View clinical trials related to Diverticulitis.
Filter by:The first objective (LOLA) of this integrated trial is to determine whether laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy in patients with perforated diverticulitis with purulent peritonitis in terms of mortality and major morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with anastomosis or sigmoidectomy with end-colostomy is the superior approach in patients with perforated diverticulitis with either purulent or faecal peritonitis in terms of stoma free survival. The study is designed as a multicenter and randomised trial.
Patients were recruited over a four year period from 1996 to 1999. Those admitted in the years 1996 and 1997 were retrospectively accrued from the clinical records, while patients treated between 1998 and 1999 patients were entered on the database prospectively on admission. Inclusion criteria All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) either alone or in combination and/or by operative findings, entered the study. The CT criteria for the diagnosis included a localized thickening (≥4 mm) of the colonic wall and signs of inflammation of the pericolic fat, with abscess and/or extraluminal air and/or extraluminal contrast. The criteria for ultrasound included at least two of the following signs: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema, intramural or pericolic inflammatory mass, intramural fistula. The diagnostic criteria for water soluble contrast enema included segmental luminal narrowing and a tethered mucosa with or without a mass effect or extravasation of contrast and/or the presence of extraluminal air. Exclusion criteria Patients with inflammatory bowel disease, irritable bowel syndrome, colorectal cancer or diseases precluding adequate follow up, were excluded from the study. Treatment Patients were treated conservatively (antibiotics, I.V. nutrition, CT/US guided abscess drainage) or surgically according to the local policy of each center. Follow up Follow up was carried out according to local policy. The following data were collected: persistence or recurrence of chronic symptoms attributable to complicated diverticular disease, new episodes of AD, new hospital admissions for AD, type of treatment and outcome. Recurrence was defined as a new episode of AD requiring hospitalization that occurred at least 2 months after complete resolution of the index episode which resulted in inclusion in the study. If surgery was performed, the timing, type of procedure, Hinchey stage and complications were recorded. Data collection A standardized flow sheet was used to collect data on medical history, diagnostic work up, type of treatment and follow up to create a dedicated database. Gender, age, date of hospital admission and discharge, diagnosis on admission and discharge, co-morbidities (diabetes mellitus, cardiovascular disease, atherosclerosis, liver or renal failure), symptoms experienced before admission and their duration, history of diverticulosis, previous episodes of AD, laboratory tests, and treatment performed were recorded. Where surgery was performed, the date and type of procedure, the operative findings including Hinchey's classification (16) and details of the operation (incision, extension of resection, type of anastomosis, covering stoma, drains), pathology report, and postoperative complications occurring within 30 days, were all recorded. End points The primary endpoint was to assess the rate of recurrence of AD requiring hospitalization during the follow-up period. Additional endpoints were to assess the risks of emergency surgery, stoma and disease-related mortality during the follow up.
This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.
The purpose of this multi-center randomized trial is to identify any differences in the complication rates of patients undergoing Hartmann's (end colostomy) versus Primary Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the stoma reversal operation).
The aim of this study is to evaluate the effectiveness and the tolerability of the Lactobacillus reuteri in the control of the diverticular disease symptoms and in the prevention of acute diverticulitis episodes.
Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.
Rationale The prevalence of colonic diverticular disease is increasing in Western countries. Approximately 10 to 25% of patients with diverticular disease will eventually develop an episode of acute diverticulitis. Currently conservative treatment often includes antibiotic therapy. This advice lacks sound evidence and is merely based on experts' opinion. An old clinical dogma is being clarified with this randomized trial. Objective Primary objective is to evaluate whether or not using antibiotics reduces to time to full recovery of an attack of uncomplicated (mild) diverticulitis. Secondary objectives are to evaluate complications, quality of life, readmission rate, recurrence rate, medical and non-medical costs, and antibiotic resistance/sensitivity in both groups. Hypothesis The investigators hypothesis is that in the treatment of uncomplicated (mild) acute diverticulitis, supportive treatment without antibiotics is a more cost-effective approach than conservative treatment with antibiotics with respect to time-to-recovery as primary outcome. Study design A randomized, open label, multicenter clinical trial comparing treatment of acute uncomplicated diverticulitis with antibiotics to observation and supportive care alone. Study population Patients 18 years or older are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. Intervention Conservative strategy with antibiotics: supportive measures and at least 48 hours of intravenous antibiotics (and therefore admittance to the hospital) and subsequently switch to oral antibiotics if tolerated (total duration of 10 days). Control Liberal strategy without antibiotics: supportive measures only. Observation and oral intake as tolerated. Admittance only if discharge criteria are not met on presentation. Main study parameters/endpoints The primary endpoint is time-to-recovery with a 6-month follow-up period. Secondary endpoints are occurrence of complicated diverticulitis requiring surgery or percutaneous treatment, morbidity, health related quality of life, readmission rate, recurrence rate, medical and non-medical costs, and antibiotic resistance/sensitivity.
The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.
This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery. Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group). Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia. Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.
After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.