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Diverticulitis clinical trials

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NCT ID: NCT06344078 Recruiting - Stoma Ileostomy Clinical Trials

Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).

SIGMA-D
Start date: January 1, 2024
Phase:
Study type: Observational

This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months.

NCT ID: NCT06287671 Not yet recruiting - Colorectal Cancer Clinical Trials

Colorectal Omics and ofCS Proteoglycans

COCO
Start date: April 2024
Phase:
Study type: Observational

This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer. The main questions to answer are: - can these biomarkers predict anastomotic leakages - can these biomarkers predict recurrence after colorectal cancer - can these biomarkers be used as diagnostic tests for colorectal cancer - can these biomarkers be identified in the tumor Participants will undergo elective colorectal resection or stoma closure.

NCT ID: NCT06265649 Recruiting - Diverticulitis Clinical Trials

Comparison of NOM for ACLD Between Medical and Surgical Ward

Start date: January 1, 2024
Phase:
Study type: Observational

In Europe, patients with acute left colon diverticulitis (ALCD) are usually admitted to surgical wards even when only medical treatment is required. The study compares ALCD non-operative management (NOM) between surgical and non-surgical environments regarding clinical outcomes, hospitalization length(LOS), and follow-up.

NCT ID: NCT06254625 Not yet recruiting - Clinical trials for Diverticulitis, Colonic

Fecal Transplantation in Patients Colonic Diverticulitis

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to investigate the safety and effect of fecal microbiome transplantation (FMT) in patients with a former episode of acute colonic diverticulitis. The main question[s] it aims to answer are: - Is FMT in patients with a former episode of acute colonic diverticulitis a safe procedure without severe adverse events - What is the impact of FMT on patient-reported outcomes and re-admission rate Participants will be asked to: - to ingest either 25-30 capsules with FMT or placebo capsules - Fill-in GI-QLI questionnaire prior to treatment/placebo and 3 months post baseline - Fill-in eating habit questionnaire - deliver blood-and stool samples prior to treatment/placebo and 3 months post baseline - In both the treatment and placebo group 5 patients will be offered sigmoideoscopy for mucosal biopsies if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects]

NCT ID: NCT06210724 Recruiting - Colorectal Cancer Clinical Trials

FIT in Diverticulitis

Start date: October 9, 2023
Phase:
Study type: Observational

Background and study aims Diverticular disease or diverticulosis is a benign disease of the colon. Anatomically this is formation of pockets of bowel wall which protrude through weaknesses in the muscular wall of the colon. The mechanisms leading to their formation remains unclear and is likely a complex interaction of multiple factors. For the majority of people these pockets are incidental findings but for some they can cause symptoms or a segment of colon containing them can become inflamed which is called acute diverticulitis. The main aim of this study is to see if a faecal samples, which will be tested for hidden blood content with a faecal immunochemical test for haemoglobin (FIT), could be used as an alternative to currently used follow-up investigations for patients who have an episode of acute diverticulitis confirmed on a computerised tomography (CT) scan. These are colonoscopy, sigmoidoscopy or a special CT called CT colonoscopy. We will also be doing a test called faecal calprotectin which is a marker of bowel inflammation and an assessment of the microbes that live in the bowel to see if this will provide further insights into the diagnosis and treatment of diverticulitis. Who can participate? All patients 18 or over admitted to a participating hospital with acute diverticulitis confirmed on a CT scan and who planned to have one of the currently used follow-up investigations are eligible. What does the study involve? The study will involve taking three stool (faecal) samples using faecal testing kits posted to participants. One is on their first solid stool after diagnosis (or as early as possible if their first solid stool is before receiving this pack), the others are at 3 weeks after diagnosis and then 6 weeks after diagnosis. What are the possible benefits and risks of participating? There are no risks of participating. FIT testing has been used in cancer screening now for a number of years and we hope to demonstrate that a negative FIT test for patients after acute diverticulitis will be able to exclude a bowel cancer and prevent the majority of future patients having invasive and time consuming tests. There no additional benefit for participants for their current episode, as they will still need to have these tests. Where is the study run from? Royal Surrey County Hospital When is the study starting and how long is it expected to run for? 09/10/2023-30/09/2024 Who is funding the study? The study is being funded by MATTU (Minimal Access Therapy Training Unit), GUTS (GUTS - Fighting Bowel Cancer) and NHIR (National Institute for Health and Care Research). Who is the main contact? James Norman On the study email rsch.colorectalDfitstudy@nhs.net

NCT ID: NCT06200857 Completed - Colorectal Surgery Clinical Trials

Impact of Socioeconomic and Territorial Inequalities on Surgical Management of Sigmoid Diverticulitis

EDIVERTICULITE
Start date: January 1, 2020
Phase:
Study type: Observational

Sigmoid diverticulitis (SD) is a common pathology characterized by inflammation/infection of a diverticulum in the sigmoid colon. Surgical treatment of DS is indicated urgently, either because of a serious complication or because of therapeutic failure. Prophylactic surgical treatment of "cold" DS is indicated in symptomatic forms (smoldering diverticulitis, frequent recurrences impacting quality of life, symptomatic fistula, and stenosis). It is also indicated for asymptomatic forms in selected patients, to avoid recurrence and/or the occurrence of a DS complication. In France, some 12,000 prophylactic colectomies for DS are performed every year. The mortality rate for this operation during the hospital stay (which does not account for 30-day mortality) is 7 per thousand in France. Morbidity is fairly high, at around 25%, with almost 10% of severe complications. At a distance, the definitive stoma rate is around 6% of patients, and recurrences have been described in up to 10% of cases. Numerous clinical determinants linked to the patient and the pathology have been identified as potential risk factors for morbidity and mortality (advanced age, undernutrition, emergency surgery, neurological history, minimally invasive approach, etc.). Among non-clinical determinants, socio-economic and territorial deprivation is thought to have an impact on postoperative morbidity and mortality for a very large number of pathologies, including cardiovascular disease, cancer, and obesity. Thus, patients from the most disadvantaged backgrounds would have a significantly higher risk of postoperative mortality and morbidity. To our knowledge, however, few data are available on the possible impact of socio-economic deprivation and geographical isolation on the operative outcome of colorectal surgery. This French multicenter study aims to assess the impact of socio-economic and territorial inequalities on the surgical management of sigmoid diverticulitis; with the primary objective being the prevalence of postoperative complications and the secondary objectives being the prevalence of recourse to emergency surgery, minimally invasive surgery, definitive stoma and post-operative recurrence.

NCT ID: NCT06153030 Completed - Clinical trials for Diverticulitis, Colonic

Unexpected Diagnosis in Right Lower Quadrant Pain: Right Colon Diverticulitis

Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

BACKGROUND: Acute right lower quadrant pain is a common symptom in emergency departments. The most common etiology is thought to be acute appendicitis. Other etiologies may be overlooked. Acute right colon diverticulitis is one of them. It is usually seen in male and young patients. It is more common in Asian population and rare in Western countries. Ultrasonography (USG) and computed tomography (CT) are used for radiologic diagnosis. OBJECTIVES: The aim of this study was to investigate the diagnosis, treatment and surgical management of right colon diverticulitis.

NCT ID: NCT06109506 Recruiting - Sepsis Clinical Trials

Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis

DivAbsc2023
Start date: June 1, 2023
Phase:
Study type: Observational

It is estimated that approximately 15% to 20% of the subjects with sigmoid diverticulosis will develop acute diverticulitis, with diverticular abscess as the most common complication of sigmoid diverticulitis. While cases with free perforations and diffuse peritonitis require emergency surgery, in cases with contained perforation and abscess formation, the approach is initially conservative. Due to its relative rarity, the treatment of diverticular abscess is not based on high-quality scientific evidence. Abscess size of 4-6 cm is generally accepted as reasonable cutoff determining the choice of treatment between antibiotic therapy and antibiotic therapy plus percutaneous drainage of the abscess. A subgroup of patients will fail the conservative approach and require a surgical rescue strategy. However, the real incidence for conservative treatment failure after non-operative management of acute diverticulitis with abscess remain poorly understood, the knowledge of which could improve decision-making processes, treatment strategies, patient counseling, and even modify the planned treatment strategy in patients deemed at highest risk. The early recognition of patients who show clinical signs of ongoing and worsening intra-abdominal sepsis due to perforation is important to ensure the success of this strategy. In the light of these, knowledge of risk predictors for failure is of utmost importance. Owing the contrasting evidence summary, we set up a multicenter retrospective cohort study that merges the cases from twelve high-volume centers for emergency surgery in Italy to assess the short-term outcomes of initial non-surgical treatment strategies for AD with abscess formation (Hinchey Ib and II) in a large number of patients, and identify risk factors associated with adverse outcomes, to help facilitate appropriate patient selection and assess the optimal treatment strategy for this peculiar subgroup of patients. The purpose of this study is to describe the incidence and risk factors for conservative treatment (antibiotics alone or antibiotics plus percutaneous drainage) failure after non-operative management of acute diverticulitis with abscess using a large multicenter patient series. The present study is designed as a multicenter retrospective observational study conducted at twelve secondary and tertiary Italian teaching surgical centers on CT-diagnosed hemodynamically stable patients (≥18 years) with perforated acute diverticulitis with abscess (with or without extraluminal air) initially treated non-surgically. The rate of failure of non-operative treatment for complicated acute diverticulitis patients with abscess formation and the risk factors of failure of the non-surgical treatment will be assessed. Failure of the conservative treatment is defined as lack of clinical improvement in the general conditions of the patient during index hospital admission, requiring urgent surgery to treat intra-abdominal sepsis.

NCT ID: NCT06040515 Recruiting - Therapy Clinical Trials

Probiotic After Acute Colonic Diverticulitis

Start date: May 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to assess the efficacy and safety of the probiotic Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic patients after an episode of both complicated and uncomplicated acute colonic diverticulitis. The main question it aims to answer are: - Is the studied probiotic able to significantly reduce symptoms, assessed by means of a validated and dedicated score? - Is there any difference in microbiota among the study group at baseline and a selected cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects after an episode of acute uncomplicated diverticulitis or an episode of complicated diverticulitis submitted to surgery with colonic resection without stoma? - Is there any difference in microbiota in the study group at baseline and after 3 and 6 months of treatment with the probiotic? - Is there any correlation between microbiota modification and symptoms during follow-up? - Is there any impact on fecal calprotectin values before and during probiotic therapy? - Is there any modification of evacuation before and during follow-up? - Is probiotic able to prevent recurrent episodes of acute diverticulitis during follow-up? - The safety of the probiotic will be assessed during the follow-up. The study group will be assessed at baseline and during follow-up with a dedicated clinical score and Bristol stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline and during follow-up. Microbiota at baseline will be also evaluated for comparison in the three selected groups with diverticulosis and both asymptomatic and symptomatic after an episode of acute diverticulitis.

NCT ID: NCT06023004 Recruiting - Colorectal Cancer Clinical Trials

The Diverticulitis Study

Start date: May 1, 2022
Phase:
Study type: Observational

Acute colonic diverticulitis is when a part of the colon gets swollen and inflamed. The diagnosis is based on a CT scan, which can show thickening of the colonic walls and infiltration of the diverticula. These changes and the concomitant symptoms can overlap with colorectal cancer (CRC). Therefore, the guidelines suggest that people with diverticulitis should be offered a colonoscopy to ensure, that CRC is not the underlying cause of the changes and symptoms. In Denmark, a lot of people get hospitalized each year due to diverticulitis, and many of them end up having colonoscopies with the purpose of excluding CRC. Currently, there are no methods for guiding colonoscopies following a diverticulitis episode, resulting in numerous unnecessary colonoscopies each year. In the Diverticulitis study, we want to investigate if a simple blood test analyzed for the presence of circulating tumor DNA (ctDNA), can help us decide who needs a colonoscopy. We will collect blood samples from 220 people with diverticulitis and categorize them into ctDNA positive and negative groups. The ctDNA category will be compared to the colonoscopy results to see if there is a correlation between being ctDNA positive and having a CRC diagnosed at the colonoscopy. This study could change clinical practice since we anticipate that ctDNA-guided triaging of diverticulitis patients is a cost-effective strategy for selecting diverticulitis patients needing colonoscopy, ensuring detection of the underlying CRC, and significantly reducing the number of patients undergoing unnecessary colonoscopy.