Factors Associated With Postoperative Pain in Patients Undergoing TAPP Hernia Repair for Inguinal Hernia

June 16, 2025 updated by: Korhan TUNCER, Tepecik Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Tepecik Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Patients undergoing TAPP for inguinal hernia for the first time

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with postoperative pain
Patients with postoperative pain after transabdominal preperitoneal hernia repair
Procedure: transabdominal preperitoneal hernia repair
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.
patients without postoperative pain
Patients without postoperative pain after transabdominal preperitoneal hernia repair
Procedure: transabdominal preperitoneal hernia repair
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tepecik Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Korhan Tuncer, MD, Tepecik Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/04-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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