Inguinal HerniasTEP-CATNCT07886814
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
A study testing Routine Urinary Catheterization and No Routine Urinary Catheterization in people with Inguinal Hernias, run by Ugur Duman at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled clinical trial is to determine whether avoiding routine urinary catheterization reduces postoperative urinary symptoms in patients undergoing laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernias
- What is being tested?
- Routine Urinary Catheterization and No Routine Urinary Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Clinical or radiological diagnosis of inguinal hernia.
- Scheduled to undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
Who cannot join
- Scrotal inguinal hernia.
- Prolapsed inguinal hernia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16310
About this study
Official title: The Effect of Routine Urinary Catheterization on Postoperative Urinary Symptoms and Complications Following Laparoscopic Total Extraperitoneal Inguinal Hernia Repair: A Prospective Randomized Controlled Trial
The goal of this randomized controlled clinical trial is to determine whether avoiding routine urinary catheterization reduces postoperative urinary symptoms in patients undergoing laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
The main questions it aims to answer are:
Read more
- Does avoiding routine urinary catheterization reduce the incidence of dysuria on postoperative day 1?
- Does avoiding routine urinary catheterization reduce postoperative urinary or urethral pain without increasing urinary retention or other complications? Researchers will compare patients undergoing laparoscopic TEP inguinal hernia repair with routine urinary catheterization to those undergoing the same procedure without urinary catheterization.
Participants will:
- Undergo laparoscopic TEP inguinal hernia repair with or without routine urinary catheterization according to randomized group assignment.
- Complete postoperative assessments of urinary symptoms and complications on days 1, 10, and 30.
- Undergo follow-up for inguinal hernia recurrence for six months after surgery.
Read the detailed description
Routine urinary catheterization is commonly performed during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair to maintain bladder decompression and facilitate preperitoneal dissection. However, catheter placement may cause postoperative urinary discomfort and urethral irritation. The clinical necessity of routine catheterization during TEP repair remains uncertain.
This prospective, single-center, randomized controlled trial was designed to evaluate the effects of routine urinary catheterization on postoperative urinary symptoms and surgical safety.
All procedures were performed under general anesthesia by a single surgeon with 24 years of surgical experience. A standardized laparoscopic TEP technique was used in both groups. The preperitoneal working space was established using balloon dissection, followed by identification and dissection of the hernia sac and exposure of the myopectineal orifice. A polypropylene mesh was placed to cover the myopectineal orifice, with limited fixation. Hemostasis was confirmed, and no surgical drains were routinely placed.
In the catheterization group, the urinary catheter was maintained throughout the immediate postoperative period and removed before discharge, approximately 24 hours after surgery. Patients in the no-catheterization group underwent the same surgical procedure without routine urinary catheter placement.
Postoperative urinary symptoms were evaluated through patient-reported assessments and clinical follow-up. Urinary or urethral pain intensity was measured using a 0-10 visual analog scale (VAS), with higher scores indicating greater pain intensity.
The study was designed to assess whether omission of routine urinary catheterization could improve postoperative patient comfort while maintaining the safety of laparoscopic TEP inguinal hernia repair.
- Conditions
- Inguinal Hernias
- Being tested
- Routine Urinary Catheterization, No Routine Urinary Catheterization
- Keywords
- Urinary Catheterization, Laparoscopic Inguinal Hernia Repair, Total Extraperitoneal Repair, Postoperative Dysuria, Urethral Pain, Randomized Controlled Trial
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Urinary CatheterizationProcedure or surgery
Routine perioperative urinary catheterization was performed in participants undergoing laparoscopic total extraperitoneal inguinal hernia repair. The urinary catheter was maintained during the immediate postoperative period and removed before hospital discharge, approximately 24 hours after surgery.
No Routine Urinary CatheterizationProcedure or surgery
Participants underwent laparoscopic total extraperitoneal inguinal hernia repair without routine perioperative urinary catheter placement. Postoperative urinary symptoms and urinary retention were assessed using the same follow-up schedule as the catheterization group.
| Study group | Role | What they receive |
|---|---|---|
| No Urinary Catheterization | Experimental | Participants assigned to this group underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair without routine perioperative urinary catheterization. The surgical procedure was performed under general anesthesia using a standardized technique. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up. Receives: Procedure: No Routine Urinary Catheterization |
| Routine Urinary Catheterization | Active comparator | Participants assigned to this group underwent laparoscopic totally extraperitoneal (TEP) inguinal hernia repair with routine perioperative urinary catheterization. A urinary catheter was placed during the perioperative period and removed before hospital discharge, approximately 24 hours after surgery. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up. Receives: Procedure: Routine Urinary Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dysuria on Postoperative Day 1
The primary outcome was the incidence of postoperative dysuria, defined as patient-reported pain, burning, or discomfort during urination within the first 24 hours following laparoscopic total extraperitoneal inguinal hernia repair. Dysuria was assessed as a binary outcome (present or absent). The proportion of participants experiencing dysuria was compared between the urinary catheterization and no-catheterization groups.
Measured: Postoperative Day 1 (within 24 hours after surgery)
Secondary outcomes (10)
Incidence of Urinary or Urethral Pain on Postoperative Day 1
The presence of urinary or urethral pain was assessed on postoperative day 1 using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain was considered present when the VAS score was greater than 0. The proportion of participants reporting pain was compared between the two study groups.
Measured: Postoperative Day 1 (within 24 hours after surgery)
Incidence of Urinary or Urethral Pain on Postoperative Day 10
Urinary or urethral pain was assessed on postoperative day 10 using a 0-10 visual analog scale (VAS). Pain was classified as present when the VAS score was greater than 0. The incidence of pain was compared between the urinary catheterization and no-catheterization groups.
Measured: Postoperative Day 10
Incidence of Urinary or Urethral Pain on Postoperative Day 30
Urinary or urethral pain was assessed on postoperative day 30 using a visual analog scale (VAS) ranging from 0 to 10. Pain was defined as a VAS score greater than 0. The proportion of participants reporting pain was evaluated in each intervention group.
Measured: Postoperative Day 30
Urinary or Urethral Pain Severity on Postoperative Day 1
The severity of urinary or urethral pain was assessed using an 11-point visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores were compared between the urinary catheterization and no-catheterization groups.
Measured: Postoperative Day 1
Urinary or Urethral Pain Severity on Postoperative Day 10
Urinary or urethral pain intensity was measured using a 0-10 visual analog scale (VAS) on postoperative day 10. Higher scores indicated greater pain intensity.
Measured: Postoperative Day 10
Urinary or Urethral Pain Severity on Postoperative Day 30
Urinary or urethral pain intensity was evaluated on postoperative day 30 using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Postoperative Day 30
Incidence of Urinary or Urethral Pain During the First 30 Postoperative Days
The composite incidence of postoperative urinary or urethral pain was defined as the presence of pain (VAS score greater than 0) at any of the scheduled postoperative assessments on days 1, 10, or 30. Participants reporting pain at least once during the follow-up period were classified as having experienced urinary or urethral pain. The proportion of affected participants was compared between the two groups.
Measured: Postoperative Days 1, 10, and 30
Incidence of Postoperative Urinary Retention
Postoperative urinary retention was assessed during postoperative follow-up. The incidence of urinary retention was recorded as a binary outcome (present or absent), and the proportion of affected participants was compared between the urinary catheterization and no-catheterization groups.
Measured: Within 30 days after surgery
Incidence of Postoperative Complications
Postoperative complications were assessed during the first 30 days after laparoscopic TEP inguinal hernia repair. Recorded complications included urinary retention, scrotal emphysema, and scrotal ecchymosis. The proportion of participants experiencing at least one postoperative complication was compared between the intervention groups.
Measured: Within 30 days after surgery
Incidence of Inguinal Hernia Recurrence Within Six Months
Hernia recurrence was assessed during a six-month postoperative follow-up period. Recurrence was defined as the reappearance of an inguinal hernia following laparoscopic TEP repair, as identified through postoperative clinical evaluation. The proportion of participants experiencing recurrence was compared between the two intervention groups.
Measured: Up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniasStudies of the same condition, open and under way.
- 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
- Model description
- This was a prospective, single-center, two-arm, parallel-group randomized controlled trial. Participants undergoing laparoscopic total extraperitoneal (TEP) inguinal hernia repair were randomly assigned using a lottery-based allocation method to either routine urinary catheterization or no urinary catheterization. Both groups underwent the same standardized surgical procedure, and postoperative urinary outcomes were assessed at predefined follow-up intervals.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ugur Duman
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ugur Duman, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ugur Duman, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886814
- Sponsor's protocol ID
- 2024-TBEK 2026/02-16
- Acronym
- TEP-CAT
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to patient confidentiality considerations and the absence of a predefined individual participant data-sharing plan in the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Routine Urinary Catheterization on Postoperative Urinary Symptoms and Complications Following Laparoscopic Total Extraperitoneal Inguinal Hernia Repair: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07886814
- Acronym / sponsor ID
- TEP-CAT / 2024-TBEK 2026/02-16
- Conditions
- Inguinal Hernias
- Keywords
- Urinary Catheterization, Laparoscopic Inguinal Hernia Repair, Total Extraperitoneal Repair, Postoperative Dysuria, Urethral Pain, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ugur DumanOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Oct 2026 (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.
The goal of this randomized controlled clinical trial is to determine whether avoiding routine urinary catheterization reduces postoperative urinary symptoms in patients undergoing laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
The main questions it aims to answer are:
- Does avoiding routine urinary catheterization reduce the incidence of dysuria on postoperative day 1?
- Does avoiding routine urinary catheterization reduce postoperative urinary or urethral pain without increasing urinary retention or other complications? Researchers will compare patients undergoing laparoscopic TEP inguinal hernia repair with routine urinary catheterization to those undergoing the same procedure without urinary catheterization.
Participants will:
- Undergo laparoscopic TEP inguinal hernia repair with or without routine urinary catheterization according to randomized group assignment.
- Complete postoperative assessments of urinary symptoms and complications on days 1, 10, and 30.
- Undergo follow-up for inguinal hernia recurrence for six months after surgery.
Detailed description
Routine urinary catheterization is commonly performed during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair to maintain bladder decompression and facilitate preperitoneal dissection. However, catheter placement may cause postoperative urinary discomfort and urethral irritation. The clinical necessity of routine catheterization during TEP repair remains uncertain.
This prospective, single-center, randomized controlled trial was designed to evaluate the effects of routine urinary catheterization on postoperative urinary symptoms and surgical safety.
All procedures were performed under general anesthesia by a single surgeon with 24 years of surgical experience. A standardized laparoscopic TEP technique was used in both groups. The preperitoneal working space was established using balloon dissection, followed by identification and dissection of the hernia sac and exposure of the myopectineal orifice. A polypropylene mesh was placed to cover the myopectineal orifice, with limited fixation. Hemostasis was confirmed, and no surgical drains were routinely placed.
In the catheterization group, the urinary catheter was maintained throughout the immediate postoperative period and removed before discharge, approximately 24 hours after surgery. Patients in the no-catheterization group underwent the same surgical procedure without routine urinary catheter placement.
Postoperative urinary symptoms were evaluated through patient-reported assessments and clinical follow-up. Urinary or urethral pain intensity was measured using a 0-10 visual analog scale (VAS), with higher scores indicating greater pain intensity.
The study was designed to assess whether omission of routine urinary catheterization could improve postoperative patient comfort while maintaining the safety of laparoscopic TEP inguinal hernia repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a prospective, single-center, two-arm, parallel-group randomized controlled trial. Participants undergoing laparoscopic total extraperitoneal (TEP) inguinal hernia repair were randomly assigned using a lottery-based allocation method to either routine urinary catheterization or no urinary catheterization. Both groups underwent the same standardized surgical procedure, and postoperative urinary outcomes were assessed at predefined follow-up intervals.
| Arm | Type | Receives |
|---|---|---|
| No Urinary Catheterization | Experimental | Procedure: No Routine Urinary CatheterizationParticipants assigned to this group underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair without routine perioperative urinary catheterization. The surgical procedure was performed under general anesthesia using a standardized technique. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up. |
| Routine Urinary Catheterization | Active comparator | Procedure: Routine Urinary CatheterizationParticipants assigned to this group underwent laparoscopic totally extraperitoneal (TEP) inguinal hernia repair with routine perioperative urinary catheterization. A urinary catheter was placed during the perioperative period and removed before hospital discharge, approximately 24 hours after surgery. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Clinical or radiological diagnosis of inguinal hernia.
- Scheduled to undergo laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
Key exclusion criteria (2 listed)
- Scrotal inguinal hernia.
- Prolapsed inguinal hernia.
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 |
|---|---|---|
| Routine Urinary CatheterizationRoutine perioperative urinary catheterization was performed in participants undergoing laparoscopic total extraperitoneal inguinal hernia repair. The urinary catheter was maintained during the immediate postoperative period and removed before hospital discharge, approximately 24 hours after surgery. | Procedure or surgery | Routine Urinary Catheterization |
| No Routine Urinary CatheterizationParticipants underwent laparoscopic total extraperitoneal inguinal hernia repair without routine perioperative urinary catheter placement. Postoperative urinary symptoms and urinary retention were assessed using the same follow-up schedule as the catheterization group. | Procedure or surgery | No Urinary Catheterization |
Primary outcome
Incidence of Dysuria on Postoperative Day 1
Time frame: Postoperative Day 1 (within 24 hours after surgery)
The primary outcome was the incidence of postoperative dysuria, defined as patient-reported pain, burning, or discomfort during urination within the first 24 hours following laparoscopic total extraperitoneal inguinal hernia repair. Dysuria was assessed as a binary outcome (present or absent). The proportion of participants experiencing dysuria was compared between the urinary catheterization and no-catheterization groups.
10 secondary outcomes
Incidence of Urinary or Urethral Pain on Postoperative Day 1
Time frame: Postoperative Day 1 (within 24 hours after surgery)
Incidence of Urinary or Urethral Pain on Postoperative Day 10
Time frame: Postoperative Day 10
Incidence of Urinary or Urethral Pain on Postoperative Day 30
Time frame: Postoperative Day 30
Urinary or Urethral Pain Severity on Postoperative Day 1
Time frame: Postoperative Day 1
Urinary or Urethral Pain Severity on Postoperative Day 10
Time frame: Postoperative Day 10
Urinary or Urethral Pain Severity on Postoperative Day 30
Time frame: Postoperative Day 30
Incidence of Urinary or Urethral Pain During the First 30 Postoperative Days
Time frame: Postoperative Days 1, 10, and 30
Incidence of Postoperative Urinary Retention
Time frame: Within 30 days after surgery
Incidence of Postoperative Complications
Time frame: Within 30 days after surgery
Incidence of Inguinal Hernia Recurrence Within Six Months
Time frame: Up to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to patient confidentiality considerations and the absence of a predefined individual participant data-sharing plan in the study protocol.
Related trials for Inguinal Hernias
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Not yet recruiting
Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
Inguinal Hernia Unilateral, Postoperative Pain
Recruiting
Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries
Bilateral Inguinal Hernia Repair, Open Upper Abdominal Surgeries
Recruiting
Spinal Anesthesia Versus General Anesthesia Plus TAP Block for Laparoscopic Inguinal Hernia Repair
Transversus Abdominis Plane Block (TAP Block), Laparoscopic Inguinal Hernia Repair
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.
Ugur Duman, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Urinary Catheterization and No Routine Urinary Catheterization in people with Inguinal Hernias, run by Ugur Duman 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dysuria on Postoperative Day 1 (time frame: Postoperative Day 1 (within 24 hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.