Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
The effects of vault drainage on post operative morbidity after vaginal hysterectomy for benign gynaecological disease: A randomised controlled trial
Query!
Secondary ID [1]
259776
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1119-9474
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Benign gynaecological conditions
261360
0
Query!
Condition category
Condition code
Renal and Urogenital
259519
259519
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
264211
0
Treatment: Devices
Query!
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
Query!
Control group
Active
Query!
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
Query!
Assessment method [1]
262321
0
Query!
Timepoint [1]
262321
0
one or more episode of temperature of 37.5 degrees C
Query!
Secondary outcome [1]
273540
0
Hospital readmission rate
Query!
Assessment method [1]
273540
0
Query!
Timepoint [1]
273540
0
number of repeat inpatient admissions after discharge within 3 months of surgery
Query!
Secondary outcome [2]
273541
0
length of stay
Query!
Assessment method [2]
273541
0
Query!
Timepoint [2]
273541
0
calculated from date of surgery to date of discharge from patient notes
Query!
Eligibility
Key inclusion criteria
All patients undergoing vaginal hysterectomy (with or without vaginal prolapse repair or oophorectomy) for benign gynaecological disease
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
30/03/2005
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
270
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
3301
0
United Kingdom
Query!
State/province [1]
3301
0
Query!
Funding & Sponsors
Funding source category [1]
264655
0
Hospital
Query!
Name [1]
264655
0
Sheffield Teaching Hospitals Charitable Trust
Query!
Address [1]
264655
0
Royal Hallamshire Hospital, Glossop road, Sheffield S10 2JF
Query!
Country [1]
264655
0
United Kingdom
Query!
Primary sponsor type
Hospital
Query!
Name
Royal Hallamshire Hospital
Query!
Address
Glossop road, Sheffield S10 2JF
Query!
Country
United Kingdom
Query!
Secondary sponsor category [1]
263797
0
None
Query!
Name [1]
263797
0
Query!
Address [1]
263797
0
Query!
Country [1]
263797
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
266653
0
South Sheffield Research Ethics Committee
Query!
Ethics committee address [1]
266653
0
Northern General Hospital, Herries Road, Sheffield S5 7AU
Query!
Ethics committee country [1]
266653
0
United Kingdom
Query!
Date submitted for ethics approval [1]
266653
0
Query!
Approval date [1]
266653
0
10/01/2005
Query!
Ethics approval number [1]
266653
0
STH
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32340
0
Query!
Address
32340
0
Query!
Country
32340
0
Query!
Phone
32340
0
Query!
Fax
32340
0
Query!
Email
32340
0
Query!
Contact person for public queries
Name
15587
0
Anupreet Dua
Query!
Address
15587
0
Royal Hallamshire Hospital, Glossop road, Sheffield S10 2JF
Query!
Country
15587
0
United Kingdom
Query!
Phone
15587
0
+441142268167
Query!
Fax
15587
0
Query!
Email
15587
0
[email protected]
Query!
Contact person for scientific queries
Name
6515
0
Andrea Gallimberti
Query!
Address
6515
0
Royal Hallamshire Hospital, Glossop road, Sheffield S10 2JF
Query!
Country
6515
0
United Kingdom
Query!
Phone
6515
0
+44112268167
Query!
Fax
6515
0
Query!
Email
6515
0
[email protected]
Query!
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.
Download to PDF