Cost-effectiveness of methods of hysterectomy for benign conditions

Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: a multi-centre randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2016/020

Enrollment

Unknown

Registered

2016-07-26

Start date

2016-08-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Post-hysterectomy outcomes

Interventions

1. Study settings: Gynaecology unit of District General Hospital-Mannar and Professorial Gynaecology unit of North Colombo Teaching Hospital-Ragama 2. Method of recruitment: Eligible patients will be

Eligibility

Inclusion criteria

Inclusion criteria: All female patients who need hysterectomy for non-malignant uterine causes

Exclusion criteria

Exclusion criteria: 1. Uterus>14 weeks on clinical examination 2. Previous pelvic surgery 3. Indication for incontinence surgery or pelvic floor surgery 4. Any medical illness which is a caution/ contraindication to laparoscopic surgery 5. Inability to read and write

Design outcomes

Primary

Measure	Time frame
Time to recover following surgery (defined as the earliest time to resume all usual activities such as; resumption of cooking, washing clothes, sexual activity and occupation). [At six weeks post-hysterectomy.]	—

Secondary

Measure	Time frame
1. Operative time (surgical time from skin to skin) 2. Post-operative hospital stay (duration) 3. Complications (Bladder injury, Ureteric injury, Bowel injury, Intra-operative blood transfusion, Convert to laparotomy, Vault haematoma, Post-operative blood transfusion, Post-operative fever, Skin wound infection, Urinary tract infection, Respiratory tract infection, Deep vein thrombosis /Pulmonary embolism, Re-operation) 4. Quality of life (measured using validated Sinhala and Tamil EQ-5D-3L questionnaire) 5. Urinary function (measured using validated Sinhala and Tamil ICIQ FLUTS questionnaire) 6. Vaginal and sexual function (assessed using validated Sinhala and Tamil ICIQ VS questionnaire) 7. Bowel function (assessed by a questionnaire, adapted fro Thakar et al) 8. Cost (using a specific costing formula to determine direct hospital costs and indirect patient costs) [1. Operative time (surgical time from skin to skin) – Immediately following surgery 2. Post-operative hospital stay (duration) – At discharge 3. Complications (Bladder injury, Ureteric injury, Bowel injury, Intra-operative blood transfusion, Convert to laparotomy, Vault haematoma, Post-operative blood transfusion, Post-operative fever, Skin wound infection, Urinary tract infection, Respiratory tract infection, Deep vein thrombosis /Pulmonary embolism, Re-operation) – Up to 6 weeks after surgery 4. Quality of life (measured using validated Sinhala and Tamil EQ-5D-3L questionnaire)- Pre-operative, Post-operative (Day 2, 1 week, 6 weeks, 3 months, 6 months) 5. Urinary function (measured using validated Sinhala and Tamil ICIQ FLUTS questionnaire) – Pre-operative, (Post-operative 6 months, 1 year) 6. Vaginal and sexual function (assessed using validated Sinhala and Tamil ICIQ VS questionnaire) – Pre-operative, (Post-operative 6 months, 1 year) 7. Bowel function (assessed by a questionnaire, adapted from Thakar et al) – Pre-operative, Post-operative 6 months, 1 year) 8. Cost (us	—

Measure

Time frame

1. Operative time (surgical time from skin to skin) 2. Post-operative hospital stay (duration) 3. Complications (Bladder injury, Ureteric injury, Bowel injury, Intra-operative blood transfusion, Convert to laparotomy, Vault haematoma, Post-operative blood transfusion, Post-operative fever, Skin wound infection, Urinary tract infection, Respiratory tract infection, Deep vein thrombosis /Pulmonary embolism, Re-operation) 4. Quality of life (measured using validated Sinhala and Tamil EQ-5D-3L questionnaire) 5. Urinary function (measured using validated Sinhala and Tamil ICIQ FLUTS questionnaire) 6. Vaginal and sexual function (assessed using validated Sinhala and Tamil ICIQ VS questionnaire) 7. Bowel function (assessed by a questionnaire, adapted fro Thakar et al) 8. Cost (using a specific costing formula to determine direct hospital costs and indirect patient costs) [1. Operative time (surgical time from skin to skin) – Immediately following surgery 2. Post-operative hospital stay (duration) – At discharge 3. Complications (Bladder injury, Ureteric injury, Bowel injury, Intra-operative blood transfusion, Convert to laparotomy, Vault haematoma, Post-operative blood transfusion, Post-operative fever, Skin wound infection, Urinary tract infection, Respiratory tract infection, Deep vein thrombosis /Pulmonary embolism, Re-operation) – Up to 6 weeks after surgery 4. Quality of life (measured using validated Sinhala and Tamil EQ-5D-3L questionnaire)- Pre-operative, Post-operative (Day 2, 1 week, 6 weeks, 3 months, 6 months) 5. Urinary function (measured using validated Sinhala and Tamil ICIQ FLUTS questionnaire) – Pre-operative, (Post-operative 6 months, 1 year) 6. Vaginal and sexual function (assessed using validated Sinhala and Tamil ICIQ VS questionnaire) – Pre-operative, (Post-operative 6 months, 1 year) 7. Bowel function (assessed by a questionnaire, adapted from Thakar et al) – Pre-operative, Post-operative 6 months, 1 year) 8. Cost (us

—

Countries

Sri Lanka

Contacts

Public ContactDr. CD Ekanayake

Consultant Obstetrician & Gynaecologist

cdekanayake2000@yahoo.co.uk0232222261

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026