Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation

NCT04532983 | Completed

• 1 other identifier: hazem tapp no fix
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

• postoperative pain

  pain in the first 6 month of surgery measured by visual analogue scale

  6 month

• hernia recurrence

  recurrence of inguinal hernia measured by computed tomography of the abdomen

  1 year

Study Arms (2)

fixation group

ACTIVE COMPARATOR

; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic),

Procedure: fixation of mesh prosthesis

non fixation group

ACTIVE COMPARATOR

group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.

Procedure: mesh placement without fixation

Interventions

fixation of mesh prosthesis PROCEDURE

in the first group mesh was fixed in position with laparoscopic tacks

fixation group

mesh placement without fixation PROCEDURE

mesh placement in preperitoneal space without fixation

non fixation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old suffering unilateral,
• non -recurrent,
• un-complicated inguinal hernia.

You may not qualify if:

• previous abdominal or pelvic surgery,
• unfit with laparoscopic surgery,
• those with ascites,
• abdominal malignancy
• on chemotherapy and immune-compromised patients.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• hazem nour

  zag university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: the participants and the follow up surgeon don't know which received fixation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: ; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: July 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)