Randomised Controlled Trial on Pre-peritoneal Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia
Pre-peritoneal Drainage Versus No Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia - a Randomised Controlled Study
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMay 10, 2016
May 1, 2016
2 years
May 3, 2016
May 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Seroma formation after TEP hernioplasty
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
post-operative day 1
Seroma formation after TEP hernioplasty
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
post-operative day 7
Seroma formation after TEP hernioplasty
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
post-operative 1 month
Seroma formation after TEP hernioplasty
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
post-operative 3 month
Seroma formation after TEP hernioplasty
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
post-operative 6 month
Seroma formation after TEP hernioplasty
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
post-operative 1 year
Secondary Outcomes (5)
Post-operative pain after TEP hernioplasty
post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Analgesic used after after TEP hernioplasty
post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Chronic discomfort after TEP hernioplasty
post-operative 1 month, 3 month, 6 month, 1 year
Hernia recurrence after TEP hernioplasty
post-operative 1 month, 3 month, 6 month, 1 year
Patient satisfaction after TEP hernioplasty
post-operative 1 month, 3 month, 6 month, 1 year
Study Arms (2)
Drain
EXPERIMENTALpreperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
No-drain
NO INTERVENTIONNo drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
Interventions
preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
Eligibility Criteria
You may qualify if:
- Age above 18 and below 80
- Male or female patients
- Unilateral inguinal hernia
- First occurrence hernia
- Consent to laparoscopic hernioplasty for inguinal hernia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, The University of Hong Kong - Shenzhen Hospital
Shenzhen, China
Related Publications (2)
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.
PMID: 19542859RESULTGao 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.
PMID: 25238803RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joe KM Fan, MBBS,MS,FRCS
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
May 3, 2016
First Posted
May 5, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2018
Study Completion
August 1, 2018
Last Updated
May 10, 2016
Record last verified: 2016-05