Comparison of Whole Mesh and Split Mesh Use in Laparoscopic Inguinal Hernia Repair
Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair
1 other identifier
interventional
80
1 country
1
Brief Summary
At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedStudy Start
First participant enrolled
June 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2023
CompletedJuly 20, 2022
July 1, 2022
11 months
May 20, 2022
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Carolinas Comfort Scale values
Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes.
6 month
Recurrence rates
Differences in recurrence rates in patients who use whole meshes and those who use split meshes.
6 month
Secondary Outcomes (1)
Recurrence rates
6 month
Study Arms (2)
Whole Mesh
ACTIVE COMPARATORFor the patients in the first group, the whole patch will be laid on the area without being fixed.
Split Mesh
ACTIVE COMPARATORThe patients in the second group will be given a patch of the same size, but partially divided horizontally and wrapped around the spermatic cord.
Interventions
TEP repair of inguinal hernias using either split or whole mesh
Eligibility Criteria
You may qualify if:
- Clinical or/and radiological diagnosed primary inguinal hernia
- TEP or TAPP surgical methods
You may not qualify if:
- Recurrent hernias
- Patients with previous groin operations on same side
- Pregnant women
- Patients who did not accept to participate in the study
- ASA score of 3 or higher,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Training and Research Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General Surgeon
Study Record Dates
First Submitted
May 20, 2022
First Posted
June 15, 2022
Study Start
June 16, 2022
Primary Completion
May 16, 2023
Study Completion
June 16, 2023
Last Updated
July 20, 2022
Record last verified: 2022-07