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

NCT01591395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-05-07

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia

Interventions

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

Sponsors & Collaborators

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    lead OTHER

Principal Investigators

  • Yao-Chou Tsai · 289 Jianguo Road, Xindian city, Taipei, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01591395 on ClinicalTrials.gov