Urinary RetentionNCT06417346
Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients
A study testing Laparoscopic TEP Repair and Open Technique (Lichtenstein) in people with Urinary Retention and Postoperative Complications, run by Mehmet Eşref Ulutaş at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Retention, Postoperative Complications, Pain
- What is being tested?
- Laparoscopic TEP Repair and Open Technique (Lichtenstein)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2023to 30 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with inguinal hernias.
- Patients aged over 65.
Who cannot join
- Younger than 65 years.
- Incarcerated or strangulated inguinal hernias.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Science Van Training and Research Hospital
Van
Abdullah Hilmi Yılmaz, MD, 0432 222 00 10, drabdullahhilmi@gmail.com
About this study
Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.
- Conditions
- Urinary Retention, Postoperative Complications, Pain, Relapse
- Being tested
- Laparoscopic TEP Repair, Open Technique (Lichtenstein)
- Medical subject headings
- Urinary Retention, Postoperative Complications, Pain, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic TEP RepairProcedure or surgery
Laparoscopic TEP Repair performed
Open Technique (Lichtenstein)Procedure or surgery
Open Technique (Lichtenstein) performed
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic TEP Repair under General Anesthesia | Experimental | A mini-incision was made at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. The RS was incised, and the rectus muscle was laterally displaced. A 10-mm trocar was inserted into the preperitoneal space, and CO2 insufflation was performed with a pressure set at 12 mmHg. Two additional 5 mm trocars were inserted between the umbilicus and the symphysis pubis under laparoscopic guidance. Using laparoscopic dissectors and graspers, all steps of myopectineal orifice dissection were performed (16). A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. Trocars were removed under camera surveillance after CO2 desufflation, and the skin was closed. Receives: Procedure: Laparoscopic TEP Repair |
| Open Technique (Lichtenstein) under Spinal Anesthesia | Active comparator | Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, a polypropylene mesh measuring approximately 60x110 mm² was placed to completely cover the transverse fascia, and continuous sutures were used to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed. Receives: Procedure: Open Technique (Lichtenstein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of postoperative mortality
Measured: postoperative 24 hours
Secondary outcomes (4)
rate of urinary retansion
Measured: postoperative 24 hours
rate of postoperative pain
Measured: postoperative 24 hours
Rate of Hernia recurrence
Measured: first year
Rate of Postoperative complications
such as wound infection, bleeding
Measured: postoperative 24 hours and 1st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start4 Oct 2023
- Primary completion4 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehmet Eşref Ulutaş
- Sponsor type
- University, hospital or other
- Collaborators
- Van Training and Research Hospital
- Responsible party
- Sponsor-investigator, Mehmet Eşref Ulutaş, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417346
- Sponsor's protocol ID
- 65646564
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vigneswaran Y, Gitelis M, Lapin B, Denham W, Linn J, Carbray J, Ujiki M. Elderly and octogenarian cohort: Comparable outcomes with nonelderly cohort after open or laparoscopic inguinal hernia repairs. Surgery. 2015 Oct;158(4):1137-43; discussion 1143-4. doi: 10.1016/j.surg.2015.08.002. Epub 2015 Aug 20.
PubMed 26299283Xi S, Chen Z, Lu Q, Liu C, Xu L, Lu C, Cheng R. Comparison of laparoscopic and open inguinal-hernia repair in elderly patients: the experience of two comprehensive medical centers over 10 years. Hernia. 2024 Aug;28(4):1195-1203. doi: 10.1007/s10029-024-03004-0. Epub 2024 Apr 4.
PubMed 38573484Bowling K, El-Badawy S, Massri E, Rait J, Atkinson J, Leong S, Stuart A, Srinivas G. Laparoscopic and open inguinal hernia repair: Patient reported outcomes in the elderly from a single centre - A prospective cohort study. Ann Med Surg (Lond). 2017 Aug 29;22:12-15. doi: 10.1016/j.amsu.2017.08.013. eCollection 2017 Oct.
PubMed 28878892Ulutas ME, Yilmaz AH. Comparison of open and laparoscopic inguinal hernia repair in the elderly patients: a randomized controlled trial. Hernia. 2025 May 23;29(1):179. doi: 10.1007/s10029-025-03368-x.
PubMed 40407912
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients
- ClinicalTrials.gov ID
- NCT06417346
- Acronym / sponsor ID
- 65646564
- Conditions
- Urinary Retention, Postoperative Complications, Pain, Relapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mehmet Eşref UlutaşUniversity, hospital or other
- Collaborators
- Van Training and Research Hospital
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 4 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 May 2024 (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.
Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic TEP Repair under General Anesthesia | Experimental | Procedure: Laparoscopic TEP RepairA mini-incision was made at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. The RS was incised, and the rectus muscle was laterally displaced. A 10-mm trocar was inserted into the preperitoneal space, and CO2 insufflation was performed with a pressure set at 12 mmHg. Two additional 5 mm trocars were inserted between the umbilicus and the symphysis pubis under laparoscopic guidance. Using laparoscopic dissectors and graspers, all steps of myopectineal orifice dissection were performed (16). A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. Trocars were removed under camera surveillance after CO2 desufflation, and the skin was closed. |
| Open Technique (Lichtenstein) under Spinal Anesthesia | Active comparator | Procedure: Open Technique (Lichtenstein)Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, a polypropylene mesh measuring approximately 60x110 mm² was placed to completely cover the transverse fascia, and continuous sutures were used to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with inguinal hernias.
- Patients aged over 65.
Key exclusion criteria (2 listed)
- Younger than 65 years.
- Incarcerated or strangulated inguinal hernias.
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 |
|---|---|---|
| Laparoscopic TEP RepairLaparoscopic TEP Repair performed | Procedure or surgery | Laparoscopic TEP Repair under General Anesthesia |
| Open Technique (Lichtenstein)Open Technique (Lichtenstein) performed | Procedure or surgery | Open Technique (Lichtenstein) under Spinal Anesthesia |
Primary outcome
rate of postoperative mortality
Time frame: postoperative 24 hours
4 secondary outcomes
rate of urinary retansion
Time frame: postoperative 24 hours
rate of postoperative pain
Time frame: postoperative 24 hours
Rate of Hernia recurrence
Time frame: first year
Rate of Postoperative complications
Time frame: postoperative 24 hours and 1st month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Results publication: PubMed 26299283Vigneswaran Y, Gitelis M, Lapin B, Denham W, Linn J, Carbray J, Ujiki M. Elderly and octogenarian cohort: Comparable outcomes with nonelderly cohort after open or laparoscopic inguinal hernia repairs. Surgery. 2015 Oct;158(4):1137-43; discussion 1143-4. doi: 10.1016/j.surg.2015.08.002. Epub 2015 Aug 20.
- Results publication: PubMed 38573484Xi S, Chen Z, Lu Q, Liu C, Xu L, Lu C, Cheng R. Comparison of laparoscopic and open inguinal-hernia repair in elderly patients: the experience of two comprehensive medical centers over 10 years. Hernia. 2024 Aug;28(4):1195-1203. doi: 10.1007/s10029-024-03004-0. Epub 2024 Apr 4.
- Results publication: PubMed 28878892Bowling K, El-Badawy S, Massri E, Rait J, Atkinson J, Leong S, Stuart A, Srinivas G. Laparoscopic and open inguinal hernia repair: Patient reported outcomes in the elderly from a single centre - A prospective cohort study. Ann Med Surg (Lond). 2017 Aug 29;22:12-15. doi: 10.1016/j.amsu.2017.08.013. eCollection 2017 Oct.
- Derived from this study: PubMed 40407912Ulutas ME, Yilmaz AH. Comparison of open and laparoscopic inguinal hernia repair in the elderly patients: a randomized controlled trial. Hernia. 2025 May 23;29(1):179. doi: 10.1007/s10029-025-03368-x.
- 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 Laparoscopic TEP Repair and Open Technique (Lichtenstein) in people with Urinary Retention and Postoperative Complications, run by Mehmet Eşref Ulutaş 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 2 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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 Abdullah Hilmi Yılmaz, MD (0432 222 00 10, drabdullahhilmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of postoperative mortality (time frame: postoperative 24 hours). 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 NCT06417346, which also lists 4 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 16 May 2024.