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Colonic Neoplasms clinical trials

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NCT ID: NCT05709249 Recruiting - Colon Cancer Clinical Trials

Xian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer

Start date: December 1, 2022
Phase: Phase 3
Study type: Interventional

This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).

NCT ID: NCT05708872 Recruiting - Pain, Postoperative Clinical Trials

The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

In this study, it will be investigated whether the methods of self-regulation of mental state have an effect on postoperative pain perception in colon cancer patients.

NCT ID: NCT05675904 Completed - Cancer of Colon Clinical Trials

Textbook Outcome in Colon Carcinoma

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

BACKGROUND: Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer. MATERIAL AND METHODS: Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days. The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.

NCT ID: NCT05662527 Active, not recruiting - Colon Cancer Clinical Trials

Response to Immunotherapy in MMR-deficient Localized Colon Cancer

RESET-C
Start date: February 22, 2023
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy of neoadjuvant treatment with pembrolizumab before colonic resection in patients with early-stage (I-III) deficient mismatch repair (dMMR) colon cancer (CC).

NCT ID: NCT05653934 Recruiting - Pain, Postoperative Clinical Trials

Use of VIrtual REAlity to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer

VIREA
Start date: May 2023
Phase: N/A
Study type: Interventional

In patients operated for colorectal cancer, pain, anxiety and depression are important factors in postoperative rehabilitation. The use of new technologies, as virtual reality immersion, could further improve their postoperative management. To date, no study has evaluated the potential benefits of using virtual reality before and after colorectal cancer surgery. The main objective is to determine if virtual reality can reduce postoperative anxiety in patients undergoing colorectal cancer surgery. To answer this question, the investigators plan to execute a randomized controlled, single-center, open-label, superiority interventional trial. Patients will be randomized into 2 parallel arms: 1 interventional "virtual immersion" arm and 1 "control" arm. Patients with colorectal cancer, regardless of oncological stage, or a colorectal lesion deemed endoscopically unresectable, with an indication for elective surgical management by laparotomy or laparoscopy will be included. For patients in the interventional arm, virtual reality headset is put on the day before the operation and in the morning just before going down to the operating theatre. Colorectal cancer surgery then proceeds as usual. In the postoperative period, virtual reality sessions are offered every day and on request without any limit in number. Virtual reality immersion offers a visual and auditory experience during a soothing journey through visual worlds filmed in natural environments. This is a purely contemplative mode, lasting maximum 30 minutes. For the control arm, patients are treated according to the usual practices of the department and do not have access to virtual reality. The main purpose is to show a greater decrease in anxiety in the interventional group by measuring the absolute difference between the State-Trait Anxiety Inventory scores before surgery and at discharge.

NCT ID: NCT05648318 Completed - Colonic Neoplasms Clinical Trials

Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients

Start date: January 8, 2022
Phase: N/A
Study type: Interventional

Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in our center. Oral lactulose is a treatment for constipation. Several studies have compared the effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk patients. However, the data in low-risk patients is vacant. The objective of current study was to compared the effectiveness of bowel preparation and patient tolerance using lactulose and 2L PEG regimen in low-risk patients.

NCT ID: NCT05643105 Enrolling by invitation - Colon Cancer Clinical Trials

Anastomotic Leakage After Colon Cancer Surgery

ANACO II
Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

Anastomotic leak (AL) is one of the most feared complications after colon cancer (CC) surgery. The incidence varies according to the studies, the definition used and the location of the excised segment. In some of the series described, AL incidence have hardly changed, despite the evolution of the technique and technological improvements. The leak rate obtained in the only Spanish prospective multicenter observational study at national level was 9% (ANACO study). The aim of the present study is to determine the current rate of AL in our country, 10 years after the ANACO study, to determine if there has been any evolution and to analyze the factors associated with it. For this purpose, AL is defined with the same criteria as in the first study, as leakage of luminal contents through the junction between two hollow visceras, diagnosed radiologically (radiography with soluble enema or CT with collection adjacent to the anastomosis), clinically (extravasation of luminal contents or gas through the wound or drainage), endoscopically or intraoperatively. To compare AL rates throughout this decade, a 60-day follow-up will be performed, the same as in the ANACO study. As a modification respect to the ANACO study protocol, the aim is to analyze the possible influence of AL and perioperative intra-abdominal infection on short-term oncologic prognosis, with a one-year follow-up. This question has hardly been studied in prospective multicenter studies to date. The variables to be collected are divided into demographic (information about the hospital center, patient comorbidities), diagnostic variables (analytical values, diagnostic reason, neoadjuvant, localization, TNM), surgical variables (type of surgery, preparation, intention, intraoperative findings and complications, type of resection and anastomosis), admission (AL, other complications), histology, 60-day follow-up (AL, readmissions), one-year follow-up (readmissions, local recurrence, peritoneal and distant recurrence). Patients included in the study must be >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed and a derivative stoma should not be associated in the same surgery. According to ANACO data and follow-up times according to the primary objective (AL) at 60 days and the secondary objective (oncologic prognosis) with annual follow-up, inclusion will be carried out until the 1628 individuals required according to the sample size calculation performed are included.

NCT ID: NCT05627635 Recruiting - Clinical trials for Stage IV Colorectal Cancer AJCC v8

FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer

Start date: May 3, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial tests the safety, side effects, best dose, and efficacy of FOLFOX and bevacizumab in combination with botensilimab and balstilimab (3B-FOLFOX) in treating patients with microsatellite stable (MSS) colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as FOLFOX, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Balstilimab and botensilimab are in a class of medications called monoclonal antibodies. They bind to proteins, called PD-L1 and CTLA-4, which is found on some types of tumor cells. These PD-1 and CTLA-4 proteins are known to affect the body's defense mechanism to identify and fight against tumor cells. The combination of these drugs may lead to improved disease control and outcomes in patients with MSS metastatic colorectal cancer.

NCT ID: NCT05619614 Recruiting - Colonic Neoplasms Clinical Trials

The Influence of Artificial Intelligence (AI )Assisted Polyp Detection (Discovery System) on Visual Gaze Patterns During Real-time Colonoscopy

REVEAL
Start date: November 1, 2022
Phase:
Study type: Observational

In this study, the investigators aim to assess the influence of a computer-aided detection (CADe) system on the visual gaze patterns of endoscopists in order to further understand the effect of AI during real-time colonoscopy.

NCT ID: NCT05608967 Recruiting - Prehabilitation Clinical Trials

Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery.

PREHAPP
Start date: September 1, 2021
Phase:
Study type: Observational [Patient Registry]

Pilot study to evaluate the effect of prehabilitation programme through a mobile application PREHapp in colon cancer surgery. The objectives of this pilot study were to evaluate the usability of the PREHapp for people undergoing colon cancer surgery, estimate the effect of the app on functional recovery after surgery and to evaluate complications during the postoperative period after 4 weeks of follow-up.