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Diverticulitis, Colonic clinical trials

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NCT ID: NCT04746326 Completed - Outcome Clinical Trials

Treatment in Right Colon Diverticulitis Patients

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy.

NCT ID: NCT04633512 Enrolling by invitation - Colorectal Cancer Clinical Trials

Safety and Feasibility of ActivSightTM in Human

Start date: November 17, 2020
Phase: N/A
Study type: Interventional

ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

NCT ID: NCT04407793 Recruiting - Clinical trials for Acute Diverticulitis

Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis

DICRO
Start date: May 25, 2020
Phase:
Study type: Observational [Patient Registry]

MAIN OBJECTIVE: Description of predicted markers of acute diverticulitis crisis, using bivariate and multivariate analyses. Analysis of acute diverticulitis predictor swings. SIDE OBJECTIVES: Descriptive analysis of HRQL in the different measurement periods to establish the evolution of the disease. Correlate HRQL values of systemic and local inflammatory markers in the diverticulitis group. Sub-analysis of patients with immunosuppression to evaluate disease virulence compared to a group of patients without immunosuppression. STUDY TYPE: Clinical, observational, prospective and multicenter study (8 hospitals) with three study groups: patients diagnosed with acute diverticulitis attending emergencies, diverticulosis patients and patients without diverticulums. INCLUSION CRITERIA: Age > 18years and radiological diagnosis by abdominal CT acute diverticulitis. EXCLUSION CRITERIA: Rejection of the patient -severe diverticulitis requiring urgent surgery -an inability to understand HRQL questionnaire - IBD - pregnancy or breastfeeding - acute diverticulitis within the prior year of the study - Roma IV criteria fulfilment. VARIABLES: Main variables: local and systemic inflammatory markers- faecal calprotectin. Secondary variables: recurrence of acute diverticulitis -the persistence of symptoms - SF 12 and GIQLI questionnaires. STATISTICS: Sample size: alpha error 0.05; beta error 0.20; bilateral; proportion 0.9 in the control group; 500 subjects group diverticulitis, 200 group diverticulosis and not diverticulums.

NCT ID: NCT04311385 Completed - Diverticulitis Clinical Trials

Management and Evolution of Acute Diverticulitis With Pericolic Free Gas

ADiFas
Start date: June 1, 2020
Phase:
Study type: Observational

The severity of diverticulitis is usually graded with the use of modified Hinchey Criteria. However, there is a condition often seen in the CT scan that is not included in this classification itself; 1-2 pericolic bubbles but no free air or fluid into the abdomen or above the liver. Outcome in these patients remains unknown. We aim to analyse the treatment that these patients and their evolution over the first year after the diagnosis in order to predict the disease related outcome. The study is set up as a retrospective multicentre observational study. Inclusion criteria are Patients over 18 years old, Diagnosed of acute diverticulitis with a CT scan reported as 1-2 pericolic bubbles with or without free fluid. Exclusion criteria: 1) CT scan showing free distant bubbles in the abdomen. 2) CT scan showing abscess. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 137 subjects are necessary in the observed group to recognize a difference in morbidity greater than or equal to 10%. A proportion in the reference group has been estimated to be 20%. It has been anticipated a drop-out rate of 0%. Primary outcome is 30-day morbidity and mortality. Secondary outcomes include malignancy and 1 year morbidity including recurrences and ongoing disease. Data will be collected in an online repository. The CT scans will be reviewed by 2 experienced independent radiologists. The management of these patients at the moment of the diagnosis will be recorded, as well as their evolution over the first year during the outpatient clinics. Figure 1 represents the study flow chart. Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (01/06/2020 - 31/12/2021). CT scans will be reviewed by 2 experienced radiologists. Every other CT scan performed during the follow-up will be reviewed by the same radiologists. The management of these patients at the moment of the diagnosis will be recorded, as well as their evolution over the first year during the outpatient clinics. This study protocol is a new approach to an unknown entity in diverticulitis. We are convince that the outcomes are clinically relevant to patients and interesting for all physicians treating diverticulitis.

NCT ID: NCT04254224 Recruiting - Clinical trials for Diverticulitis Colon

Scandinavian Diverticulitis Trial SCANDIV-II

SCANDIV-II
Start date: April 10, 2018
Phase:
Study type: Observational

This study focuses on the treatment for complicated diverticulitis classified as Hinchey I-IV. The aim of this prospective observational study is to evaluate type of treatment and the success rate of treatment in acute complicated diverticulitis (ACD) at participating hospitals in Sweden and Norway. Furthermore, the effects on quality of life for this patient group will be evaluated.

NCT ID: NCT03557216 Completed - Colonic Neoplasms Clinical Trials

Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study)

ADACOLON
Start date: June 15, 2018
Phase: N/A
Study type: Interventional

This study evaluate the prevalence of advanced colonic neoplasia (ACN) in acute diverticulitis. A sub-analysis of complicated and uncomplicated acute diverticulitis will be made in order to determinate whether there are differences of advanced colonic neoplasia (ANC) prevalence in both groups and to assess if a colonoscopy is necessary.

NCT ID: NCT03496090 Completed - Diet Modification Clinical Trials

Randomized Multicentric Trial to Evaluate a Free Diet With a Progressive Diet in the Treatment of Acute Diverticulitis (DIVERDIET)

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

Phase III trial is designed to demonstrate the non-inferiority of a free diet versus a progressive diet in the treatment of acute diverticulitis (AD) without complications. In this study, the effectiveness of the short-term free diet is evaluated, as well as its safety and the quality of life that is perceived in front of the progressive diet.

NCT ID: NCT03448874 Withdrawn - Colorectal Cancer Clinical Trials

Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]

SEALAR
Start date: April 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate safety of Seal-G MIST System in reinforcing colorectal anastomosis, in subjects undergoing colorectal surgery.

NCT ID: NCT03316677 Not yet recruiting - ColoRectal Cancer Clinical Trials

Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?

ITCORA
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis. Two of the most common tests that are performed routinely are: 1. Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis. 2. Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis. The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis. In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.

NCT ID: NCT02958566 Recruiting - Pain, Postoperative Clinical Trials

Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Start date: January 2017
Phase: Phase 4
Study type: Interventional

The General Objective of this study is to investigate the cost and efficacy of treating patients undergoing colorectal surgical resections with an opioid limited pain control regimen as part of an Enhanced Recovery After Surgery (ERAS) Protocol. This group will be compared to a traditional opioid based pain control regimen.