Colorectal SurgeryNCT05020613
Early and Late Removal of the Urinary Catheter After Rectum Resection
A study testing Procedure: Early removal group and Procedure: Late removal group in people with Colorectal Surgery and Rectal Cancer, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Surgery, Rectal Cancer, Urinary Retention Postoperative
- What is being tested?
- Procedure: Early removal group and Procedure: Late removal group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara university Pendik Research and Education Hospital
Istanbul, 3846
Tevfik Uprak, MD, 905337273328, kuprak@gmail.com
About this study
Official title: Comparison of Early and Late Removal of the Urinary Catheter After Low Anterior Resection
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.
Read the 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.
- Being tested
- Procedure: Early removal group, Procedure: Late removal group
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Early removal groupProcedure or surgery
Participants assigned this arm will have their urethral catheters removed at 2 days after low anterior resection of the rectum
Procedure: Late removal groupProcedure or surgery
Participants assigned this arm will have their urethral catheters removed after 48.th hours after Low anterior resection of the rectum
| Study group | Role | What they receive |
|---|---|---|
| Early group | Other | Patients whose catheters are removed within the first 48 hours after surgery will form the early group. Receives: Procedure: Procedure: Early removal group |
| Late group | Other | Patients whose catheters are removed after the first 48 hours of surgery will form the early group. Receives: Procedure: Procedure: Late removal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Postoperative urine culture
Investigate any colonization before discharge in both groups
Measured: 7 days
Discharge with urinary catheter
Any need for urinary catheter at the time of the discharge
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tevfik Kivilcim Uprak, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020613
- Sponsor's protocol ID
- 412
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30353391Xu 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.
PubMed 30770766Yoo 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.
PubMed 26200683
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early and Late Removal of the Urinary Catheter After Low Anterior Resection
- ClinicalTrials.gov ID
- NCT05020613
- Acronym / sponsor ID
- 412
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early group | Other | Procedure: Procedure: Early removal groupPatients whose catheters are removed within the first 48 hours after surgery will form the early group. |
| Late group | Other | Procedure: Procedure: Late removal groupPatients whose catheters are removed after the first 48 hours of surgery will form the early group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients whose post-treatment status cannot be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure: Early removal groupParticipants assigned this arm will have their urethral catheters removed at 2 days after low anterior resection of the rectum | Procedure or surgery | Early group |
| Procedure: Late removal groupParticipants assigned this arm will have their urethral catheters removed after 48.th hours after Low anterior resection of the rectum | Procedure or surgery | Late group |
Primary outcome
Post-operative urinary retention requiring re-catheterisation
Time frame: 1 day
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
Time frame: 7 days
Investigate any colonization before discharge in both groups
Discharge with urinary catheter
Time frame: 7 days
Any need for urinary catheter at the time of the discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 30353391Duchalais 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.
- Background: PubMed 30770766Xu 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.
- Background: PubMed 26200683Yoo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Early removal group and Procedure: Late removal group in people with Colorectal Surgery and Rectal Cancer, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tevfik Uprak, MD (+905337273328, kuprak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative urinary retention requiring re-catheterisation (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020613, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.