Hernia, InguinalNCT03326700
Effects of Hernia Repair on Men's Sexual Functions
A study testing Inguinal Hernia Repair in people with Hernia, Inguinal and Men, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
Trial summary
In the literature, there are several studies that compare Laparoscopic totally extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no studies that compare sexual functions on men's health and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hernia, Inguinal, Men, Sexual Dysfunction
- What is being tested?
- Inguinal Hernia Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to May 2017
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having male gender
- patients diagnosed on unilateral inguinal hernia
- patients aged between 18 and 65 years
- ASA I and II patients
Who cannot join
- having female gender
- patients diagnosed on bilateral or recurrence inguinal hernia,
- patients suffering erectile dysfunction
About this study
Official title: Effects of Laparoscopic Totally Extraperitoneal and Lichtenstein Hernia Repair on Men's Sexual Functions and Quality of Life.
In the literature, there are several studies that compare Laparoscopic totally extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no studies that compare sexual functions on men's health and quality of life. Our aim was to study the sexual functions of men, who underwent TEP or LH repair according to Health Survey Scoring Demonstration (SF36) and The International Index of Erectile Function (IIEF).
Read the detailed description
176 men with unilateral inguinal hernia were randomized into two groups. Group T (n=88) underwent TEP and Group L(n:88) underwent LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.
- Conditions
- Hernia, Inguinal, Men, Sexual Dysfunction
- Being tested
- Inguinal Hernia Repair
- Medical subject headings
- Hernia, Inguinal, Multiple Endocrine Neoplasia Type 1, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal Hernia RepairProcedure or surgery
Inguinal hernia repair is surgery to repair a hernia in the groin. A hernia is tissue that bulges out of a weak spot in the abdominal wall. The intestine may bulge out through this weakened area. During surgery to repair the hernia, the bulging tissue is pushed back in. The abdominal wall is strengthened and supported with sutures (stitches), and sometimes mesh. This repair can be done with open or laparoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic hernia repair. | Active comparator | Intervention: inguinal hernia repair. Receives: Procedure: Inguinal Hernia Repair |
| Open hernia repair. | Active comparator | Intervention: inguinal hernia repair. Receives: Procedure: Inguinal Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF Scale
international index of erectile functions
Measured: 7 to 90 days
Secondary outcomes (1)
SF36
health survey scoring demonstration
Measured: 7 to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study startNov 2015
- Primary completionNov 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Model description
- 176 men with unilateral inguinal hernia were randomized in two groups. Group T(n=88) were operated TEP and Group L(n:88) were operated by LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riza Gurhan ISIL, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326700
- Sponsor's protocol ID
- SEEAH 2015 / 568
- Status last verified
- Oct 2017
- First submitted
- 22 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can share study data only without patients names.
Publications
Kushwaha JK, Enny LE, Anand A, Sonkar AA, Kumar A, Pahwa HS. A Prospective Randomized Controlled Trial Comparing Quality of Life Following Endoscopic Totally Extraperitoneal (TEP) Versus Open Stoppa Inguinal Hernioplasty. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):257-261. doi: 10.1097/SLE.0000000000000450.
PubMed 28727632
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laparoscopic Totally Extraperitoneal and Lichtenstein Hernia Repair on Men's Sexual Functions and Quality of Life.
- ClinicalTrials.gov ID
- NCT03326700
- Acronym / sponsor ID
- SEEAH 2015 / 568
- Conditions
- Hernia, Inguinal, Men, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 31 Oct 2017 (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.
In the literature, there are several studies that compare Laparoscopic totally extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no studies that compare sexual functions on men's health and quality of life. Our aim was to study the sexual functions of men, who underwent TEP or LH repair according to Health Survey Scoring Demonstration (SF36) and The International Index of Erectile Function (IIEF).
Detailed description
176 men with unilateral inguinal hernia were randomized into two groups. Group T (n=88) underwent TEP and Group L(n:88) underwent LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 176 men with unilateral inguinal hernia were randomized in two groups. Group T(n=88) were operated TEP and Group L(n:88) were operated by LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic hernia repair. | Active comparator | Procedure: Inguinal Hernia RepairIntervention: inguinal hernia repair. |
| Open hernia repair. | Active comparator | Procedure: Inguinal Hernia RepairIntervention: inguinal hernia repair. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having male gender
- patients diagnosed on unilateral inguinal hernia
- patients aged between 18 and 65 years
- ASA I and II patients
Key exclusion criteria (3 listed)
- having female gender
- patients diagnosed on bilateral or recurrence inguinal hernia,
- patients suffering erectile dysfunction
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 |
|---|---|---|
| Inguinal Hernia RepairInguinal hernia repair is surgery to repair a hernia in the groin. A hernia is tissue that bulges out of a weak spot in the abdominal wall. The intestine may bulge out through this weakened area. During surgery to repair the hernia, the bulging tissue is pushed back in. The abdominal wall is strengthened and supported with sutures (stitches), and sometimes mesh. This repair can be done with open or laparoscopic surgery. | Procedure or surgery | Laparoscopic hernia repair., Open hernia repair. |
Primary outcome
IIEF Scale
Time frame: 7 to 90 days
international index of erectile functions
1 secondary outcome
SF36
Time frame: 7 to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Background: PubMed 28727632Kushwaha JK, Enny LE, Anand A, Sonkar AA, Kumar A, Pahwa HS. A Prospective Randomized Controlled Trial Comparing Quality of Life Following Endoscopic Totally Extraperitoneal (TEP) Versus Open Stoppa Inguinal Hernioplasty. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):257-261. doi: 10.1097/SLE.0000000000000450.
- Individual participant dataSharing planned: No. We can share study data only without patients names.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inguinal Hernia Repair in people with Hernia, Inguinal and Men, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
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 3 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: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IIEF Scale (time frame: 7 to 90 days). 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 NCT03326700, which also lists 1 linked publication.
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 31 Oct 2017.