed sphincterotomy group (p > 0.05). Fissures were notably less likely to heal in patients in whom the condition had been present for longer than 12 months and who had a sentinel pile before treatment. At the 2-year revision, incontinence was present in two patients (5%) in the open sphincterotomy group and one patient (2.5%) in the closed sphincterotomy group (p > 0.05). In all cases, the incontinence was mild (<4, Cleveland score). Increased mean resting pressure (113.9 mmHg) was found in patients with anal fissure before treatment compared with the healthy control group (mean resting pressure = 66 mmHg) (p < 0.001). The mean resting pressure in patients cured after 2 years was 75.65 mmHg, and in those with a recurrent fissure was 112.85 mmHg (p < 0.001).
                Morbidity and recurrence were similar in open and closed sphincterotomies when the procedures were performed under local anesthetic, and sphincterotomy under local anesthesia as an outpatient procedure has several socioeconomic advantages (high degree of satisfaction and comfort to the patient, rapid solution of the problem, and no admission to the hospital or an operating room and no preoperative studies). Topical nitroglycerin (GTN) is one of the medical treatments of choice in chronic anal fissure. The present prospective, randomized, clinical trial was conducted to study the symptomatic relief, healing, and changes in the maximum anal resting pressure (MARP) in patients with chronic anal fissure comparing topical GTN and lateral sphincterotomy.
                Forty consecutive patients with chronic anal fissure were randomized for treatment with either topical GTN or internal sphincterotomy (20 patients in each group). Anal manometry was done before treatment in all patients, and 1 h after application of GTN or sphincterotomy. Patients were followed at 2-weekly intervals for 6 weeks for symptomatic relief and healing.
                Both GTN and sphincterotomy brought about a highly significant, but comparable drop in the MARP after treatment (P < 0.0001 in both groups). Sphincterotomy relieved pain much earlier compared to GTN (70% vs 40% at 2 weeks, P = 0.0032); but after 4 weeks of treatment, pain relief in both groups was comparable. Healing in the sphincterotomy group was also earlier than with GTN (55% vs 0% at 2 weeks, P < 0.0001; and 85% vs 30% at 4 weeks, P < 0.0001); but after 6 weeks, healing in both groups was comparable. Sphincterotomy had a significant incidence of minor, short-term complications; it also required surgical expertise, theatre time, and day-care beds. Nitroglycerin is safe, with mild and tolerable side-effects of headache and local burning sensation.
                Topical GTN should be the initial treatment in chronic anal fissure. Lateral sphincterotomy should be reserved for patients with severe disabling pain (because pain relief is much faster), and for patients not responding to at least 4 weeks of GTN therapy. This was a multicenter, randomized, controlled trial to compare the effectiveness of topical nitroglycerin with internal sphincterotomy in the treatment of chronic anal fissure.
                Patients with symptomatic chronic anal fissures were randomly assigned to 0.25 percent nitroglycerin tid or internal sphincterotomy. Both groups received stool softeners and fiber supplements and were assessed at six weeks and six months.
                Ninety patients were accrued, but 8 were excluded from the analysis because they refused internal sphincterotomy after randomization (6), the fissure healed before surgery (1), or a fissure was not observed at surgery (1). There were 38 patients in the internal sphincterotomy group (22 males; mean age, 40.3 years) and 44 patients in the nitroglycerin group (15 males; mean age, 38.7 years). At six weeks 34 patients (89.5 percent) in the internal sphincterotomy group compared with 13 patients (29.5 percent) in the nitroglycerin group had complete healing of the fissure (P = 5x10(-8)). Five of the 13 patients in the nitroglycerin group relapsed, whereas none in the internal sphincterotomy group did. At six months fissures in 35 (92.1 percent) patients in the internal sphincterotomy group compared with 12 (27.2 percent) patients in the nitroglycerin group had healed (P = 3x10(-9)). One (2.6 percent) patient in the internal sphincterotomy group required further surgery for a superficial fistula compared with 20 (45.4 percent) patients in the nitroglycerin group who required an internal sphincterotomy (P = 9x10(-6)). Eleven (28.9 percent) patients in the internal sphincterotomy group developed side effects compared with 37 (84 percent) patients in the nitroglycerin group (P<0.0001). Nine (20.5 percent) patients discontinued the nitroglycerin because of headaches (8) or a severe syncopal attack (1).
                Internal sphincterotomy is superior to topical nitroglycerin 0.25 percent in the treatment of chronic anal fissure, with a high rate of healing, few side effects, and low risk of early incontinence. Thus, internal sphincterotomy remains the treatment of choice for chronic anal fissure. Endoscopic retrograde cholangiopancreatography is commonly performed to remove bile duct stones. The aim of this study was to determine short-term outcomes of endoscopic balloon dilation of the sphincter of Oddi compared with sphincterotomy for stone extraction.
                A randomized, controlled multicenter study of 117 patients assigned to dilation and 120 to sphincterotomy was performed in a spectrum of clinical and academic practices.
                Characteristics of the patients, procedures, and endoscopists were similar except that dilation patients were younger. Procedures were successful in 97.4% and 92.5% of the dilation and sphincterotomy patients, respectively. Overall morbidity occurred in 17.9% and 3.3% ( P < .001; difference, 14.6; 95% confidence interval, 7-22.3) and severe morbidity, including 2 deaths, in 6.8% and 0%( P < .004; difference, 6.8; 95% confidence interval, 2.3-11.4) for dilation and sphincterotomy, respectively. Complications for dilation and sphincterotomy, respectively, included: pancreatitis, 15.4% and .8% ( P < .001; difference, 14.6; 95% confidence interval, 7.8-21.3); cystic duct fistula, 1.7% and 0%; cholangitis, .9% and .8%; perforation, 0% and .8%; and cholecystitis, 0% and .8%. There were 2 deaths (1.7%) due to pancreatitis following dilation and none with sphincterotomy. The study was terminated at the first interim analysis. Dilation patients required significantly more invasive procedures, longer hospital stays, and longer time off from normal activities.
                In a broad spectrum of patients and practices, endoscopic balloon dilation compared with sphincterotomy for biliary stone extraction is associated with increased short-term morbidity rates and death due to pancreatitis. Balloon dilation of the sphincter of Oddi for stone extraction should be avoided in routine practice.
These results suggest that sphincterotomy for biliary sphincter of Oddi dysfunction appears effective in those patients with an elevated sphincter of Oddi basal pressure (>40 mmHg), but is no better than placebo in those patients with a normal basal pressure. The results reported in this review must be interpreted with caution as there are only two studies and one of the reviewers (Toouli) has been an author in both studies. Further trials by independent groups are recommended.