Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia

NCT06389331 | Completed DMC

• 1 other identifier: IRC/1971/020
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.

Conditions

Hernia; Direct Inguinal Hernia; Seroma Following Procedure

Keywords

TEP; Direct Hernia Closure; Seroma Formation; Pain

Outcome Measures

Primary Outcomes (1)

• seroma formation in defect closure group

  After closing the defect, there is less seroma formation than in the defect non closure group

  till 6 months

Study Arms (2)

defect closure

the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture

Other: closed the defect with barbed suture

non closure group

defect was left open

Interventions

closed the defect with barbed suture OTHER

In direct hernia, content was reduced, and the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture

defect closure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with inguinal hernia presenting to surgery OPD

You may qualify if:

• age greater than 18 years
• uncomplicated direct inguinal hernia (≥M3)

You may not qualify if:

• defect size ≤M2
• complicated hernia (irreducible, obstructed, or recurrent hernia)
• patients unfit for general anesthesia

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Vijay Pratap Sah

Malaṅgawā, Madhesh Pradesh, Nepal

Location

Related Publications (4)

• Rutkow IM, Robbins AW. Demographic, classificatory, and socioeconomic aspects of hernia repair in the United States. Surg Clin North Am. 1993 Jun;73(3):413-26. doi: 10.1016/s0039-6109(16)46027-5.

  PMID: 8497793 BACKGROUND

• McKernan JB, Laws HL. Laparoscopic repair of inguinal hernias using a totally extraperitoneal prosthetic approach. Surg Endosc. 1993 Jan-Feb;7(1):26-8. doi: 10.1007/BF00591232.

  PMID: 8424228 BACKGROUND

• Usmani F, Wijerathne S, Malik S, Yeo C, Rao J, Lomanto D. Effect of direct defect closure during laparoscopic inguinal hernia repair ("TEP/TAPP plus" technique) on post-operative outcomes. Hernia. 2020 Feb;24(1):167-171. doi: 10.1007/s10029-019-02036-1. Epub 2019 Sep 6.

  PMID: 31493054 BACKGROUND

• Kockerling F, Bittner R, Adolf D, Fortelny R, Niebuhr H, Mayer F, Schug-Pass C. Seroma following transabdominal preperitoneal patch plasty (TAPP): incidence, risk factors, and preventive measures. Surg Endosc. 2018 May;32(5):2222-2231. doi: 10.1007/s00464-017-5912-3. Epub 2017 Oct 26.

  PMID: 29075973 BACKGROUND

MeSH Terms

Conditions

Hernia; Hernia, Inguinal; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Rakesh Kumar Gupta, MS

  B. P. Koirala institute of health science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)