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Diverticulitis of Sigmoid clinical trials

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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: NCT05942833 Recruiting - Clinical trials for Diverticulitis of Sigmoid

Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis

DATE
Start date: January 16, 2023
Phase: N/A
Study type: Interventional

Patients presenting in hospital with symptoms of acute diverticulitis. Acute inflammation of the left-sided colon is confirmed with CT scan or ultrasound in experienced centers and diagnosis is defined according to the "Classification of Diverticular Disease (CDD)". CDD Type 2a, 2b and 3b will be included and then randomized in two groups. Group A will get an early left hemicolectomy 7 to 10 days after admission and initial antibiotic therapy and/or drainage of the abscess. Group B is designated for an elective resection 6 to 8 weeks after dismissal at the earliest and initial conservative treatment and/or after drainage of the abscess. Six weeks after the operation patients of Group A will be asked for their present quality of life with a standardized scoring system (Gastrointestinal Quality of Life Index = GIQLI; Short-form 36 Score = SF-36 Score; Low anterior resection syndrome = LARS Score). Group B (elective resection) will be asked at their readmission prior to elective surgery is done. This survey package will be repeated again 6 to 8 weeks later in both groups. Primary endpoints will be the two GIQLI at the said examination times. Secondary endpoints will be SF-36 score, LARS-score, GIQLI-Domains, anastomosis insufficiency and other complications, mortality and length of hospital stay. Comparisons between the groups are made at the said examination times but also 6-8 weeks after the operation.