Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
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
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 12, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedNovember 1, 2021
October 1, 2021
2.2 years
June 12, 2018
October 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pain scores (0-100) after surgery
Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome
from day 1 to 1 month postoperatively
Secondary Outcomes (2)
Number of operative complications
from day 1 to 1 month postoperatively
Number of re-operations
1 month after the operation
Study Arms (2)
Endoscopic TEP surgery
ACTIVE COMPARATORRoutine total extraperitoneal technique surgery for inguinal hernia
Open Lichtenstein hernioplasty
ACTIVE COMPARATORRoutine lichtenstein surgery for inguinal hernia
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of symptomatic inguinal hernia Age 18-80
You may not qualify if:
- Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- Helsinki University Central Hospitalcollaborator
- North Karelia Central Hospitalcollaborator
- Mikkeli Central Hospitalcollaborator
- Päijänne Tavastia Central Hospitalcollaborator
Study Sites (1)
Kuopio University Hospital
Kuopio, 70600, Finland
Related Publications (1)
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.
PMID: 34791044DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hannu Paajanen, Prof
Kuopio University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2018
First Posted
June 25, 2018
Study Start
November 1, 2017
Primary Completion
December 31, 2019
Study Completion
May 31, 2020
Last Updated
November 1, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share