NCT05420818

Brief Summary

According to the EHS classification, at least 80 patients who will undergo TEP repair for the first time with the diagnosis of M2 and M3 direct inguinal hernia will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data, clinical/radiological seroma rate, postoperative pain (VAS values),quality of life(SF36 questionnaire), recurrence and other complications at postoperative 1st, 7th day, 3rd and 6th month will be monitored. When the desired number of patients and the follow-up period are reached, the data in the 2 groups will be compared.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

May 5, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

May 13, 2022

Last Update Submit

July 19, 2022

Conditions

Hernia, Inguinal

Keywords

Inguinal HerniaTEPSeromaLaparoscopic HerniaTransversalis fascia inversion

Outcome Measures

Primary Outcomes (1)

  • Seroma formation rate

    The clinical/radiological seroma formation rates between the groups with and without transversalis fascia inversion and fixation.

    3 month

Secondary Outcomes (3)

  • Chronic pain and quality of life measures

    3 month

  • Pain levels

    7 day

  • Postoperative pain levels

    1 day

Study Arms (2)

Active Group

EXPERIMENTAL

Patients who underwent transversalis fascia inversion during TEP

Procedure: Transversalis Fascia Inversion

Control Group

NO INTERVENTION

Patients who did not undergo transversalis fascia inversion during TEP

Interventions

Transversalis Fascia InversionPROCEDURE

This study will be carried out at SBU Istanbul Training and Research Hospital, General Surgery Clinic. Patients diagnosed with M2 and M3 direct primary inguinal hernia according to EHS classification and who will undergo TEP repair surgery will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data of patients in both groups, postoperative pain (VAS values) at postoperative 1st, 7th day and 3rd month, clinical/radiological seroma rate, postoperative pain, QOL, recurrence and other complications will be recorded. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.

Also known as: TEP
Active Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical or/and radiological diagnosis of primary inguinal hernia
  • EHS type M2 and M3 direct hernias
  • Laparoscopic totally extraperitoneal (TEP) repair

You may not qualify if:

  • Indirect hernias
  • M1 direct hernias
  • 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 Research and Training Hospital

Istanbul, Fatih, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalSeroma

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInflammationPathologic Processes

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
MD

Study Record Dates

First Submitted

May 13, 2022

First Posted

June 15, 2022

Study Start

May 5, 2022

Primary Completion

May 5, 2023

Study Completion

July 5, 2023

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

TU(1)