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Trial registered on ANZCTR


Registration number
ACTRN12616000244404
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
22/02/2016
Date last updated
22/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Onlay hernioplasty versus Rives–Stoppa repair for management of paraumbilical hernia associated with divarication of recti in diabetic patients in terms of recurrence and surgical site infection. A prospective randomized controlled trial.
Scientific title
Onlay hernioplasty versus Rives–Stoppa repair for management of paraumbilical hernia associated with divarication of recti in diabetic patients in terms of recurrence and surgical site infection. A prospective randomized controlled trial.
Secondary ID [1] 288318 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paraumbilical hernia 297286 0
Divarication of recti 297287 0
Diabetes Mellitus 297290 0
Surgical Site Infection 297570 0
Condition category
Condition code
Surgery 297481 297481 0 0
Surgical techniques
Metabolic and Endocrine 297765 297765 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Onlay hernioplasty procedure: After skin incision and identification of the sac, opening of the sac followed by reduction of the contents. The defect is closed and the mesh is applied on the anterior rectus sheet. Approximate duration of the procedure is 60 minutes.
Intervention code [1] 293616 0
Treatment: Surgery
Comparator / control treatment
Rives–Stoppa repair, a longitudinal incision in the medial part of the anterior rectus sheet will be performed to reach the retro-rectal space. Then the defect is closed and the mesh is designed in an H shape and applied over the posterior rectus sheet beneath the recti muscles with the transverse part of the H lying between the xiphoid process and the umbilicus. This will be followed by closure of anterior rectus sheet. Approximate duration of the procedure is 60 - 90 minutes.
Control group
Active

Outcomes
Primary outcome [1] 297045 0
Recurrence of the paraumbilical hernia
Timepoint [1] 297045 0
at 1, 3, 6 and 12 months by examination by the surgeon during follow-up visits in outpatient clinic
Primary outcome [2] 297046 0
Surgical Site infection
Timepoint [2] 297046 0
at 1, 3, 6 and 12 months by examination by the surgeon during follow-up visits in outpatient clinic
Secondary outcome [1] 319912 0
Operative time (minutes) measured from first skin incision till final repair of the incision
Timepoint [1] 319912 0
measured by operative nurse at the time of operation.
Secondary outcome [2] 319913 0
Time to regain domestic and work activities (days)
Timepoint [2] 319913 0
noticed by the patient and recorded by the surgeon during the first visit of the patient to outpatient clinic at 14th day.
Secondary outcome [3] 319914 0
Postoperative chronic postoperative pain
Timepoint [3] 319914 0
measured by Modified Visual Analog Scale after 3, 6 and12 month at rest and with movement by the surgeon during follow-up visits in outpatient clinic

Eligibility
Key inclusion criteria
diabetic patients suffering from paraumbilical hernia associated with divarication of recti.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previous hernioplasty or who are planning to be pregnant within less than 2 years will be excluded from the research

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Closed envelop technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A total number of 60 envelops (30 onlay repair and 30 Rives–Stoppa) was prepared. OR nurse with no involvement in the research chose an envelope and informed the surgeons just before the operation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
1/04/2016
Actual
19/04/2016
Date of last data collection
Anticipated
Actual
7/05/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7516 0
Egypt
State/province [1] 7516 0
Alexandria

Funding & Sponsors
Funding source category [1] 292689 0
Hospital
Name [1] 292689 0
Alexandria Main University Hospital
Country [1] 292689 0
Egypt
Primary sponsor type
Hospital
Name
Alexandria Main University Hospital
Address
1 Kolleyet al teb st.
Azareeta
Alexandria
21526
Egypt
Country
Egypt
Secondary sponsor category [1] 291411 0
None
Name [1] 291411 0
None
Address [1] 291411 0
None
Country [1] 291411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294162 0
Ethical committee of Alexandria college of Medicine
Ethics committee address [1] 294162 0
1 Kolleyet al teb st.
Azareeta
Alexandria
21526
Egypt
Ethics committee country [1] 294162 0
Egypt
Date submitted for ethics approval [1] 294162 0
18/08/2015
Approval date [1] 294162 0
01/10/2015
Ethics approval number [1] 294162 0

Summary
Brief summary
Para-umbilical hernia is one of the common types of hernia. It has a female to male ratio of 5:1. Not uncommonly, para-umbilical is associated with divarication of recti which is separation of the two muscles, usually as a result of the linea alba thinning and stretching. There are many surgical procedures for repair of hernia; however,the recurrence rate remains the main expected consequence. Many studies proved the effect of diabetes on increasing surgical site infection which may affect the result of hernia repair especially when using prostheses.
Repairs of the abdominal wall that use permanent prostheses differ based on where the prosthesis is placed anatomically. Onlay repair is one of the commonest repairs used to repair abdominal wall in which mesh is applied superficial to anterior rectus sheeths. Being an easy technique may be the cause of its wide practice. However, Onlay techniques have reported recurrence rates as high as 23% in cases with complex weak abdomen. In addition, locating the mesh in the subcutaneous space carries the risk of surgical site infection with subsequent fistulas or even recurrence.

Rives–Stoppa repair, is technically difficult repair and involves retro muscular prefascial placement of a large mesh anterior to the posterior rectus sheath and primary closure of the anterior fascia. It has a theoretical advantage of keeping the mesh away from the wound and subsequently less liability of surgical site infection.
The aim of this study is to compare between Onlay hernioplasty and Rives–Stoppa repair for management of paraumbilical hernia associated with divarication of recti in diabetic patients in terms of recurrence and surgical site infection.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 706 706 0 0
/AnzctrAttachments/369922-Ethical approval.docx

Contacts
Principal investigator
Name 62746 0
A/Prof Walid Abd El Maksoud PhD, MD, MRCS
Address 62746 0
Associate Professor, General Surgery Department, Faculty of Medicine, Alexandria University. Chamblion street, el azareeta, Alexandria Governorate, Egypt. 21526
Country 62746 0
Egypt
Phone 62746 0
+20 1211433351
Fax 62746 0
Email 62746 0
[email protected]
Contact person for public queries
Name 62747 0
Walid Abd El Maksoud PhD, MD, MRCS
Address 62747 0
Associate Professor, General Surgery Department, Faculty of Medicine, Alexandria University. Chamblion street, el azareeta, Alexandria Governorate, Egypt. 21526
Country 62747 0
Egypt
Phone 62747 0
+20 1211433351
Fax 62747 0
Email 62747 0
[email protected]
Contact person for scientific queries
Name 62748 0
Walid Abd El Maksoud PhD, MD, MRCS
Address 62748 0
Associate Professor, General Surgery Department, Faculty of Medicine, Alexandria University. Chamblion street, el azareeta, Alexandria Governorate, Egypt. 21526
Country 62748 0
Egypt
Phone 62748 0
+20 1211433351
Fax 62748 0
Email 62748 0
[email protected]

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