Comparison of fixation and non fixation of mesh in Laparoscopic TEP

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/09/009680
• Date of registration: 07-09-2017
• Prospective Registration: No
• Primary sponsor: Office of DGAFMS
• Public title: Comparison of fixation and non fixation of mesh in Laparoscopic TEP
• Scientific title: A pilot randomized control study to evaluate non-fixation vs fixation of mesh in laparoscopic total extraperitoneal hernioplasty for inguinal hernias with large posterior wall defects
• Date of first enrolment: 24-09-2015
• Target sample size: 54
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18169
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Adil A Kalam
• Affiliation: Armed Forces Medical College Pune

• Name: Manoj Kumar
• Affiliation: Armed Forces Medical College Pune

Key inclusion & exclusion criteria

Inclusion criteria: All cases of inguinal hernias undergoing lap TEP with defect equal or more than 3cm diameter,confirmed intra-operatively seen during the period of study
Exclusion criteria: 1) Age > 18 years, Age < 85 yrs

2)Irreducible inguinal hernias

3)Preexisting scar of lower midline incision

4)Pts on immunosuppressive drugs/diseases

5)Patients with ascitis, active abdominal infections

• Patients not consenting for the study

• Inguinal hernias with defect < 3cms intra operatively



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Inguinal Hernia with large posterior wall defects more than 3 cm

Intervention(s)

Intervention1: Laparoscopic TEP with fixation:
Intervention: Fixation Mesh with laparoscopic tackers

Control Intervention1: Laparaoscopic TEP without mesh fixation: Comparator: No mesh fixation in lap TEP

Primary Outcome(s)

Technical feasibility, Duration of surgery, Early recurrenceTimepoint: six months to one year

Secondary Outcome(s)

Local complications if any, length of hospital stay, pain scoresTimepoint: six months to one year

Secondary ID(s)

NIL

Source(s) of Monetary Support

Department of surgery, Armed forces medical College, pune

Ethics review

Status: Approved
Approval date: 24/09/2015
Contact:

Institutional Ethics Committee, AFMC