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NCT07219160
Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal surgery and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims: 1. The investigators will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery. 2. The investigators will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases. 3. The investigators will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery. 4. The investigators will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.
NCT07464600
In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic. Digestive surgeons use a variety of pre-, per- and post-operative techniques to reduce the rate of anastomotic fistula, but the risk persists, with a rate of 7% reported in the literature. It has been shown that the value of CRP between D1 and D5 correlates with the risk of AL, and that the trajectory between two consecutive days (D1 to D5 post-op) is the most discriminating element in predicting the risk of AF. This assay requires repeated intravenous sampling, which is the opposite of simplifying care. CRP point-of-care testing (POCT) is used in clinical practice, notably in pediatrics and outpatient medicine (in children and adults) to help prescribe probabilistic antibiotic therapy, as the instantaneousness of the result has an impact on patient management. For the diagnosis of AL, CRP POCT assessment could reduce the number of blood samples taken, shorten the time between sampling and medical management in cases of suspected AL, and thus improve the patient's post-operative experience.
NCT07388953
Effective postoperative pain management is essential for enhanced recovery after laparoscopic colorectal surgery. This randomized, controlled, double-blind trial will compare conventional postoperative analgesia (intravenous medications plus surgical wound infiltration) with a locoregional strategy combining a peripheral autonomic block (inferior mesenteric and superior hypogastric plexuses) and a transversus abdominis plane (TAP) block. We hypothesize that the combined strategy (BAPTAP) reduces pain intensity and opioid consumption in the first 48 hours after Left-Sided Colorectal Resection.
NCT04359069
This study is being conducted to determine the length of time a urinary catheter is needed to drain urine from the bladder after colorectal surgery. Urinary retention is a well known complication after pelvic colorectal surgery, and current practice is to continue urinary catheterization for 3- days following pelvic colorectal surgery in an effort to avoid this complication. However, prolonged urinary catheterization is associated with increased risk of urinary tract infections as well as longer hospital stays. The investigators hypothesize that postoperative urinary catheters may be safely removed on postoperative day 1 without increased urinary retention rates. The purpose of this study is to evaluate whether a shorter duration of urinary catheterization (1 day) is non-inferior when compared to standard duration (3 days) in regards to postoperative urinary retention. The investigators plan to perform a prospective, randomized, non-inferiority trial comparing the urinary catheter duration of 1 day and 3 days with the primary endpoint of postoperative urinary retention. Secondary endpoints are urinary tract infection and length of hospital stay. The participants will be randomly assigned to the control group (catheter removal on postoperative day 3) or the experimental group (catheter removal on postoperative day 1).
NCT07065994
This study aims to determine the effect of virtual reality glasses on pain and anxiety levels in colorectal surgery patients. This study is a single-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted with 60 patients who underwent colorectal surgery between August 2025 and December 2025. Participants will be randomized into two groups as the intervention group (n=30) and the control group (n=30). All patients in the experimental and control groups will be asked to fill out the "Informed Consent Form" the day before the surgery, and the patients who agree to participate in the study will be asked to fill out the "Patient Introduction Form" and the "State Anxiety Scale" by the researchers. The "Simulator Illness Questionnaire" used in the Virtual Reality disease field will be applied to the experimental group to determine their physiological conditions before the application. Then, a relaxing music-backgrounded video containing images of nature will be watched with virtual reality glasses for 10-15 minutes the day before the surgery. Then, the "Simulator Illness Questionnaire" and the "State Anxiety Scale" will be filled out again. The "Simulator Illness Questionnaire" will be applied to the patients 2 hours after their transfer from the postoperative care unit to the clinic, which is the most appropriate time after the surgery, when their vital signs have stabilized and clinical compliance has been achieved, and their physiological conditions before the application will be determined. Then, the patients in the experimental group will be asked to watch a relaxing music-backgrounded video containing images of nature for 10-15 minutes with virtual reality glasses. The researcher will perform the video with virtual reality glasses in the patient rooms and beds. Afterwards, the "Simulator Disease Survey" will be repeated. There will be no compelling effect that will negatively affect the health of the patients during the application, and the application will be terminated when the patients feel uncomfortable. A safe environment will be created so that there are no objects around the patients that they can bump into or trip over. A 5-10 minute trial period will be performed at the beginning with the observer and the virtual reality glasses will be applied. The patient will be able to end the study at any time. If the patients use glasses/lenses, compliance will be checked. No intervention will be applied to the control group patients and the routine practices of the clinic will continue. All patients in the experimental and control groups will be assessed for pain with the Visual Analog Scale (VAS) at the 2nd and 4th hours and the "State Anxiety Scale" will be applied.
NCT06752031
The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.
NCT06810648
The Enhanced Recovery After Surgery (ERAS) protocols have demonstrated their efficacy in expediting recovery and minimizing postoperative complications, especially in patients undergoing abdominal surgery. Perioperative hydration is one of the most critical pillars of the ERAS protocols, with goal-directed methods for administering fluids increasingly incorporated into these protocols. The Goal-Directed Fluid Therapy (GDFT) method is a strategy used in perioperative and critical care settings to optimize fluid administration tailored to a patient's individual needs. Its goal is to maintain adequate tissue perfusion and oxygenation by precisely balancing fluid administration, avoiding both hypovolemia (too little fluid) and fluid overload. Rather than using a "one-size-fits-all" approach, GDFT adjusts fluid delivery based on real-time monitoring of the patient's physiological parameters. GDFT focuses on dynamic hemodynamic indicators, such as stroke volume (SV), stroke volume variation (SVV), and cardiac output (CO), which provide better insight into the patient's fluid responsiveness. Advanced monitoring tools, such as esophageal Doppler, pulse contour analysis, or invasive devices like a pulmonary artery catheter, are used to assess the patient's response to fluid administration. The implementation of such protocols, particularly in colorectal surgery, has proven beneficial, as both overhydration and underhydration in this context can significantly impair organ function and, consequently, affect patient outcomes. Hypovolemia may lead to tissue ischemia at the anastomotic site, potentially causing breakdown. Conversely, fluid overload can have harmful consequences; hyperhydration may cause tissue edema, thereby reducing anastomotic strength. However, these findings have been validated primarily in high-risk patients, with a limited number of studies involving low- to moderate-risk patients undergoing major abdominal surgery. Colorectal surgery is routinely managed with epidural analgesia combined with general anaesthesia. However, concerns have been raised that epidurally induced sympathetic blockade and vasoplegia (vasodilation) can cause haemodynamic instability, necessitating fluid and vasopressor administration to an uncertain extent. In this single-center trial, we aimed to investigate whether epidural analgesia, in addition to general anaesthesia, influences Stroke Volume Variation (SVV)-guided GDFT using the FloTrac/Vigileo monitor during major open abdominal surgery. The study hypothesis was that epidural analgesia may result in fluid overload to compensate for the induced vasoplegia and that this fluid overload, in turn, could lead to gastrointestinal dysfunction and prolong the length of hospital stay. The primary outcomes were the incidence of postoperative gastrointestinal dysfunction and the length of hospital stay following elective colorectal surgery in patients managed with GDFT, either with or without epidural analgesia. Additionally, patient records of those treated with conventional fluid therapy (CFT), with or without epidural analgesia, were reviewed retrospectively for comparison.
NCT06662799
Postoperative pulmonary complications (PPCs) are common in patients after major abdominal surgery. It has been shown that 5-40% of patients occur PPCs after major surgery, and the mid to high PPC rate is observed after laparoscopic colorectal cancer surgery. PPCs are associated with poor clinical outcomes including prolonged hospital length of stay and increased morbidity and mortality. Mechanical ventilation during general anesthesia can lead to a redistribution of ventilation, increase the aereation in the ventral parts of the lung, whereas reduce ventilation in the dorsal parts of the lung compared with spontaneous breathing (SB) in the awake state in supine position. The reduction of ventilation of dorsal lung regions indicates the presence of dorsal atelectasis during mechanical ventilation after general anesthesia, which may be associated with PPCs. However, there is still no evidence to reveal the association between the reduction of dorsal ventilation and PPCs. Recently, electrical impedance tomography (EIT), which allows visualization of lung ventilation in real time, and assessment of regional lung ventilation. It is feasible to assess the change of ventral/dorsal lung ventilation during the surgery using EIT. To date, no study has investigated whether the change of ventral/dorsal lung ventilation revealed by EIT could be associated with PPCs. So, this prospective observational study aims to clarify whether patients developing postoperative pulmonary complications had higher reduction of dorsal lung ventilation during operation after general anesthesia as compared to patients not developing postoperative pulmonary complications. Ratio of dorsal ventilation during spontaneous respiration (T0) in the awake state as a reference, the proportion of dorsal ventilation after anesthesia induction and endotracheal intubation (T1), body position change and capnoperitoneum (T2), and at the end of surgery (T3) were analyzed. Thereafter, evaluating the change of dorsal ventilation in patients with PPCs and without PPCs at different time points. According to the method of sample size calculation published by Scaramuzzo G et al. (Anesthesiology. 2024 Oct 1;141(4):693-706.). A minimum sample size required for this study was calculated as following: using the difference of reduction of dorsal ventilation at the end of surgery between the patients with PPCs and non-PPCs as the primary outcome. Considering the data of our preliminary experiment showed that a reduction of dorsal lung ventilation at the end of surgery is 12 ± 6% and hypothesizing 30% of patients experiencing postoperative pulmonary complications and a relative clinically relevant increase in reduction of dorsal lung ventilation of 40% in those with postoperative pulmonary complications, we found that 83 patients were sufficient to evaluate differences between groups (effect size 0.8) with a power of 0.90 and an α error of 0.05. Considering a dropout of 10%, we found a minimum sample size of 92 patients.
NCT06700317
The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.
NCT06350916
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.
NCT00771290
Intra-operative colonoscopy (inserting a flexible endoscope with a camera at its tip through the anus and up into the rectum and colon) is most often indicated to locate or verify the location of small cancer, polyp, bleeding site, or simply to inspect the bowel after the two ends have been rejoined together. Usually colonoscopy utilizes ambient air to expand and inflate the colon and, as a result, leaves the colon bloated or distended until the gas is either expelled or absorbed. This endoscopy related bowel distension is problematic in the setting of both traditional open (big incision) colorectal surgery and after minimally invasive (laparoscopic assisted) procedures. In the case of the former, it may prove difficult to close a traditional laparotomy incision if the bowel is distended and may hinder respiration with the abdomen closed. In the setting of a laparoscopic procedure, the bowel distension limits the working space available to the surgeon. Since the laparoscopic domain is limited, a distended colon following intra-operative colonoscopy can prevent the minimally invasive completion of a case (meaning that a conversion to traditional "open" methods would be necessary) that otherwise was going well with good prospects of laparoscopic completion. Colonic distension also causes abdominal pain and lengthens the recovery time from the procedure. The investigators believe that the use of CO2 during intra-operative colonoscopy or sigmoidoscopy (exam of only the last 2 to 2 ½ feet of the colon) will not cause long lasting bloating or distension of the colon as opposed to air. Carbon dioxide is absorbed 250 times faster than ambient air and may decrease after procedure colonic distension. This prospective, randomized study will compare the two gases in terms of colonic distension. Patients undergoing open or minimally invasive colorectal resection will be randomized to undergo intra-operative colonoscopy using one of the two gases. Direct measurements of colon diameter will be taken at specific time intervals after the colonoscopy.
NCT06369194
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).
NCT04752033
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.
NCT05300711
This study aims to evaluate the feasibility, safety and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the time of colorectal surgery to prevent ovarian cancer. Ovarian cancer is the fifth cause of cancer-related mortality in females in Canada. OS can prevent the most common and lethal type of ovarian cancer, high grade serous carcinoma (HGSC). OS during gynecologic surgery (hysterectomy or instead of tubal ligation) is safe and effective. However, rates of hysterectomies and tubal sterilization are decreasing. This research team aims to extend the prevention of ovarian cancer by expanding to offer OS during other surgeries in the pelvis where fallopian tubes are accessible, beginning with colorectal surgery. This study will examine: 1) the feasibility of OS at the time of colorectal surgery; 2) the safety of OS at the time of colorectal surgery; 3) the cost-effectiveness of OS at the time of colorectal surgery. The hypothesis is that OS will be well accepted by individuals with fallopian tubes undergoing colorectal surgery, and that the vast majority (around 90 percent) of attempts to remove both fallopian tubes will be successful. It is expected that there will be 10-20 minutes additional operating room time for completing OS and that there will be no increased risk of complications when OS is included in a colorectal surgery. The researchers also hypothesize that OS at the time of colorectal surgery will be cost-effective because of the reduced number of ovarian cancer cases and associated treatment costs.
NCT06200857
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.
NCT04134104
Colorectal cancer is the second most common cancer by the site in Europe and the third most common cancer in the USA with high morbidity and mortality. Survival after the treatment has improved over the past few decades as a result of early diagnosis, radiotherapy, and advances in surgical techniques such as abdominoperineal resection (APR), low anterior resection (LAR) and total mesorectal excision (TME). These innovative surgeries are the current standard treatment for the mid and the low rectal cancers which avoids the permanent colostomy. It is very difficult to find out the incidence of the bowel, bladder and sexual dysfunction of patients either because they are embarrassed or because they do not relate their symptoms to rectal cancer treatment. This article reports the incidence of the bowel, bladder and sexual dysfunction following surgery for rectal cancer from the National Academy of Medical Sciences, Bir Hospital, a tertiary level hospital.
NCT03702621
The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery
NCT05167890
Colorectal surgery, even performed by laparoscopy is followed by a transient episode of GI hypomotility, which results in a postoperative ileus (POI). The usual duration of this benign postoperative situation varies between 3 and 5 days for colon surgery. A longer duration of POI will result in more postoperative complications such as delayed surgical wound healing, atelectasis, pneumonia, and deep vein thrombosis; in a prolonged hospital stay; and increased healthcare cost. Different studies reported that the duration of POI correlates with total surgery time, blood loss, total opiate dose degree of surgical trauma, and bowel manipulation. Many attempts have been made to reduce the phase of postoperative intestinal hypomotility. The different strategies are well described in enhanced recovery and fast-track concepts and focus on minimal surgical trauma, rapid postoperative mobilization, early feeding, preemotive laxative treatment, restrictive fluid management, and minimal postoperative opioid prescription. Furthermore, several pharmacologic agents have been evaluated; however, not all offered a convincing benefit, nor were they free of adverse effects. Coffee is a worldwide highly consumed beverage, offering pleasure to many people of different cultures, and which many associate with an increase of bowel function. The aim of this study is to compare the time to first bowel movement after laparoscopic colorectal surgery between patients drinking coffee or orange juice postoperatively, in a randomized controlled trial (RCT).
NCT03433014
The study design is a prospective randomized, double-blind, controlled trial of patients who are due to have elective laparoscopic colorectal surgery in Ramathibodhi Hospital. The primary objective is to measure pain scores (Visual Analog Scale) in the postoperative period. The secondary objective is to compare the VAS scores between the two types of technique used for specimen retrieval incision.After approval by the ethics committee, patients scheduled for elective laparoscopic colorectal surgery under general anesthesia who are eligible for inclusion criteria were recruited for this study after informed consent by surgical residents or surgical staff at the Outpatient Department (OPD). Patients who meet the exclusion criteria will be excluded.
NCT03080142
This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.