Benign gynaecological diseases requiring hysterectomy (e.g., leiomyoma, adenomyosis, endometriosis).
Conditions
Interventions
Study setting: Professorial Gynaecology Ward of the Teaching Hospital, Peradeniya.
Method of Randomization: Patients meeting the inclusion and exclusion criteria are recruited through consecutive sam
Sponsors
Faculty of Medicine, University of Peradeniya, Sri Lanka
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 35 to 70 years Patients of any age with benign gynaecological diseases with an enlarged, non-prolapsed uterus- up to 12 weeks in size.
Exclusion criteria
Exclusion criteria: 1. Patients with severe comorbidities – ASA 3 and 4 classes 2. Patients with malignant conditions 3. When the diagnosis of an enlarged uterus is doubtful 4. Emergency surgeries 5. Postpartum hysterectomies 6. When a hysterectomy is part of another complicated procedure 7. Patients with more than past three caesarean sections 8. When the uterus is adhered to the anterior abdominal wall 9. A patient who lacks capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operation time Definition / objective criterion: Total theatre time for the hysterectomy measured in minutes, calculated as: (time of exit from theatre) ? (time of entry to theatre). Record to the nearest minute. Source of data / tool: Theatre log / Bed Head Ticket (BHT) entry times. [Time of assessment / points of measurement: Recorded intra-operatively (start when patient enters theatre; end when patient leaves theatre). Entered in study CRF immediately after surgery by the research assistant and cross-checked with BHT.] Intraoperative blood loss (mL) Definition / criterion: Measured blood loss in millilitres (mL) = suction canister volume (minus irrigation fluid) + estimated blood on swabs (weighing method where possible: 1 g weight ? 1 mL blood). If weighing not possible, theatre estimate recorded. Tool/source: Theatre record / anaesthesia chart / weighed swabs. [Timepoints: Measured intra-operatively, recorded immediately after procedure. ] Change in haemoglobin (g/dL) Definition / criterion: Difference between preoperative haemoglobin (baseline) and postoperative haemoglobin at 24 hours (post-op day 1). Report absolute change (g/dL). Tool/source: Laboratory full blood count (FBC) results entered into CRF. [Timepoints: Baseline (within 7 days pre-op, ideally day of admission) and 24 hours post-op.] Intraoperative complications Definition / criterion: Any unexpected adverse event during surgery (e.g., visceral injury — bladder, ureter, bowel; massive bleeding requiring >1000 mL replacement; anaesthesia complications). Each event coded and described. Tool/source: Theatre notes, anaesthesia record, BHT. [Timepoints: During surgery and immediate recovery (recorded on day of surgery).] Major adverse outcomes / postoperative complications Definition / criterion: Includes conversion to open surgery, visceral injury recognized intra- or post-op, ICU admission, re-operation, vault hematoma requiring intervention, surgical site infection (per CDC criteria), thr | — |
Secondary
| Measure | Time frame |
|---|---|
| None [] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Sampath Gunanarthne
Senior Lecturer
Outcome results
None listed