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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522608
• Other study ID #: 2021/04-09
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2022
• Source: Tepecik Training and Research Hospital
• Contact: Korhan Tuncer, MD
• Phone: +905053746812
• Email: korhantuncer19[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Tepecik Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Etele ÉE, Neagoe RM, Márton D, Sala D, Török Á. 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/chir — View Citation

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 Ma — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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