Blood and Lymph Conditions

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Neoplasms

Digestive System Diseases

Anemia, Iron-Deficiency

Iron Deficiencies

Postoperative Complications

Anemia

Colorectal Neoplasms

Deficiency Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

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Iron Metabolism Disorders

Anemia, Hypochromic

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Chrysarobin

Iron

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Antibiotics, Antitubercular

Defined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as decreased haemoglobin concentration (HGB)

Defined as: decreased serum iron concentration and TSAT, increased TIBC, UIBC, as well as normal HGB

Defined as: normal serum iron concentration, TSAT, TIBC, UIBC and HGB

Erythrocyte indices based on the preoperative complete blood count results will be calculated for each patient one day prior to surgical treatment.

Overall morbidity of each patient during hospital stay will be scored using the Comprehensive Complication Index (CCI). Intraoperative complications will be graded according to the ClassIntra classification of intraoperative adverse events. The quality of postoperative recovery of each observed patient will be scored on the first, second and fifth postoperative day, using the 15-item quality of recovery scale (QoR-15).

Data about red blood cell transfusion rate, all-cause infection rate, number of days when antibiotics were administered and the number of different antibiotics administered during hospital-stay will be collected.

Laboratory analyses for the detection of iron deficiency anaemia

Nora Mihalek, MD

Dragana Radovanovic, Prof. Dr.

The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are:

* whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery
* whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients.

Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin.

Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected.

The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices.

The following erythrocyte indices based on the preoperative complete blood count results will be calculated for each patient one day prior to surgical treatment:

* Mentzer index: MCV / RBC
* Green and King index: MCV2 x RDW / (100 x HGB)
* RDW index: MCV x RDW / RBC
* Shine and Lal index: MCV2 x MCH / 100
* England and Fraser index: MCV - RBC - (5 x HGB) - 3.4
* Srivastava index: MCH / RBC
* Ricerca index: RDW / RBC
* Ehsani index: MCV - (10 x RBC)
* Sirdah index: MCV - RBC - (3 x HGB)
* Sehgal index: MCV2 / RBC

The Ganzoni equation for calculating total iron deficit will be calculated for each patient one day prior to surgical treatment, using the following formula:

total iron deficit \[mg\] = body weight \[kg\] x (target hemoglobin \[g/L\] - actual hemoglobin \[g/L\]) x 2.4 + iron depot \[mg\]

Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery

Preoperative Evaluation and Impact of Iron Deficiency Anaemia on the Incidence of Perioperative Complications and Quality of Recovery After Radical Colorectal Cancer Surgery

score of Comprehensive Complication Index (CCI)

grade of ClassIntra classification of intraoperative adverse events

calculated based on the complete blood count parameters

University of Bern

Oncology Institute of Vojvodina

Patients with IDA presenting with bowel symptoms like change in bowel habits, weight loss and abdominal mass other than rectal bleed

Patients referred with a suspected bowel malignancy were subjected to top and bottom endoscopic examination or a cross sectional imaging like CT scan and MRI scan.

Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

TALAL MAJEED, MRCS

A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.

In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have Colorectal cancer compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.

Although there are strict and specific guidelines for referring patients with iron deficiency anaemia (IDA) to fast track colorectal cancer (FT CRC) clinics for further assessment and investigation, patients with other types of anaemia are still referred by primary care physicians in the UK. Investigators aim was to find out whether this practice is correct, or if it is causing an overburden on colorectal clinics and endoscopy services. Investigators also want to find out whether true/absolute IDA has a higher predictive value for diagnosing colorectal cancer (CRC) compared to other types of anaemia and specific bowel symptoms.

Investigator's hypothesis was that patients with IDA are more likely to have CRC compared to patients with no anaemia or non-IDA anaemia. By confirming this hypothesis, Investigators can identify high risk patients from the population who can then be preferentially subjected to investigations mandated by guidelines. This strategy can help to increase the diagnostic yield of FT CRC clinics.

A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.

In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have CRC compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.

Physicians should be able to stratify patients based on blood indices when referring them to FT CRC clinics. Diagnostic yield of these clinics can be increased if clinicians strictly adhere to fast track guidelines and confirm true IDA before referring patients to clinic.

Measures to Increase the Effectiveness of Fast Track Colorectal Clinics for Iron Deficiency Anaemia.

Establishing Absolute Iron Deficiency Anaemia Before Referring Patients to Colorectal Fast Track Clinics Can Help to Increase the Diagnostic Yield of the Bowel Cancer Screening Programme.

I have an excel sheet of the data and statistics done on the data which can be provided on request

diagnostic yield of colorectal cancer in patients presenting to fast track clinics with symptomatic ,asymptomatic anaemia, anaemia with normal blood indices, anaemia with Iron deficiency anaemia and certain bowel symptoms was measured. Patients were subjected to endoscopy for diagnosis. Diagnostic yield was expressed as diagnostic odds ratio and measured by statistical tools like Mantel Haenszel trend test and results are illustrated in the from of odds ratio. Crude odds ratio could not be used as association of binary outcome (colorectal caner or no cancer) with binary predictors in multiple case control groups was assessed.

Wirral University Teaching Hospital NHS Trust

Research Fellow

Rare Diseases

Syndrome

Hemorrhage

Crohn Disease

Gastrointestinal Hemorrhage

Celiac Disease

Intestinal Polyposis

Inflammatory Bowel Diseases

Gastroenteritis

Malabsorption Syndromes

Small Intestine Cancer

Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach.

Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. When the region of interest in the small bowel is reached by NMSE standard endoscopic techniques, e.g. argon plasma coagulation (APC), forceps biopsy or endoscopic mucosal resection (EMR) are performed for treatment and/or tissue acquisition.

motorized spiral enteroscopy

Horst Neuhaus, MD

The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The NMSE system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the small bowel on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and limitation of rotation to a short cuff instead of a long overtube promise to accelerate the procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to conventional spiral enteroscopy

General anesthesia and/or sedation will be prescribed according to institutional practices and clinical judgment; type, amount and duration will be recorded.

A standard esophagogastroduodenoscopy (EGD) will be performed prior to the enteroscopy. If during this preliminary exam the endoscopist identifies any stricture or believes the patient has anatomy that would cause excessive resistance during Novel Motorized Spiral insertion or examination, the patient will be withdrawn from the study and the reason for study withdrawal will be noted.

The Novel Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, (controlled directly by the operating physician via the foot pedal). If at any point a stricture is observed or excessive resistance to the advancement of the endoscope is encountered, further advancement of the endoscope must cease and the reason for procedure termination documented on the case report form.

After reaching the depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. Maximum depth of insertion will be recorded as the maximum insertion depth when failure to advance the endoscope tip after repositioning the patient, applying abdominal pressure and/or using other standard measures fails to advance the endoscope OR the investigator decides to terminate advancement based on clinical judgment. During withdrawal, the endoscopist will cumulatively estimate the length of bowel released from the endoscope tip in order to calculate the total depth of insertion. Insertion depth will be referenced to the Ligament Treitz. If the clinician decides to mark the point of maximum insertion, the tissue may be tattooed by first creating a saline bleb, followed by the injection of India ink (e.g., SPOT).

Tissue sampling and/or therapies will be performed during withdrawal as clinically appropriate. The details of all sampling and/or therapies (number, type \& location) will be recorded.

The comfort and cardiopulmonary stability of the patient will be monitored throughout the procedure, as per the standard of care - this includes continuous pulse oximetry, blood pressure, and heart rate monitoring.

Photographs or video recordings are used to document any significant lesions and any tissue trauma.

Postprocedural measures Patients will be hospitalized for at least 24 hours after NMSE because of the potential risk of delayed adverse events. Only liquid diet is allowed during the first 12 hours in asymptomatic patients. Clinical investigation and determination of the blood cell count and the serum level of C-reactive protein will be done after 24 hours. 30 days after the procedure patients will be interviewed by a telephone call for evaluation of complaints or delayed complications. Discomfort (location and severity (0-10 VAS) should be documented immediately after NMSE, after 24 hours and before discharge.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery	NCT06276140	Iron Deficienci... Iron Deficiency... Postoperative C... Colorectal Canc...	Laboratory anal...	18 Years -	Oncology Institute of Vojvodina
Measures to Increase the Effectiveness of Fast Track Colorectal Clinics for Iron Deficiency Anaemia.	NCT03988712	Colorectal Canc...	Colonoscopy, ga...	18 Years -	Wirral University Teaching Hospital NHS Trust
Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery	NCT06276140	Iron Deficienci... Iron Deficiency... Postoperative C... Colorectal Canc...	Laboratory anal...	18 Years -	Oncology Institute of Vojvodina
European Novel Motorized Spiral Endoscopy Trial	NCT02965209	Disorder of Sma... Gastrointestina... Iron Deficiency... Crohn's Disease Small Bowel Tum... Intestinal Poly... Coeliac Disease	motorized spira...	18 Years -	Evangelisches Krankenhaus Düsseldorf

Spots Global Cancer Trial Database for iron deficiency anaemia