Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair

Study Overview
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Brief Summary
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The current study aims to determine whether a use of closed suction drain following laparoscopic inguinal hernia surgery performed for an inguinoscrotal variety can decrease the incidence of symptomatic seroma formation requiring interventions and thus, prevent postoperative morbidity.

Detailed Description
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Patients with laparoscopic inguinal repair, TEP as well as TAPP approach, which matches the inclusion criteria will be randomized intraoperatively, based on a complete assessment of eligibility, just before the mesh placement. Patients recruited in closed suction drain arm will receive suction drain(14 French sizes) in preperitoneal space via a separate incision. The patients without drain arm, the regular postoperative course will be followed. The drain will be removed once the output falls below 50 ml per day. Both groups will be followed up until three months post-surgery. Clinical suspicion of seroma in symptomatic patients will be confirmed by ultrasound. Seroma will be managed conservatively till three weeks in the post-op period.

Official Title
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Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair

Conditions
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Inguinal Hernia Without Obstruction or Gangrene

Intervention / Treatment
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* Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients having an inguinoscrotal hernia (complete type) Exclusion Criteria: Obstructed, incarcerated or strangulated hernia Patients unwilling to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label, randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lap Inguinal Hernia repair with Drain<br>A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery. | Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery<br>* Standardized minimally invasive approach to inguinal hernia repair<br>|
| Active Comparator: Lap Inguinal Hernia repair without Drain<br>No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery. | Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery<br>* Standardized minimally invasive approach to inguinal hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients developing symptomatic seroma requiring intervention after surgery | The patients developing symptomatic seroma after hernia surgery, assessed by clinical and radiological evaluation, which needs intervention in form of needle aspiration or sac excision. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection |  | Month 3 | 
| Postoperative Pain | Measured by Visual Analogue Pain Scale | Day 1 | 
| Recurrence | Early recurrence of Hernia | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complete Inguinal Hernia, Inguinoscrotal Hernia, Laparoscopic hernia repair