NCT02415543

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

April 8, 2015

Last Update Submit

August 25, 2016

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

  • SIL-TEP Conversion to TEP / TAPP or open operation

    This refers to whether any SIL-TEP procedure needs to be converted to TEP/TAPP or open procedure. This is quite a normal process as a proportion of multiport procedures are converted to open procedures for safety reasons.

    during operation

Secondary Outcomes (9)

  • Operating time

    during operation

  • interoperation complication

    during operation

  • Pain score (Visual Analog Scale) at 12、24 hour and one week after surgery

    12、24hour and day 7 postoperation

  • Length of hospital stay

    1 day postoperation

  • return to work or normal physical activities

    4 weeks postoperation

  • +4 more secondary outcomes

Study Arms (2)

GROUP A

ACTIVE COMPARATOR

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

Procedure: SIL-TEP Inguinal Hernia Repair

GROUP B

ACTIVE COMPARATOR

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

Procedure: TEP Inguinal Hernia Repair

Interventions

SIL-TEP Inguinal Hernia RepairPROCEDURE

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

Also known as: SIL-TEP repair
GROUP A
TEP Inguinal Hernia RepairPROCEDURE

perform the multiport laparoscopic total extraperitoneal inguinal hernia repair

Also known as: TEP repair
GROUP B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • JIAN WANG, MD

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

    STUDY CHAIR

Central Study Contacts

TAO CHEN, MD

CONTACT

+8613601779874dr_chentao78@163.com

YUNHE ZHANG, MD

CONTACT

+8613917908722zyhe31@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 14, 2015

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

CN(1)