Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

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
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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

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
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3301 0
United Kingdom
State/province [1] 3301 0

Funding & Sponsors
Funding source category [1] 264655 0
Name [1] 264655 0
Sheffield Teaching Hospitals Charitable Trust
Address [1] 264655 0
Royal Hallamshire Hospital, Glossop road, Sheffield S10 2JF
Country [1] 264655 0
United Kingdom
Primary sponsor type
Royal Hallamshire Hospital
Glossop road, Sheffield S10 2JF
United Kingdom
Secondary sponsor category [1] 263797 0
Name [1] 263797 0
Address [1] 263797 0
Country [1] 263797 0

Ethics approval
Ethics application status
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
Ethics approval number [1] 266653 0

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

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
Fax 15587 0
Email 15587 0
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
Fax 6515 0
Email 6515 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary