Laparscopic Hernioplasty in Recurrent Inguinal Hernia

Recurrent Inguinal Hernia Clinical Trial

Official title:

A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06050538
• Other study ID #: MD.21.03.439
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia.

Description:

The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with unilateral or bilateral recurrent inguinal hernias.
• Patients between 18 and 70 years old
• Fit for anesthesia.
• Agree to participate in the study
• Both genders were included.

Exclusion Criteria:

• Unfitness for general anesthesia and operation.
• Age < 18 years or >70 years.
• Complicated hernias (acute irreducible, obstruction or strangulation).
• The presence of mental or psychological disorders.
• Refusal to participate in the study.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Recurrence
• Recurrent Inguinal Hernia

Intervention

Procedure:
• Transabdominal preperitoneal (TAPP) using polyprolene mesh
Transabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh
• Total extraperitoneal (TEP) hernioplasty using polyprolene mesh
Total extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitl	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.	6 months
Secondary	operative time	operative time by minutes was reported to get mean and standard deviation	6 months
Secondary	complications	complications will be described as number and percentages in each group	6 months