Prospective Randomized Trial Comparing Three-port and Single-port TEP Repair in Adults
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedMay 7, 2012
May 1, 2012
2.3 years
May 2, 2012
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
7 days post-operatively
Secondary Outcomes (4)
modified Medical Outcome Study (MOS)
Post -op 6 months
systemic stress response to surgery
post-operative 1 day
Testicular volume
3 months post-operatively
intervention related complication
6 months post-operatively
Study Arms (2)
Multiport TEP
ACTIVE COMPARATORAdult inguinal hernia patients who randomized to receive multiport endoscopic TEP repair
LESS TEP
ACTIVE COMPARATORAdult inguinal hernia patients who randomized to receive laparoendoscopic single-site TEP repair
Interventions
comparison of single port laparoscopic TEP and multiport laparoscopic TEP repair for adult inguinal hernia
Eligibility Criteria
You may qualify if:
- primary or recurrent inguinal hernia
You may not qualify if:
- previous major lower abdominal surgery, patient refusal of randomization, or unable to accept general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Buddhist Tzu Chi General Hospital, Taipei branch
Taipei, Taiwan, 231, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yao-Chou Tsai
289 Jianguo Road, Xindian city, Taipei, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 4, 2012
Study Start
August 1, 2010
Primary Completion
December 1, 2012
Last Updated
May 7, 2012
Record last verified: 2012-05