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

August 30, 2022 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

75

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 Locations

  • Turkey
      • İzmir, Turkey
        • Recruiting
        • Tepecik Training and Research Hospital
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

Tepecik Training and Research Hospital

Investigators

  • 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)

May 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

July 16, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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