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Colorectal Surgery clinical trials

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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 "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: 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: NCT05522790 Completed - Colorectal Surgery Clinical Trials

Impact of Iron Infusion in Anemic Patients on Their Postoperative Outcome After Colorectal Surgery

IRON_PREHAB
Start date: May 18, 2022
Phase:
Study type: Observational

In 2005, colorectal surgery in France represented nearly 40,000 procedures per year, of which 80% were scheduled and 70% were for carcinological purposes. Overall postoperative mortality was estimated at 3.4%, morbidity at 35% and average length of stay at 18 days. In addition, the number of newly diagnosed cases of colorectal cancer was 44,872 in 2017, making it the second leading cause of cancer in women and the third in men. The implementation of colorectal Enhanced Rehabilitation After Surgery (EARS) programs has resulted in a significant reduction in length of stay due to an approximately 50% decrease in postoperative complication rates and a faster return of patients to independence. However, despite the integration of RASC into routine practice, morbidity remains high with an estimated complication rate of 15-20%. The persistence of a high complication rate despite the rehabilitation measures can be explained in part by factors present preoperatively that impair postoperative recovery, such as the existence of comorbidities, low functional capacity, the presence of martial or nutritional deficiencies or glycemic imbalance. Links between the presence of these different "deficits", which may coexist, and postoperative morbidity and mortality have already been shown. Anemia is common in preoperative colorectal surgery and affects approximately one in two patients with cancer. In case of preoperative anemia, the frequency of postoperative complications and the length of stay are increased. Under these conditions, preoperative correction of anemia could facilitate postoperative recovery and reduce the incidence of postoperative complications. In colorectal cancer, anemia is the consequence of an absolute martial deficiency due to iron losses from bleeding and a functional martial deficiency due to decreased availability of iron for erythropoiesis due to inflammation. Correction of preoperative anemia is usually based on 2 types of molecules: iron and erythropoiesis stimulating agents. Erythropoiesis-stimulating agents are not recommended to correct anemia in cancer patients not receiving chemotherapy. Iron can be given orally or intravenously. Intravenous administration is more effective than oral administration in patients with colorectal cancer to correct preoperative anemia. In patients undergoing colon cancer surgery outside of a RAAC program, preoperative iron infusion appears to decrease the incidence of postoperative complications, improve the quality of postoperative recovery, and reduce length of stay. These gains do not appear to be related to correction of preoperative anemia, since preoperative intravenous iron increases hemoglobin levels by only 0.8 g/dl, on average. And, insufficiently to reduce the rate of postoperative transfusion in abdominal or general surgery. Also, the benefits observed with preoperative iron infusion seem to be more related to the direct effects of iron on cardiac and skeletal muscle than by correction of anemia. Since 2016, all patients undergoing scheduled colorectal surgery at the Paris Saint Joseph Hospital Group benefit from the application of a RAAC program. If we do not take into account patients who die during hospitalization (≈ 2%) and patients transferred to Follow-up and Rehabilitation Care (SSR) (≈15%), the impact of the application of a RAAC program is easily measured with the length of stay. Indeed, reducing the frequency of postoperative complications and improving the speed of postoperative recovery translates into reduced lengths of stay. Today, the average length of stay for all patients undergoing colorectal surgery at Saint Joseph Hospital is 7.5 days. The length of stay is longer (8.7 days) in patients with anemia preoperatively compared to those without anemia (7 days). Since 2017, anemic patients scheduled for colorectal surgery, have received intravenous iron infusion preoperatively at Paris Saint Joseph Hospital.

NCT ID: NCT05264467 Completed - Colorectal Surgery Clinical Trials

Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis

Start date: March 12, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. The objective of this study was to assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.

NCT ID: NCT05084131 Completed - Colorectal Surgery Clinical Trials

Web-based Visit for Colorectal Surgery

Web-visit
Start date: May 14, 2019
Phase:
Study type: Observational

The purpose of this study to evaluate how well an online format would work for the first post-operative visit after a patient undergoes colon and rectal surgery. This online format is integrated into Epic MyChart. This study aims to determine whether the online format is feasible and acceptable to patients and surgeons as a standard post-operative visit.

NCT ID: NCT04752033 Completed - Pain, Postoperative Clinical Trials

Intrathecal Opioids for Colorectal Resection

Start date: March 10, 2021
Phase: Phase 4
Study type: Interventional

This research study is being done to determine the optimal dose of spinal morphine and hydromorphone in patients undergoing minimally-invasive (i.e., surgery performed through small entry sites and using cameras) colorectal surgery.

NCT ID: NCT04573075 Completed - Colorectal Surgery Clinical Trials

Ghost Ileostomy (GI) Versus Loop Ileostomy (LI) After Colorectal Resections

GI_versus_LI
Start date: January 31, 2019
Phase: N/A
Study type: Interventional

A Ghost Ileostomy (GI) as an alternative to a diverting protective Loop Ileostomy (LI) after colorectal resection is offered the patients at risk preoperatively. A GI is only applied in cases, who would receive a LI otherwise.

NCT ID: NCT04462705 Completed - Colorectal Surgery Clinical Trials

Abdominal Massage to Prevent Postoperative Ileus After Colorectal Surgery

MATRAC
Start date: August 18, 2020
Phase: N/A
Study type: Interventional

Post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of nausea and vomiting. It occurs in about 15-20% of colorectal surgeries. Some preventive measures have been included in the Enhanced Recovery After Surgery Program such as early mobilisation and enteral feeding or minimal invasive approach. Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported. Various studies have evaluated the value of physiotherapy and massage for resumption of normal bowel function. A study from Rouen University Hospital demonstrated that a mechanical stress to the cuteaneous tissue by LPG Cellu M50® machine would reduce pain and lower the time to first flatus. Similar results were obtained after Cardiac surgery. In a preclinical study on operated rats, abdominal massage also improved normal bowel function recovery. Physiotherapist plays a key role in RAC. Their action on respiratory function (movement of diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a reduction of time of hospitalization. Even though the results on time to first flatus and anxiety seem interesting, Deep abdominal massage has never been evaluated.

NCT ID: NCT04438655 Completed - Colorectal Surgery Clinical Trials

Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery.

COLORAL1
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Elective colon surgery is considered a clean-contaminated procedure, with a Surgical Site Infection (SSI) rate not inferior to 10%. For many years the role of Mechanical Bowel Preparation (MBP) has been universally recognized as an effective measure to reduce colonic bacterial load and consequently SSI rate, mostly in European Countries. However, in the early 1970s has been demonstrated a further SSI risk reduction in colon surgery if oral non-absorbable antibiotics were added to MBP and for the next 30 years this became the standard of care prior to elective colon surgery, especially in the US. Nowadays, Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or mortality, and as such it should not be prescribed routinely. Conversely, recent evidence has suggested that there may be a role for combined MBP and oral antibiotics, or oral antibiotics alone in the prevention of surgical site infection (SSI). The aim of this trial is to evaluate the efficacy of preoperative oral antibiotics prophylaxis for preventing surgical site infections in elective colorectal surgery.