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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lap Inguinal Hernia repair with Drain | Experimental | A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery. |
|
| Lap Inguinal Hernia repair without Drain | Active Comparator | No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery | Procedure | Standardized minimally invasive approach to inguinal hernia repair |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Month 3 | |
| Postoperative Pain | Measured by Visual Analogue Pain Scale | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Factors affecting seroma | To study the various factors associated with seroma like patients demographics, surgeon related factors, etc. | Day 7 |
Inclusion Criteria:
All patients having an inguinoscrotal hernia (complete type)
Exclusion Criteria:
Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
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| Name | Affiliation | Role |
|---|---|---|
| Chinnusamy Palanivelu, MS,MCh,FRCS,FACS | Gem Hospital and Research Center, Coimbatore, India | Study Chair |
| Sandeep C. Sabnis, MS,DNB | Gem Hospital and research center, Coimbatore, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandeep C. Sabnis | Coimbatore | Tamil Nadu | 641015 | India |
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| ID | Term |
|---|---|
| D005734 | Gangrene |
| ID | Term |
|---|---|
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Open-label, randomized clinical trial
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| Recurrence |
Early recurrence of Hernia |
| Month 3 |