Home » Trials » SLCTR/2026/004
Comparison of Total Laparoscopic Hysterectomy and Non-Descent Vaginal Hysterectomy in Benign Gynaecological Conditions: A Randomized Controlled Trial
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SLCTR Registration Number
SLCTR/2026/004
Date of Registration
The date of last modification
Feb 23, 2026
Scientific Title of Trial
Comparison of Total Laparoscopic Hysterectomy and Non-Descent Vaginal Hysterectomy in Benign Gynaecological Conditions: A Randomized Controlled Trial
Public Title of Trial
Comparison of Laparoscopic and Vaginal Hysterectomy in Women with Non-Prolapsed Uteri Due to Benign Conditions in Terms of Operative Time, Complications, Recovery, and Cost: A Randomized Controlled Trial
Disease or Health Condition(s) Studied
Benign gynaecological diseases requiring hysterectomy (e.g., leiomyoma, adenomyosis, endometriosis).
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1335-3048
Any other number(s) assigned to the trial and issuing authority
2023/EC/05, FoM, UoP
What is the research question being addressed?
Among patients undergoing hysterectomy for benign gynaecological disease, how do total laparoscopic hysterectomy and non-descent vaginal hysterectomy compare in terms of operative time, complications, recovery, and cost?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Professorial Gynaecology Ward of the Teaching Hospital, Peradeniya.
Method of Randomization: Patients meeting the inclusion and exclusion criteria are recruited through consecutive sampling. Randomization is performed using a computer-generated random number sequence.
Intervention Group 1: Non-descent Vaginal Hysterectomy (NDVH) – Performed under general anaesthesia using standard vaginal surgical technique.
Group 2: Total Laparoscopic Hysterectomy (TLH) – Performed under general anaesthesia using laparoscopic ports and endoscopic suturing.
Both groups will undergo the same pre-operative preparation, anaesthetic management, and postoperative care protocols.
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
Primary outcome(s)
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1.
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. ] |
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2.
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. ] |
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3.
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. ] |
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4.
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). ] |
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5.
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), thromboembolism, or death. Tool/source: BHT, operative notes, imaging reports, discharge summary. |
[ Timepoints: Recorded during initial admission and at 30-day follow-up. ] |
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6.
Blood transfusion (proportion and units transfused) Definition / criterion: Number and proportion of participants receiving one or more blood transfusion units during the index admission or within 7 days of surgery; units transfused recorded. Tool/source: Blood bank records, BHT transfusion chart. |
[ Timepoints: During admission and up to 7 days post-op. ] |
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7.
Length of hospital stay (days) Definition / criterion: Number of calendar days from admission for surgery to discharge (discharge date ? admission date). If same-day discharge, record 0 days. Tool/source: Hospital admission/discharge records. |
[ Timepoints: Recorded at discharge. ] |
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8.
Postoperative pain (Visual Analogue Scale, VAS 0–10) Definition / criterion: Patient-reported pain on a 10 cm VAS (0 = no pain, 10 = worst pain imaginable). Use the same validated VAS instrument for all patients. Tool/source: VAS scale completed by patient and recorded by research assistant/nurse. Timepoints: 6 hours, 12 hours, and 24 hours post-op. Early mobilisation / ability for basic activities Definition / criterion: Binary / ordinal measure of whether patient can (a) ambulate within the ward without assistance and (b) manage own basic sanitary care. Score: 0 = not independently mobile, 1 = mobile with assistance, 2 = independently mobile. Tool/source: Structured interviewer- administered questionnaire completed by research assistant. |
[ Timepoints: 12 hours and 24 hours post-op. ] |
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9.
Readmission within 30 days (proportion) Definition / criterion: Any readmission related to the index surgery within 30 days of discharge. Record reason and length of readmission. Tool/source: Hospital records and telephone follow-up / clinic records. Timepoints: Tracked up to 30 days after discharge. Re-operation rate within 30 days Definition / criterion: Any return to theatre for complications of the index procedure within 30 days. Tool/source: Theatre log / hospital records. |
[ Timepoints: Within 30 days post-op. ] |
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10.
Postoperative fever and infection Definition / criterion: Fever defined as temperature ?38.0 °C on two occasions 4 hours apart, or ?38.5 °C once. Surgical site infection per CDC definitions (superficial, deep, organ- space). Tool/source: BHT vitals, culture results, wound assessments. |
[ Timepoints: During admission and 30-day follow-up. ] |
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11.
Vault haematoma Definition / criterion: Clinically suspected vault hematoma confirmed by ultrasound when indicated; record size and need for intervention. Tool/source: Ultrasound report, BHT. |
[ Timepoints: During admission and if symptomatic within 30 days. ] |
Secondary outcome(s)
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1.
None |
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Target number/sample size
60 participants (30 per arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2026-01-12
Anticipated end date
2026-11-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self-funded / University of Peradeniya (institutional support)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2024-01-11
Approval number
2023/EC/05
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya. |
| Institutional Address: | Faculty of Medicine, University of Peradeniya, Sri Lanka |
| Telephone: | +94812388840 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. Sampath Gunanarthne
Senior Lecturer
Department of Obstetrics and
Gynaecology, Faculty of Medicine, University of
Peradeniya, Sri Lanka
+94 777520088
sgresearchuop@gmail.com
Contact Person for Public Queries
Dr. Sampath Gunanarthne
Senior Lecturer
Department of Obstetrics and
Gynaecology, Faculty of Medicine, University of
Peradeniya, Sri Lanka
+94 777520088
sgresearchuop@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data collected during the trial, after de-identification will be shared. The study protocol, data collection tools, and statistical analysis plan will be made available upon reasonable request, immediately following publication, no end date. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose to achieve the aims in an approved proposal. Requests for access to the de-identified IPD should be directed to the Principal Investigator via email (sgresearchuop@gmail.com). Researchers requesting access will be required to submit a written proposal outlining theplanned analysis and sign a data access agreement. Approved datasets will be shared electronically in a secure format.
Study protocol available
Yes
Protocol version and date
Version 1.0, September 2023
Protocol URL
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
