Clinical Research Directory

SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Colorectal surgery is associated with a high risk of morbidity and mortality in comparison to other general surgery subspecialties. This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a larger scale.

Feasibility of a Newly Developed Ostomy Prototype

Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life. To overcome this, Coloplast are in the process of developing a leakage measurement device. Each participant will undergo five 24-hour test periods over three weeks, wearing the prototype around the stoma (Test) and on the opposite side (Control).

Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1

The goal of this clinical trial is to evaluate if intensified omeprazole therapy can reduce high-output stoma (HOS) in adults undergoing ileostomy formation surgery. The main objectives of the study are: * To assess if intensified omeprazole treatment significantly reduces mean daily ileostomy output (ml/24h) during the first three postoperative days compared to standard omeprazole treatment. * To evaluate the proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml/day) on consecutive postoperative days. * To measure the time required for stabilization of ileostomy output (\<1400 ml/day maintained for three consecutive days). * To determine the incidence of dehydration-related complications, specifically electrolyte disturbances (hyponatremia, hypokalemia). * To compare the length of initial hospital stay, frequency of rehospitalizations within 30 days post-discharge, and total length of hospital stay (including rehospitalizations). Researchers will compare 10 days intensified omeprazole treatment (loading dose of 80 mg IV followed by 40 mg IV twice daily) with standard treatment (40 mg IV once daily) to determine the effectiveness of intensified dosing in reducing ileostomy output and improving postoperative outcomes. Participants will: * Receive either standard or intensified intravenous omeprazole during their hospitalization and after discharge for 10 days combined. * Undergo daily measurements of ileostomy output. * Have routine laboratory assessments of electrolyte levels. * Participate in follow-up assessments up to 30 days post-discharge, conducted either through outpatient visits or telephone consultations.

Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital

Stoma creation is a common surgical procedure, employed in certain contexts within general surgery, particularly in colorectal and emergency surgery. Although stoma formation is a life-saving technique, the diversion of intestinal contents has pathophysiological, aesthetic, and psychological repercussions on patients' lives. Stomas may be either permanent or temporary. In temporary cases, a second intervention is required to perform ileostomy closure and restore normal intestinal transit. Several studies indicate that stimulation of the efferent loop prior to ileostomy closure yields benefits in patients' postoperative outcomes. Currently, there is no established protocol for this intervention at Hospital Universitario La Paz. However, implementing such a protocol-given that it is a simple, inexpensive, and accessible intervention-could offer significant cost-effectiveness. It may reduce complications and hospital stay, improve patients' quality of life, and represent a valuable contribution to the General Surgery Departmen