NCT01727050

Brief Summary

Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for the repair of primary unilateral inguinal hernia. Previous studies showed that patients underwent TEP have less post-operative pain and earlier return to normal activities. However, chronic pain is still a major issue affecting quality of life after TEP with a reported incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable pain had been reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS) in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for application of FS laparoscopically is now available which can achieve mesh fixation by using fewer amounts of FS. In this study, the investigators aim to compare the effectiveness of using fibrin spray for mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized controlled trial by allocating patients in two study arm in random manner. The treatment group will have the mesh fixed by fibrin sealant spray, whereas the control group will have conventional mechanical staples for fixation. Operative procedures and post-operative management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month after operation to evaluate the operative results and the incidence of chronic pain. Any complications related to the mesh and operation will also be recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

4 years

First QC Date

November 12, 2012

Last Update Submit

November 16, 2012

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic pain

    6 months

Secondary Outcomes (4)

  • Severity of acute pain

    1 week

  • Morbidities

    30 day

  • Recurrence rate

    6 month

  • Quality of life assessment

    6 months

Study Arms (2)

Mechanical stapling

ACTIVE COMPARATOR
Device: Mechanical stapling

Fibrin sealant spray

ACTIVE COMPARATOR
Device: Fibrin sealant spray

Interventions

Fibrin sealant sprayDEVICE

Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter

Fibrin sealant spray
Mechanical staplingDEVICE

Fixation of mesh would be performed using mechanical staplers

Mechanical stapling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive male patients aged between 18 to 70 years with reducible unilateral inguinal hernia undergoing day-case TEP under general anaesthesia will be considered eligible.

You may not qualify if:

  • Bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large inguinal-scrotal hernia, previous abdominal incision (including previous contralateral hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs, end-stage renal failure, cirrhosis, impaired cognitive function and those not consent to study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Chan MS, Teoh AY, Chan KW, Tang YC, Ng EK, Leong HT. Randomized double-blinded prospective trial of fibrin sealant spray versus mechanical stapling in laparoscopic total extraperitoneal hernioplasty. Ann Surg. 2014 Mar;259(3):432-7. doi: 10.1097/SLA.0b013e3182a6c513.

    PMID: 24045438DERIVED

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Assistant Professor

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 15, 2012

Study Start

June 1, 2007

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

HK(1)