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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yao-Chou Tsai, Principle investigator, Buddhist Tzu Chi General Hospital, Taipei
ClinicalTrials.gov Identifier:
NCT01591395
First received: May 2, 2012
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Inguinal Hernia
Procedure: laparoscopic total extraperitoneal hernia repair (single port vs. multiport)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing the Short-term and Long-term Outcomes of Three-port and Single-port TEP Repair in Adults

Resource links provided by NLM:


Further study details as provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:

Primary Outcome Measures:
  • Visual analogue pain score [ Time Frame: 7 days post-operatively ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • modified Medical Outcome Study (MOS) [ Time Frame: Post -op 6 months ] [ Designated as safety issue: No ]
    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.

  • systemic stress response to surgery [ Time Frame: post-operative 1 day ] [ Designated as safety issue: No ]
    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

  • Testicular volume [ Time Frame: 3 months post-operatively ] [ Designated as safety issue: No ]
    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.

  • intervention related complication [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
    wound infection, ecchymosis of skin, bleeding complication, seroma formation, chronic wound pain..etc.


Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multiport TEP
Adult inguinal hernia patients who randomized to receive multiport endoscopic TEP repair
Procedure: laparoscopic total extraperitoneal hernia repair (single port vs. multiport)
comparison of single port laparoscopic TEP and multiport laparoscopic TEP repair for adult inguinal hernia
Active Comparator: LESS TEP
Adult inguinal hernia patients who randomized to receive laparoendoscopic single-site TEP repair
Procedure: laparoscopic total extraperitoneal hernia repair (single port vs. multiport)
comparison of single port laparoscopic TEP and multiport laparoscopic TEP repair for adult inguinal hernia

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.
  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary or recurrent inguinal hernia

Exclusion Criteria:

  • previous major lower abdominal surgery, patient refusal of randomization, or unable to accept general anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591395

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

Locations
Taiwan
Buddhist Tzu Chi General Hospital, Taipei branch Recruiting
Taipei, Taiwan, 231
Contact: Yao-Chou Tsai    +886-2-66289779 ext 5712    tsai1970523@yahoo.com.tw   
Principal Investigator: Yao-Chou Tsai         
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
Principal Investigator: Yao-Chou Tsai 289 Jianguo Road, Xindian city, Taipei, Taiwan
  More Information

No publications provided

Responsible Party: Yao-Chou Tsai, Principle investigator, M.D., Buddhist Tzu Chi General Hospital, Taipei
ClinicalTrials.gov Identifier: NCT01591395     History of Changes
Other Study ID Numbers: 99-IRB-003-X
Study First Received: May 2, 2012
Last Updated: May 4, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
inguinal hernia
laparoscopy
laparoendoscopic single-site surgery

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 20, 2014