Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection
Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection
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 increase in AUR in these patients, it can be withdrawn early in a safe way with a lower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.
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 local 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.