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Randomized controlled trial to determine the efficacy and safety of a novel method of laparoscopic entry using free flow of saline

Randomized controlled trial to determine the efficacy and safety of a novel method of laparoscopic entry using free flow of saline

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2013/007
Enrollment
Unknown
Registered
2013-02-20
Start date
2013-02-25
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

Laparscopic Entry in Gynaecological Practice

Interventions

Participants will be randomized into intervention and control groups. The intervention group will undergo laparocopic entry using the new test to assess correct intra-peritoneall placement of the Ve

Sponsors

Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Colombo.
Lead Sponsor
Dr. R.M.C.B Hunukumbure
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Female patients • Aged between 18 – 49 years • Undergoing diagnostic and/or therapeutic laparoscopy for gynaecological reasons

Exclusion criteria

Exclusion criteria: Previous laparotomy, involving a sprapubic midline or paramedian incision. • Patients not fit to undergo general anaesthesia • Cardiac or respiratory conditions where it is not possible to operate in the modified Lloyd-Davis position with a head

Design outcomes

Primary

MeasureTime frame
Duration of time from the initial intra-umbilical incision to the successful intra-peritoneal placement of the Veress needle as confirmed by observation through the video laparoscope [At the time of laparoscopic entry]

Secondary

MeasureTime frame
The number of attempts at the laparoscopic entry [At the time of laparoscopic entry] Any vascular or visceral injuries, or extra-peritoneal gas (CO2) insufflations [At the time of laparoscopic entry]

Countries

Sri Lanka

Contacts

Public ContactProfessor Hemantha M. Senanayake .

Senior consultant Obstetrician and Gynaecologist and Head Department of Obstetrics and Gynaecology,

senanayakeh@gmail.com

Outcome results

None listed

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