Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair

NCT07886814 | Active Not Recruiting

• 1 other identifier: 2024-TBEK 2026/02-16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether routine urinary catheterization is necessary in patients undergoing laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. Urinary catheters are sometimes used during laparoscopic inguinal hernia surgery to empty the bladder and facilitate surgical dissection. However, catheterization may cause postoperative urinary discomfort, dysuria, and urethral pain. Avoiding routine catheterization may reduce these symptoms without increasing the risk of postoperative urinary retention. In this prospective, single-center, randomized controlled trial, 100 patients undergoing laparoscopic TEP inguinal hernia repair were randomly assigned by a lottery-based method to receive either routine urinary catheterization or no urinary catheterization. The primary outcome is the incidence of dysuria on postoperative day 1. Secondary outcomes include urinary or urethral pain, pain severity assessed using a visual analog scale (VAS), postoperative urinary retention, surgical complications, and hernia recurrence. Urinary symptoms and complications are assessed on postoperative days 1, 10, and 30. Hernia recurrence is evaluated during a six-month follow-up period. The study aims to determine whether omitting routine urinary catheterization reduces postoperative urinary symptoms without compromising patient safety.

Conditions

Inguinal Hernias

Keywords

Urinary Catheterization; Laparoscopic Inguinal Hernia Repair; Total Extraperitoneal Repair; Postoperative Dysuria; Urethral Pain; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of Dysuria on Postoperative Day 1

  The primary outcome was the incidence of postoperative dysuria, defined as patient-reported pain, burning, or discomfort during urination within the first 24 hours following laparoscopic total extraperitoneal inguinal hernia repair. Dysuria was assessed as a binary outcome (present or absent). The proportion of participants experiencing dysuria was compared between the urinary catheterization and no-catheterization groups.

  Postoperative Day 1 (within 24 hours after surgery)

Secondary Outcomes (10)

• Incidence of Urinary or Urethral Pain on Postoperative Day 1

  Postoperative Day 1 (within 24 hours after surgery)

• Incidence of Urinary or Urethral Pain on Postoperative Day 10

  Postoperative Day 10

• Incidence of Urinary or Urethral Pain on Postoperative Day 30

  Postoperative Day 30

• Urinary or Urethral Pain Severity on Postoperative Day 1

  Postoperative Day 1

• Urinary or Urethral Pain Severity on Postoperative Day 10

  Postoperative Day 10

Study Arms (2)

No Urinary Catheterization

EXPERIMENTAL

Participants assigned to this group underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair without routine perioperative urinary catheterization. The surgical procedure was performed under general anesthesia using a standardized technique. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up.

Procedure: No Routine Urinary Catheterization

Routine Urinary Catheterization

ACTIVE COMPARATOR

Participants assigned to this group underwent laparoscopic totally extraperitoneal (TEP) inguinal hernia repair with routine perioperative urinary catheterization. A urinary catheter was placed during the perioperative period and removed before hospital discharge, approximately 24 hours after surgery. Postoperative urinary symptoms, urinary retention, and surgical complications were assessed during follow-up.

Procedure: Routine Urinary Catheterization

Interventions

Routine Urinary Catheterization PROCEDURE

Routine perioperative urinary catheterization was performed in participants undergoing laparoscopic total extraperitoneal inguinal hernia repair. The urinary catheter was maintained during the immediate postoperative period and removed before hospital discharge, approximately 24 hours after surgery.

Routine Urinary Catheterization

No Routine Urinary Catheterization PROCEDURE

Participants underwent laparoscopic total extraperitoneal inguinal hernia repair without routine perioperative urinary catheter placement. Postoperative urinary symptoms and urinary retention were assessed using the same follow-up schedule as the catheterization group.

No Urinary Catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical or radiological diagnosis of inguinal hernia. Scheduled laparoscopic total extraperitoneal (TEP) inguinal hernia repair.

You may not qualify if:

• Scrotal inguinal hernia. Prolapsed inguinal hernia.

Sponsors & Collaborators

• Ugur Duman: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ugur Duman, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of General Surgery

Model Details: This was a prospective, single-center, two-arm, parallel-group randomized controlled trial. Participants undergoing laparoscopic total extraperitoneal (TEP) inguinal hernia repair were randomly assigned using a lottery-based allocation method to either routine urinary catheterization or no urinary catheterization. Both groups underwent the same standardized surgical procedure, and postoperative urinary outcomes were assessed at predefined follow-up intervals.

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)