Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair

Evaluating the Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair

The aim of the study is to evaluate the effect of drainage on the incidence of seroma after laparoscopic transabdominal preperitoneal inguinal hernia repair.

Study Overview

• Status: Completed
• Conditions: Drainage; Seroma; Laparoscopic; Trans-abdominal; Preperitoneal Inguinal Hernia Repair
• Intervention / Treatment: Procedure: Trans-abdominal preperitoneal repair + Drainage; Procedure: Trans-abdominal preperitoneal repair

Detailed Description

Inguinal hernia repair is one of the most common surgical conditions encountered in primary care settings. Globally, around 20 million groin hernia repairs are performed each year. Surgical procedure is the gold standard treatment for inguinal hernia repair.

Laparoscopic hernioplasty is suitable for patients with inguinal hernia who can undergo general anesthesia, especially in cases like hernia recurrence after open repair, bilateral hernias, and simultaneous procedures like cholecystectomy.

Although open mesh repair has already demonstrated a low recurrence rate, laparoscopic mesh repair has become increasingly popular in recent years due to its benefits, including a better view of the groin anatomy, ease in addressing bilateral hernias, and superior cosmetic outcomes. The two most widely used laparoscopic mesh repair techniques are Totally Extra peritoneal (TEP) and Trans abdominal Preperitoneal (TAPP) repair, both of which are based on the myopectineal orifice theory. The key difference between TEP and TAPP lies in the method used to access the preperitoneal space.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged from18 to 70 years.
• Both sexes.
• Patients were diagnosed with all types of inguinal hernia who are candidates for elective trans-abdominal Preperitoneal (TAPP) repair.

Exclusion Criteria:

• Previous history of pelvic or lower abdominal surgery.
• Coagulopathy.
• Any condition contraindicating laparoscopic surgery.
• Patients with complicated hernia (irreducible/incarcerated or obstructed/strangulated hernia).
• Active infections.
• Uncorrected medical comorbidities.
• Bilateral inguinal hernia either preoperative or intraoperative diagnosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.	Procedure: Trans-abdominal preperitoneal repair + Drainage; Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
Experimental: Group B; Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.	Procedure: Trans-abdominal preperitoneal repair; Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of patients suffering from Seroma	Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	Pain was assessed using Visual Analogue Scale (VAS) in which the pain score is defined from 0 (no pain) to 10 (maximum pain) at rest and during activity recorded at similar intervals.	24 hours post-procedure
Degree of patient satisfaction	Degree of patient satisfaction was assessed using 3-likert point scale where (1, Neutral; 2, Satisfied; 3, Very satisfied)	24 hours post-procedure
Measurement of operative time	Measurement of operative time was done from skin incision to closure.	Till closure of the skin (Up to 60 minutes).
Incidence of recurrence	Incidence of recurrence of hernia was assessed during follow-up visits.	6 months post-procedure

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: June 27, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Pathological Conditions, Signs and Symptoms; Seroma; Therapeutics; Surgical Procedures, Operative; Drainage
• Other Study ID Numbers: MS-55-2025 (28-4-2025)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No