Clinical trial NCT06389331: Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia
Official title: A Comparative Study on Effects of Defect Closure Versus Non-Closure in Laparoscopic Totally Extraperitoneal Repair of Direct Inguinal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Direct Inguinal Hernia
Seroma Following Procedure
Keywords: TEP
Direct Hernia Closure
Seroma Formation
Pain
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inguinal hernia presenting to surgery OPD

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.

Detailed description: Inguinal hernia is a common and widespread condition from which millions of people suffer. Repair of an inguinal hernia is one of the most frequently performed operations in general surgery. Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair. Laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias. It has also been recommended for patients with primary unilateral inguinal hernia, contingent on the availability of surgical expertise and resources, due to a lower incidence of post-operative pain and chronic pain.

Seroma formation is a frequent complication of laparoscopic mesh repair of moderate-large direct inguinal hernia defects. While rates of seroma formation have been reported to be as high as 10-30%. Several attempts have been made to reduce the incidence of seroma formation, such as tacking the transversalis fascia (TF) to the ramus of the pubis, closing the direct inguinal hernia defect via the endoloop technique, and filling the potential dead space with fibrin glue. However, there is a potential increase in the risk of infection and also a risk of chronic pubic bone pain from the tack staples or vasculo-nervous injury if fixing the TF to the abdominal wall, which would lead to extra discomfort for the patient. The closure of a direct hernia defect with a barbed suture not only closes the defect superficially but also exterminates the defect cavity; consequently, the incidence of seroma formation has been greatly reduced.

However, there is still controversial evidence regarding the choice of the two procedures in terms of reducing the rate of seroma formation and pain. Thus, it is ambiguous which surgical technique should be considered best to repair an inguinal hernia. In this study, we tried to evaluate the technical aspect of direct defect closure in laparoscopic TEP inguinal hernia repair and its effect on the primary outcomes in terms of seroma formation and pain at different time intervals, along with the secondary outcomes such as operative time, length of postoperative hospital stay, days to resume normal activities, recurrence, and intraoperative complications like injury to the vas, vessel, and visceral injury or peritoneal tear.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: seroma formation in defect closure group
timeFrame: till 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malangwa
country: Nepal
facility: Vijay Pratap Sah
state: Madhesh Pradesh
Study officials:
affiliation: B. P. Koirala institute of health science
name: Rakesh Kumar Gupta, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.