Anterior Transversalis Fascia Approach Versus Preperitoneal Space Approach for Inguinal Hernia Repair in Residents
1 other identifier
interventional
2,000
1 country
9
Brief Summary
To investigate the advantages and disadvantages of the anterior transversalis fascia approach versus the preperitoneal approach for inguinal hernia repair in residents from northern China regarding common postoperative complications (including acute and chronic pain, wound infection, rates of wound infection, hematoma, seroma, and hernia recurrence) and severe postoperative complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
9 active sites
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
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedStudy Start
First participant enrolled
February 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 15, 2017
June 1, 2017
2.8 years
December 1, 2016
June 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS pain score
Visual Analogue Scale(VAS) pain score is one of the most commonly used tools for assessing pain.It comprises a 10 cm line with 0 at one end, representing no pain, and 10 at the other end, representing the worst pain imaginable; the patient places a mark on the line to indicate the degree of pain that they are experiencing.
changes of month 1, month 3, month 12, month 24 after operation
Secondary Outcomes (1)
Postoperative complications
changes of month 1, month 3, month 12, month 24 after operation
Study Arms (2)
anterior transversalis fascia approach
EXPERIMENTALPatients with inguinal hernia will undergo inguinal hernia repair via the anterior transversalis fascia approach.
preperitoneal space approach
EXPERIMENTALPatients with inguinal hernia will undergo inguinal hernia repair via the preperitoneal space approach.
Interventions
Patients will undergo inguinal hernia repair via the anterior transversalis fascia approach.
Patients will undergo inguinal hernia repair via the preperitoneal space approach.
Eligibility Criteria
You may qualify if:
- Diagnosed with primary unilateral inguinal hernia
- Aged 18-80 years
- American Society of Anesthesiologists (ASA) classification I-II
- Provision of informed consent
You may not qualify if:
- Severe organ dysfunction or inability to tolerate surgery
- Hernia recurrence
- Giant hernia (inner size of the hernia \> 4 cm)
- Scrotal hernia
- Incarcerated inguinal hernia
- Inability to complete follow-up or questionnaire because of mental disorder or other reasons
- History of preperitoneal surgery, such as radical prostatectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
General Hospital of Benxi Steel and Iron (Group) Co., LTD
Benxi, Liaoning, 117000, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
The First Hospital of Dandong City
Dandong, Liaoning, 118000, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121001, China
The 202nd Hospital of PLA
Shenyang, Liaoning, 110000, China
Fengtian Hospital of Shenyang Medical College
Shenyang, Liaoning, 110024, China
General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110031, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110032, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 117004, China
Related Publications (1)
Fan Q, Zhang DW, Yang DY, Li HW, Wei SB, Yang L, Yang FQ, Zhang SJ, Wu YQ, An WD, Dai ZS, Jiang HY, Wang FR, Qiao SF, Li HY. Anterior transversalis fascia approach versus preperitoneal space approach for inguinal hernia repair in residents in northern China: study protocol for a prospective, multicentre, randomised, controlled trial. BMJ Open. 2017 Aug 31;7(8):e016481. doi: 10.1136/bmjopen-2017-016481.
PMID: 28860228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hangyu Li, Ph.D
The Fourth Affiliated Hospital of China Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 7, 2016
Study Start
February 6, 2017
Primary Completion
December 1, 2019
Study Completion
June 1, 2020
Last Updated
June 15, 2017
Record last verified: 2017-06