Pathology underrates colon cancer extranodal and nodal metastases; ex vivo radioimmunodetection helps staging.

PURPOSE: Colorectal carcinoma is frequently accompanied by small lymph nodes metastases that often escape pathologic examination. We evaluated whether ex vivo radioimmunodetection with the Affinity Enhancement System (AES) could improve detection of mesocolonic metastases. EXPERIMENTAL DESIGN: A bivalent 111In-labeled hapten was injected (16 patients) 4 days after a bispecific antibody (anticarcinoembryonic antigen, antihapten). Surgery was done 1 to 3 days later, and radioactive uptake in the mesocolon was recorded. Extensive pathologic examination of the mesocolon (reference method) was done after fat dissolution. This method visualizes all lymph nodes but is not in routine use. RESULTS: The reference method disclosed 705 nodes. There was no significant difference between the number of node metastases detected by AES or by the reference method (16 versus 17). Better detection would have been obtained by AES than by routine pathology (P<0.01). In addition 12 extranodal metastases were found in this study of which eight were detected by AES. The prognostic importance of such extranodal metastases has been underlined in the literature. Routine pathology combined with AES would have disclosed all node metastases and 86% of total metastases versus 35% by routine pathology alone. CONCLUSIONS: Ex vivo radioimmunodetection could improve nodal and extranodal metastases detection in patients with colorectal cancer. Its value for improving pathologic analysis, together with the effect of these small metastases on prognosis, should be further evaluated. The benefit of adjuvant chemotherapy for patients upstaged with radioimmunodection should also be assessed because adjuvant chemotherapy improves the 5-year survival of stage III patients.

Time course of behavioral changes following basal forebrain cholinergic damage in rats: Environmental enrichment as a therapeutic intervention.

The present experiment was designed to study changes in behavior following immunolesioning of the basal forebrain cholinergic system. Rats were lesioned at 3 months of age by injection of the 192 IgG-saporin immunotoxin into the medial septum area and the nucleus basalis magnocellularis, and then tested at different times after surgery (from days 7-500) on a range of behavioral tests, administered in the following order: a nonmatching-to-position task in a T-maze, an object-recognition task, an object-location task, and an open-field activity test. The results revealed a two-way interaction between post-lesion behavioral testing time and memory demands. In the nonmatching-to-position task, memory deficits appeared quite rapidly after surgery, i.e. at a post-lesion time as short as 1 month. In the object-recognition test, memory impairments appeared only when rats were tested at late post-lesion times (starting at 15 months), whereas in the object-location task deficits were apparent at early post-lesion times (starting from 2 months). Taking the post-operative time into account, one can hypothesize that at the shortest post-lesion times, behavioral deficits are due to pure cholinergic depletion, while as the post-lesion time increases, one can speculate the occurrence of a non-cholinergic system decompensation process and/or a gradual degeneration process affecting other neuronal systems that may contribute to mnemonic impairments. Interestingly, when middle-aged rats were housed in an enriched environment, 192 IgG-saporin-lesioned rats performed better than standard-lesioned rats on both the nonmatching-to-position and the object-recognition tests. Environment enrichment had significant beneficial effects in 192 IgG-saporin-lesioned rats, suggesting that lesioned rats at late post-lesion times (over 1 year) still have appreciable cognitive plasticity.

[Fecal incontinence following anal sphincter rupture: influence of the aetiology on the repair results]. / Incontinence anale par rupture sphinctérienne: rôle de l'étiologie dans la qualité des résultats après réparation chirurgicale.

UNLABELLED: Short-term functional results are usually good after sphincter repair but they could deteriorate with time if the disruption is due to obstetric damage. The aim of this study was to compare short and long-term results after sphincter repair according to the etiology of the damage. METHODS: Fifty-five women have been operated on for a sphincter disruption due to obstetrical damage (Ob) (28) or to postoperative damage (Op) (27) and were retrospectively studied. Surgical procedure was similar for every patients but the puborectalis muscle was also approximated in case of obstetric damage. Functional results were recorded by clinical examinations two months after the operation and during the year 2001. RESULTS: The two groups were similar, except for the rate of defunctionning stoma undergone and for the duration of symptoms before the operation. Mortality and morbidity were similar between the two groups. Short-term functional results were better in the postoperative group (96 vs 78%) (P =0.05). At the end of the follow-up the results remained significantly better in group Op (85 vs 65%; P <0.05). The cumulative rates of functional good results also decreased more rapidly in group Ob but the difference was not significant. CONCLUSION: Short and long-time functional results after sphincter repair seem to be better in case of postoperative disruption. Pudendal nerve damages frequently observed after traumatic delivery could explain this difference.

Reversal of abnormal collagen production in Crohn's disease intestinal biopsies treated with regenerating agents.

BACKGROUND: Crohn's disease (CD) is characterised by inflammation, muscle layer overgrowth, and collagenous fibrosis of the intestinal tract, with no effective therapy against collagen accumulation. AIMS: We quantified production of collagen in resection specimens from normal and CD patients and investigated the effect of regenerating agents (RGTAs) on collagen production. RGTAs are chemically substituted dextrans engineered to mimic the growth factor protecting effects of heparan sulphates. RGTAs have been shown to enhance tissue repair in various in vivo models and to modulate in vitro collagen phenotype differentially according to their structure. PATIENTS: We studied intestinal biopsies from two groups of CD patients: treated with glucocorticoids (CD-GC group: 10 patients) or not treated (CD group: seven patients), and from seven control patients. METHODS: After 24 hours of ex vivo incubation with (3H) proline, collagen I, III, and V were extracted by pepsin and quantitatively separated by sodium dodecyl sulphate-polyacrylamide gel electrophoresis. Biosynthesis of each collagen type was quantified on radiolabelled isolated collagen. RESULTS: Total intestinal collagen production in CD patients compared with controls was increased up to 3.5-fold overall (p<0.001). In particular, collagen III biosynthesis was enhanced by 6.2-fold (p<0.001) in CD patients. In the CD-GC group, collagen production abnormalities were less marked. RGTAs added to the incubation medium in the CD group decreased total collagen production by 50% and decreased collagen III synthesis by 76%. CONCLUSION: This finding offers a rationale for using RGTAs in the treatment of intestinal fibrosis in CD, thus opening up a potential new therapeutic field for this family of drugs.

Comparative anatomical study of division of the ileocolic pedicle or the superior mesenteric pedicle for mesenteric lengthening.

BACKGROUND: Lengthening of the mesentery by vascular division may be necessary to perform an ileal pouch-anal anastomosis without tension. The aim of this study was to compare, in fresh cadavers, the increase in mesentery length after division of the ileocolic pedicle (ICP) and the superior mesenteric pedicle (SMP). METHODS: Total colectomy was performed in 12 fresh cadavers, which were then randomly divided into two groups. Pouch-anal anastomosis was performed with division of the ICP in one group of six cadavers and with division of the SMP in the other. The ileum was measured and the increase in length was recorded and compared statistically. RESULTS: The mean(s.d.) increase in length was 3.0(0.8) cm after ICP division and 6.5(1.1) cm after SMP division (P < 0.001). The distance between the end of the ileum and the point giving the greatest length was 25.5(5.0) cm in the ICP group and 46.8(4.2) cm in SMP group (P < 0.001). CONCLUSION: In fresh cadavers, the increase in mesenteric length was greater after SMP division than after ICP division, but if pouch-anal anastomosis is performed a short segment of small bowel must be removed.

[Direct and reservoir colonic-anal anastomoses. Short and long term results]. / Anastomoses colo-anales directes et avec réservoir. Résultats à court et à long-terme.

STUDY AIM: This retrospective study was designed to assess the operative, oncologic and functional results of total proctectomy with coloanal anastomosis (CAA). PATIENTS AND METHOD: Between 1990 and 1994, 81 patients (44 males/37 females: mean age: 59 years) were operated for a cancer (n = 67) or a benign lesion (n = 14) of the rectum. Sixty-four patients had a straight CAA and 17 patients had a colonic J-pouch. RESULTS: There was no operative mortality. Two patients were reoperated for colonic necrosis and underwent abdominoperineal resection. An anastomotic leak was observed in 11 patients and its severity was decreased by a diverting stoma. An anastomotic stricture was observed in 10 patients. Of the 67 patients with cancer, 19 (28%) developed metastases and 11 (16%) developed local recurrence. The 5-year survival rate was 69%. Twelve months after the operation, continence was similar with the two types of CAA, but the mean daily stool frequency was lower in patients with a reservoir. With a long follow-up (mean = 9 years), functional results were good with regard to continence and stool frequency, almost similar with the two types of CAA; functional disorders (noctumal stools, fragmentation, urgency) were reported by 25 to 40% of patients. CONCLUSION: Total proctectomy with coloanal anastomosis yields good oncologic results. With regard to functional results, the superiority of the colonic J-pouch, which is observed in the first postoperative year, was lost beyond this period; long-term results are good for continence and stool frequency, but some disorders persist in a significant proportion of patients.

[Surgical treatment of Crohn's disease of the large intestine: do rectal complications influence the results of ileorectal anastomosis?]. / Traitement chirurgical de la maladie de Crohn du gros intestin: l'atteinte rectale influence-t-elle les résultats de l'anastomose iléorectale?

STUDY AIM: The purpose of this retrospective study was to compare the morbidity and long-term outcome of patients undergoing total colectomy and ileorectal anastomosis (IRA) performed for Crohn's colitis with or without associated proctitis. PATIENTS AND METHODS: Thirty-nine patients with a mean age of 35 years (17-72 years) underwent total colectomy with IRA. Patients were retrospectively classified into two groups; group 1 (28) without rectal involvement; group 2 (11) with proctitis. Follow-up data were obtained during 1998, by reviewing all patients. Mean postoperative follow-up was 10.6 years (1.5-22). RESULTS: There were no postoperative deaths. Six (15%) patients experienced postoperative complications, with no difference between the two groups. Sixteen patients (41%) developed recurrence requiring surgery: 9 in group 1 (32%) and 7 in group 2 (64%) (p > 0.05). The IRA had to be removed or was no longer functional in 12 patients: 6 in group 1 (21.5%) and 6 in group 2 (54.5%) (p < 0.05). CONCLUSION: Moderate proctitis does not increase the morbidity of total colectomy with IRA for Crohn's disease. The risk of reoperation and secondary protectomy is higher when proctitis was present, but the IRA was still functional in one-half of patients after more than 10 years of follow-up.

[Atypical metastatic sites in rectal cancer]. / Localisations métastatiques atypiques d'un cancer du rectum.

We report the case of a 48-year-old woman operated on for rectal carcinoma and subsequently for metastasis located in three unusual sites (i.e., laryngeal, muscular and cutaneous). Three months after the last surgery, the patient was still alive, without any detectable metastasis.

[Posterior rectopexy in total rectal prolapse-]. / Rectopexie selon orr-loygue dans le prolapsus total du rectum.

STUDY AIM: The aim of this retrospective study was to report the results of posterior Orr-Loygue rectopexy in 55 patients operated on for rectal prolapse. PATIENTS AND METHOD: From 1986 to 1997, 114 patients were operated on for rectal prolapse and 55 had an Orr-Loygue operation. There were 47 women and 8 men (mean age: 55 years). Twenty-five patients (45%) had fecal incontinence, 26 (47%) described preoperative 'constipation'. The procedure was performed under general anesthesia, through laparotomy in 51 patients, through laparoscopy in 4 patients. Resection of sigmoid colon was associated to rectopexy in four patients. RESULTS: Mortality rate was 0 and morbidity rate 12%. Mean hospital stay duration was 13.5 days. Mean follow-up was 63 months and at the end of the study, four patients (7%) had recurrence, 5/25 patients had still incontinence; 55% of the patients had unchanged postoperative bowel function, 22% described improvement (including the four patients with resection-rectopexy) but 38% (21/55) suffered from postoperative 'constipation'. The rate of 'constipation' induced or majored by rectopexy was 22% but the functional trouble described appeared often complex. CONCLUSION: Posterior Orr-Loygue rectopexy is the operation recommended for patients in good general condition, especially if fecal incontinence is associated. In the course of the procedure, preservation of pelvic nerves and hypogastric plexus, and positioning of the strips not too tight between the anterolateral rectal walls and promontory must be emphasized. Posterior Orr-Loygue rectopexy is contraindicated when general anesthesis is too risky and when bowel dysfunction and/or rectal exoneration dysfunction are present.

Long-term functional results of colonic J pouch versus straight coloanal anastomosis.

BACKGROUND: There are very few studies evaluating the long-term functional outcome of coloanal anastomoses. This retrospective study aimed to compare long-term functional results of straight and colonic J pouch anastomoses. METHODS: Thirty-seven patients, 25 with a straight anastomosis and 12 with a J pouch anastomosis, responded to a standardized telephone questionnaire. The mean time since surgery was 10 (range 4-18) years. RESULTS: The mean daily stool frequency was similar in both groups of patients (1.1 in patients with a reservoir, 1.5 in patients with a straight anastomosis). In both groups, two-thirds of patients had perfect continence or limited gas incontinence. Faecal incontinence was reported by two patients with a straight anastomosis and one patient with a pouch. Nocturnal stools and fragmentation were slightly more frequent in patients with a straight anastomosis. Half of the patients regularly used medication. Thirty-five of the 37 patients reported satisfaction with functional results. CONCLUSION: Long-term functional results of coloanal anastomoses are satisfactory and, unlike early results, similar for both types of anastomosis. The functional benefit of a reservoir, seen in the first year after operation, is less evident with increasing time.

Small intestine protection from radiation by means of a removable adapted prosthesis.

BACKGROUND: A prosthesis has been designed to protect intestinal loops from radiation when postsurgical radiotherapy is necessary in cancer treatment. It is a silicone balloon that allows the small bowel to be pushed back away from the radiation field, and it is easily removed at the conclusion of radiotherapy. METHODS: The device was used in 22 patients: 5 retroperitoneal tumors and 17 pelvic cancers. After surgical resection of the tumor, the device is placed either in the retroperitoneal area or in the pelvic cavity. A polyglactine 910 mesh is placed between the spacer and the bowel to prevent incarceration of the loops. The prosthesis can be filled or emptied between each radiation course and finally removed by means of a short incision under local or locoregional anesthesia. RESULTS: The tolerance of the small intestine to radiation therapy has been satisfactory in each case, with a mean follow-up of 24.5 months (range 10 to 73). No modification of biological parameters was observed during the pelvic radiation therapy at 30, 45, and 65 Gy. CONCLUSION: This device should appears to efficient for prevention of bowel injury during postsurgical radiation in successful treatment of abdominal, pelvic, or retroperitoneal tumors when indicated.

[Contribution of telemedicine applied to digestive cancer]. / Apport de la télémédecine appliquée à la cancérologie digestive.

AIM OF THE STUDY: Telemedicine offers new possibilities for multidisciplinary care of cancer patients, allowing direct communications between different, complementary and geographically distant specialists. Thus, it is possible to form oncology committees in small hospitals where all specialties are not represented. The purpose of this study was to evaluate the medical and economic impact of visioconferences in the therapeutic management of cancer patients without access to oncology centers. MATERIALS: A telemedicine network was created in Paris between the General Surgery and Gastroenterology services of Rothschild Hospital and the services of Oncology at Saint-Antoine Hospital and Radiotherapy at Tenon Hospital. The three hospitals were connected simultaneously (multipoint) by visioconference and thus constituted a pluridisciplinary oncology committee of radiotherapy, chemotherapy and surgery. Eighty seven cases were evaluated in 27 staff conferences. In 48 cases, this consisted of re-evaluating therapeutic decisions made in surgery or gastroenterology, and in 39 cases opinions were requested by surgery (18), gastroenterology (14) or oncology departments (7). RESULTS: In only 34/87 cases therapeutic agreement was reached directly. The 53 other cases (60.9%) were debated. In fact, all 39 requests for opinion in difficult therapeutic decisions resulted in consensus. Among the 48 re-evaluations, disagreement persisted in one case between the surgeon in charge of the patient and the chemotherapist. Importantly, in 13 of 48 cases (27%), the discussion modified the therapeutic protocol initially proposed. The average cost was 118 French Francs per case and per center. Total initial investment was 334,762 French Francs, but the price of some equipment has already dropped from 30 to 60%. CONCLUSION: In our study, the visioconference improved management of cancer patients for a weak working cost.

[Comparison of long-term course of perforating and non-perforating Crohn disease]. / Comparaison de l'évolution à long terme des maladies de Crohn perforantes et non perforantes.

OBJECTIVES: To evaluate the influence of the indication of the first surgical procedure on the prognosis of Crohn's disease. METHODS: We compared retrospectively the long-term course of 179 patients operated on for a perforating disease and 322 patients operated on for a nonperforating disease. Mean follow-up was 11 years and 2 months in the two groups. RESULTS: Forty of 179 (25%) and 106 of 322 (33%) patients with perforating and nonperforating diseases underwent a second intestinal resection, respectively. The patients who had been operated on for a perforating disease were significantly more often reoperated on for the same indication, and conversely. Patients with perforating diseases experienced less second resections (actuarial rates: 37 +/- 11% vs 51 +/- 8% at ten years respectively), less post-surgical handicaps (mean index 24.9 vs 27.9), and fewer patients required immunosuppressive drugs (25 vs 35%). CONCLUSION: Long-term prognosis of perforating Crohn's disease does not appear to be more severe than that of nonperforating disease.

Mesenteric lengthening in ileoanal pouch anastomosis for ulcerative colitis: Is high division of the superior mesenteric pedicle a safe procedure?

PURPOSE: Lengthening of the mesentery is the technical key point of the ileoanal pouch procedure. Division of the superior mesenteric pedicle high in the mesentery is an original artifice that regularly provides sufficient descent of the pouch to reach the dentate line without any tension. A retrospective study compares two groups of patients with ulcerative colitis. METHODS: Group 1 consisted of 21 patients with superior mesenteric pedicle division (mean lengthening, 6.1 cm), and Group 2 consisted of 44 patients without superior mesenteric pedicle division. Mortality and postoperative and late morbidity were studied along with functional outcome. RESULTS: One patient died in Group 2 (postoperative pelvic sepsis); one patient died in Group 1 at six months from late liver transplant complications. Postoperative morbidity was insignificantly less important in Group 1 (P=0.02). Five patients in Group 2 had the pouch removed; none in Group 1 did. Pouchitis episodes developed in both groups, with no significant difference (P=0.5). Three patients in Group 1 developed anastomotic stenosis vs. 8 in Group 2 (P=0.5). Functional results at one-month, one-year, and two-year follow-ups are not significantly different, except that nighttime stool frequency increased in Group 2. CONCLUSIONS: On the whole, morbidity and functional outcome appear similar. This suggests that high superior mesenteric pedicle division has no adverse effect and can be proposed routinely as an effective lengthening technique.

[Colorectal adenocarcinoma in patients under 40 years of age]. / Adénocarcinome colorectal chez le sujet de moins de 40 ans.

OBJECTIVES: The aim of this study was to assess prognosis and treatment of colorectal cancer in young adults. METHODS: In a retrospective review of 1,917 patients with colorectal cancer, 80 patients were under the age of 40 years (4.2%). RESULTS: The mean follow-up was 5.2 years (range: 0-16 years). There was a family history of colorectal cancer in 20% of the patients, either familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC syndrome). Five prognostic factors for the 10 year survival rate were found: stage of tumor in the Astler-Coller classification (A, B1-2, C1-2 and D, 100, 75, 38 and 11% respectively), tumor vascular invasion (16%), poorly differentiated tumors (30%), emergency surgery (21%) and non curative resections (5%). The colon recurrence rate at 8 years was 14% in the case of HNPCC syndrome. The recurrence rate for patients with neither FAP nor HNPCC syndrome was 11.5% at 8 years and for patients alive at 1 year was 16.5%. CONCLUSIONS: In patients under the age of 40 years, a subtotal colectomy, even as a second operation should be considered, if the prognostic factors are favorable. A genetic analysis seems to be essential in the management of these patients.

[Acute basal ganglia necrosis with favorable course during Mycoplasma encepahlitis]. / Nécrose aiguë des noyaux gris d'évolution favorable lors d'une encéphalite à mycoplasme.

BACKGROUND: Acute bilateral striatal necrosis complicating the course of a post-infectious encephalitis is rare. CASE REPORT: A previously healthy 5-year-old boy presented with an atypical pneumonia; he rapidly developed, encephalitis revealed by a generalized status epilepticus. After transient improvement, he became confused and mutic, with dystonic postures of his limbs. Painful stimulation resulted in prolonged facial grimacing and doleful cry. CT scan and MRI showed abnormal signals in the whole basal ganglia, typical of bilateral striatal necrosis. Serologic tests for Mycoplasma pneumoniae were positive. The child recovered almost completely. CONCLUSION: A parainfectious process is probably responsible for the transient bilateral striatal necrosis seen in this patient who had Mycoplasma pneumoniae infection several days before the onset of neurologic symptoms. MRI seemed more reliable than CT-scan for the diagnosis of this condition.

The role of anatomic factors in nutritional autonomy after extensive small bowel resection.

BACKGROUND: It is difficult to predict which patients with a postsurgical short bowel will require long-term parenteral nutrition. METHODS: We performed a retrospective prognostic study for the time to home parenteral nutrition or death from malnutrition (nonautonomy), on the basis of 103 patients with a residual short bowel of 17 to 150 cm. The influence of anatomic variables was summarized through the use of Cox regression model. RESULTS: Of the 103 patients included, 24 lost nutritional autonomy. Three anatomic variables were identified as having independent predictive information; remaining small bowel length (measured on small bowel x-rays; p = .0001), and jejunoileal anastomosis (p = .01) promoted autonomy, whereas end jejunostomy (p = .002) increased the risk of losing nutritional autonomy. CONCLUSIONS: On the basis of these results and on the relative weight of these variables, high-risk patients for loss of nutritional autonomy were defined as those with jejunoileal anastomosis and a remaining small bowel length < 35 cm, patients with jejunocolic anastomosis and remaining small bowel length < 60 cm, and patients with an end jejunostomy and remaining small bowel length < 115 cm. This classification was thereafter validated on a prospective series of 32 patients.

[Prognosis in pancolonic forms of hemorrhagic rectocolitis]. / Pronostic des formes pancoliques de rectocolite hémorragique.

OBJECTIVE: To assess the prognosis of pancolitis in ulcerative colitis including survival, colectomy rate, colon cancer risk, activity of disease, functional and socioprofessional impact. METHODS: Retrospective study of 130 cases of ulcerative pancolitis referred consecutively to Rothschild Hospital from 1962 to 1993. They were 58 men and 72 women. The mean age at onset of ulcerative colitis was 30 years (range: 5-77). The extension to the right colon was secondary in 68% of patients. The period of observation ranged from 0.8 year to 46 years from the onset, with a median of 10.6 years. Three patients were lost to follow up. RESULTS: Eight patients died, the survival rate being 93% at 10 years. Surgical treatment was performed in 85 patients. The cumulative colectomy rates were 61% and 77% at 10 and 20 years respectively. Colonic cancer developed in three patients, corresponding to a cumulative risk after 25 years of 6% in unoperated patients and 1.9% in the whole series. No cancer occurred after colectomy and ileorectal anastomosis. In the group of unoperated patients there was a decrease of activity of the disease during the first fifteen years. The quality of life of colectomized patients with reestablishment of intestinal continuity and of those treated conservatively did not differ significantly. CONCLUSION: In this series, long term prognosis of ulcerative pancolitis was favourable. The high colectomy rate was balanced by a very low risk of colorectal cancer.

Placebo-controlled clinical trial of mesalazine in the prevention of early endoscopic recurrences after resection for Crohn's disease. Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID).

OBJECTIVE: Endoscopic postoperative recurrences occur early after 'curative' surgery for Crohn's disease. Pentasa has been shown to be effective in the maintenance treatment of quiescent Crohn's disease. The aim of this study was to test the efficacy of a 12-week oral intake of Claversal in the prevention of endoscopic recurrences after 'curative' resection for ileal, colonic or ileocolonic Crohn's disease. We conducted a multicentre double-blind controlled trial comparing Claversal (1g tid) with placebo, starting within 15 days after surgery. The macroscopic normality of the two anastomotic segments was assessed at surgery. Patients were clinically and biologically evaluated twice (6-week interval), and colonoscopy was performed at 12 weeks. Endoscopic relapse was defined by any anastomotic ulcerations or stenosis and staged according to a four-grade score. RESULTS: Between May 1989 and May 1991 12 centres included 126 patients, 70 women and 56 men, aged 33 +/- 12 years (range 16-70) in the study. Disease locations were ileal, colonic and ileocolonic in 45, 6 and 49%, respectively. Claversal and placebo groups were similar at inclusion, except for ESR (37 +/- 26 vs. 27 +/- 23 mm/h in the Claversal and placebo groups, respectively; P < 0.05). Nine patients were withdrawn from the study. Adverse reactions occurred only in six patients. Five patients were excluded for protocol violation. Finally, 106 patients could be evaluated at 12 weeks (55 Claversal and 51 placebo). An endoscopic relapse was observed in 50% and 63% of the Claversal and placebo groups, respectively (P = 0.16), with a similar grade distribution. Claversal was well tolerated. CONCLUSIONS: Our study confirms that a large proportion of endoscopic recurrences occur within 3 months of resection in Crohn's disease. There was a slight trend towards greater efficacy of Claversal; it could be worthwhile trying higher dosages and/or 5-ASA compounds with different intestinal release profiles.