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

Hernia, Inguinal Clinical Trial

Official title:

Pre-peritoneal Drainage Versus No Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia - a Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762747
• Other study ID #: HERN-LAPDRAIN-01
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2016
• Last updated: May 3, 2016
• Start date: May 2016
• Est. completion date: August 2018

Study information

• Verified date: May 2016
• Source: The University of Hong Kong
• Contact: Joe KM Fan, MBBS,MS,FRCS
• Phone: +86-18307555114
• Email: drjoefan[@]hku.hk
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• preperitoneal suction drainage
preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia

Locations

Country	Name	City	State
China	Department of Surgery, The University of Hong Kong - Shenzhen Hospital	Shenzhen

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The University of Hong Kong-Shenzhen Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroma formation after TEP hernioplasty	Seroma formation after TEP hernioplasty	Month	No
Secondary	Post-operative pain after TEP hernioplasty	Post-operative pain after TEP hernioplasty	Year	No
Secondary	Analgesic used after after TEP hernioplasty	Analgesic used after after TEP hernioplasty	Year	No
Secondary	Chronic discomfort after TEP hernioplasty	Chronic discomfort after TEP hernioplasty	Year	No
Secondary	Hernia recurrence after TEP hernioplasty	Hernia recurrence after TEP hernioplasty	Year	No
Secondary	Patient satisfaction after TEP hernioplasty	Patient satisfaction after TEP hernioplasty	Month - Year	No