NCT05522608

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

July 16, 2022

Last Update Submit

June 16, 2025

Conditions

Keywords

inguinal herniapostoperative paintransabdominal preperitoneal repairvisual analogue scale

Outcome Measures

Primary Outcomes (1)

  • 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.

    one month

Study Arms (2)

patients with postoperative pain

Patients with postoperative pain after transabdominal preperitoneal hernia repair

Procedure: transabdominal preperitoneal hernia repair

patients without postoperative pain

Patients without postoperative pain after transabdominal preperitoneal hernia repair

Procedure: transabdominal preperitoneal hernia repair

Interventions

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 with postoperative painpatients without postoperative pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients undergoing TAPP for inguinal hernia for the first time

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28490321BACKGROUND
  • Tolver 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.

    PMID: 22260427BACKGROUND
  • Etele 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.

    PMID: 33138898BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalPain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Korhan Tuncer, MD

    Tepecik Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

July 16, 2022

First Posted

August 31, 2022

Study Start

May 1, 2021

Primary Completion

March 1, 2024

Study Completion

July 1, 2024

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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

Locations