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At least 19 recordsLinked to original sources
PubMed1988

Lymphoid follicular proctitis. A condition different from ulcerative proctitis?

A heterogeneous group is formed by patients presenting with clinical features suggestive of inflammatory bowel disease limited to the rectum and whose rectal biopsies show lymphoid follicular hyperplasia of the mucosa. All these cases are traditionally considered as one variant of chronic ulcerative colitis, so-called ulcerative proctitis. Twenty such cases were critically assessed on clinical, endoscopic, and histologic grounds, as well as on response to treatment and follow-up data. While 11 patients showed clinicopathologic features consistent with typical chronic ulcerative colitis, the other nine patients appeared to form a different group, for which the term "lymphoid follicular proctitis" seemed justified. Lymphoid follicular proctitis was, overall, characterized by rectal bleeding, a congested and granular mucosa without ulceration, abnormal and coalescing hyperplastic lymphoid follicles without acute inflammation, and failure to respond to local steroid therapy. The nature of lymphoid follicular proctitis is uncertain at present but seems unrelated to chronic ulcerative colitis.

Adolescent↗
PubMed2003

Haemorrhagic radiation proctitis: endoscopic severity may be useful to guide therapy.

BACKGROUND AND AIMS: Management of haemorrhagic radiation proctitis remains controversial. Both endoscopically delivered argon plasma coagulation and rectal administration of formalin have been recommended. We evaluated the efficacy of argon plasma coagulation according to endoscopic severity of radiation proctitis. PATIENTS AND METHODS: Fourteen patients treated with argon plasma coagulation for rectal bleeding due to radiation proctitis were reviewed. Patients were classified with a new endoscopic score for haemorrhagic radiation proctitis, comprising three factors: telangiectasia distribution, surface area involved, and presence of fresh blood. Seven patients were categorised as having grade A (mild), four grade B (moderate), and three grade C (severe) radiation proctitis. Rectal bleeding was assessed pre- and post-treatment using a five-point bleeding scale. RESULTS: All patients with grade A and B radiation proctitis were treated successfully by argon plasma coagulation (mean 1.5 sessions). In one patient with grade C radiation proctitis argon plasma coagulation was successful after four sessions, but in the other two patients bleeding could not be controlled; a subsequent single formalin administration was successful in both. Overall in 12 patients (85.7%) bleeding ceased or improved significantly. The mean rectal bleeding scale reduced significantly from 2.6 to 0.9. One patient treated with argon plasma coagulation developed an asymptomatic rectosigmoid stenosis. CONCLUSION: Argon plasma coagulation is a simple, safe and efficacious therapy for mild/moderate radiation proctitis. In patients with severe radiation proctitis several sessions are usually necessary, and success is not certain; in these cases, topical formalin administration may be more effective. Endoscopic severity of haemorrhagic radiation proctitis may be useful to guide appropriate therapy.

Adult↗
PubMed2001

Defining the risk of developing grade 2 proctitis following 125I prostate brachytherapy using a rectal dose-volume histogram analysis.

OBJECTIVE: To determine the rectal tolerance for developing Grade 2 radiation proctitis after 125I prostate implantation based on the rectal dose-volume histogram. METHODS AND MATERIALS: Two hundred twelve patients with T1-T2 prostate cancer underwent 125I implantation without external beam irradiation. One month after the procedure, all patients underwent CT-based postimplant dosimetry (3-mm abutting slices). The rectal volumes, defined by an inner and outer wall, were determined from 9 mm above the seminal vesicles to 9 mm below the prostate apex. All doses were calculated by TG43 formalism. The prostate prescription dose was 160 Gy. A dose response analysis was undertaken for volumes of rectal tissue receiving a given dose. Dose levels examined were 80 Gy, 100 Gy, 120 Gy, 140 Gy, 160 Gy, 180 Gy, 200 Gy, 220 Gy, and 240 Gy. Grade 2 proctitis was defined as rectal bleeding occurring at least once a week for a minimum period of one month. The risk of proctitis was calculated using actuarial methods. For each dose level, a critical volume cutpoint was chosen to define a low and high volume group of patients. The cutpoint was determined based on two goals: minimizing thep value and finding a < or =5% risk of proctitis in the low volume group. Patients were followed from 12 to 61 months (median: 28 months) after implantation. RESULTS: Twenty-two patients developed Grade 2 proctitis: 14% within the first year, 72% between the first and second year, and 14% during the third year after the implant date. After the third year postimplantation, no cases of proctitis were reported. Proctitis was found to be significantly volume dependent for a given dose. The prescription dose (160 Gy) delivered to < or =1.3 cc of rectal tissue resulted in a 5% rate of proctitis at 5 years vs. 18% for volumes >1.3 cc (p = 0.001). Similar results were found for all doses examined. As the rectal volume receiving the prescription dose (160 Gy) increased, so did the proctitis rate: 0% for < or =0.8 cc, 7% for >0.8-1.3 cc, 8% for >1.3-1.8 cc, 24% for >1.8-2.3 cc, and 25.5% for >2.3cc (p = 0.002). CONCLUSIONS: Rectal dose-volume histogram analysis is a practical and predictive method of assessing the risk of developing Grade 2 proctitis after 125I prostate implantation. Delivered dose should be kept below defined rectal volume thresholds to minimize this risk. This information can allow one to decrease rectal morbidity by modifying prostate implant technique.

Aged↗
PubMed2000

High external parametrial dose can increase the probability of radiation proctitis in patients with uterine cervix cancer.

OBJECTIVE: The aim of this study was to evaluate the relationship between external parametrial dose and radiation proctitis after external irradiation and high-dose-rate intracavitary (HDR-IC) brachytherapy among patients with cervical cancer. METHODS: From May 1993 through December 1996, 191 patients with stage IB-IVA cervical cancer were managed by curative-intent radiotherapy. External irradiation to the whole pelvis (44-45 Gy/ 22-25 fractions) was delivered to all patients initially. One hundred twenty-seven patients received additional bilateral parametrial and sidewall boost (5.4-14.4 Gy/ 3-8 fractions) with 4-cm midline shielding. HDR-IC brachytherapy, 19.2-24 Gy/ 5 fractions to Point A, was given after external irradiation. Patients receiving an external dose of 44-45, 50-54, and >54 Gy were categorized as no parametrial boost (NPMB), low parametrial boost (LPMB), and high parametrial boost (HPMB) group, respectively. The actuarial proctitis rate was compared among the three groups. RESULTS: Three-year overall and Grade 2-4 proctitis rates were 30 and 15%, respectively. Overall proctitis rates were 12, 34, and 51% in the NPMB, LPMB, and HPMB groups (P < 0.0001), respectively. Grade 2-4 proctitis rates were 5, 17, and 27% in the NPMB, LPMB, and HPMB groups (P = 0.0022), respectively. In multivariate analysis of overall and Grade 2-4 radiation proctitis, external parametrial dose was the only independent prognostic factor (P = 0.0002 and 0.0030, respectively). CONCLUSION: Regardless of central shielding after 44-45 Gy whole pelvis irradiation, more patients with high external parametrial dose developed radiation proctitis. Incomplete midline shielding of the upper rectum may be the cause. Diminishing the external beam doses further may decrease rectal complications.

Adult↗
PubMed1980

Allergic proctitis, a clinical and immunopathological entity.

Patients with isolated ulcerative proctitis form a heterogeneous group. Some may develop ulcerative colitis, others have a limited, benign disease. Twelve patients with isolated proctitis with a mean course of seven years were studied. All patients had a typical clinical picture consisting of a mild and intermittent course of the disease with the presenting symptom of rectal blood loss. At endoscopic examination the inflammatory process was limited to the rectal and distal sigmoid colonic mucosa with a clear upper border beyond which the mucosa of the sigmoid colon was normal. Histologically the mucosal biopsy specimens of the affected rectum resembled those of ulcerative colitis. However, in contrast with proctitis on the base of ulcerative colitis or Crohn's disease, immunoperoxidase staining revealed a markedly increased number of IgE containing cells in the lamina propria of rectal mucosa biopsies. As an IgE-mediated immune mechanism was considered to play a role in this type of proctitis, eight of the 12 patients were treated with oral administration of disodium cromoglycate (DSCG). All patients were improved by the drug. The remaining four patients with mild proctitis did not require treatment. We concluded that, in patients with isolated proctitis on clinical and immunopathological criteria, a group can be separated which responds to DSCG, a condition for which we suggest the name 'allergic proctitis'.

Adult↗
PubMed2001

Argon plasma coagulation is an effective treatment for refractory hemorrhagic radiation proctitis.

INTRODUCTION: Chronic radiation proctitis complicating pelvic radiotherapy can be debilitating. It commonly presents with rectal bleeding, which can be difficult to control. Medical management of hemorrhagic radiation proctitis is not very successful, although surgery carries high risks. Thus, endoscopic treatments are preferred. The aim of this study is to assess the efficacy of argon plasma coagulation applied endoscopically to treat hemorrhagic radiation proctitis that has been refractory to topical formalin therapy. METHODS: Twelve patients who had ongoing bleeding from radiation proctitis, after previously failed formalin therapy, underwent endoscopic treatment using argon plasma coagulation. The efficacy of treatment was assessed by grading the frequency and severity of bleeding (0-4, 0 being no bleeding), hemoglobin level, and transfusion requirements. RESULTS: At a median follow-up of 11 months, ten patients (83 percent) had a significant reduction in the severity and frequency of bleeding, with complete cessation in six (50 percent). The presence of coexistent radiation-induced sigmoiditis in two patients was associated with reduced but persistent bleeding, because of difficulty in targeting the bleeding sites in the sigmoid colon. The median number of treatment sessions per patient was two (range, 1-3), with the number of sessions correlated with the extent of the proctitis. All patients had an improvement in their hemoglobin level, with the mean increasing from 11.2 to 12.3 g/dl. In the six months before starting therapy, all patients had been taking iron supplements, and four had required blood transfusions (median 3 units, range, 2-6). Iron supplements were ceased four weeks after the completion of therapy in all cases, and no further transfusions were required during the study period. None of the patients experienced any significant side effects or complications. CONCLUSIONS: Argon plasma coagulation is an effective and safe treatment for hemorrhagic radiation proctitis that has been refractory to topical formalin therapy.

Aged↗
PubMed2000

Argon plasma coagulation for the treatment of hemorrhagic radiation proctitis.

BACKGROUND AND STUDY AIMS: Chronic radiation proctitis is a complication of radiotherapy for malignant pelvic diseases. Rectal bleeding caused by radiation proctitis is difficult to manage. Argon plasma coagulation (APC) is an electrocoagulation technique that appears to be an effective and low-cost alternative to the use of lasers in gastrointestinal endoscopy. The aim of this study was to evaluate the efficacy of APC, as well as patients' tolerance of the procedure, in the treatment of bleeding radiation-induced proctitis. PATIENTS AND METHODS: The charts of 16 patients with chronic radiation proctitis were analyzed retrospectively. Their average age was 73.5 (range 62-80). Fifteen patients had prostate cancer, and one had uterine cancer. The average time to onset of symptoms after radiotherapy was 15 months (range 6-36 months). All patients had intermittent or daily rectal bleeding, and three patients needed blood transfusions. The severity of bleeding was graded from 0 to 4. APC treatment was administered every month; the argon gas flow was set at 0.6 l/min with an electrical power setting of 40 W. RESULTS: All patients were improved with APC treatment. A mean of 3.7 sessions was necessary to relieve symptoms. APC therapy resulted in a reduction in the mean severity score from 2.4 to 0.6. Seven patients had no recurrent rectal bleeding, and the bleeding was significantly reduced to occasional and negligible spotting (less than one bleeding episode per week) in nine patients. None of the patients required transfusions after treatment. During the follow-up period (average 10.7 months, range 8-28 months), one patient had a recurrence of rectal bleeding that required two repeat sessions. The tolerance was good, with no long-term treatment-related complications. CONCLUSIONS: APC is an effective, safe and well-tolerated treatment for rectal bleeding caused by chronic radiation proctitis. It should be considered as a first-line therapy for radiation proctitis.

Aged↗
PubMed1992

Idiopathic ulcerative proctitis may be the initial manifestation of Crohn's disease.

Of 213 patients with proctitis of all etiologies seen between 1977 and 1987, we studied an original cohort of 96 patients with idiopathic ulcerative proctitis (mean follow-up of 62 months). The diagnosis was made according to strict inclusion criteria, and all cases with any initial feature suggestive of Crohn's disease were excluded. Follow-up showed that 13 patients (13.6%) eventually progressed to Crohn's disease, usually within the first 3 years of the initial diagnosis of idiopathic ulcerative proctitis. Their clinical, endoscopic and histological features at initial presentation were indistinguishable from those in whom the diagnosis remained that of idiopathic ulcerative proctitis. In nine of 13 of these patients (70.0%), the clinical course was characterized by a more protracted course and a poorer response to standard treatment. Such features were not found in those in whom the diagnosis of idiopathic ulcerative proctitis was maintained. Clinicians should be aware that Crohn's disease may present initially as apparent idiopathic ulcerative proctitis.

Adolescent↗
PubMed1995

Proctitis after conventional external radiation therapy for prostate cancer: importance of minimizing posterior rectal dose.

PURPOSE: To identify factors associated with the prevalence of radiation proctitis in patients with prostate cancer treated with external radiation therapy and to determine if a dose-response relationship exists. MATERIALS AND METHODS: The study included 101 prostate cancer patients treated at the University of Minnesota Hospital and Clinics between 1970 and 1987. Radiation therapy at a daily dose of 175-200 cGy was given for 5 consecutive days per week for 7 weeks with a 10-24-MV linear accelerator. Mean dose to the prostate was 6,795 cGy (range, 5,579-7,417 cGy). Simulation radiographs obtained with rectal barium were analyzed in 51 patients. Doses were calculated at specific points in the boost field. RESULTS: Radiation proctitis developed in 19 patients. No pretreatment or treatment factors were associated with a higher prevalence of proctitis. Statistically significant correlation (P < .042) was found between the development of proctitis and dose to the posterior rectum. At chi 2 analysis, proctitis was statistically significantly (P < .005) associated with posterior rectal doses of > 5,000 cGy. CONCLUSION: A high posterior rectal dose (> 5,000 cGy) is associated with increased prevalence of proctitis after radiation therapy.

Aged↗
PubMed2003

Conservative therapies for hemorrhagic radiation proctitis: a review.

Chronic radiation proctitis represents a challenging condition seen with increased frequency due to the common use of radiation for treatment of pelvic cancer. Hemorrhagic radiation proctitis represents the most feared complication of chronic radiation proctitis. There is no consensus for the management of this condition despite the great number of clinical approaches and techniques that have been employed. Rectal resection represents an available option although associated with high morbidity and risk of permanent colostomy. The effectiveness of nonoperative approaches remains far from desirable, and hemorrhagic recurrence represents a major drawback that leads to a need for consecutive therapeutic sessions and combination of techniques. We conducted a critical review of published reports regarding conservative management of hemorrhagic chronic radiation proctitis. Although prospective randomized trials about hemorrhagic radiation proctitis are still lacking, there is enough evidence to conclude that topical formalin therapy and an endoscopic approach delivering an argon plasma coagulation represent available options associated with elevated effectiveness for interruption of rectal bleeding in patients with chronic radiation proctitis.

Chronic Disease↗
PubMed2001

Diverting loop colostomy for the treatment of refractory gastrointestinal bleeding secondary to radiation proctitis.

Chronic radiation proctitis is an uncommon and serious complication of radiotherapy for pelvic malignancies. It has been suggested that fecal stream diversion decreases bowel irritation, resulting in decreased rectal bleeding. We report on the outcome of patients after a diverting loop colostomy for the treatment of severe radiation proctitis. All consecutive patients with chronic proctitis treated with diverting loop colostomy for bleeding at one institution between October 1991 and June 1999 were studied. Four patients presented with rectal bleeding and diarrhea, and two patients had only bleeding. The mean dose of radiation received was 6,115.11 +/- 955.11 rad. Symptoms of chronic proctitis appeared at varying intervals of time after radiation, ranging from 14 months to 17 years. There were no operative complications. During follow-up (36 +/- 29 months), only one of nine patient continued to bleed. Four patients died during the study (cancer relapse, two patients; heart failure, one patient; one death was caused by severe radiation proctitis). Diverting sigmoid loop colostomy, when performed in properly selected patients with severe bleeding secondary to radiation proctitis refractory to medical management, is well tolerated and effective.

Aged↗
PubMedDate not supplied

[Course and natural history of idiopathic ulcerative proctitis in adults].

BACKGROUND AND AIMS: Epidemiological studies have shown that ulcerative proctitis represents 25-55% of ulcerative colitis. In western countries, the incidence of ulcerative proctitis has been increased, while the incidence of more extensive colitis remained unchanged. Compared with extensive ulcerative colitis, the idiopathic proctitis seems to be a benign disease, with an extension to proximal segments in less than 30% of cases, low surgical and cancer risk. On the basis of epidemiological studies, not confirmed by endoscopic and histological features, it has been hypothesized that ulcerative colitis and proctitis could represent two different clinical entities. The aim of the study was to evaluate some clinical and demographic features related to the two different localizations, colitis and proctitis, in the attempt to clarify the above mentioned issues. METHODS: Demographic data of 156 patients observed in our institution from 1982 to 1999, were retrospectively analysed. Diagnosis, extension and severity of ulcerative procto-colitis were based on endoscopic and histological criteria. Local and systemic symptoms, extraintestinal manifestations, surgical and cancer risk, were also recorded. RESULTS AND CONCLUSIONS: Ulcerative proctitis has shown to be a benign disease, with a prevalence of local symptoms, less systemic and extraintestinal manifestations, and low endoscopic grades of activity. Furthermore no surgical intervention and cancer development were recorded. Extension to proximal segments was observed in 10.25% of cases. Young age of onset of symptoms,-smoking and appendectomy were associated to an higher risk of extension of the disease.

Adolescent↗
PubMed1988

Empirical therapy for the management of acute proctitis in homosexual men.

An effective empirical treatment regimen would provide a more rapid and less expensive approach to the management of homosexual men with acute proctitis. We conducted a randomized trial in 129 homosexual men who presented with acute proctitis, comparing treatment with an empirical regimen (4.8 million U of aqueous penicillin G procaine intramuscularly and 1.0 g of probenecid orally, followed by 100 mg of oral doxycycline twice daily for seven days) with specific therapy for each infection as it was recognized. Therapy with the empirical regimen resulted in more rapid resolution of the symptoms of proctitis, the objective signs of proctitis, and the infecting microorganisms. However, nearly one fourth of the patients, primarily those with unrecognized herpes simplex virus proctitis, did not respond to empirical therapy. We recommend empirical therapy coupled with appropriate pretreatment diagnostic testing for the initial management of acute proctitis in homosexual men with no clinical evidence of acquired immunodeficiency syndrome or AIDS-related complex.

Adolescent↗
PubMed2002

Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis.

BACKGROUND: Chronic radiation proctitis (inflammation of the rectum) may develop after the completion of pelvic radiotherapy. Presently there is no recommended standard management. OBJECTIVES: To assess the effects of various non-surgical treatment options for the management of late chronic radiation proctitis. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, issue 1, 2001, MEDLINE 1966 to 2001, EMBASE 1980 to 2001, CANCERCD 1980 to 2001, Science Citation Index 1991 to 2001, CINAHL 1982 to 2001, as well as sources of grey literature. We also hand searched relevant textbooks and contacted experts in the field. SELECTION CRITERIA: Studies (preferentially randomised controlled trials) of interventions for the non-surgical management of late radiation proctitis in patients who have undergone pelvic radiotherapy as part of their cancer treatment. DATA COLLECTION AND ANALYSIS: The inclusion criteria were independently applied by two of the reviewers (AD and EJM) and where there was disagreement this was resolved by involving a third reviewer to form a consensus. MAIN RESULTS: Six randomised controlled trials were included. None of the trials compared anti-inflammatories with placebo. However rectal sucralfate showed greater clinical improvement for proctitis than anti-inflammatories (odds ratio 14.00, 95% confidence interval 1.46 to 134.26; n=1 study), though no difference was seen for endoscopic improvement (odds ratio 2.74, 95% confidence interval 0.64 to 11.76, n=1 study). The addition of metronidazole to the anti-inflammatory regime also appeared to improve the response rate, as measured by the reduction in rectal bleeding, diarrhoea, erythema and ulceration (n=1 study). Similarly rectal hydrocortisone appeared to be more effective than rectal betamethasone for clinical improvement although no difference was seen in endoscopic improvement (n=1 study). Short chain fatty acid enemas did not appear to be effective compared to placebo (n=2 studies). In the comparison of the heater probe and bipolar electrocautery (n=1 study), there was no discernible difference for severe bleeding after one year, but the heater probe demonstrated a greater increase in the haematocrit and reduced transfusion requirements. REVIEWER'S CONCLUSIONS: Late radiation complications are a relatively rare manifestation, with many potential carers and poor diagnostic criteria. Although certain interventions look promising and may be effective (such as rectal sucralfate, adding metronidazole to the anti-inflammatory regime and heater probes), single small studies (even if well conducted) provide insufficient evidence. The episodic and variable nature of late radiation proctitis also requires placebo controlled studies to establish whether particular treatments are effective. Regional or centralised registers of radiation toxicity should be established so that interventions can be administered in the setting of multi-centre trials with specific entry criteria, formal baseline and therapeutic assessments providing standardised outcome data including quality of life evaluations.

Anti-Inflammatory Agents↗
PubMed1991

Ulcerative proctitis in central Sweden 1965-1983. A population-based epidemiological study.

Ulcerative proctitis has by tradition been regarded as a subgroup of ulcerative colitis. Population-based epidemiological studies of ulcerative proctitis are, however, virtually nonexistent. In an epidemiological study of inflammatory bowel disease in the Uppsala Health Care Region, 1065 cases of ulcerative proctitis were diagnosed from 1965 through 1983. Males predominated, with the male to female ratio 1.4:1. Annual incidence rates were higher in urban than in rural areas. The annual incidence rates increased threefold from 2.8 per 10(5) to 6.6 per 10(5) during the period, affecting all age groups over 14 years of age, in both urban and rural areas and in both sexes. Differences in temporal trends and certain other epidemiological characteristics between ulcerative proctitis and extensive ulcerative colitis suggest that ulcerative proctitis is a specific disease whose etiology differs from that of extensive ulcerative colitis.

Adolescent↗
PubMedDate not supplied

Electrorectography in chronic proctitis.

Rectal electrical activity, measured by electrorectography (ERG), was studied in 18 patients with chronic proctitis (11 ulcerative and 7 bilharzial proctitis). Mean age was 36.6 +/- 9.4 (SD) years. Eight healthy volunteers were included as controls. Monopolar recordings were made from silver-silver chloride electrodes situated 1 cm from the tip of the catheter, which was applied to the rectal mucosa. Signals from the electrode were displayed on a U-V recorder. Rectal neck and rectal pressures were recorded simultaneously. Pacesetter potentials (PP) were also recorded from all subjects. The healthy volunteers had a mean frequency of 2.6 +/- 0.6 cycles per minute (cpm), an amplitude of 2.4 +/- 0.5 mV, and a velocity of 4.3 +/- 0.5 cm/sec. The potentials had the same frequency and regular rhythm when the test was repeated and were followed randomly by bursts of action potentials (AP). The rectal pressure increased simultaneously with the AP. In the proctitis patients the PP frequency was higher than normal (mean 8.2 +/- 1.6 cpm in patients with bilharziasis and 8.9 +/- 2.1 cpm in those with ulcerative proctitis) (p < 0.001), whereas the amplitude and velocity were lower than normal (p < 0.05 and p < 0.01, respectively). APs had higher frequency and amplitude and were accompanied by higher rectal pressure than in the normal volunteers. The increased PP, or tachyrectia, may be due to rectal wall or rectosigmoid pacemaker irritation caused by proctitis, whereas the diminished amplitude and velocity may be caused by a diseased rectal wall. The increased AP frequency and amplitude seem to cause increased rectal contractile activity with a resulting tenesmus.(ABSTRACT TRUNCATED AT 250 WORDS)

Action Potentials↗
PubMed1997

A phase III double-blind randomised study of rectal sucralfate suspension in the prevention of acute radiation proctitis.

BACKGROUND AND PURPOSE: A limited number of studies have suggested that oral sucralfate reduces the acute and late gastro-intestinal side-effects of pelvic radiotherapy and sucralfate enemas ameliorate symptoms of chronic proctitis. Sucralfate may act via local bFGF at the mucosal level in promoting angiogenesis and reducing epithelial associated microvascular injury. This multi-institutional study was designed to test the hypothesis that sucralfate given as an enema would have a significant protective effect against acute radiation induced rectal injury by direct application to the mucosa. MATERIALS AND METHODS: Eighty-six patients having radiotherapy for localised carcinoma of the prostate were randomised in a double-blind placebo-controlled study to receive either 15 ml of placebo suspension or 3 g of sucralfate in 15 ml suspension, given as a once daily enema during and for 2 weeks following radiotherapy. Assessment was based on the EORTC/RTOG acute toxicity criteria and a patient self-assessment diary. RESULTS: There was no significant difference between placebo and sucralfate for peak incidences of EORTC/RTOG proctitis. For the placebo and sucralfate arms 95 and 88% (difference 7 +/- 11%) suffered some degree of proctitis, with 71 and 61% (difference 10 +/- 19%) reaching grade 2, respectively. The median period to onset of grade 2 proctitis was 33.5 and 36 days, with the median duration being 9.5 and 15 days, respectively, again these difference being non-significant. Thirty-five and 37% of patients rated the effect of radiotherapy on bowel habit as 'a lot' with a moderate or severe effect on normal daily living in 52 and 49%, respectively. CONCLUSION: This study suggests that sucralfate given as a once daily enema does not substantially reduce the incidence of symptoms associated with acute radiation proctitis and its routine clinical use cannot be recommended. This cohort of patients will be followed to determine if any difference develops in relation to late toxicity.

Acute Disease↗