Back to resultsPostoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
Primary Purpose
Inguinal Hernia, Hernia
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Tep surgery for inguinal hernia
Lichtenstein
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of symptomatic inguinal hernia Age 18-80
Exclusion Criteria:
Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endoscopic TEP surgery
Open Lichtenstein hernioplasty
Arm Description
Routine total extraperitoneal technique surgery for inguinal hernia
Routine lichtenstein surgery for inguinal hernia
Outcomes
Primary Outcome Measures
Pain scores (0-100) after surgery
Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome
Secondary Outcome Measures
Number of operative complications
Any minor or major complication
Number of re-operations
Any re-operation
Full Information
NCT ID
NCT03566433
First Posted
June 12, 2018
Last Updated
October 25, 2021
Sponsor
Kuopio University Hospital
Collaborators
Helsinki University Central Hospital, North Karelia Central Hospital, Mikkeli Central Hospital, Päijänne Tavastia Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03566433
Brief Title
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
Official Title
Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
Helsinki University Central Hospital, North Karelia Central Hospital, Mikkeli Central Hospital, Päijänne Tavastia Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.
Detailed Description
Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic TEP surgery
Arm Type
Active Comparator
Arm Description
Routine total extraperitoneal technique surgery for inguinal hernia
Arm Title
Open Lichtenstein hernioplasty
Arm Type
Active Comparator
Arm Description
Routine lichtenstein surgery for inguinal hernia
Intervention Type
Procedure
Intervention Name(s)
Tep surgery for inguinal hernia
Intervention Description
TEP surgery
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein
Intervention Description
Lichtenstein surgery for inguinal hernia
Primary Outcome Measure Information:
Title
Pain scores (0-100) after surgery
Description
Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome
Time Frame
from day 1 to 1 month postoperatively
Secondary Outcome Measure Information:
Title
Number of operative complications
Description
Any minor or major complication
Time Frame
from day 1 to 1 month postoperatively
Title
Number of re-operations
Description
Any re-operation
Time Frame
1 month after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of symptomatic inguinal hernia Age 18-80
Exclusion Criteria:
Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu Paajanen, Prof
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70600
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34791044
Citation
Matikainen M, Vironen JH, Silvasti S, Ilves I, Kossi J, Kivivuori A, Paajanen H. A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia. Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354.
Results Reference
derived
Learn more about this trial
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
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