Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Urinary Bladder Neoplasms

Hemorrhage

Hematuria

Prostatic Hyperplasia

Hyperplasia

Transfusion Reaction

Postoperative Hemorrhage

Urinary Retention

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Urologic Neoplasms

Urogenital Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Urination Disorders

Postoperative Complications

Hematologic Diseases

Anticoagulants

All Drugs and Chemicals

Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic prostatectomy (TURP).

Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic prostatectomy (TURP).

Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic bladder tumor resection (TUR-BT).

Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic bladder tumor resection (TUR-BT).

Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent open prostatectomy (OP).

Patients with no history of anticoagulant/antiaggregant medication and underwent open prostatectomy (OP).

Abdullah Ilktac, MD

Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared.

Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia

Investigation of the Effects of Anticoagulant/Antiaggregant Use on Postoperative Bleeding Risk in Patients Operated for Bladder Tumor and Benign Prostatic Hyperplasia

Presence of clot retention due to hematuria after the operation which requires manuel irrigation

Gross hematuria requiring blood transfusion

Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.

Amount of postoperative continuous bladder irrigation volume

Bezmialem Vakif University

Pincipal investigator

Infections

Wounds and Injuries

Digestive System Diseases

Rare Diseases

Communicable Diseases

Urinary Tract Infections

Surgical Wound Infection

Anastomotic Leak

Surgical Wound

Wound Infection

Rectal Neoplasms

Disease Attributes

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Acute Graft Versus Host Disease

Urinary Catheter will be removed the first postoperative day after rectal resection

Urinary Catheter will be removed the third postoperative day after rectal resection

Urinary Catheter will be removed the fifth postoperative day after rectal resection

Urinary catheter will be removed in aeseptic conditions. Before the removal a urinary culture will be obtained from the catheter.

Removal of Urinary Catheter

Garazi Elorza, MD

Jose Maria Enriquez-Navascues, PhD

DESIGN:

Randomized, open-label and parallel clinical trial, assigned to early, mid, or late withdrawal of urinary catheter with a 1: 1: 1 allocation ratio.

POPULATION:

Patients undergoing anterior rectal resection, low rectal resection, or abdominoperineal amputation for any reason.

OBJECTIVES:

The main objective is to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection.

Secondary objectives are:

1. Incidence of urinary tract infection after urinary catheter removal.
2. Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus).
3. Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.

DESCRIPTION OF THE INTERVENTION:

In all patients, a Rectal Resection (anterior rectal resection, posterior pelvic exenteration or abdominoperineal amputation) will be performed. In group 1A, the urinary catheter will be removed on the 1st postoperative day. In group 1B patients, the urinary catheter will be removed on the 3rd postoperative day. In group 1C patients, the urinary catheter will be removed on the 5th postoperative day. All patients will have a urine culture taken at the time of withdrawal.

Currently there is a trend towards prolonged urinary catheterization in patients undergoing rectal resection surgery. However, there are studies that defend although there is a slight increase in AUR in these patients, it can be withdrawn early in a safe way with a lower incidence of UTI.

The aim of the study is to analyse whether there are differences in the incidence of AUR in rectal surgery patients and to observe whether it has an impact on other postoperative complications. A randomized clinical trial is proposed to compare an early, mid or late removal of the urinary catheter in patients with rectal resection.

- Potential Risks and Benefits:

Both techniques, both early and late withdrawal, are approved practices that are carried out in a standardized way in the current practice. There are no potential risks associated with the study intervention, beyond the intrinsic risks of the procedure itself.

- Objectives of the study:

Main objective: to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection.

Secondary objectives:

Incidence of urinary tract infection after urinary catheter removal. Incidence of specific postoperative complications (surgical wound infection, respiratory infection, anastomotic dehiscence, ileus).

Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.

* Variables:

  * Demographic: sex, date of birth, BMI, ASA, Benign Prostate Hyperplasia, surgical history, usual treatment, date of diagnosis of the tumor, neoadjuvant treatment, tumor stage (TNM).
  * Preoperative evaluation: IPSS (International Prostate Syndrome Score) for evaluation of preoperative urinary function in men.
  * Surgical treatment: date of surgery, antibiotic prophylaxis, type of surgical approach, blood volume administered during surgery, mechanical preparation of the colon, type of surgery, ligation of the inferior mesenteric artery (IMA), need for intraoperative transfusion, duration of intervention, bleeding, intraoperative complications.
  * Postoperative evolution: Acute retention of urine, urinary tract infection, surgical wound infection, respiratory infection, paralytic ileus, blood volume administered postoperatively, postoperative complications (ICC), date of diagnosis, reoperation, hospital stay, postoperative mortality and readmission .
  * Evolution and follow-up: Need for catheterization, removal of urinary catheter, urinary tract infection.
* Definitions:
* Postoperative morbidity includes all postoperative complications that occurred during the first 30 postoperative days. Complications will be evaluated according to the CCI (classification that considers the accumulation of complications based on the Clavien-Dindo scale).
* Severe prostate symptomatology is considered to be an IPSS score (established questionnaire for prostate symptoms) greater than 20.
* Urinary catheter placement is considered to be the placement of a catheter through the urethra, always performed under antiseptic conditions.
* AUR is considered the impossibility of urine output despite urinary desire and at least 30 minutes, or anuria of 8 hours after the removal of the UC with a retention of more than 250 mL.
* UTI is defined as a positive urine culture with\> 10 5 bacterial colonies / mL of urine.
* Respiratory infection is considered a positive sputum culture and / or a chest radiograph with parenchymal condensations.
* The wound infection is considered deep, superficial or parastomal according to the CDC (Center for Disease Control) criteria for wound infections.
* A delay in oral tolerance due to vomiting, abdominal distention or the need for nasogastric tube placement will be considered ileus.
* Anastomotic dehiscence and its severity is defined according to the International Study Group of Rectal Cancer.
* Postoperative mortality is defined as death within the first 90 days after surgery or before hospital discharge.
* Readmission is defined as admission to the hospital within 30 days of discharge from the hospital.
* Neoadjuvant chemotherapy is considered to be that received prior to surgery.
* The duration of the surgical intervention is considered the time from the beginning of the skin section to the end of the last skin point, calculated in minutes.
* The volume administered during the surgery is considered the volume of fluids administered by the venous route from the induction of anesthesia to the extubation of the patient.
* A high ligation of the IMA is considered to be the ligation that is performed about 2 cm from the root of the IMA, preserving the superior hypogastric plexus. Low ligation of the IMA is considered one that is distal to the bifurcation of the IMA.
* Study Design:

  * Randomized clinical trial, with an allocation ratio of 1: 1: 1, controlled, of patients undergoing rectal resection surgery.
  * The study population is hospitalized patients, who underwent anterior rectal resection, low anterior rectal resection or abdominoperineal amputation of any etiology.
  * It is a single-center trial.
  * The expected recruitment period is 36 months. The follow-up time of the patients in the study is 30 days.
  * The approximate duration of the study is 3 years.

Calculation of the sample size:

According to published clinical trials, up to 30% of rectal surgery patients who have VS removed will have an AUR for the first POD. The estimated risk of AUR after removal of VS on the 3rd PDO is 5%. If a confidence level at 95% is set and a statistical power of 80% is desired and having an expected proportion of losses of 10% in each group, the sample size should be 48 in each group.

Randomization process:

Patients who meet the inclusion criteria for the study will be randomized using random number generator functions with the SPSS v.25 program in the UC withdrawal group on the first, third and fifth postoperative days. The randomization will be 1: 1: 1.

Allocation concealment will be done by sealed opaque envelopes. The envelope will be opened inside the operating room at the beginning of the surgical procedure.

Masking process:

Patients, surgeons, and research staff know the intervention group to which the patient have been assigned.

Dropouts, withdrawals and losses

* Dropouts: patients included in a clinical trial who are unwilling or unable to continue in the study or in follow-up.
* Withdrawals: patients who are forced to abandon the study due to the appearance of exclusion criteria, but whose follow-up is feasible.
* Loss of follow-up: patients included in the study, who do not carry out the indicated controls, for whom it is not possible to obtain follow-up data.
* Criteria for Inclusion and Exclusion

  • INCLUSION CRITERIA:
* Patients undergoing programmed rectal surgery.
* Age ≥ 18 years and \<85 years.
* Any type of tumor, any T, N, M.
* Consent signed by the patient and the researcher.

  • EXCLUSION CRITERIA:
* IPSS\> 20
* Transanal resection.
* Urinary catheterization in the 7 days prior to surgery.
* Patients taking treatment for benign prostatic hyperplasia.
* Urine infection in the month prior to surgery.
* Patients with chronic kidney failure with Creatinine\> 2 mg / dL.
* Enterovesical fistula.
* Neurogenic bladder.
* Patients with a sacral nerve stimulator or artificial sphincter.
* Inability to read or understand any of the languages of informed consent.
* Emergency surgery.
* Psychiatric illnesses, addictions or any disorder that prevents the understanding of informed consent.
* Description of the intervention:

Management common to all patients included in the study:

Lithotomy position for surgery, regardless of whether it is subsequently modified to the prone position. Laparotomy or laparoscopic surgery, performing Anterior Rectum Resection, Lower Anterior Resection, with or without anastomosis or Abdominoperineal Resection.

Transurethral 16 Fr Foley catheter placement. Balanced general anesthesia, with or without epidural catheter, at the discretion of the responsible anesthesiologist. Avoid hydric overload and favor normothermia.

Positioning of the usual trocars (but modifiable according to the surgeon's preferences). An oncological or transmesorectal mesorectal dissection will be performed according to the needs of each patient, always trying to identify the upper and lower hypogastric plexus, without injuring them. The inferior mesenteric artery will be cut at least 2 cm from the root to avoid the superior hypogastric plexus or a distal ligation with preservation of the left colic artery. The extraction of the sample will be by a Minipfannenstiel, laparotomy or perineum.

In group 1A, the UC will be removed in the first 24 hours after surgery, accompanied by a urine culture taken from UC. In group 1B, the UC will be removed approximately 72 hours after surgery, accompanied by a urine culture taken for UC. In group 1C, the UC will be removed approximately 96 hours after surgery, accompanied by a urine culture taken from UC.

In cases of APR, the UC will be replaced, which will be maintained for at least 4 more days, at which point its removal will be attempted again along with taking another urine culture.

Complications data will be collected together with the other variables in the data collection sheet.

The other fast-track principles approved by different participating centers will be applied.

Early removal of urinary catheter Medial removal of urinary catheter Late removal of urinary catheter

Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection

Acute Urinary Retention After Early, Medium or Late Removal of the Urinary Catheter in Rectal Cancer Surgery. RAOREC Study

to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection, measured by the proportion of patients that need to be newly catheterized in the first 30 postoperative days.

Proportion of patients that hace a urinary tract infection measured by the culture obtained at the time of the removal of the catheter.

Incidence of surgical wound infection after rectal resection surgery measured by a positive culture or a drained abscess.

Respiratory infection is considered a positive sputum culture and / or a chest radiograph with parenchymal condensations.

The incidence of anastomotic dehiscence and its severity is measured by the International Study Group of Rectal Cancer. Anastomotic dehiscence is defined as a defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments

Incidence of ileus measured by the proportion of patients with delay in oral tolerance due to vomiting, abdominal distension, or the need for nasogastric tube placement.

Postoperative complications according to the Comprehensive Complication Index (CCI) scale. The CCI integrates all complications of the Clavien-Dindo classification and offers a metric approach to measure morbidity. Higher rates mean more complications.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia	NCT05314582	Hematuria Retention, Urin... Operative Bleed... Blood Transfusi...		-	Bezmialem Vakif University
Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection	NCT04751149	Rectal Cancer Retention, Urin... Urinary Tract I... Surgical Site I... Anastomotic Lea...	Removal of Urin...	18 Years - 85 Years	Hospital Donostia
Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection	NCT04751149	Rectal Cancer Retention, Urin... Urinary Tract I... Surgical Site I... Anastomotic Lea...	Removal of Urin...	18 Years - 85 Years	Hospital Donostia

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