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Intestinal Obstruction clinical trials

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NCT ID: NCT06347120 Not yet recruiting - Clinical trials for Small Bowel Obstruction Adhesion

Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction

BOWNTI
Start date: April 2024
Phase: N/A
Study type: Interventional

Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses. The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) : - OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours; - NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h. NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM. However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia. Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management. To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO.

NCT ID: NCT06182319 Not yet recruiting - Clinical trials for Adhesive Small Bowel Obstruction

Optimizing Treatment of Adhesive Small Bowel Obstruction

Start date: January 15, 2024
Phase: Phase 3
Study type: Interventional

Small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO. This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.

NCT ID: NCT06140173 Not yet recruiting - Clinical trials for Small Bowel Obstruction

Low-osmolar Water Soluble Contrast Agent in Management of Adhesive Small Bowel Obstruction

Start date: June 2024
Phase: N/A
Study type: Interventional

Adhesive small bowel obstruction (ASBO) is a condition that is commonly found in patients with history of abdominal surgery. The management for such condition can be controversial. In terms of conservative treatment, recent studies have shown conflicting outcomes on whether water soluble contrast would provide benefit in reducing number of patients needed for surgery. In addition, there are a limited number of literature that investigates the role of low-osmolar contrast in reducing operative need in patients diagnosed with ASBO. The objective of this study is to compare the operative rate of patient diagnosed with ASBO between patients who were treated with low osmolar water soluble contrast (Iohexol) and patients who were treated traditionally.

NCT ID: NCT06065150 Not yet recruiting - Clinical trials for Small Bowel Obstruction

Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)

SURGI-BOW
Start date: January 2, 2024
Phase: N/A
Study type: Interventional

For uncomplicated acute small bowel obstruction (aSBO), the "Bologna guidelines" recommend non-surgical management of 72 hours before considering surgery. This treatment is based on the placement of a nasogastric tube and the correction of hydro-electrolyte disorders. Non-surgical management is only effective in 60 to 70% and surgery is therefore necessary in 30 to 40% of cases after medical treatment for at least 3 days. This therefore leads to an increase in the length of hospital stay. Some authors also point out that postponing surgery for 3 days would aggravate the morbidity and mortality of surgery. Indeed, aSBO surgery has a complication rate of 10-40% and a mortality of up to 4%. There is a lack of studies evaluating what is the best management strategy for aSBO, especially with regard to the duration of medical treatment. Many recent studies plead in favor of early surgical treatment (<24 hours) which would reduce the morbidity and mortality rate of surgery but also the overall cost of treatment by reducing the length of stay. This paradigm shift is linked to the improvement of anesthetic and intensive care management over the last few years, but also to the advent of laparoscopy in emergency surgery. Indeed, laparoscopy could reduce the duration of hospitalization but also the operative morbidity and mortality. However, this surgical approach is not feasible in all situations and the conversion rate is reported in 30 to 76% of cases. One of the factors favoring the feasibility of the laparoscopic approach is the performance of early surgery. Another parameter favoring the feasibility of the laparoscopic approach is the aSBO mechanism: an aSBO on flange (SBA) is more likely to be treated effectively by laparoscopic than an aSBO on multiple adhesions (MA). In the literature, there is little to differentiate SBAs from MAs. Advances in CT scans have made it possible to describe the signs associated with the SBA mechanism and then to propose a score making it possible to predict the SBA mechanism with good performance (sensitivity 67.6%, specificity 84.6%). This score not only has the advantage of predicting the mechanism of the occlusion but it also makes it possible to predict the failure of non-surgical treatment if the score is ≥5.

NCT ID: NCT05864378 Not yet recruiting - Clinical trials for Small Bowel Obstruction

POCUS for Small Bowel Obstruction in the ED: a Retrospective Study

SBOCUS
Start date: September 1, 2023
Phase:
Study type: Observational

This study protocol aims to evaluate the impact of point-of-care ultrasound (POCUS) on the diagnosis and management of small bowel obstruction (SBO) in the emergency department (ED). SBO is a potentially life-threatening condition that requires prompt diagnosis and management. Currently, the diagnosis of SBO is based on clinical evaluation and imaging tests, including plain abdominal radiography and computed tomography (CT) scan. POCUS is a bedside imaging technique that is rapid, non-invasive, repeatable, cost-effective and radiation-free, and can provide valuable information for the diagnosis and management of SBO. The primary objective of this study is to compare the time to diagnosis of SBO between patients who undergo POCUS intestinal loops examination and those who do not undergo POCUS in the ED. The secondary objectives include comparing the hospital length of stay, the rate of surgical intervention, the rate of complications, and the mortality rate between the two groups. This is a monocentric retrospective cohort study that will include all adult patients (> 18 years old) who presented to the ED with suspected SBO. The study population will be divided into two groups: the POCUS group and the non-POCUS group. The sample size calculation will be based on the assumption of a 30% reduction in the time to diagnosis of SBO in the POCUS group compared to the non-POCUS group, with a power of 80%. The results of this study may provide more robust evidence on the diagnostic accuracy and impact of POCUS for SBO in the ED.

NCT ID: NCT05843097 Not yet recruiting - Clinical trials for Small Bowel Obstruction

SnapSBO - Small Bowel Obstruction Snapshot Audit

SnapSBO
Start date: November 1, 2023
Phase:
Study type: Observational

Small bowel obstruction (SBO) and its complications are frequently seen in patients admitted through the Emergency Departments of all acute care hospitals2. There is variation in the optimal use of imaging, the appropriate timing and duration of non-operative management attempts, anti-microbial therapies, and the criteria for surgical management, which results in heterogeneity in approaches and outcomes across international clinical centers. The expected number of SBO cases in most clinical centers is predictable, enabling a suitably-sized cohort of patients to be gathered in the snapshot audit. This 'ESTES snapshot audit' -a prospective observational cohort study- has a dual purpose. Firstly, as an epidemiological study, it aims to uncover the burden of disease. Secondly, it aims to demonstrate current strategies employed to diagnose and treat these patients. These twin aims will serve to provide a 'snapshot' of current practice, but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of the particular clinical questions.

NCT ID: NCT05450393 Not yet recruiting - Clinical trials for Small Intestine Cancer

Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)

Start date: May 1, 2024
Phase:
Study type: Observational

A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).

NCT ID: NCT05442164 Not yet recruiting - Bowel Obstruction Clinical Trials

Effect of Implementation of the Danish Emergency Surgery (DANAKIR) Support Network on Post-discharge Outcomes After Major Emergency Abdominal Surgery

DANAKIR
Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

Effect of implementation of the Danish Emergency Surgery (DANAKIR) support Network on post-discharge outcomes after major emergency abdominal surgery: a prospective before and-after study Background Major emergency abdominal surgery is performed in more than 5000 patients yearly in Denmark. In general, little is known about the period after the discharge of these patients besides that chronic pain, physical dysfunction, and quality of life are severely affected in up to 50% of patients at long-term follow-up. A recent study investigating unplanned readmission after major emergency abdominal surgery found that up to 50% undergo unplanned readmission within the first 180 days after discharge. Purpose The purpose of this study is to evaluate the effects of inviting patients undergoing major emergency surgery and their relatives to join a support network after discharge (the DANAKIR network). Methods This study is designed as a before- and after study. Prior to establishing the DANAKIR (Danish Emergency Surgery Network) support network, the investigators will consecutively during a one year inclusion period prospectively include all patients undergoing emergency abdominal surgery with a midline laparotomy. The inclusion period starts 1st August 2021. The investigators will register the following in the pre-implementation phase: - Postoperative day (POD) 30: Quality of life (EQ-5D-5L) (by telephone) - POD90: Quality of life (EQ-5D-5L) (by telephone), readmissions (by hospital file) - POD 180: Quality of life (EQ-5D-5L) (by telephone), readmissions (by hospital file) - Number of days at home with 90 days (by hospital file) - Number of participants with at least one readmission (by hospital file) Hereafter the investigators will establish the DANAKIR support network. The investigators plan for a six-month inclusion period with DANAKIR starting 1th of September 2022 Intervention The DANAKIR intervention will consist of: - Structured written discharge information for the participanats and relatives about expectations and precautions - Invitation to the DANAKIR monthly information meeting All patients undergoing emergency abdominal surgery and members of their family are invited to participate in at least one DANAKIR meeting. Patients and their relatives can participate in as many meetings as they wish; however, we encourage all patients to participate at least once. DANAKIR meetings The monthly meetings are a core component of the support network. One time each month, a meeting will be held at Herlev Hospital with the participation of an emergency surgeon, an emergency surgery dedicated nurse, a dietician, and a physiotherapist. Furthermore, there will be research personnel present. Each professional (surgeon, nurse, dietician, physiotherapist) will host an informative 15 minute session regarding the postoperative course after major emergency surgery. Following the presentations time for questions in plenum and private with the different experts will be held. Furthermore, there will be an opportunity for networking at the DANAKIR meeting. Each meeting is planned to last 2 hours. At the end of each meeting the patients will be asked to evaluate the meeting and content. Outcome measures The primary outcome of this study is the number of days at home within 90 days of surgery. The secondary outcomes are quality of life at 30 days, 90 days, and 180 days after surgery and the number of patients with at least one emergency readmission 90 days and 180 days from surgery. Trial size The investigators expect to include 200 patients in the before group and 200 patients in the after group. Perspectives The DANAKIR support network examines if a structure with physical network meetings is effective in regard to quality of life and preventing readmissions after major emergency surgery. The investigators hypothesize that the days at home will increase within 90 days from surgery and that quality of life will increase for both participants and their relatives by implementing a simple and obvious solution. If the DANAKIR network proves efficient it is an easily implemented solution to increase quality of life and days at home after major emergency surgery.

NCT ID: NCT05253222 Not yet recruiting - Clinical trials for Fecal Microbiota Transplantation

Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET

RIT;TET
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The etiology of bowel obstruction is usually diagnosed by imaging techniques such as MSCTE,MRE, et al, which have some disadvantages. For example, in order to obtain better image quality, MSCTE(Multi-slices spiral computed tomography enterography) and MRE( Magnetic resonance enterography)require patients to take a large amount of intestinal contrast solution orally, while for patients with intestinal obstruction, which may further aggravate the disease. Our study team had confirmed the mid-gut TET could serve as the delivery way of contrast solution for MRE bowel preparation with better accuracy of lesion detection and lower reduction of pain in CD(Crohn's Disease) patients. In this study, contrast solution will be delivered by colonic TET placed by lower GI-endoscopy, then we will evaluate the methodology and clinical value of this kind retrograde imaging technique in patients with intestinal obstructive diseases.

NCT ID: NCT05117645 Not yet recruiting - Clinical trials for Intestinal Obstruction

Role of Computed Tomography in Evaluation of Different Causes of Intestinal Obstruction Correlated With Operative Findings

Start date: December 2021
Phase:
Study type: Observational

Intestinal obstruction is a common clinical problem that occurs secondary to mechanical or functional obstruction of the intestine, preventing normal transit of its contents. It is a frequent cause of hospitalization and represents 15-20% of surgical admissions for acute abdominal pain . The underlying aetiology of large bowel obstructions (LBOs) is age dependent, but in adulthood, the most common cause is colonic cancer (50-60%), typically in the sigmoid. The second most common cause in adults is acute diverticulitis (involving the sigmoid colon). Together, obstructing tumors and acute diverticulitis account for 90% of all causes of LBO. Adhesions are the most common cause of small bowel obstruction (SBO) , For practical purposes, they do not tend to cause LBO.Other causes which cause symptoms that are mimic intestinal obstruction as in bowel ischemia that mainly caused by mesenteric vessels occlusion (adynamic obstruction). Computed tomography (CT) has become a mainstay in diagnosing bowel obstruction. This is because the management of obstruction has dramatically changed with a decrease in the proportion of patients who need surgery Multi Detector Computed Tomography scanners provide a huge gain in performance that can be used to reduce the scan time, reduce section collimation, or to increase scan length surgery. Diagnosis of intestinal obstruction is established by patient history and clinical findings include abdominal distension, acute abdominal pain, vomiting and inability to pass stools or flatus . The role of CT in diagnosing intestinal obstruction has been expanding by determining presence, degree, level and cause (extrinsic lesions, intrinsic lesions, intussusception, intraluminal lesions) of obstruction and in identifying any associated strangulation, and also it has an important role in diagnosing the mesenteric vessels obstruction by thrombi by injection of IV contrast media which causes adynamic bowel obstruction .