Early and Late Removal of the Urinary Catheter After Rectum Resection

Rectal Cancer Clinical Trial

Official title:

Comparison of Early and Late Removal of the Urinary Catheter After Low Anterior Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020613
• Other study ID #: 412
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Marmara University
• Contact: Tevfik Uprak, MD
• Phone: +905337273328
• Email: kuprak[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Surgery
• Rectal Cancer
• Urinary Retention
• Urinary Retention Postoperative

Intervention

Procedure:
• Procedure: Early removal group
Participants assigned this arm will have their urethral catheters removed at 2 days after low anterior resection of the rectum
• Procedure: Late removal group
Participants assigned this arm will have their urethral catheters removed after 48.th hours after Low anterior resection of the rectum

Locations

Country	Name	City	State
Turkey	Marmara university Pendik Research and Education Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Primary	Postoperative urine culture	Investigate any colonization before discharge in both groups	7 days
Primary	Discharge with urinary catheter	Any need for urinary catheter at the time of the discharge	7 days