Early and Late Removal of the Urinary Catheter After Rectum Resection
Primary Purpose
Colorectal Surgery, Rectal Cancer, Urinary Retention Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Procedure: Early removal group
Procedure: Late removal group
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Surgery
Eligibility Criteria
Inclusion Criteria:
- Patients who will undergo Low Anterior Resection due to rectal cancer in the Department of General Surgery of our university.
- Competent to consent to participate in trial
- Elective surgery
- ASA classification of 1~3
Exclusion Criteria:
Patients whose post-treatment status cannot be obtained.
- Having Bladder surgery before
- Having a previous prostate surgery.
- Patient's refusal to participate in the study.
Sites / Locations
- Marmara university Pendik Research and Education HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Early group
Late group
Arm Description
Patients whose catheters are removed within the first 48 hours after surgery will form the early group.
Patients whose catheters are removed after the first 48 hours of surgery will form the early group.
Outcomes
Primary Outcome Measures
Post-operative urinary retention requiring re-catheterisation
Development of acute post-operative urinary retention requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period.
Postoperative urine culture
Investigate any colonization before discharge in both groups
Discharge with urinary catheter
Any need for urinary catheter at the time of the discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05020613
Brief Title
Early and Late Removal of the Urinary Catheter After Rectum Resection
Official Title
Comparison of Early and Late Removal of the Urinary Catheter After Low Anterior Resection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It was aimed to investigate the need for urinary retention and recatheterization in the postoperative period by removing the urinary catheter in patients undergoing low anterior resection, in the early or late period.
Detailed Description
Urinary catheter is placed before abdominal surgery to increase visualization during the operation, prevent bladder injury and provide perioperative urine output monitoring. It is especially useful in patients who will undergo low anterior resection, with a high risk of nerve damage and consequent urinary retention and bladder dysfunction. Urinary catheter removal time differs between operations. Traditionally, the urinary catheter is kept in place for 7 days because urinary retention occurs in some patients whose urinary catheter is displaced in the early period. As the urinary catheter retention time increases, the risk of urinary tract infection also increases.
According to the current ERAS protocol, it is recommended to remove the urinary catheter 48 hours after the surgery in patients who have undergone colorectal surgery and are treated with epidural pain management. However, the ERAS protocol is not specific to patients who have undergone low anterior resection, which is the main point of our study and includes all patients who have undergone colorectal surgery. Most authors still believe that prolonged retention of the urinary catheter will prevent urinary retention and long-term bladder dysfunction. In a randomized controlled study (published in 1999) that we encountered during our own literature search, early removal of the urinary catheter was associated with increased urinary retention [2]. In recent studies, some authors have associated the early removal of the urinary catheter with increased urinary retention [3], while others claimed the opposite and reported contradictory results [4]. Advances in laparoscopic techniques have made it possible to visualize the hypogastric and pelvic nerves (nerves associated with urinary functions) during surgery. In addition to these developments, dissections on embryonic planes and tumor reduction with neoadjuvant chemotherapy protect these nerves during surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery, Rectal Cancer, Urinary Retention Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early group
Arm Type
Other
Arm Description
Patients whose catheters are removed within the first 48 hours after surgery will form the early group.
Arm Title
Late group
Arm Type
Other
Arm Description
Patients whose catheters are removed after the first 48 hours of surgery will form the early group.
Intervention Type
Procedure
Intervention Name(s)
Procedure: Early removal group
Intervention Description
Participants assigned this arm will have their urethral catheters removed at 2 days after low anterior resection of the rectum
Intervention Type
Procedure
Intervention Name(s)
Procedure: Late removal group
Intervention Description
Participants assigned this arm will have their urethral catheters removed after 48.th hours after Low anterior resection of the rectum
Primary Outcome Measure Information:
Title
Post-operative urinary retention requiring re-catheterisation
Description
Development of acute post-operative urinary retention requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period.
Time Frame
1 day
Title
Postoperative urine culture
Description
Investigate any colonization before discharge in both groups
Time Frame
7 days
Title
Discharge with urinary catheter
Description
Any need for urinary catheter at the time of the discharge
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who will undergo Low Anterior Resection due to rectal cancer in the Department of General Surgery of our university.
Competent to consent to participate in trial
Elective surgery
ASA classification of 1~3
Exclusion Criteria:
Patients whose post-treatment status cannot be obtained.
Having Bladder surgery before
Having a previous prostate surgery.
Patient's refusal to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tevfik Uprak, MD
Phone
+905337273328
Email
kuprak@gmail.com
Facility Information:
Facility Name
Marmara university Pendik Research and Education Hospital
City
Istanbul
ZIP/Postal Code
3846
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tevfik Uprak, MD
Phone
905337273328
Email
kuprak@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30353391
Citation
Duchalais E, Larson DW, Machairas N, Mathis KL, Dozois EJ, Kelley SR. Outcomes of Early Removal of Urinary Catheter Following Rectal Resection for Cancer. Ann Surg Oncol. 2019 Jan;26(1):79-85. doi: 10.1245/s10434-018-6822-x. Epub 2018 Oct 23.
Results Reference
background
PubMed Identifier
30770766
Citation
Xu L, Tao ZY, Lu JY, Zhang GN, Qiu HZ, Wu B, Lin GL, Xu T, Xiao Y. A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):133. doi: 10.1186/s13063-019-3210-1.
Results Reference
background
PubMed Identifier
26200683
Citation
Yoo BE, Kye BH, Kim HJ, Kim G, Kim JG, Cho HM. Early Removal of the Urinary Catheter After Total or Tumor-Specific Mesorectal Excision for Rectal Cancer Is Safe. Dis Colon Rectum. 2015 Jul;58(7):686-91. doi: 10.1097/DCR.0000000000000386.
Results Reference
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Early and Late Removal of the Urinary Catheter After Rectum Resection
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