Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000276954
Ethics application status
Approved
Date submitted
14/03/2011
Date registered
16/03/2011
Date last updated
16/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
To evaluate the efficacy of vault drainage in reducing the post-operative morbidity associated with vaginal hysterectomy
Scientific title
The effects of vault drainage on post operative morbidity after vaginal hysterectomy for benign gynaecological disease: A randomised controlled trial
Secondary ID [1] 259776 0
Nil
Universal Trial Number (UTN)
U1111-1119-9474
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign gynaecological conditions 261360 0
Condition category
Condition code
Renal and Urogenital 259519 259519 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of vault drain during vaginal hysterectomy. If the patient was randomised to 'drain' group, a non-suction drain was inserted in the vault at the time of hysterectomy. The drain was removed postoperatively at the discretion of the operating surgeon.
Duration of vault closure with drain: 10-15 minutes
Intervention code [1] 264211 0
Treatment: Devices
Comparator / control treatment
Standard vault closure without use of drains. Standard vault closure involves non closure of peritoneum and intermittent sutures to the vagina
Duration of standard vault closure: 10-15 minutes
Control group
Active

Outcomes
Primary outcome [1] 262321 0
reduction in postoperative febrile morbidity.
The postoperative care was according to standard hospital policy where temperature is recorded in the nursing observation chart every 4 hours. This observation was recorded from patient notes at the time of data collection
Timepoint [1] 262321 0
one or more episode of temperature of 37.5 degrees C
Secondary outcome [1] 273540 0
Hospital readmission rate
Timepoint [1] 273540 0
number of repeat inpatient admissions after discharge within 3 months of surgery
Secondary outcome [2] 273541 0
length of stay
Timepoint [2] 273541 0
calculated from date of surgery to date of discharge from patient notes

Eligibility
Key inclusion criteria
All patients undergoing vaginal hysterectomy (with or without vaginal prolapse repair or oophorectomy) for benign gynaecological disease
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients in whom the hysterectomy was performed for malignant disease and also cases where it was felt by the operating surgeon that the insertion of a surgical drain to the vault would be clinically indicated.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation (‘drain’ or ‘no drain’) was carried out using a sealed envelope technique. Randomisation envelopes were prepared at the beginning of the study. Envelopes were double sealed to prevent bias. The randomisation envelope was opened on surgeon’s request at the time of closure of the vaginal vault.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
350 envelopes were prepared, numbered and sealed at the beginning of study. After consent for recruitment 1 envelope was included in the noted by simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment outside Australia
Country [1] 3301 0
United Kingdom
State/province [1] 3301 0

Funding & Sponsors
Funding source category [1] 264655 0
Hospital
Name [1] 264655 0
Sheffield Teaching Hospitals Charitable Trust
Country [1] 264655 0
United Kingdom
Primary sponsor type
Hospital
Name
Royal Hallamshire Hospital
Address
Glossop road, Sheffield S10 2JF
Country
United Kingdom
Secondary sponsor category [1] 263797 0
None
Name [1] 263797 0
Address [1] 263797 0
Country [1] 263797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266653 0
South Sheffield Research Ethics Committee
Ethics committee address [1] 266653 0
Northern General Hospital, Herries Road, Sheffield S5 7AU
Ethics committee country [1] 266653 0
United Kingdom
Date submitted for ethics approval [1] 266653 0
Approval date [1] 266653 0
10/01/2005
Ethics approval number [1] 266653 0
STH

Summary
Brief summary
Vaginal Hysterectomy (VH) is one of the most commonly performed gynaecological opaerations and is associated with a significant risk of vault hematomas (25%-40%). Hematoma represents the most common peri-operative complication following VH and is significantly associated with febrile morbidity, post-operative haemoglobin drop, need for blood transfusion, re-admission to hospital and length of hospital stay
Prophylactic measures to reduce hematoma formation such as use of vault drainage may help to reduce the post-operative complications and morbidity of VH. The role of drains in abdominal surgery is well recognised and clinicians have been debating if this can be applied to VH. However no formal evaluation of routine drain insertion at VH has ever been performed. The aim of our study was to evaluate the efficacy of vault drains in reducing the risk of early post-operative morbidity following VH for benign gynaecological conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32340 0
Address 32340 0
Country 32340 0
Phone 32340 0
Fax 32340 0
Email 32340 0
Contact person for public queries
Name 15587 0
Anupreet Dua
Address 15587 0
Royal Hallamshire Hospital, Glossop road, Sheffield S10 2JF
Country 15587 0
United Kingdom
Phone 15587 0
+441142268167
Fax 15587 0
Email 15587 0
duaanupreet@yahoo.com
Contact person for scientific queries
Name 6515 0
Andrea Gallimberti
Address 6515 0
Royal Hallamshire Hospital, Glossop road, Sheffield S10 2JF
Country 6515 0
United Kingdom
Phone 6515 0
+44112268167
Fax 6515 0
Email 6515 0
Andrea.Gallimberti@sth.nhs.uk

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

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