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Inguinal HerniaNCT01591395

Prospective Randomized Trial Comparing Three-port and Single-port TEP Repair in Adults

A study testing laparoscopic total extraperitoneal hernia repair (single port vs. multiport) in people with Inguinal Hernia, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Inguinal hernia is one of the most common surgical diseases. Over the past years, the safety and feasibility of laparoscopy was established and gaining popularity in recent few years. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Inguinal Hernia
What is being tested?
laparoscopic total extraperitoneal hernia repair (single port vs. multiport)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTaiwan
Study dates
Aug 2010to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • primary or recurrent inguinal hernia

Who cannot join

  • previous major lower abdominal surgery, patient refusal of randomization, or unable to accept general anesthesia

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Buddhist Tzu Chi General Hospital, Taipei branch

    Taipei, Taiwan, 231

    Yao-Chou Tsai, +886-2-66289779 ext. 5712, tsai1970523@yahoo.com.tw

    Yao-Chou Tsai

    Recruiting

Other trials in Taiwan

About this study

Official title: Prospective Randomized Trial Comparing the Short-term and Long-term Outcomes of Three-port and Single-port TEP Repair in Adults

Inguinal hernia is one of the most common surgical diseases. Over the past years, the safety and feasibility of laparoscopy was established and gaining popularity in recent few years. Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period, earlier return to normal daily activities and work, and better cosmetic results. The laparoscopic hernia repair usually require three working ports ranging from 5 to 10 mm. However, with each increasing laparoscopic ports usually associated with possible increasing morbidity and pain related to ports.

Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single site surgery. LESS has been performed for variable indications including extirpative and reconstructive urologic procedure via the transperitoneal approach. Early experience has demonstrated the feasibility as well as the safe and successful completion of these LESS procedures. Although these initial reports are promising, the clinical advantages of LESS procedures over conventional laparoscopic procedures have not been defined. Therefore, we conducted a single center, randomized trial to compare the safety and other outcomes after conventional laparoscopic and LESS inguinal hernia repair in adult patients.

Read the detailed description

Inguinal hernia is one of the most common surgical diseases in adult. Tension free hernioplasty is regarded as gold standard of treatment in adult inguinal hernia. The reported incidence of hernia recurrence after tension free repair is less than 5 percent. Over the past years, the safety and feasibility of laparoscopy was established and gaining popularity in recent few years. With the advancing technology, laparoscopic approach has become the standard treatment for cholecystectomy and adrenalectomy. Laparoscopic procedures improved surgical precision through enhanced visualization, magnification and limited exposure, dissection. Laparoscopic inguinal hernia repair was associated with less postoperative pain, a shorter recovery period, earlier return to normal daily activities and work, and better cosmetic results. The laparoscopic hernia repair usually require three working ports ranging from 5 to 10 mm. However, with each increasing laparoscopic ports usually associated with possible increasing morbidity and pain related to ports.

Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery. LESS has been performed for variable indications including extirpative and reconstructive urologic procedure via the transperitoneal approach. Early experience has demonstrated the feasibility as well as the safe and successful completion of these LESS procedures. Although these initial reports are promising, the clinical advantages of LESS procedures over conventional laparoscopic procedures have not been defined.

To date, LESS hernia repair had been rarely reported in the literature except in some case reports and one small series. Although these initial reports revealed that LESS hernia repair is safe and feasible in adult inguinal hernia, the definite clinical benefits of LESS hernia repair could not be identified in these small and short term reports. Thus, a prospective randomized trial comparing LESS and conventional multiport laparoscopic hernia repair with long-term follow up was mandatory to define the clinical advantages of LESS hernia repair. Therefore, we conducted a randomized trial to compare LESS total extraperitoneal hernia repair and conventional multiport TEP repair in adult inguinal hernia with inflammatory, gonadal responses, complication rate and recurrence rate and pain score, functional status and activity level.

Overall Goal

-To compare the surgical outcomes, patient center outcomes and surgery induced inflammatory , gonadal responses after LESS TEP and conventional multiport TEP hernia repair in adult.

Specific Aims

  • Compare the surgery induced inflammatory responses after LESS TEP and conventional multiport TEP hernia repair with inflammatory markers by blood sampling before and after operation.
  • Compare the surgery induced testicle changes in male adults after LESS TEP and conventional multiport TEP hernia repair with color Doppler ultrasonography to determine testicular volume and resistive index before surgery and 3 months postoperatively.
  • Compare the postoperative pain score after LESS TEP and conventional multiport TEP hernia repair with Visual analog pain score.
  • Compare the postoperative activity level after LESS TEP and conventional multiport TEP hernia repair with modified Medical Outcome Study.
  • Compare the clinical results and complication rates after LESS TEP and conventional multiport TEP hernia repair by clinic follow up.
  • Compare the longterm functional outcomes 6 months after LESS TEP and conventional multiport TEP hernia repair with follow up questionnaire.
Conditions
Inguinal Hernia
Being tested
laparoscopic total extraperitoneal hernia repair (single port vs. multiport)
Keywords
inguinal hernia, laparoscopy, laparoendoscopic single-site surgery
Medical subject headings
Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic total extraperitoneal hernia repair (single port vs. multiport)Procedure or surgery

    comparison of single port laparoscopic TEP and multiport laparoscopic TEP repair for adult inguinal hernia

Study groups in NCT01591395
Study groupRoleWhat they receive
Multiport TEPActive comparatorAdult inguinal hernia patients who randomized to receive multiport endoscopic TEP repair
Receives: Procedure: laparoscopic total extraperitoneal hernia repair (single port vs. multiport)
LESS TEPActive comparatorAdult inguinal hernia patients who randomized to receive laparoendoscopic single-site TEP repair
Receives: Procedure: laparoscopic total extraperitoneal hernia repair (single port vs. multiport)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue pain score

    The pain score was recorded by a blinded observer at the time points of 2 hours post-op, 24 hours post-op and 7 days post-op with a Visual analoge pain scale (0-10 scale)

    Measured: 7 days post-operatively

Secondary outcomes (4)
  1. modified Medical Outcome Study (MOS)

    The post-op convalescence was evaluated by a Modified medical outcome study with item 3-12. The time points being evaluated are at 1 day after operation, 7 days after operation and 6 months after operation.

    Measured: Post -op 6 months

  2. systemic stress response to surgery

    Compare the surgery induced inflammatory responses after LESS TEP and conventional multiport TEP hernia repair with inflammatory markers (IL-6, CRP and neutrophil counts) by blood sampling before and after operation

    Measured: post-operative 1 day

  3. Testicular volume

    Compare the surgery induced testicle changes in male adults after LESS TEP and conventional multiport TEP hernia repair with color Doppler ultrasonography to determine testicular volume and resistive index (RI) before surgery and 3 months postoperatively.

    Measured: 3 months post-operatively

  4. intervention related complication

    wound infection, ecchymosis of skin, bleeding complication, seroma formation, chronic wound pain..etc.

    Measured: 6 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2012 (estimated)
  2. Study startAug 2010
  3. Primary completionDec 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01591395
Sponsor's protocol ID
99-IRB-003-X
Status last verified
May 2012
First submitted
2 May 2012
Last updated
7 May 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic total extraperitoneal hernia repair (single port vs. multiport) in people with Inguinal Hernia, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yao-Chou Tsai (+886-2-66289779 ext. 5712, tsai1970523@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue pain score (time frame: 7 days post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.

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