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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Unknown

Conditions

Hernia, Inguinal

Treatments

Procedure: preperitoneal suction drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT02762747
HERN-LAPDRAIN-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups

Drain
Experimental group
Description:
preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
Treatment:
Procedure: preperitoneal suction drainage
No-drain
No Intervention group
Description:
No drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia

Trial contacts and locations

1

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Central trial contact

Joe KM Fan, MBBS,MS,FRCS; WL Law, MBBS,MS,FRCS

Data sourced from clinicaltrials.gov

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