Home » Trials » SLCTR/2016/020


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

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SLCTR Registration Number

SLCTR/2016/020


Date of Registration

26 Jul 2016

The date of last modification

Jan 29, 2019



Application Summary


Scientific Title of Trial

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


Public Title of Trial

Cost-effectiveness of methods of hysterectomy for benign conditions


Disease or Health Condition(s) Studied

Post-hysterectomy outcomes


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1194-8422


Any other number(s) assigned to the trial and issuing authority

P 12/01/2016 (ERC: Kelaniya)


Trial Details


What is the research question being addressed?

Is non-descent vaginal hysterectomy (NDVH) (intervention) or total laparoscopic hysterectomy (TLH) (intervention) better than total abdominal hysterectomy (TAH) (comparator) for women undergoing hysterectomy for benign causes in Sri Lanka.


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 4


Intervention(s) planned

  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 identified and counselled by gynaecologists at each study setting, and screened for inclusion/exclusion criteria.

  3. Method of allocation: Participants will be allocated to the study arms using block randomization (in multiples of 3).

  4. Interventions:
    Arm 1: non-descent vaginal hysterectomy (NDVH) (intervention)
    Arm 2: total laparoscopic hysterectomy (TLH) (intervention)
    Arm 3: total abdominal hysterectomy (TAH) (comparator)

Standard surgical techniques will be followed for each arm. Any complication would be dealt with according to standard protocols/guidelines and the decision to convert to laparotomy at TLH or NDVH would be at the discretion of the primary surgeon. Patients in the three groups will receive the same standard post-operative care following hysterectomy.

No masking will be used in this study.


Inclusion criteria

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


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


Primary outcome(s)

  1. 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 outcome(s)

    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 (using a specific costing formula to determine direct hospital costs and indirect patient costs) –Initial presentation, during admission for hysterctomy and 6 weeks post-hysterectomy.

    ]

Target number/sample size

147 (49 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-08-01


Anticipated end date

2018-07-31


Date of first enrollment

2016-08-01


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

National Research Council, Sri Lanka (Grant no. 16/086)


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2016-06-14


Approval number

P/12/01/2016


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address: PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone: +94-11-2961267
Email: erckelaniya@gmail.com


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. CD Ekanayake
Consultant Obstetrician & Gynaecologist
District General Hospital Mannar
0232222261
0713283668
0232250748
cdekanayake2000@yahoo.co.uk

Contact Person for Public Queries

Dr. CD Ekanayake
Consultant Obstetrician & Gynaecologist
District General Hospital Mannar
0232222261
0713283668
0232250748
cdekanayake2000@yahoo.co.uk


Primary study sponsor/organization

National Research Council

380/97, Bauddhaloka Mawatha Colombo 07, Sri Lanka
+94 11 269 5060
+94 11 267 5136

http://www.nrc.gov.lk/

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results