Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use

• Sponsor: Damanhour Teaching Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05574751
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 50
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation.

Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use.

Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia Unilateral	Other: Titanium tacker; Other: Polypropylene 0	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Nov 1, 2022
• Actual Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Titanium tacker group (n=30) Group A	Other: Titanium tacker; Mesh fixation with Titanium tacker
Active Comparator: Polypropylene group (n=30) Group B	Other: Polypropylene 0; Mesh was sutured and fixed with polypropylene 0

Outcome Measures

Primary Outcome Measures

1. Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] [7 days after the end of the operation]

   NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)

2. Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) [7 days after the end of the operation]

   NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)

Secondary Outcome Measures

1. Mean and Standard deviation of Operative duration (minutes) (mean±SD) [2 minutes after the end of the operation]

   Time from skin incision till skin closure

2. Mean and Standard deviation of Length of hospital stay (hours) (mean±SD) [24 hours after the end of the operation]

   Time from hospital admission till discharge

3. Number of participants and Rate of Intraoperative complications [2 minutes after the end of the operation]

   Number of participants and Rate of: Bowel injury, Injury to inferior epigastric artery, Injury to major vessels, Bleeding of venous plexus around pubic bone, Injury to vas deferens, Bladder injury.

4. Number of participants and Rate of Postoperative complications [1 year after the end of the operation]

   Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 21 years

• American Society of Anesthesiologists (ASA) physical status ≤ II

• Patients with body mass index (BMI) of 25 to 35 kg/m²

• Unilateral inguinal hernia

Exclusion Criteria:

• Age < 21 years

• ASA physical status > II

• Patients with body mass index (BMI) > 35 kg/m²

• Pregnant women

• Bilateral inguinal hernia

• Large inguinoscrotal hernia

• Incarcerated hernia

• Recurrent hernia

• Strangulated hernia

• Prostatic diseases

• History of; Convulsions, Cerebrovascular accident, Previous neurological diseases

• Dysrhythmia

• Hypertension

• Ischemic heart disease

• Hyperthyroidism

• Liver or Renal impairment

• Alcohol or drug abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damanhour Teaching Hospital	Damanhūr	El-Beheira	Egypt

Sponsors and Collaborators

• Damanhour Teaching Hospital

Investigators

• Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Damanhour Teaching Hospital
• ClinicalTrials.gov Identifier: NCT05574751
• Other Study ID Numbers: DTH: 22002
• First Posted: Oct 12, 2022
• Last Update Posted: Nov 22, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Damanhour Teaching Hospital: Inguinal hernia; Mesh fixation; Titanium tacker
• Additional relevant MeSH terms: Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Nov 22, 2022