Topical treatment of anal condylomata with Propionibacterium acnes lysate: results of a multicentric observational study.

BACKGROUND: Condylomata are a manifestation of HPV infection of the ano-genital epithelium. Recurrence is frequent after any type of treatment (from 20% up to 50%). We assessed the use of a gel containing panthenol, tocopheryl acetate and Propionibacterium extract in the treatment of anal warts. METHODS: Enrollment period was from January 15 to June 15, 2018. Main exclusion criteria were immunodepression, extensive condylomatosis and other treatments (topical/ablative) in the previous six months. RESULTS: Seventy-nine patients were included. Median age was 33 years (19-65), 72.2% were males. Median number of partners and symptoms duration were 6 (1-98) and 3 months (1-18), respectively. Almost all cases had perianal disease (97.5%), while endoanal warts were present in 51.9% of cases. After 30 days of treatment, complete regression occurred in 17 (21.5%) patients, while partial or absent response was reported in 36 (45.6%) and 26 (32.9%) cases, respectively. Forty-seven (59.5%) patients underwent a second month of topical therapy. After a 6-month follow-up, complete or partial response was reported in 53 (67.1%) patients, while in 26 (32.9%) cases the disease remained stable or even worsened. Nineteen (24.1%) patients required cryotherapy, 23 (29.1%) surgical excision, while 2 (2.5%) needed both cryotherapy and surgery. Absence of clinical response was associated with a number of partners ≥10 and symptoms duration of 6 months or shorter (P<0.001 and P=0.050). CONCLUSIONS: In our study, the gel containing P. acnes lysate was a safe topical treatment for perianal and endoanal condylomata and could help to overcome HPV infection. A high number of partners and short symptoms duration appeared to worsen the outcome.

Local excision with adjuvant imatinib therapy for anorectal gastrointestinal stromal tumors.

Rectal gastrointestinal stromal tumors (GISTs) are uncommon, and the role of local excision versus a more extensive resection after the advent of effective targeted chemotherapy with imatinib is not known. Our aim is to present two cases of large anorectal GIST treated with local excision through a new anterolateral trans-sphincteric approach followed by adjuvant therapy with imatinib. Two patients (both males, 68 and 63 years old) presented at our institution with anorectal GIST in the period October-November 2010. Their medical records, pathology results, and imaging studies were retrospectively reviewed. Both patients presented with an anterior perianal mass. Imaging studies were characteristic of GIST originating in the lower rectum, circumscribed by a pseudocapsule, and protruding into the ischiorectal fossa. Both patients underwent local excision via an anterolateral trans-sphincteric approach. Both tumors were removed intact, with microscopically negative margins. The maximum tumor diameter was 8 and 9 cm, and the diagnosis of GIST was confirmed by positive CD117 and CD34 staining in both cases. Both tumors had a high (>5/50HPF) mitotic index. The patients had an uneventful postoperative course and were discharged on days 5 and 6. Both patients were started on imatinib 400 mg bid postoperatively. Postoperative magnetic resonance imaging and positron emission tomography computed tomography were carried out at 12 months and did not reveal any signs of recurrence. The patients are currently disease-free at 24 and 23 months of follow-up. In selected cases, complete excision of rectal GIST with negative margins is feasible via a trans-sphincteric approach. With the use of adjuvant therapy, which is currently advocated in all high-risk cases, it is possible that local excision with its reduced morbidity may become a viable alternative, especially in patients who would otherwise require abdominoperineal excision such as the two presented here. Prospective studies with longer follow-up are needed to confirm adequate oncologic results.

Emerging technologies in coloproctology: results of the Italian Society of Colorectal Surgery Logbook of Adverse Events.

BACKGROUND: The aim of this paper is to present the results of the Italian Society of Colorectal Surgery [or Società Italiana di Chirurgia Colorettale (SICCR)] Logbook of adverse events (AE) occurring in relation to emerging technologies in coloproctology (ETCs), over a 3-year period. METHODS: A total of 245 AE were reported (patients age: mean = 49.6 years, range = 20-75 years; gender: 155 = F, 90 = M). The "observations" originated from the same institution of the AEs in 44 cases (18.0%), while 201 patients (82.0%) had been operated on somewhere else. RESULTS: The three most reported ETCs were: Procedure for prolapsed haemorrhoids (PPH) (n = 120-48.9%), stapled transanal rectal resection (STARR (n = 96-39.2%), and transanal haemorrhoidal dearterialization (THD) (n = 11-4.5%). PPH, STARR, and THD together accounted for n = 227 (92.6%) observations. For the three main reported ETCs, the various AEs are listed. Chronic pain after PPH was 46/120 (38.3%), and after STARR of 21/96 (21.9%). The overall re-operation rate was n = 135 (55.1%) versus n = 110 (44.9%) no reoperation. In particular, for the three main reported ETCs, n = 68/120 (56.7%) following an AE after PPH, n = 47/94 (50.0%) following an AE after STARR, and n = 6/11 (54.5) following an AE post-THD. The various types of treatment to solve AE after each of the three most observed ETCs are reported in the text. CONCLUSIONS: Our results do not allow us to draw statistical conclusions; however, this was not the aim of our survey. ETCs are important, yet they are not without major risks. Manufacturers should help colorectal surgeons to convey the right message to patients.

[Medical-surgical integrated approach in the treatment of non-paraneoplasic hyperparathyroidism: our experience]. / Approccio integrato medico-chirurgico nel trattamento dell'iperparatiroidismonon-paraneoplastico: la nostra esperienza.

OBJECTIVE: Hyperparathyroidism is a generalized alteration of calcium, phosphorus and bone metabolism due to an increased secretion of parathyroid hormone (PTH). In addition to the paraneoplastic ectopic type, we can distinguish three eutopic types of hyperparathyroidism, i.e., the primary form, mostly due to a benign or malignant tumor of parathyroid gland, the secondary form, typical of kidney disease and tertiary form, due to the progression of secondary forms. There is not agreement, in medical literature, on the treatment of these patients. To establish the correct therapeutic approach in patients with hyperparathyroidism, we have followed a group of symptomatic subjects suffering from primary, secondary and tertiary hyperparathyroidism, taking into account the therapeutic needs. MATERIALS AND METHODS: We followed for 12 months 155 patients suffering from primary, secondary and tertiary hyperparathyroidism; 82 were in end stage kidney disease, 93 were hypertensive. Subjects with primary forms has been treated, before parathyroidectomy, with idration (physiological solution of NaCl), bisphosphonates i.v. (pamidronate 60-90 mg in 4-6h) and, if serum calcium was higher than 12 mg/dl, loop diuretics (furosemide 40 mg/day). Subjects with secondary forms has been treated with hypophosphoric diet, phosphate bindings (calcium carbonate 1 g/day) and oral calcitriol (1 microg/d) before subtotal parathyroidectomy. After surgery it was administered support therapy with calcium gluconate (40 ml/day) and vitamin D (2.5mg/d) until serum calcium normalization. RESULTS: There were 55 cases of post surgery hypertensive attack treated with clonidine (300 microg/d); 8 months later there was not relapses but in all patients there was reduction of serum calcium concentration that required a substitutive treatment (calcium 1 g/day and calcitriol 1 microg/day). There was 1 case of heavy hypocalcemic state treated with calcium gluconate i.v. (40 ml/day). CONCLUSIONS: A correct approach to a non-paraneoplastic hyper-parathyroid patient need of an integration of both current medical and surgical options. In primary forms the first option is the surgical approach supported by medical treatment. In secondary forms medical approach is preferable to control renal and vascular complications, while surgical therapy is to prefer in non-responders to medical therapy forms.

[Medical-surgical integrated approach in the treatment of non-paraneoplasic hyperparathyroidism: our experience]. / Approccio integrato medico-chirurgico nel trattamento dell'iperparatiroidismonon-paraneoplastico: la nostra esperienza.

OBJECTIVE: Hyperparathyroidism is a generalized alteration of calcium, phosphorus and bone metabolism due to an increased secretion of parathyroid hormone (PTH). In addition to the paraneoplastic ectopic type, we can distinguish three eutopic types of hyperparathyroidism, i.e., the primary form, mostly due to a benign or malignant tumor of parathyroid gland, the secondary form, typical of kidney disease and tertiary form, due to the progression of secondary forms. There is not agreement, in medical literature, on the treatment of these patients. To establish the correct therapeutic approach in patients with hyperparathyroidism, we have followed a group of symptomatic subjects suffering from primary, secondary and tertiary hyperparathyroidism, taking into account the therapeutic needs. METHODS: We followed for 12 months 155 patients suffering from primary, secondary and tertiary hyperparathyroidism; 82 were in end stage kidney disease, 93 were hypertensive. Subjects with primary forms has been treated, before parathyroidectomy, with hydration (physiological solution of NaCl), bisphosphonates i.v. (pamidronate 60-90 mg in 4-6h) and, if serum calcium was higher than 12 mg/dl, loop diuretics (furosemide 40 mg/day). Subjects with secondary forms has been treated with hypo-phosphoric diet, phosphate bindings (calcium carbonate 1 g/day) and oral calcitriol (1 microg/d) before subtotal parathyroidectomy. After surgery it was administered support therapy with calcium gluconate (40 ml/day) and vitamin D (2.5mg/d) until serum calcium normalization. RESULTS: There were 55 cases of post surgery hypertensive attack treated with clonidine (300 microg/d); 8 months later there was not relapses but in all patients there was reduction of serum calcium concentration that required a substitutive treatment (calcium 1 g/day and calcitriol 1 microg/day). There was 1 case of heavy hypocalcemic state treated with calcium gluconate i.v. (40 ml/day). CONCLUSIONS: A correct approach to a non-paraneoplastic hyper-parathyroid patient need of an integration of both current medical and surgical options. In primary forms the fi rst option is the surgical approach supported by medical treatment. In secondary forms medical approach is preferable to control renal and vascular complications, while surgical therapy is to prefer in non-responders to medical therapy forms.

[Hepatic iron, iron depletion and response to therapy with peg-Interferon and Ribavirin in chronic hepatitis C. Pilot study]. / Ferro epatico, ferrodeplezione e risposta alla terapia con peg-Interferone e Ribavirina nell'epatite cronica C. Studio pilota.

AIM: To estimate whether pretreatment serum iron levels, the HIC (hepatic iron concentration) and the distribution of hepatic iron identify the long-term "responders" and "non-responders" to therapy with peg-IFN and RBV, and whether the addition of phlebotomy could increase the likelihood of therapeutic response. PATIENTS AND METHODS: 45 subjects with chronic hepatitis C were taking peg-IFN alpha-2a 180 microg once a week and RBV 1000 mg/die. The "responders" continued therapy with peg-IFN plus RBV, while, the "non-responders" were subjected to phlebotomy. After two weeks and subsequently every month the patients were subjected to blood test and clinical appraisal. RESULTS: Hepatic iron storage meaningfully conditions the outcome of therapy with peg-IFN and RBV, its reduction by phlebotomy favourably correlates with response to treatment and, at last, the semiquantitative histological appraisal would have to be included in the pre-treatment work-up of patients with chronic hepatitis C. CONCLUSIONS: The study results, even though obtained on a small size of cases, allow to conclude that serum corporeal iron evaluation underestimates the real hepatic iron concentration; the hepatic iron concentration, in turn, negatively conditions the response to therapy with peg-IFN and RBV (by reducing the percentage of the fast virological response). Lastly, iron removal by phlebotomy favourably correlates with the response to treatment.

Meaning of elevated CA 19-9 serum levels in chronic hepatitis and HCV-related cirrhosis.

AIM: Carbohydrate 19-9 antigen (CA 19-9) has been used in the diagnosis and follow-up of gastrointestinal tumors. However, a remarkable reduction of specificity has been described in subjects with chronic diseases. Elevated CA 19-9 serum levels have been described in non neoplastic liver diseases, such as hepatic cirrhosis, where they correlate with the fibrosis grade and the disease severity. The aim of the study is to evaluate CA 19-9 levels in chronic hepatitis patients (CH) and hepatic cirrhosis patients, Hepatitis C Virus (HCV)-correlated. Our goal was to establish whether elevated CA 19-9 levels can be considered a non casual event in chronic liver disease and whether a correlation can be found between CA 19-9 levels and the severity of the disease. METHODS: 116 patients have been recruited (76 m, 40 f, average 54 years); 56 patients were affected by CH and 60 by hepatic cirrhosis (Child A). All patients were HCV+, genotype 1b. Patients positive to CA 19-9 high levels were subjected to abdominal echography, EGDS, colonscopy, abdominal CT. RESULTS: Fifty two percent presented high levels of CA 19-9. None was affected by intestinal or pancreatic neoplasia, or colestatic icterus. CA 19-9 levels were elevated in 46% of patients with chronic hepatitis, and in 54% in patients with hepatic cirrhosis. Furthermore, CA 19-9 levels in hepatic cirrhosis compared to CA 19-9 levels in chronic hepatitis was statistically significant (P>0.007). CONCLUSION: Increased serum levels of CA 19-9 are frequent in chronic viral hepatitis; this often does not indicate a contemporary neoplastic disease and correlates in a statistically significant way (P>0.007) with the severity of the disease.

A prospective evaluation of occult disorders in obstructed defecation using the 'iceberg diagram'.

OBJECTIVE: Surgical treatment of constipation and obstructed defecation (OD) carries frequent recurrences, as OD is an 'iceberg syndrome' characterized by 'underwater rocks' or occult diseases which may affect the outcome of surgery. The aim of this study was to evaluate occult disorders, in order to alert the clinician of these and minimize failures. METHOD: One hundred consecutive constipated patients with OD symptoms, 81 women, median age 52 years, underwent perineal examination, proctoscopy, anorectal manometry and anal/vaginal ultrasound (US). Anorectal physiology and imaging tests were also carried out when indicated, as well as psychological and urogynaecological consultations. Symptoms were graded using a modified 1-20 constipation score. Both evident (e.g. rectocele) and occult (e.g. anismus) diseases were prospectively evaluated using a novel 'iceberg diagram'. The type of treatment, whether conservative or surgical, was also recorded. RESULTS: Fifty-four (54%) patients had both mucosal prolapse and rectocele. All patients had at least two occult OD-related diseases, 66 patients had at least three of them: anxiety-depression, anismus and rectal hyposensation were the most frequent (66%, 44% and 33%, respectively). The median constipation score was 11 (range 2-20), the median number of 'occult disorders' was 5 (range 2-8). Conservative treatment was carried out in most cases. Surgery was carried out in 14 (14%) patients. CONCLUSION: The novel 'iceberg diagram' allowed the adequate evaluation of OD-related occult diseases and better selection of patients for treatment. Most were managed conservatively, and only a minority were treated by surgery.

Anal endosonography: a survey of equipment, technique and diagnostic criteria adopted in nine Italian centers.

BACKGROUND: Anal endosonography (AES) has become an essential part of the pre-operative diagnostic workup in both organic and functional anal diseases. METHODS: Nine Italian centres with an average volume activity of >10 exams/week each were surveyed with the aim of determining the concordance with respect to indications for the procedure and interpretation of the results. RESULTS: Overall, anal sepsis, faecal incontinence and anorectal tumours were the more common indications for AES while evacuation dysfunctions and anal pain were not always considered indications. All centres use the same diagnostic criteria for simple and complicated perirectal sepsis and sphincteric defects, but adopt different classifications for stage 1 and stage 2 anal tumours. Participants agreed in that lymph-node staging by AES is less precise than tumour staging, especially after chemoradiation therapy. CONCLUSIONS: A list of recommendations and guidelines based on the groups's experience has been produced for those radiologists and coloproctologists interested in the use of AES and accreditation of their centres.

A prospective evaluation of occult disorders in obstructed defecation using the 'iceberg diagram'.

OBJECTIVE: Surgical treatment of constipation and obstructed defecation (OD) carries frequent recurrences, as OD is an 'iceberg syndrome' characterized by 'underwater rocks' or occult diseases which may affect the outcome of surgery. The aim of this study was to evaluate occult disorders in order to alert the clinician of these and minimize failures. METHOD: One hundred consecutive constipated patients with OD symptoms, 81 female patients, median age 52 years, underwent perineal examination, proctoscopy, anorectal manometry, and anal/vaginal ultrasound. Anorectal physiology and imaging tests were also carried out when indicated, as well as psychological and urogynaecological consultation. Symptoms were graded using a modified 1-20 constipation score. Both evident (e.g. rectocele) and occult (e.g. anismus) diseases were prospectively evaluated using a novel 'iceberg diagram'. The type of treatment, whether conservative or surgical, was also recorded. RESULTS: Fifty-four (54%) patients had both mucosal prolapse and rectocele. All patients had at least two occult OD-related diseases, 66 patients had at least three: anxiety-depression, anismus and rectal hyposensation were the most frequent (66%, 44% and 33% respectively). The median constipation score was 11 (range 2-20), the median number of 'occult disorders' was 5 (range 2-8). Conservative treatment was carried out in most patients. Surgery was carried out in 14 (14%) patients. CONCLUSION: The novel 'iceberg diagram' allowed the adequate evaluation of OD-related occult diseases and better selection of patients for treatment. Most were managed conservatively, and only a minority were treated by surgery.

Horner's syndrome in a patient with cervical sympathetic chain schwannoma.

Schwannomas are benign, slow-growing tumors arising from nerves. Those originating from the sympathetic cervical chain are rare. The clinical presentation, surgical treatment and outcomes of a patient with this pathology personally observed, are described.

[Heterozygosis H63D in patients with steatohepatitis and chronic hepatitis C]. / Eterozigosi H63D per emocromatosi in pazienti affetti da steatoepatite e epatite cronica da virus C.

OBJECTIVE: Classic hereditary hemochromatosis is an autosomal recessive iron-overload disorder associated with mutation of the HFE gene. The homozygous genetic defect predisposes to a chain of events that may culminate in severe damage in multiple organs. Pathologic implications of heterozygous defect are still questionable; in fact since these individuals may have slight increases in intra-cellular iron, it has been questioned whether this would enhance damage from other diseases. We investigated whether steatohepatitis and chronic hepatitis C can be worsened by heterozygosis for C282Y and H63D. PATIENTS AND METHODS: We investigated 216 subjects with Steatohepatitis and/or chronic hepatitis C diagnosed by ultrasonography and liver biopsy with histological assessment compared with 110 healthy subjects. In all subjects we performed Saturated Transferrine, Plasma Ferritin and the research of HFE mutation by a Real Time Method. A statistical analysis was performed. RESULTS: A H63D mutation was present in 32/108 patients with Steatohepatitis, in 30/108 patients with chronic hepatitis C and in 22/110 healthy subjects. A C282Y mutation was present in 2/108 patients with chronic hepatitis C, in 4/108 with steatohepatitis and in 2/108 healthy subjects. No significant difference was present about incidence of this mutation between pathological and healthy subjects. No significant differences have observed between pathological groups and normal group about the degree of histological damage. CONCLUSIONS: Our study revealed that steatohepatitis and chronic hepatitis C cannot be worsened by heterozygosis for C282Y and H63D.

A case of progression from type II cryoglobulinaemia to Waldenstrom's macroglobulinaemia in a patient with chronic hepatitis C.

Hepatitis C infection is associated with B-cell lymphoproliferative disorders, including mixed cryoglobulinaemia and B-cell lymphoma. A direct pathogenetic role of this infection in lymphomagenesis has been suggested but the molecular basis for viral induced B-cell proliferation is still unknown. We report an unusual case of a patient affected by chronic hepatitis C who presented severe type II cryoglobulinaemia and subsequently lymphoplasmacytoid lymphoma consistent with Waldenstrom's macroglobulinaemia and type I cryoglobulinaemia. In this patient antiviral treatment induced beneficial effects.

Ultrasound imaging in diagnosis of superior mesenteric artery syndrome.

OBJECTIVES: We screened a cohort of subjects affected by various degree of dyspepsia to reveal if they presented a reduction of the aorto-mesenteric angle and to diagnose suspected cases of superior mesenteric artery (SMA) syndrome. DESIGN: Controlled, prospective, study. SETTING: Subjects were studied as outpatients. SUBJECTS: The study investigated a total of 3622 subjects referred to our department by their general practitioners for dyspepsia and/or abdominal pain. Interventions. Abdominal ultrasonography with power colour Doppler, gastroduodenoscopy, hypotonic duodenography, contrast-enhanced spiral computerized tomography were performed. MAIN OUTCOME MEASUREMENT AND RESULTS: Color Doppler revealed a significant reduction of the SMA angle in 29 of 950 subjects; gastroscopy showed duodenal compressive pulsation in 14 of 29 patients and X-ray revealed compression of the third segment of the duodenum in 28 of 29 patients. CT confirmed the presence of a reduced angle and various degrees of duodenal compression in all patients. Ultrasonography and CT examinations gave overlapping results (P > 0.05) in diagnosing pathological aorto-mesenteric angle. CONCLUSION: The authors believe that the incidence of reduced aorto-mesenteric angle and SMA syndrome might be underrated. Ultrasound power colour Doppler imaging is useful in epidemiological screening of reduced aorto-mesenteric angle to diagnose suspected cases of SMA syndrome.

Which surgical approach for rectocele? A multicentric report from Italian coloproctologists.

The most effective surgical technique for rectocele has not yet been clearly established. A retrospective multicentric study was carried out to compare the long-term results of 3 endorectal techniques (Block, Sarles and stapled) and the perineal levatorplasty, alone and in association, in a series of patients with symptomatic rectocele. From January 1992 to December 1999, 2212 patients with defecation disorders were referred to 5 Italian coloproctology units. An anterior rectocele was clinically diagnosed in 1045 patients and confirmed with defecography. On the basis of clinical and radiological parameters, 317 patients (312 women; mean age, 52.4+/-20.1 years) were selected for surgery. Group 1 consisted of 141 patients (136 women; mean age, 50.4+/-18.8 years) who were submitted to endorectal operations. Group 2 consisted of 126 women (mean age, 52.5+/-19.7 years) who received perineal levatorplasty. Finally, 50 women (mean age, 54.3+/-21.9 years) in Group 3 received endorectal operations associated with perineal levatorplasty. A total of 269 patients were followed postoperatively (mean period, 24.2+/-3.1 months, 27.5+/-5.4 months and, 22.8+/-2.8 months, respectively) with the same questionnaire and clinical examination. Three months after surgery, a defecography examination and anorectal manometry were performed in 136 and 132 patients, respectively. Operative time, hospital stay and time to return to work were significantly higher in Group 3 (p<0.001). There was one death in Group 3 due to severe sepsis. Main postoperative complications were: in Group 1, hemorrhage (7.8%, all Sarles), dehiscence of the endorectal suture (5.0%, all Block), distal rectal stenosis (2.1%, 1 stapled, 2 block), and rectovaginal fistula (1.4%, all Sarles); in Group 2, delayed healing of the perineal wound (16.4%); in Group 3 delayed healing of the perineal wound (22.0%), hemorrhage (6%, all Sarles), dehiscence (4.0%), stenosis (2.0%). 17.3% of patients of Group 2 and 22.5% of Group 3 complained of dyspareunia. Postoperative defecography showed a complete absence of the rectocele in 44.1% of patients and reduction of size in the others, without significant differences among the three groups. Manometric pattern was not significantly modified by surgery. Significant symptoms recurred in 5.9% of the patients in Group 1, 6.4% in Group 2, and 5.0% in Group 3. Perineal levatorplasty did not significantly improve obstructed defecation, as it did not allow to excise the rectal mucosal prolapse, and was followed by an high incidence of delayed healing of the perineal wound and dyspareunia. Sarles procedure achieved better control of mucosal prolapse but carried a higher complication rate compared to the others. The association of the perineal levatorplasty with an endorectal technique required significantly longer operative time, and led to a longer hospital stay and time to return to work. In conclusion, the investigated techniques showed different patterns of postoperative complications: bleeding after Sarles, dehiscence after Block, dyspareunia after perineoplasty and fatal gangrene after stapled, but non of them showed a clear superiority over the others in term of clinical or functional results 2 years after surgery.

Glyceryl trinitrate for chronic anal fissure--healing or headache? Results of a multicenter, randomized, placebo-controled, double-blind trial.

PURPOSE: Internal anal sphincterotomy for treating chronic anal fissure can irreversibly damage anal continence. Reversible chemical sphincterotomy may be achieved by anal application of glyceryl trinitrate ointment (nitric oxide donor), which has been reported to heal the majority of patients with anal fissure by inducing sphincter relaxation and improving anodermal blood flow. This trial aimed to further clarify the role of glyceryl trinitrate in the treatment of chronic anal fissure. METHODS: A total of 132 consecutive patients from nine centers were randomly assigned to receive 0.2 percent glyceryl trinitrate ointment or placebo twice daily for at least four weeks. The severity of pain and maximum anal resting pressure were measured before and after one week of treatment. Anodermal blood flow was measured before and after application of glyceryl trinitrate or placebo in ten patients. RESULTS: The study was completed by 119 patients (59 glyceryl trinitrate and 60 placebo), matched for gender, age, duration of symptoms, duration of treatment, site of fissure, previous attempts to treat, pain score, and maximum anal resting pressure. Twenty-nine patients (49.2 percent) healed after glyceryl trinitrate and 31 patients (51.7 percent) healed after placebo (P = not significant). Pain score fell significantly in both groups, in addition to maximum anal resting pressure. Anodermal blood flow improved significantly in seven patients receiving glyceryl trinitrate, but not in the three receiving placebo. Twenty-three patients (33.8 percent) experienced headache and 4 (5.9 percent), orthostatic hypotension after glyceryl trinitrate. CONCLUSION: This trial fails to demonstrate any superiority of topical 0.2 percent glyceryl trinitrate treatment vs. a placebo, although the effects of glyceryl trinitrate on anodermal blood flow and sphincter pressure are confirmed. This finding, together with the high incidence of side-effects, should discourage the use of this treatment as a substitute for surgery in chronic anal fissure.