Hernia, Inguinal
Conditions
Keywords
Hernia, Inguinal, Extraperitoneal Hernioplasty, Drain, Mesh Repair, Laparoscopic
Brief summary
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
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.
Interventions
PROCEDUREpreperitoneal suction drainage
preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
Sponsors
The University of Hong Kong-Shenzhen Hospital
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroma formation after TEP hernioplasty | post-operative day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain after TEP hernioplasty | post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year | 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 |
| Analgesic used after after TEP hernioplasty | post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year | 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 |
| Chronic discomfort after TEP hernioplasty | post-operative 1 month, 3 month, 6 month, 1 year | Chronic discomfort after TEP hernioplasty will be asked by independent assessor upon follow-up |
| Hernia recurrence after TEP hernioplasty | post-operative 1 month, 3 month, 6 month, 1 year | Hernia recurrence after TEP hernioplasty will be assessed by independent assessor upon follow-up |
| Patient satisfaction after TEP hernioplasty | post-operative 1 month, 3 month, 6 month, 1 year | Patient satisfaction after TEP hernioplasty will be asked by independent assessor upon follow-up |
Countries
China
Contacts
Primary ContactJoe KM Fan, MBBS,MS,FRCS
Backup ContactWL Law, MBBS,MS,FRCS
Outcome results
None listed