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Colorectal Surgery clinical trials

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NCT ID: NCT06438484 Completed - Colorectal Surgery Clinical Trials

The Challenges of Evidence-based Prehabilitation in a Real-life Context for Patients Preparing for Colorectal Surgery

Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

Background: Multimodal prehabilitation programs are effective in reducing complications after colorectal surgery in patients with high risk of postoperative complications due to low aerobic capacity and/or malnutrition. However, high implementation fidelity is needed to achieve these effects in real-life practice. Therefore, this study aimed to investigate the implementation fidelity of an evidence-based prehabilitation program in the real-life context of a regional hospital. Methods: In this observational cohort study with multiple case analysis, we enrolled all patients who underwent surgery for colorectal cancer from January 2023 to June 2023, in one Dutch peripheral hospital. Patients meeting criteria for low aerobic capacity or malnutrition were advised to participate in a personalized prehabilitation program. Implementation fidelity was investigated on four domains; 1) coverage (participation rate), 2) duration (number of days following the prehabilitation program), 3) content (delivery of prescribed intervention modalities), and 4) frequency (attendance of sessions and compliance with prescribed parameters). An aggregated percentage of content and frequency was calculated to determine overall adherence. The intended outcomes were improvement in preoperative aerobic capacity and malnutrition, and improved postoperative recovery (i.e., reducing complications, length of stay, and time to functional recovery).

NCT ID: NCT06369194 Active, not recruiting - Colorectal Surgery Clinical Trials

POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol

Start date: November 14, 2023
Phase:
Study type: Observational

The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT). It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up. To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p <0.05 (two tails).

NCT ID: NCT06350916 Completed - Colorectal Surgery Clinical Trials

Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery

Start date: January 28, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery.

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 &#34;cold&#34; 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: NCT06168669 Not yet recruiting - Colorectal Surgery Clinical Trials

A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.

NCT ID: NCT06154785 Recruiting - Colorectal Surgery Clinical Trials

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

CROSS
Start date: December 15, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

NCT ID: NCT06114446 Recruiting - Virtual Reality Clinical Trials

The Evaluation of the Effectiveness of Nursing Care Education Provided With Immersive Virtual Reality

Start date: March 6, 2024
Phase: N/A
Study type: Interventional

Nursing education is composed of both theoretical and practical training that complement each other. The clinical practice environment for students is quite complex and practical applications are highly variable. Practical application areas do not offer effective and equal opportunities to meet the learning and application goals. There are also problems in theoretical education, and current teaching techniques cannot adequately support students' learning. In nursing education, it is recommended to use different teaching methods that strengthen students' skills. One of these methods is virtual reality simulation, which simulates real-life procedures. The investigators's aim in this project is to reveal the effect of the use of immersive virtual reality on the effectiveness of education in surgical nursing education through nursing care offered for a specific surgical procedure. With the laboratory setup, software tool(s), and the self-sufficient employees being able to use the software, via the capabilities gained through this project, it will be possible to carry out various types of virtual reality training activities by different departments of investigator's university without the need for out-sourcing. The investigators's advanced goal in this project is to transfer the nursing care specific to frequently applied surgical interventions to the immersive virtual reality environment.

NCT ID: NCT06018961 Not yet recruiting - Colorectal Surgery Clinical Trials

Study of Postoperative Ileus in Digestive Surgery

IPCID
Start date: November 15, 2023
Phase:
Study type: Observational

Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of resumption of transit can lead to the implementation of specific treatments such as the placement of a nasogastric tube and drug treatments. To date, the definition of this event is not accepted by everyone and is not based on reproducible evaluation criteria. The main objective of this study is to evaluate a score used to date to define postoperative ileus, the IFEED score, and to compare it to the length of postoperative stay.

NCT ID: NCT06010225 Completed - Colorectal Cancer Clinical Trials

Effects of Implementing an ERAS Protocol

Start date: May 1, 2020
Phase:
Study type: Observational [Patient Registry]

Introduction: Successful colorectal surgery is determined based on postoperative mortality and morbidity rates, complication rates, and cost-effectiveness. One of the methods to obtain an excellent postoperative outcome is the Enhanced Recovery After Surgery (ERAS) protocol. This study aims to see the effects of implementing an ERAS protocol in colorectal surgery patients. Methods: Eighty-four patients who underwent elective colorectal surgery at National Tertiary-level Hospital were included between January 2021 and July 2022. Patients were then placed into ERAS and control groups according to the criteria. The Patients in the ERAS group underwent a customized 18-component ERAS protocol and were assessed for adherence. Postoperatively, both groups were monitored for up to 30 days and assessed for complications and readmission. The investigators then analyzed the length of stay and total patient costs in both groups.

NCT ID: NCT05941806 Not yet recruiting - Urinary Retention Clinical Trials

Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection

R-POUR
Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

The study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication.The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.