Randomised Controlled Trial on Pre-peritoneal Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia

Study Overview
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Brief Summary
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This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. Other secondary outcomes will be measured including post-operative pain, discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.

Detailed Description
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Inguinal hernia is a common disease and causes significant morbidity if left untreated. With the advances of laparoscopic approach of extra-peritoneal hernioplasty, it significantly reduces the post-operative pain and lead to a better quality of life with higher acceptance to patients.However, similar to traditional Litchenstein approach, post operative seroma formation is still a common problem encountered after surgery. Numerous method has been described to reduce chance of seroma formation, however, none was proven to be effective except pre-peritoneal drainage. There are currently 2 large retrospective non-randomized cohort study to evaluate the effectiveness of preperitoneal drainage available for reference. We therefore study the feasibility and efficacy of preperitoneal drainage with large scale randomized trial. Patient fulfill inclusion criteria and consent to surgery and study will be recruited. A standardized pre-peritoneal dissection and mesh placement will be adopted. Immediately before deflation of pre-peritoneal space, randomization will be performed by calling research assistant for study group using computer generated code. Drain will be placed for 23 hours after operation and ultrasonography will be performed immediately after removal of drain. USG will be repeated at post-operative 1 week, 1 month, 3 months, 6 months and 1 year after surgery. For non-drain group, a fake drain will be attach to the skin of the wound to achieve double blinding to patients and assessors. In addition to seroma, patient demographics and secondary outcome including post-operative pain score, discomfort, foreign body sensation, patient satisfaction, infection, recurrence, etc will be studied.

Official Title
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Pre-peritoneal Drainage Versus No Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia - a Randomised Controlled Study

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: preperitoneal suction drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 and below 80 Male or female patients Unilateral inguinal hernia First occurrence hernia Consent to laparoscopic hernioplasty for inguinal hernia Exclusion Criteria: Inguino-scrotal hernia Recurrent inguinal hernia Incarcerated hernia Bilateral inguinal hernia Bleeding tendency On anti-platelet agent or anti-coagulant Co-morbidies Decline or not consent to surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drain<br>preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia | Procedure: preperitoneal suction drainage<br>* preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia<br>|
| No Intervention: No-drain<br>No drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative day 1 | 
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative day 7 | 
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative 1 month | 
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative 3 month | 
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative 6 month | 
| Seroma formation after TEP hernioplasty | Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP | post-operative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain after TEP hernioplasty | Post-operative pain after TEP hernioplasty will be assessed by self-evaluated VAS questionnaire during initial 7 days after operation. Then will be asked by independent assessor upon follow-up | post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year | 
| Analgesic used after after TEP hernioplasty | Number of analgesic used after after TEP hernioplasty will be assessed by self-evaluated questionnaire during initial 7 days after operation. Then will be asked by independent assessor upon follow-up | post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year | 
| Chronic discomfort after TEP hernioplasty | Chronic discomfort after TEP hernioplasty will be asked by independent assessor upon follow-up | post-operative 1 month, 3 month, 6 month, 1 year | 
| Hernia recurrence after TEP hernioplasty | Hernia recurrence after TEP hernioplasty will be assessed by independent assessor upon follow-up | post-operative 1 month, 3 month, 6 month, 1 year | 
| Patient satisfaction after TEP hernioplasty | Patient satisfaction after TEP hernioplasty will be asked by independent assessor upon follow-up | post-operative 1 month, 3 month, 6 month, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia, Inguinal, Extraperitoneal Hernioplasty, Drain, Mesh Repair, Laparoscopic