Laparscopic Hernioplasty in Recurrent Inguinal Hernia

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06050538
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Inguinal Hernia	Procedure: Transabdominal preperitoneal (TAPP) using polyprolene mesh; Procedure: Total extraperitoneal (TEP) hernioplasty using polyprolene mesh	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: patients diagnosed with recurrent inguinal hernia. The study population were randomly distributed into 2 groups by computer generating program; group (1) included patients who had Transabdominal preperitoneal (TAPP) approach while group (2) included patients who had Total extraperitoneal (TEP) approach.patients diagnosed with recurrent inguinal hernia. The study population were randomly distributed into 2 groups by computer generating program; group (1) included patients who had Transabdominal preperitoneal (TAPP) approach while group (2) included patients who had Total extraperitoneal (TEP) approach.
• Masking: Double (Participant, Care Provider)
• Masking Description: Each patient was randomly allocated to the TAPP group or the TEP group by sequentially numbered, opaque , sealed envelope (SNOSE) technique on the day of surgery. An independent statistician , who was not involved in patient care, generated the randomization sequence via a computer generated random number. The randomization code was contained in opaque sealed envelopes. A junior resident , who opened the envelope , was not actively involved in outcome measurements .Before randomization and during the consent, all patients received an explanation of the objectives of the study, techniques and complications associated with both procedures.
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Feb 1, 2023
• Actual Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transabdominal preperitoneal (TAPP) patients with recurrent inguinal hernia who had Transabdominal preperitoneal (TAPP) approach	Procedure: Transabdominal preperitoneal (TAPP) using polyprolene mesh; Transabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh
Active Comparator: Total extraperitoneal (TEP) approach patients with recurrent inguinal hernia who had Total extraperitoneal (TEP) approach	Procedure: Total extraperitoneal (TEP) hernioplasty using polyprolene mesh; Total extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh

Outcome Measures

Primary Outcome Measures

1. Postoperative pain [6 months]

   by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.

Secondary Outcome Measures

1. operative time [6 months]

   operative time by minutes was reported to get mean and standard deviation

2. complications [6 months]

   complications will be described as number and percentages in each group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitl	Mansoura		Egypt

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: Islam Hisham, MSc, Mansoura University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Islam Hisham, Principal Investigator, Mansoura University
• ClinicalTrials.gov Identifier: NCT06050538
• Other Study ID Numbers: MD.21.03.439
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Islam Hisham, Principal Investigator, Mansoura University: TAPP; TEP; Laparoscopic Inguinal Hernia; Recurrent hernia
• Additional relevant MeSH terms: Recurrence; Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Sep 22, 2023