STUDY TO CHECK ANY DIFFERENCE OF PAIN OVER GROIN AREA AND ANY DIFFERENCE IN PATTERN OF EARLY RECURRENCE AFTER OPEN MESH REPAIR OF INGUINAL HERNIA USING TWO VARIETIES OF MESH

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012746
• Date of registration: 22-03-2018
• Prospective Registration: No
• Primary sponsor: Lady Hardinge Medical College
• Public title: STUDY TO CHECK ANY DIFFERENCE OF PAIN OVER GROIN AREA AND ANY DIFFERENCE IN PATTERN OF EARLY RECURRENCE AFTER OPEN MESH REPAIR OF INGUINAL HERNIA USING TWO VARIETIES OF MESH
• Scientific title: PROSPECTIVE RANDOMIZED CONTROLLED SINGLE BLIND STUDY ASSESSING IMPACT OF COMPOSITE MESH AND POLYPROPYLENE MESH ON CHRONIC GROIN PAIN AND EARLY RECURRENCE IN OPEN MESH REPAIR OF INGUINAL HERNIA
• Date of first enrolment: 01-11-2012
• Target sample size: 300
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9110
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Permuted block randomization, variable 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: DEBORSHI SHARMA
• Affiliation: Lady Hardinge Medical College

• Name: Rajinder Kumar
• Affiliation: Lady Hardinge Medical College

Key inclusion & exclusion criteria

Inclusion criteria: a. Patientâ??s attending surgery OPD.

b. Uncomplicated symptomatic inguinal hernia

c. Consent for operation


Exclusion criteria: a. Patient unfit for general/spinal anaesthesia.

b. Below 20 yrs and above 70yrs.

c. Pregnancy.

d. Past history of malignancy.

e. Complicated Hernia (Obstruction/emergency presentations)

f. Morbid Obesity

g. Uncorrected coagulopathy



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Inguinal Hernia

Intervention(s)

Intervention1: Open inguinal hernia mesh repair: Type of mesh
Composite, Polypropylene
Intervention2: Inguinal Hernia Surgery using composite mesh: Post Operative pain, Discomfort, Seroma formation, Early Recurrance
Control Intervention1: Open Inguinal Hernia repair surgery using Polypropylene Mesh: Post operative Pain, Discomfort, Seroma formation, early recurrances

Primary Outcome(s)

Mean pain score

Early pain at rest (2days)

Late pain during physical activity (1 month)

Chronic pain at 3 months

2. Early recurrence (6 months)

Timepoint: 2 days to 6 months

Secondary Outcome(s)

Mesh Manoeuvre ability during surgery

a.Suture cutting through mesh/suture holding mesh

b.Time taken for surgery

c.Blood loss

d.Any intra-operative complications

2.To assess and compare post-operative recovery

a.Seroma

Early(2daysâ??7days)

Late(1month)

b.Haematoma

c.Feeling of foreign body

Early (15 days)

Intermediate(3months)

Late(6 month)

d.Testicular atrophy ( ultrasound at 3 months)



Timepoint: 3-6MONTHS

Secondary ID(s)

NIL

Source(s) of Monetary Support

Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 110001

Ethics review

Status: Approved
Approval date: 24/05/2014
Contact:

Lady Hardinge Medical College

Results

• Date Completed: 31/12/2017