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Diverticulum 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: NCT05973227 Recruiting - Clinical trials for Left-sided Colorectal Resection : Diverticular Diseases

InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections

TRIDENT
Start date: July 6, 2023
Phase: N/A
Study type: Interventional

The objective of the study is to assess the safety and technical feasibility of a new imaging system, used during colorectal resection surgery, named Trident in version 1.0, which could be used by the surgeon during colorectal procedures to obtain information on intestinal tissue oxygenation.

NCT ID: NCT05905016 Recruiting - Gastroparesis Clinical Trials

Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders

POEM
Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

NCT ID: NCT05829343 Recruiting - Diverticulitis Clinical Trials

RObotic Versus LAparoscopic Colectomy for DIverticulitis.

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

Over the last decade there has been a growing interest toward the application of robotic approach for diverticular disease. The evidence available on the literature showed that robotic approach, compared to the laparoscopic surgery, offers significant advantages in terms of conversion rate and shortened hospital stay for the treatment of diverticular disease. The investigators aimed at evaluating whether robotic colectomy may offer some advantages over the laparoscopic approach for surgical treatment of diverticular disease by analyzing a one year multicenter prospective study. Primary objective is to evaluate if robotic approach reduce the rate of conversion to open approach compared to laparoscopic surgery. Secondary objective is to assess difference between the two approaches in terms of rate of intraoperative complication, postoperative morbidities (according with Clavien and Dindo Classification), hospital stay and at one year follow up. Inclusion criteria are: elective colectomy for complicated or non-complicated diverticular disease performed with laparoscopic or robotic approach and age between 18 and 90 years. Exclusion criteria are non-elective colectomy (emergency resection), open procedure, diverticular resection performed during other procedure (i.e. colectomy for cancer). Data will be collected in one year from the start of the study. Due to the lack of available evidence, it is impossible to draw definitive conclusions. With this study, the investigators hope to clarify the role of the robotic approach in the treatment of diverticular disease.

NCT ID: NCT05432934 Recruiting - Colorectal Cancer Clinical Trials

Transversus Abdominis Plane Blocks With and Without Dexamethasone

TAP-DEX
Start date: September 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Dexamethasone will be used as an adjunct to local anesthetics (bupivacaine) to prolong the duration of laparoscopically-placed transversus-abdominis plane blocks in elective colorectal resection.

NCT ID: NCT05393609 Recruiting - Quality of Life Clinical Trials

Quality of Life and Surgery in Diverticular Disease

Start date: April 22, 2022
Phase:
Study type: Observational [Patient Registry]

Diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. Prevalence and admission rate due to diverticular disease increases. Symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. Recurrence rates of complicated diverticulitis are estimated to 10-30%. Recurrences, chronic complications or persisting pain, here collectively referred to as chronic diverticular disease, may be treated by elective sigmoidectomy. Currently, there is no specific criteria for elective surgery, but only a recommendation of a tailored approach depending on the patient's symptoms. It is well established that diverticular disease has a negative impact on quality of life (QoL). Elective laparoscopic sigmoidectomy may increase QoL. In this prospective study, we will prospectively examine QoL, patient-related outcomes and peri- and postoperative outcome of elective sigmoidectomy for chronic diverticular disease, and compare it to conservatively treated patients.

NCT ID: NCT05373784 Recruiting - Diverticulitis Clinical Trials

FMT in Uncomplicated Diverticulitis

Start date: March 15, 2024
Phase: Early Phase 1
Study type: Interventional

Fecal Microbiota Transplantation (FMT) is an established treatment for Clostridium difficile (C. diff) infection refractory to medical management. As C. diff infection usually arises due to significant disturbances in the gut microbiome, FMT is typically performed to restore a healthy microbiome among affected patients who have failed other treatments. Diverticulitis is a major, and often recurrent, source of morbidity in the U.S for which antibiotics and surgical resection constitute the only treatment options to date. Although alterations of the intestinal microbiome have also been shown among patients with diverticular disease, research on FMT in diverticulitis is sparse. The intended goal of this project is to determine the feasibility, effectiveness and safety of FMT in the treatment of uncomplicated diverticulitis, using clinical outcomes and microbiome analyses.

NCT ID: NCT04729283 Recruiting - Sigmoid Cancer Clinical Trials

Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer

SIG-QOL
Start date: April 12, 2021
Phase:
Study type: Observational

The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.

NCT ID: NCT04660214 Recruiting - Endoscopy Clinical Trials

Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.

Start date: June 28, 2021
Phase: N/A
Study type: Interventional

The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.

NCT ID: NCT04279821 Recruiting - Clinical trials for Diverticulosis, Colonic

Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

Start date: February 1, 2020
Phase:
Study type: Observational

Colonic diverticula are common in Western countries, affecting up to 60% of subjects over 70 years of age. In about 80% of patients, colonic diverticula remain asymptomatic (diverticulosis), while approximately 20% of patients may develop abdominal symptoms (symptomatic uncomplicated diverticular disease, SUDD) and, eventually, complications such as bouts of diverticulitis or bleeding. A small proportion of patients with colonic diverticulosis may develop segmental colitis associated with diverticulosis (SCAD). SCAD is separate clinical disease with specific macroscopic (erythema, friability and ulcerations) and microscopic features characterized by chronic, mucosal inflammation involving the inter-diverticular mucosa (usually sigmoid colon) sparing the proximal colon and rectum colon. The most common symptoms of SCAD are rectal bleeding, diarrhoea and abdominal pain. To achieve SCAD diagnosis a correct biopsies sampling is mandatory. It is necessary to take biopsies on the borders of the diverticula and in the apparently normal adjacent mucosa as well as biopsies in both the colon proximal to the diverticular area and the rectum in order to exclude chronic inflammatory bowel disease. The spectrum of histological lesions associated with SCAD is variable, including mild non-specific inflammation and inflammatory bowel disease (IBD)-like changes. Currently, data regarding prevalence of SCAD are scarce. It has been estimated that in patients with diverticulosis, SCAD prevalence ranged from 0.3-1.3%. The aim of the present study is to assess prospectively the prevalence of segmental colitis associated with colon diverticulosis (SCAD), in consecutive patients with colic diverticulosis, in a tertiary university centre.