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Comparision of two energy devices ENSEAL and standard bipolar for small incision abdominal hysterectomy (laparoscopic) in large uterus

Comparision of articulating advanced bipolar device (ENSEAL) and standard bipolar for total laparoscopic hysterectomy in large uterus - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023541
Enrollment
38
Registered
2020-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N858- Other specified noninflammatory disorders of uterus

Interventions

Intervention1: ENSEAL device: ENSEAL device will be used throughout the procedure and total Operative time for ENSEAL in total laparoscopic hysterectomy is compared with that of bipolar device in this

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are scheduled to undergo Total laparoscopic hysterectomy for benign conditions 2. Uterus > 12 weeks

Exclusion criteria

Exclusion criteria: 1. Uterus > 24weeks 2.Acute PID

Design outcomes

Primary

MeasureTime frame
To compare operative time with ENSEAL and standard bipolar in TLH for large uterusTimepoint: Intraoperative period—

Secondary

MeasureTime frame
To compare blood loss, postoperative pain, time for discharge, complications, surgeons perception of ease of instrument use and workload using NASA RAW TASK LOAD INDEX (RTLX)scale Timepoint: post operative day 0, 1 week ,4 weeks after surgery—

Countries

India

Contacts

Public ContactDr S Murali

JIPMER, Pondicherry

muralidraiims@gmail.com8940760837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026