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Diverticulum clinical trials

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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: 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: NCT06061432 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Endoscopic Ultrasound- Guided Hartmann Reversal Procedure

EndoHARP
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about clinical usefulness endoscopic gastrointestinal anastomoses to restore the gastrointestinal continuity in patients with permanent colostomy after Hartmann procedure. The main questions it aims to answer are: - is the endoscopic restore the gastrointestinal continuity procedure effective? - is this endoscopic procedure safe?

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: NCT05893095 Completed - Clinical trials for Gastrointestinal Diseases

Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study

Start date: July 1, 2014
Phase:
Study type: Observational

The goal of this observational study is to study the emergency surgical treatment of diverticular disease in Sweden outside clinical trials. The main questions it aims to answer are: - Which is the preferred surgical method of acute diverticular disease in Sweden? - Which are the short and long-term outcomes of the different surgical methods? Researchers will compare the different methods to see if there is a surgical operation that is superior for the treatment of acute diverticulitis.

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: NCT05793385 Completed - Clinical trials for To Report the Rare Occurrence of Meckel's Diverticulum

The Uncommon Complications of Meckel's Diverticulum

MD
Start date: January 1, 2022
Phase:
Study type: Observational

Acas series study was conducted on emergency acute abdomen patients who finally confirmed intraoperatively as Meckel's diverticulum with different complications. Simple perforation to isolated axial torsioned gangrene was observed. The patients signed consent for their cases to be published.

NCT ID: NCT05643703 Not yet recruiting - Clinical trials for Cesarean Scar Defect; Transvaginal Diverticulum Resection

Cesarean Section Defect Mechanism and Transvaginal Repair

Start date: December 20, 2022
Phase: N/A
Study type: Interventional

Background and aims: Cesarean section defect (CSD) can cause abnormal uterine bleeding or impaired fertility, which severely impaire the quality of life in women of pregnant age. For women with moderate or severe CSD, surgery can be performed. The objectives of this study is to compare the efficacy and safety of different suture methods in the treatment of transvaginal diverticulum resection, and the underlying mechanism of CSD occurrence. Methods: The patients diagnosed with CSD will be enrolled and randomizely assigned into suture method A and suture method. The fresh isolated tissue and swab of different sites in genital tract will be collected for NGS, microbiome, metabonomics and proteomics analysis. Hypothesis: The menstruation will be analyzed at different following time. The other clinical information will be also collected, including age at surgery, skin-to skin operative time, estimated blood loss (EBL). The perioperative complications, postoperative hopitalization, cost for hospital stay, blasser/intestinal function recovery will also be compared between two gorup. The outcome of fertility will be compared, such as the premature birth, premature rupture of membranes, and rupture of uterus. The clinical manifestation related to CSD and recurrence will be followed. Besides, the underlying mechanism will be analyzed.

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.