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Colonic Diseases clinical trials

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NCT ID: NCT05249192 Recruiting - Clinical trials for Postoperative Complications

Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate. The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.

NCT ID: NCT05231473 Recruiting - Nurse's Role Clinical Trials

Impact Of The Nurse Enhanced Recovery After Surgery Coordinator On The Compliance In Colorectal Surgery (nursERAS-BCN)

nursERAS-BCN
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Purpose. The aim of this study is to evaluate the impact of the implementation of the Nurse Enhanced Recovery After Surgery Coordinator (NEC), within the Enhanced Recovery After Surgery (ERAS) program, in relation to the compliance of patients undergoing colorectal surgery. Methods. Quasi-experimental study with a control group, an intervention group and without random assignment in a multicenter trial; between December 2021 and November 2023. Patients older than 18 years with planned elective intervention of major colorectal surgery will be included; excluding those without social support, with psychiatric illness, cognitive difficulty, planning of simultaneous or emergency surgery. In the intervention arm they will have NEC and in the control group they will not have that resource. Compliance will be the main variable of the study and, in addition, the study aims to assess secondary endpoints such as quality of life (QOL). Conclusions. NEC could increase compliance to ERAS programs, improving health outcomes and QOL perceived by the patient. The applicability in the different hospital centers could generate an opportunity to advance professionally in the nursing figure within the ERAS program. The fact of having NEC could also increase the efficiency of the program due to the cost-effectiveness of the nursing position, although this is not the object of the study. It would be applicable in improving perceived health and QOL, so it could also have an economic impact on the health system.

NCT ID: NCT04829032 Recruiting - Emergencies Clinical Trials

GOODBYE HARTMANN TRIAL: 100 YEARS OF HARTMANN'S PROCEDURE

Start date: March 1, 2021
Phase:
Study type: Observational

Hartmann's procedure was described for the first time in 1921 as an alternative to abdominoperineal resection for the treatment of upper rectal tumours. Although Hartmann's procedure fell out of favour for rectal cancer after the introduction of restorative procedures, it remained the most common procedure in emergency setting for many years. Nowadays Hartmann's procedure is a useful procedure in selected cases e.g. severely ill patients with a high risk of anastomotic failure. However, restoring intestinal continuity for Hartmann patients is often associated with high morbidity, and about 70% will live with a permanent colostomy. Hartmann procedure' is a rapid and simple surgical technique intended to decrease perioperative morbidity and mortality. This technique is often performed by young surgeons Indeed, end colostomy may be necessary in situations where restoration of continuity is risky, either because of unfavorable local conditions or because a more definitive resection must be aborted due to hemodynamic instability. In the last decade the Hartmann's procedure has been revalued in many studies. In diverticular disease the results of DIVA arm of the LADIES trial showed that more patients in the primary anastomosis group were stoma free compared with patients in the Hartmann's procedure group. Other studies have observed no differences in major postoperative complications or postoperative mortality between patients undergoing primary anastomosis versus Hartmann's procedure. Hartmann's procedure reversals were associated with a higher risk of serious postoperative complications than were stoma reversals after primary anastomosis with ileostomy. Despite the growing evidence in favour of primary anastomosis and its inclusion as a valid treatment option for perforated diverticulitis or perforated sigmoid colon in recent clinical practice guidelines, some surgeons have been hesitant to undertake anastomosis in the setting of purulent or faecal contamination and continue to choose Hartmann's procedure to eliminate concerns about anastomotic leakage.

NCT ID: NCT04693299 Recruiting - Colonic Disease Clinical Trials

Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy

REPREP
Start date: November 1, 2020
Phase:
Study type: Observational

Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again. Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units. Inclusion criteria: Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing. Exclusion criteria: - Emergency regime - Inability to obtain consent - Refusal of the patient Primary end-point: Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model. The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score <6 or a score <2 even in only one of the colic segments. Secondary end-point: • Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing

NCT ID: NCT04598880 Recruiting - Colonic Diseases Clinical Trials

Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing

Start date: November 6, 2020
Phase: Phase 4
Study type: Interventional

Background: Colorectal cancer is the most frequent neoplasm and the second cause of cancer death in Spain. Colon cleansing is critical for visualization of lesions at colonoscopy. High-quality cleansing allows for correct detection and resection of all lesions and may contribute to adequate risk stratification and follow-up interval. Low-volume laxatives improve tolerance of the colonoscopy preparation without reducing its effectiveness. Currently, the most widely used low-volume laxatives are one liter of Polyethylene glycol + ascorbate (PEG1A) and sodium picosulfate + magnesium citrate (PSCM). The evidence on the comparison of laxatives to achieve a high-quality colonic cleansing is very scarce. Hypothesis: Polyethylene glycol 1 liter with ascorbate is superior to sodium picosulfate and magnesium citrate in high-quality colon cleansing. Objective: Overall objective: To compare the global high-quality cleansing frequency between the two laxatives using the Harefield Scale (HS). The primary objective is to demonstrate non-inferiority in global high-quality cleansing of PEG1A compared to PSCM. If non-inferiority is demonstrated, superiority of PEG1A will be analyzed. Specific objectives: - Frequency of global high-quality cleansing using the Boston Bowel Preparation Scale (BBPS). - Frequency of adequate-quality cleansing using the HS and BBPS scales. - Tolerance and adverse effects of both laxatives. - Detection of lesions, total adenomas, advanced adenomas, total serrated lesions, advanced serrated lesions and colorectal cancer. - Detection of neoplastic lesions in the different colon segments (proximal, transverse, descending, sigmoid and rectum). - Association between detected lesions and the quality of the preparation, according to the HS and BBPS scales. Methods: Phase 4, multi-centric, randomized, single-blind (endoscopist), parallel study with two treatment arms: PEG1A (Pleinvue®) and PSCM (Citrafleet®).

NCT ID: NCT04216901 Recruiting - Clinical trials for Artificial Intelligence

A Single Center Study on the Effectiveness and Safety of Polyp Classification With Artificial Intelligence

Start date: December 24, 2019
Phase:
Study type: Observational

This is an artificial intelligence-based optical endoscopic polyp diagnosis system that can assist endoscopic doctors in diagnosing polyps and improve the quality of training in clinical Settings.

NCT ID: NCT04084249 Recruiting - Colorectal Cancer Clinical Trials

ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.

NCT ID: NCT03854422 Recruiting - Endoscopy Clinical Trials

For Easy, Fast and Comfortable Colonoscopy, Which Position

EFC_COLON
Start date: January 18, 2019
Phase: N/A
Study type: Interventional

Colonoscopy is one of the most common endoscopic procedures today. However, it sometimes can be a serious challenging situation both for the clinicians and patients. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.

NCT ID: NCT03466632 Recruiting - Colonic Diseases Clinical Trials

Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy

Start date: April 1, 2016
Phase: Phase 3
Study type: Interventional

Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

NCT ID: NCT03428724 Recruiting - Colon Disease Clinical Trials

Individualized Bowel Preparation for Colonoscopy

PREP2TARGET
Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics