SIL-TEP vs TEP for Inguinal Hernia Repair in Day Surgery

NCT ID: NCT02415543

Last Updated: 2016-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GROUP A

Group A will undergo SIL-TEP inguinal hernia repair with a single port LESS (12 to 15 mm paraumbilical)

Group Type: ACTIVE_COMPARATOR

SIL-TEP Inguinal Hernia Repair

Intervention Type: PROCEDURE

perform the laparoscopic total extraperitoneal inguinal hernia repair using a single incision

GROUP B

Group B will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )

Group Type: ACTIVE_COMPARATOR

TEP Inguinal Hernia Repair

Intervention Type: PROCEDURE

perform the multiport laparoscopic total extraperitoneal inguinal hernia repair

Interventions

SIL-TEP Inguinal Hernia Repair

perform the laparoscopic total extraperitoneal inguinal hernia repair using a single incision

Intervention Type: PROCEDURE

TEP Inguinal Hernia Repair

perform the multiport laparoscopic total extraperitoneal inguinal hernia repair

Intervention Type: PROCEDURE

Other Intervention Names

SIL-TEP repair; TEP repair

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TAO CHEN

OTHER

Sponsor Role: lead

Responsible Party

TAO CHEN

attending doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

JIAN WANG, MD

Role: STUDY_CHAIR

Director of Biliary and Pancreatic Surgery Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Locations

RenJi Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

TAO CHEN, MD

Role: CONTACT

dr_chentao78@163.com

+8613601779874 ext. 12157918664

YUNHE ZHANG, MD

Role: CONTACT

zyhe31@163.com

+8613917908722

Facility Contacts

TAO CHEN, MD

Role: primary

dr_chentao78@163.com

+8613601779874

YUNHE ZHANG, MD

Role: backup

zyhe31@163.com

+8613917908722

Other Identifiers

RenJi Hospital

Identifier Type: -

Identifier Source: org_study_id