Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751149
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2020-10-27
Brief Title:
Incidence of Acute Urine Retention Randomized Clinical Trial Comparing Early Mid or Late Urinary Catheter Removal in Patients With Rectal Resection
Sponsor:
Hospital Donostia
Organization:
Hospital Donostia
Study Overview
Official Title:
Acute Urinary Retention After Early Medium or Late Removal of the Urinary Catheter in Rectal Cancer Surgery RAOREC Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAOREC
Brief Summary:
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
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
Detailed Description:
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 v25 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 surgeons 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
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 v25 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 surgeons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None