Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001227785
Ethics application status
Approved
Date submitted
5/11/2013
Date registered
7/11/2013
Date last updated
7/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimally Access versus Conventional Hydrocelectomy:
A Randomized Trial
Scientific title
A randomised controlled trial comparing minimally access and conventional Hydrocelectomy on identifying the scrotal oedema and hardening, wound infections, patient satisfaction and recurrence in patients with primary non recurrent vaginal hydroceles
Secondary ID [1] 283513 0
none
Universal Trial Number (UTN)
U1111-1149-9210
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary hydrocele 290432 0
Condition category
Condition code
Surgery 290832 290832 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1- Minimally access hydrocelectomy:
A small scrotal incision 2 cm long is done as well as incision of the Dartos muscles in the same line . The parietal tunica vaginalis is grasped and minimal blunt dissection is made by the aid of index finger and a small hole is made for aspiration of hydrocele fluid . Then a disc of tissue is excised of the parietal tunica vaginalis about double of the skin incision dimension using electrocautery. The edge of the tunica vaginalis is sutured to the Dartos and scrotal skin in an everted manner aiming to expose the visceral tunica toward scrotal skin . Closure with drain and discharge is allowed at the same day. Cephradine 1 gm administered intravenously at the time of induction of anaesthesia or just after the administration of spinal anaesthesia was given followed by another dose 2 h postoperatively. Patients are seen in the second day and examined for scrotal edema and hematoma. In all patients, drains are removed in the second day. All the excised tissues are sent for pathological examination to rule out any epididymal or vasal structures in the specimen. The mean operative is 15 minutes. The total duration of the study period and its follow-up is 60 months

2- Conventional hydrocelectomy:
Incision of the hydrocele sac after complete mobilization of the hydrocele. Partial resection of the hydrocele sac, leaving a margin of 1–2 cm. Care is taken not to injure testicular vessels, epididymis or ductus deferens. The edges of the hydrocele sac are sewn together behind the spermatic cord (Winkelmann's or Jaboulay's technique). The mean operative is 27 minutes. The total duration of the study period and its follow-up is 60 months
Intervention code [1] 288226 0
Treatment: Surgery
Comparator / control treatment
Intervention: Minimally access hydrocelectomy.
Control: Conventional hydrocelectomy
Control group
Active

Outcomes
Primary outcome [1] 290818 0
The primary end point of the study is recurrence , defined as a clinically detectable characteristic swelling in the scrotum and diagnosed by the author.
Timepoint [1] 290818 0
From the 1st week of surgery until the end of the follow up period of 60 months.
Secondary outcome [1] 305360 0
Postoperative hematoma, assessed clinically by the treating surgeon.
Timepoint [1] 305360 0
Monitored on a 6 hourly basis immediately after surgery until the end of the 3rd postoperative day.
Secondary outcome [2] 305362 0
Persistent scrotal edema and hardening, assessed clinically by the treating surgeon.
Timepoint [2] 305362 0
Monitored on a daily basis from the 2nd postoperative day until the end of the 3rd postoperative week.
Secondary outcome [3] 305363 0
Wound sepsis, assessed clinically by the treating surgeon.
Timepoint [3] 305363 0
Monitored on a daily basis from the 3rd postoperative day until the end of the 3rd postoperative week.

Eligibility
Key inclusion criteria
Male patients with primary non recurrent vaginal hydroceles.
Minimum age
18 Years
Maximum age
56 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
patients with secondary or recurrent vaginal hydroceles.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Opaque envelopes are numbered sequentially from 1 to 120 ( 60 patients for each groups). A computer-generated table of random numbers is used for group assignment; if the last digit of the random number is from 0 to 4, assignment was to Group A (minimally access hydrocelectomy), and if the last digit is from 5 to 9, assignment was to Group B (conventional hydrocelectomy). The assignments are then placed into the opaque envelopes and the envelopes sealed. The envelopes are opened by the operating surgeon after patient consent and just prior to the surgery.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Calculation of the sample size of participants to be recruited for the study uses the mathematical equation. The author used this equation to calculate the minimum number required to reliably answer the research question.

m = m= K(p_1 q_1+p_2 q_2 )/d^2 =60 patients


Where:
q1 = (1 - p1) , q2 = (1 - p2) and d = (p1- p2)
K = constant, which depends on: alpha and beta levels, where alpha =0.05 and beta =0.1. Then K =8.6.
P1 represents the overall complications of conventional surgical hydrocelectomy in previous studies.

P2 represents the overall complications of minimally access hydrocelectomy reported in previous studies.
The statistical tests were run on a compatible personal computer using the Statistical Package for Social Scientists (SPSS) for windows 15. Chi-square distribution was used for studying the frequencies of recurrence, pain, hospital stay and postoperative complications. The values were expressed as means +/-standard errors of deviation. The mean values of the groups were compared by one-way analysis of variance (ANOVA) and paired comparisons of the groups were done using the paired student t test. P< 0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
25/04/2007
Date of last participant enrolment
Anticipated
1/11/2011
Actual
19/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5570 0
Egypt
State/province [1] 5570 0

Funding & Sponsors
Funding source category [1] 288216 0
Hospital
Name [1] 288216 0
Port-Fouad general hospital
Country [1] 288216 0
Egypt
Funding source category [2] 288217 0
Self funded/Unfunded
Name [2] 288217 0
none
Country [2] 288217 0
Primary sponsor type
Individual
Name
Aly Saber
Address
Port-Fouad General Hospital.
19 Al-guish street, postal code:11433 Port-Fouad ,Port-Said , Egypt
Country
Egypt
Secondary sponsor category [1] 286940 0
Hospital
Name [1] 286940 0
Port-Fouad general hospital
Address [1] 286940 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country [1] 286940 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290126 0
Ethical committee of Port- Fouad general hospital
Ethics committee address [1] 290126 0
Ethics committee country [1] 290126 0
Egypt
Date submitted for ethics approval [1] 290126 0
Approval date [1] 290126 0
07/04/2007
Ethics approval number [1] 290126 0
1/2007

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44078 0
Dr Aly Saber
Address 44078 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 44078 0
Egypt
Phone 44078 0
+201223752032
Fax 44078 0
Email 44078 0
[email protected]
Contact person for public queries
Name 44079 0
Aly Saber
Address 44079 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 44079 0
Egypt
Phone 44079 0
+201223752032
Fax 44079 0
Email 44079 0
[email protected]
Contact person for scientific queries
Name 44080 0
Aly Saber
Address 44080 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 44080 0
Egypt
Phone 44080 0
+201223752032
Fax 44080 0
Email 44080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.