Inguinal Hernia Without Obstruction or Gangrene
Conditions
Keywords
Complete Inguinal Hernia, Inguinoscrotal Hernia, Laparoscopic hernia repair
Brief summary
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
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.
Interventions
PROCEDURELaparoscopic Inguinal Hernia (TEP/TAPP) Surgery
Standardized minimally invasive approach to inguinal hernia repair
Sponsors
GEM Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients having an inguinoscrotal hernia (complete type)
Exclusion criteria
Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients developing symptomatic seroma requiring intervention after surgery | Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | Month 3 | — |
| Postoperative Pain | Day 1 | Measured by Visual Analogue Pain Scale |
| Recurrence | Month 3 | Early recurrence of Hernia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Factors affecting seroma | Day 7 | To study the various factors associated with seroma like patients demographics, surgeon related factors, etc. |
Countries
India
Outcome results
None listed