Clinical trial NCT01591395: Prospective Randomized Trial Comparing Three-port and Single-port TEP Repair in Adults
Official title: Prospective Randomized Trial Comparing the Short-term and Long-term Outcomes of Three-port and Single-port TEP Repair in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: inguinal hernia
laparoscopy
laparoendoscopic single-site surgery
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Visual analogue pain score
timeFrame: 7 days post-operatively
Secondary outcomes:
measure: modified Medical Outcome Study (MOS)
timeFrame: Post -op 6 months
measure: systemic stress response to surgery
timeFrame: post-operative 1 day
measure: Testicular volume
timeFrame: 3 months post-operatively
measure: intervention related complication
timeFrame: 6 months post-operatively
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Buddhist Tzu Chi General Hospital, Taipei branch
Study officials:
affiliation: 289 Jianguo Road, Xindian city, Taipei, Taiwan
name: Yao-Chou Tsai
role: PRINCIPAL_INVESTIGATOR
References: