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

Hernia Clinical Trial

Official title:

A Comparative Study on Effects of Defect Closure Versus Non-Closure in Laparoscopic Totally Extraperitoneal Repair of Direct Inguinal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06389331
• Other study ID #: IRC/1971/020
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2024
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Direct Inguinal Hernia
• Hernia
• Hernia, Inguinal
• Seroma

Intervention

Other:
• closed the defect with barbed suture
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

Locations

Country	Name	City	State
Nepal	Vijay Pratap Sah	Malangwa	Madhesh Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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