Clinical trial NCT02415543: SIL-TEP vs TEP for Inguinal Hernia Repair in Day Surgery
Official title: A Prospective, Randomized, Controlled Trial of Comparing Single Incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair With Traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in Day Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to compare the efficacy and safety of Single incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair and traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in day surgery. This study also aim to improve the surgical-related technical details and the device design.

In addition, this study also evaluate the operability of SIL-TEP in term of a day surgery item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the SIL-TEP technology in the investigators country.

Detailed description: This is a prospective, randomized，controlled trail. It compared Single Incisional Laparoscopic Total Extraperitonea(SIL-TEP) with traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in condition of day surgery.

Laparoscopic hernia repair technique including two tyes, TEP and TAPP, which were recognized as mordern minimally invasive technique. Laparoscopic hernia repair were recommended by the Association of Surgeons of Great Britain and Ireland (ASGBI) and European Hernia Society Guideline (EHS) as the first choice for primary inguinal hernia. Compared with TAPP, TEP was performed much more frequently for its advantages of avoiding abdominal visceral injury.

Traditional TEP hernia repair involves 3-port insertions: one incision of 2cm in para-umbilical region for the camera and two smaller incisions of 5mm each in the midline for the surgical instruments. Some surgeons think the second and third ports could led to bowel and bladder injury. Early literatures showed that bowel injuries and bladder injuries were observed in TAPP or TEP hernia repair.

Since 2009, Cugura JF and Filipovic-Cugura J led their teams for a preliminary exploration of SIL-TEP. Later, several cases were reported about this surgical technique globally. Since then, a number of retrospective studies about the comparation of SIL-TEP and traditional TEP were carried. Yang GP et al found that SIL-TEP had a longer operation time than traditional TEP, but in terms of postoperative complications and incision aesthetics. Tu Wenbin et al thought that SIL-TEP was effective and also had advantages in postoperative pain, postoperative complications and time in hospital. Several other reports also had similiar opnions.

However, randomized controlled trial related to this suject is quite limited. Our study aim to compare the efficacy and safety of SIL-TEP and traditional TEP surgery with a RCT design and also aim to improve the surgical-related technical details and the device design. Our study also evaluate the operability of SIL-TEP in term of a day surgery item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the SIL-TEP technology in our country.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed of primary unilateral inguinal hernia and age between 18 and 70 ;
2. Good condition of family care and observation, understand and be willing to accept day surgery mode;
3. Willing to participate in this study and signed an informed consent.

Exclusion Criteria:

1. Diagnosed as femoral hernia, recurrent hernia, scrotal hernia, bilateral hernia and strangulated hernia;
2. Patients with severe chronic diseases or cardiopulmonary dysfunction;
3. American Society of Anesthesiologists (ASA) grade III and IV level;
4. Obese patients ( BMI\> 30 );
5. Patients with a history of lower abdominal surgery;
6. prefer to a centain surgical approach.

Primary outcomes:
measure: SIL-TEP Conversion to TEP / TAPP or open operation
timeFrame: during operation
Secondary outcomes:
measure: Operating time
timeFrame: during operation
measure: interoperation complication
timeFrame: during operation
measure: Pain score (Visual Analog Scale) at 12、24 hour and one week after surgery
timeFrame: 12、24hour and day 7 postoperation
measure: Length of hospital stay
timeFrame: 1 day postoperation
measure: return to work or normal physical activities
timeFrame: 4 weeks postoperation
measure: Cosmetic scar score
timeFrame: 4 weeks
measure: post-operative complications including urinary retention, wound infection, wound haematoma，seroma formation, chronic pain, testicular atrophy
timeFrame: 1 week, 4 weeks after postoperation
measure: Recurrence of hernia
timeFrame: 4 weeks，3 mounths and 1 year postoperation
measure: hospitalization costs
timeFrame: 1 day postopetation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
Study officials:
affiliation: Director of Biliary and Pancreatic Surgery Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
name: JIAN WANG, MD
role: STUDY_CHAIR
References: