Inguinal HerniaNCT05522608
Factors Associated With Postoperative Pain in Patients Undergoing TAPP Hernia Repair for Inguinal Hernia
An observational study of Inguinal Hernia and Postoperative Pain, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The most common symptom after an inguinal hernia is postoperative pain. According to the severity of the pain, the quality of life of the patient is also affected. There are many factors associated with postoperative pain. In this study, the results related to the factors affecting postoperative pain were investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain
- What is being tested?
- transabdominal preperitoneal hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Jul 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Preoperative demographic data, visual analog scale (VAS) to measure preoperative pain, type and size of inguinal hernia will be evaluated in patients who will undergo TAPP with the diagnosis of inguinal hernia. In the postoperative period, pain intensity will be evaluated on the 1st day, the 3rd day, the 10th day and the 1st month postoperatively. A visual analog scale (VAS) will be applied to the patients for pain scoring. The patients will be followed up for 6 months postoperatively and monitored for complications. The collected data will be statistically analyzed in SPSS.
Who may be able to join
- Patients undergoing TAPP for inguinal hernia for the first time
Who cannot join
- Patients under 18 years of age
- Patients undergoing open hernia repair
- Patients converted from laparoscopic to open
- Patients who are pregnant or likely to become pregnant
- Patients who cannot comply with the treatment or give their own consent for treatment due to their mental state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Postoperative Pain in Patients Undergoing Transabdominal Preperitoneal Hernia Repair for Inguinal Hernia
The most common symptom after an inguinal hernia is postoperative pain. According to the severity of the pain, the quality of life of the patient is also affected. There are many factors associated with postoperative pain. In this study, the results related to the factors affecting postoperative pain were investigated.
Read the detailed description
The most common symptom after an inguinal hernia is postoperative pain. According to the severity of the pain, the quality of life of the patient is also affected. There are many factors associated with postoperative pain. In the literature, there are factors whose relationship could not be determined clearly in the guidelines prepared for this. A meta-analysis showed that TAPP was associated with less chronic pain than open hernia repair. In another study, it was reported that hernia size and type were unrelated to pain. In the same study, the relationship between preoperative pain and postoperative pain was examined. Etele et al. reported that mesh fixation may increase pain. It is thought that the determination of these multiple predictive factors will both guide postoperative pain management and strengthen patient communication. As a result of the research, it is planned to obtain results related to the factors affecting the postoperative pain.
- Conditions
- Inguinal Hernia, Postoperative Pain
- Being tested
- transabdominal preperitoneal hernia repair
- Keywords
- inguinal hernia, postoperative pain, transabdominal preperitoneal repair, visual analogue scale
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transabdominal preperitoneal hernia repairProcedure or surgery
It is made through 3 holes, 10 mm optical port from the umbilicus, and 5 mm ports each from the right and left lower quadrants. The peritoneum is opened a few cm above the defect in the form of an arc. Dissection of the peritoneum, first lateral and then medial to the defect, is performed. It is continued until the pubic bone is found medially and the periphery of the bone is released. The dissection of the cord elements and the sac is completed. Posterior dissection is a very important step to avoid recurrence. Here, the peritoneum is thoroughly dissected posteriorly, the ductus deferens and vessels are removed from the peritoneum so that no recurrence occurs under the patch. 1-2 to the pubic tubercle, 3-5 to the upper edge of the patch, to the upper edge. Staples at the upper edge should remain above the iliopubic tract, no staples should be placed below. The patch is closed by overlapping the peritoneal leaves so that the patch is not visible.
| Study group | Role | What they receive |
|---|---|---|
| patients with postoperative pain | Patients with postoperative pain after transabdominal preperitoneal hernia repair Receives: Procedure: transabdominal preperitoneal hernia repair | |
| patients without postoperative pain | Patients without postoperative pain after transabdominal preperitoneal hernia repair Receives: Procedure: transabdominal preperitoneal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Factors associated with postoperative pain in patients undergoing transabdominal preperitoneal hernia repair due to inguinal hernia will be investigated. A visual analogue scale (VAS) will be used for postoperative pain. Patients will use this scale to score from 0 (no pain) to 10 (worst possible pain) according to their pain status.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 May 2021
- Primary completion1 Mar 2024
- Study completion1 Jul 2024
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 Inguinal HerniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Korhan TUNCER, Tepecik Training and Research Hospital
- Investigators
- Korhan Tuncer, MD, Principal investigator, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522608
- Sponsor's protocol ID
- 2021/04-09
- Status last verified
- Jun 2025
- First submitted
- 16 Jul 2022
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Scheuermann U, Niebisch S, Lyros O, Jansen-Winkeln B, Gockel I. Transabdominal Preperitoneal (TAPP) versus Lichtenstein operation for primary inguinal hernia repair - A systematic review and meta-analysis of randomized controlled trials. BMC Surg. 2017 May 10;17(1):55. doi: 10.1186/s12893-017-0253-7.
PubMed 28490321Tolver MA, Rosenberg J, Bisgaard T. Early pain after laparoscopic inguinal hernia repair. A qualitative systematic review. Acta Anaesthesiol Scand. 2012 May;56(5):549-57. doi: 10.1111/j.1399-6576.2011.02633.x. Epub 2012 Jan 19.
PubMed 22260427Etele EE, Neagoe RM, Marton D, Sala D, Torok A. Influence of Mesh Fixation on the Development of Postoperative Pain after Laparoscopic Inguinal Hernia Repair: A Single Surgeon Experience. Chirurgia (Bucur). 2020 Sept-Oct;115(5):609-617. doi: 10.21614/chirurgia.115.5.609.
PubMed 33138898Kilinc Tuncer G, Tuncer K, Yesilyurt D, Ogucu H, Kirmizi Y. Risk factors for postoperative pain after laparoscopic transabdominal preperitoneal repair of inguinal hernia: a prospective observational study. BMC Surg. 2026 Aug 6;26(1):740. doi: 10.1186/s12893-026-04077-7.
PubMed 42972307
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Postoperative Pain in Patients Undergoing Transabdominal Preperitoneal Hernia Repair for Inguinal Hernia
- ClinicalTrials.gov ID
- NCT05522608
- Acronym / sponsor ID
- 2021/04-09
- Conditions
- Inguinal Hernia, Postoperative Pain
- Keywords
- inguinal hernia, postoperative pain, transabdominal preperitoneal repair, visual analogue scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 31 Aug 2022 (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 most common symptom after an inguinal hernia is postoperative pain. According to the severity of the pain, the quality of life of the patient is also affected. There are many factors associated with postoperative pain. In this study, the results related to the factors affecting postoperative pain were investigated.
Detailed description
The most common symptom after an inguinal hernia is postoperative pain. According to the severity of the pain, the quality of life of the patient is also affected. There are many factors associated with postoperative pain. In the literature, there are factors whose relationship could not be determined clearly in the guidelines prepared for this. A meta-analysis showed that TAPP was associated with less chronic pain than open hernia repair. In another study, it was reported that hernia size and type were unrelated to pain. In the same study, the relationship between preoperative pain and postoperative pain was examined. Etele et al. reported that mesh fixation may increase pain. It is thought that the determination of these multiple predictive factors will both guide postoperative pain management and strengthen patient communication. As a result of the research, it is planned to obtain results related to the factors affecting the postoperative pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with postoperative pain | – | Procedure: transabdominal preperitoneal hernia repairPatients with postoperative pain after transabdominal preperitoneal hernia repair |
| patients without postoperative pain | – | Procedure: transabdominal preperitoneal hernia repairPatients without postoperative pain after transabdominal preperitoneal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Preoperative demographic data, visual analog scale (VAS) to measure preoperative pain, type and size of inguinal hernia will be evaluated in patients who will undergo TAPP with the diagnosis of inguinal hernia. In the postoperative period, pain intensity will be evaluated on the 1st day, the 3rd day, the 10th day and the 1st month postoperatively. A visual analog scale (VAS) will be applied to the patients for pain scoring. The patients will be followed up for 6 months postoperatively and monitored for complications. The collected data will be statistically analyzed in SPSS.
Key inclusion criteria (1 listed)
- Patients undergoing TAPP for inguinal hernia for the first time
Key exclusion criteria (5 listed)
- Patients under 18 years of age
- Patients undergoing open hernia repair
- Patients converted from laparoscopic to open
- Patients who are pregnant or likely to become pregnant
- Patients who cannot comply with the treatment or give their own consent for treatment due to their mental state
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 |
|---|---|---|
| transabdominal preperitoneal hernia repairIt is made through 3 holes, 10 mm optical port from the umbilicus, and 5 mm ports each from the right and left lower quadrants. The peritoneum is opened a few cm above the defect in the form of an arc. Dissection of the peritoneum, first lateral and then medial to the defect, is performed. It is continued until the pubic bone is found medially and the periphery of the bone is released. The dissection of the cord elements and the sac is completed. Posterior dissection is a very important step to avoid recurrence. Here, the peritoneum is thoroughly dissected posteriorly, the ductus deferens and vessels are removed from the peritoneum so that no recurrence occurs under the patch. 1-2 to the pubic tubercle, 3-5 to the upper edge of the patch, to the upper edge. Staples at the upper edge should remain above the iliopubic tract, no staples should be placed below. The patch is closed by overlapping the peritoneal leaves so that the patch is not visible. | Procedure or surgery | patients with postoperative pain, patients without postoperative pain |
Primary outcome
postoperative pain
Time frame: one month
Factors associated with postoperative pain in patients undergoing transabdominal preperitoneal hernia repair due to inguinal hernia will be investigated. A visual analogue scale (VAS) will be used for postoperative pain. Patients will use this scale to score from 0 (no pain) to 10 (worst possible pain) according to their pain status.
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 19 Jun 2025.
- Results publication: PubMed 28490321Scheuermann U, Niebisch S, Lyros O, Jansen-Winkeln B, Gockel I. Transabdominal Preperitoneal (TAPP) versus Lichtenstein operation for primary inguinal hernia repair - A systematic review and meta-analysis of randomized controlled trials. BMC Surg. 2017 May 10;17(1):55. doi: 10.1186/s12893-017-0253-7.
- Results publication: PubMed 22260427Tolver MA, Rosenberg J, Bisgaard T. Early pain after laparoscopic inguinal hernia repair. A qualitative systematic review. Acta Anaesthesiol Scand. 2012 May;56(5):549-57. doi: 10.1111/j.1399-6576.2011.02633.x. Epub 2012 Jan 19.
- Results publication: PubMed 33138898Etele EE, Neagoe RM, Marton D, Sala D, Torok A. Influence of Mesh Fixation on the Development of Postoperative Pain after Laparoscopic Inguinal Hernia Repair: A Single Surgeon Experience. Chirurgia (Bucur). 2020 Sept-Oct;115(5):609-617. doi: 10.21614/chirurgia.115.5.609.
- Derived from this study: PubMed 42972307Kilinc Tuncer G, Tuncer K, Yesilyurt D, Ogucu H, Kirmizi Y. Risk factors for postoperative pain after laparoscopic transabdominal preperitoneal repair of inguinal hernia: a prospective observational study. BMC Surg. 2026 Aug 6;26(1):740. doi: 10.1186/s12893-026-04077-7.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Korhan Tuncer, MD principal investigator
Tepecik 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?
An observational study of Inguinal Hernia and Postoperative Pain, run by Tepecik Training and Research Hospital 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 1 inclusion and 5 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 19 Jun 2025. 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?
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?
postoperative pain (time frame: one month). 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 NCT05522608, 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 19 Jun 2025.