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

May 8, 2016 updated by: Dr. Joe King-Man Fan, The University of Hong Kong

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joe KM Fan, MBBS,MS,FRCS
  • Phone Number: +86-18307555114
  • Email: drjoefan@hku.hk

Study Contact Backup

  • Name: WL Law, MBBS,MS,FRCS
  • Phone Number: +852-22554763
  • Email: lawwl@hku.hk

Study Locations

  • China
      • Shenzhen, China
        • Recruiting
        • Department of Surgery, The University of Hong Kong - Shenzhen Hospital
        • Contact:
          • Joe KM Fan, MBBS,MS,FRCS
          • Phone Number: +86-18307555114
          • Email: drjoefan@hku.hk
        • Sub-Investigator:
          • WL Law, MBBS MS FRCS
        • Sub-Investigator:
          • Dominic CC Foo, MBBS FRCS
        • Principal Investigator:
          • JW Liu
        • Sub-Investigator:
          • XF Yang
        • Sub-Investigator:
          • KJ Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drain
preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
Procedure: preperitoneal suction drainage
preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
No Intervention: No-drain
No drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroma formation after TEP hernioplasty
Time Frame: 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
post-operative day 1
Seroma formation after TEP hernioplasty
Time Frame: post-operative day 7
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
Time Frame: post-operative 1 month
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
Time Frame: post-operative 3 month
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
Time Frame: post-operative 6 month
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
Time Frame: post-operative 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain after TEP hernioplasty
Time Frame: 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
post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Analgesic used after after TEP hernioplasty
Time Frame: 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
post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year
Chronic discomfort after TEP hernioplasty
Time Frame: post-operative 1 month, 3 month, 6 month, 1 year
Chronic discomfort after TEP hernioplasty will be asked by independent assessor upon follow-up
post-operative 1 month, 3 month, 6 month, 1 year
Hernia recurrence after TEP hernioplasty
Time Frame: post-operative 1 month, 3 month, 6 month, 1 year
Hernia recurrence after TEP hernioplasty will be assessed by independent assessor upon follow-up
post-operative 1 month, 3 month, 6 month, 1 year
Patient satisfaction after TEP hernioplasty
Time Frame: post-operative 1 month, 3 month, 6 month, 1 year
Patient satisfaction after TEP hernioplasty will be asked by independent assessor upon follow-up
post-operative 1 month, 3 month, 6 month, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

The University of Hong Kong-Shenzhen Hospital

Investigators

  • Study Chair: Joe KM Fan, MBBS,MS,FRCS, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 8, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HERN-LAPDRAIN-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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