Clinical trial NCT02762747: Randomised Controlled Trial on Pre-peritoneal Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia
Official title: Pre-peritoneal Drainage Versus No Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia - a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Hernia, Inguinal
Extraperitoneal Hernioplasty
Drain
Mesh Repair
Laparoscopic
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong-Shenzhen Hospital
First posted: 2016-05-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seroma formation after TEP hernioplasty
timeFrame: post-operative day 1
measure: Seroma formation after TEP hernioplasty
timeFrame: post-operative day 7
measure: Seroma formation after TEP hernioplasty
timeFrame: post-operative 1 month
measure: Seroma formation after TEP hernioplasty
timeFrame: post-operative 3 month
measure: Seroma formation after TEP hernioplasty
timeFrame: post-operative 6 month
measure: Seroma formation after TEP hernioplasty
timeFrame: post-operative 1 year
Secondary outcomes:
measure: Post-operative pain after TEP hernioplasty
timeFrame: post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
measure: Analgesic used after after TEP hernioplasty
timeFrame: post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
measure: Chronic discomfort after TEP hernioplasty
timeFrame: post-operative 1 month, 3 month, 6 month, 1 year
measure: Hernia recurrence after TEP hernioplasty
timeFrame: post-operative 1 month, 3 month, 6 month, 1 year
measure: Patient satisfaction after TEP hernioplasty
timeFrame: post-operative 1 month, 3 month, 6 month, 1 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Department of Surgery, The University of Hong Kong - Shenzhen Hospital
Study officials:
affiliation: The University of Hong Kong
name: Joe KM Fan, MBBS,MS,FRCS
role: STUDY_CHAIR
References:
citation: Ismail M, Garg M, Rajagopal M, Garg P. Impact of closed-suction drain in preperitoneal space on the incidence of seroma formation after laparoscopic total extraperitoneal inguinal hernia repair. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):263-6. doi: 10.1097/SLE.0b013e3181a4d0e1.
citation: Gao D, Wei S, Zhai C, Chen J, Li M, Gu C, Wu H. Clinical research of preperitoneal drainage after endoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2015 Oct;19(5):789-94. doi: 10.1007/s10029-014-1310-0. Epub 2014 Sep 20.