Home » Trials » SLCTR/2013/007
Randomized controlled trial to determine the efficacy and safety of a novel method of laparoscopic entry using free flow of saline
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SLCTR Registration Number
SLCTR/2013/007
Date of Registration
The date of last modification
Oct 15, 2019
Trial Status
Scientific Title of Trial
Randomized controlled trial to determine the efficacy and safety of a novel method of laparoscopic entry using free flow of saline
Public Title of Trial
Randomized controlled trial to determine the efficacy and safety of a novel method of laparoscopic entry using free flow of saline
Disease or Health Condition(s) Studied
Laparscopic Entry in Gynaecological Practice
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-12-039 (Ethics Review Committee, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Is a novel method of laparoscopic entry utilizing free flow of saline within a 10cc syringe attached to the Veress needle, safer and more efficient when compared to the conventional pressure profile test, when assessing the correct intra-peritoneal placement of the Veress needle at closed laparoscopic entry?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
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 Veress needle, while the control group would undergo the laparoscopic entry using the conventional Pressure Profile Test to evaluate the position of the Veress needle at entry. No alteration to the positioning of the patient or Veress needle insertion technique would be done
Inclusion criteria
Female patients • Aged between 18 – 49 years • Undergoing diagnostic and/or therapeutic laparoscopy for gynaecological reasons
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
Primary outcome(s)
|
1.
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 outcome(s)
|
1.
The number of attempts at the laparoscopic entry |
[ At the time of laparoscopic entry ] |
|
2.
Any vascular or visceral injuries, or extra-peritoneal gas (CO2) insufflations |
[ At the time of laparoscopic entry ] |
Target number/sample size
90 (45 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-02-25
Anticipated end date
2013-05-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2012-08-16
Approval number
EC-12-039
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Professor Hemantha M. Senanayake .
Senior consultant Obstetrician and Gynaecologist and Head Department of Obstetrics and Gynaecology,
Faculty of Medicine, University of Colombo
071-4762176
senanayakeh@gmail.com
Primary study sponsor/organization
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Colombo.
No 25, Kynsey Road, Colombo 8
011-2695300
www.med.cmb.ac.lk
Secondary study sponsor (If any)
Dr. R.M.C.B Hunukumbure
Senior Registrar in Subfertility
Professorial Unit in Obstetrics and Gynaecology, De Soyza Hospital for Women, Colombo 8
071-4785836
rmcbhunu@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
