To evaluate the efficacy of vault drainage in reducing the post-operative morbidity associated with vaginal hysterectomy

The effects of vault drainage on post operative morbidity after vaginal hysterectomy for benign gynaecological disease: A randomised controlled trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000276954

Enrollment

270

Registered

2011-03-16

Start date

2005-03-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients undergoing vaginal hysterectomy (with or without vaginal prolapse repair or oophorectomy) for benign gynaecological disease

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.

Outcome results