Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010672295788 Date of Approval: 22/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided veress needle insertion, a prospective randomized study.
Official scientific title Ultrasound guided veress needle insertion, a prospective randomized study.
Brief summary describing the background and objectives of the trial Laparoscopy has become the primary operative techniques for large number of abdominal surgeries. Besides offering smaller incisions, and a better cosmetic result, laparoscopic surgery decreases postoperative pain, decreases hospital stay, and reduce the number of wound infections and hernias compared to the more traditional open techniques(Thepsuwan et al., 2013; Ogaick and Martel, 2014). However, complications do occur during laparoscopic surgery and the most frustrating ones are those occurring during initial entry into the peritoneal cavity. Intraperitoneal access is associated with injuries to the gastrointestinal tract and major blood vessels and at least 50% of these major complications occur prior to commencement of the intended surgery To avoid such complications, several techniques for entry has been developed, including the open Hasson method, the Veress needle method, the use of specialized instruments such as optical trocars and different entry points(Sajid et al., no date; Jansen et al., 2004; Cakir et al., 2006; Toro et al., 2012). Ultrasound is being used for many abdominal wall blocks for perioperative analgesia. The muscle layers and the peritoneum are easily visualized and injury is avoided by direct needle visualization in each technique(Yarwood and Berrill, 2010). The same idea was described for veress needle insertion to avoid entry complications; however, this method was never evaluated in a prospective study and compared to the classic technique(Pratap, Oleynikov and Kothari, 2018). In our study, US guided veress needle technique will be compared to classic technique postulating that US will minimize the insertion time, number of trials and decrease the incidence or related complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2020
Actual trial start date 01/01/2021
Anticipated date of last follow up 01/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group S during insertion of veress needle The veress needle will be applied guided by the US image. Superficial probe will be used to visualize the abdominal wall layers and guide the operator for correct placement 25
Control Group Control group during the veress needle insertion Veress needle will be inserted through the umbilicus in the traditional way 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
scheduled for all patents elective laparoscopic surgeries ASA I and II open abdominal surgeries admitted for emergency surgery coagulopathy (INR 1.5, platelet less than 100X103) abdominal or pelvic masses umbilical hernia super-obese patients Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2020 Institutional review board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome first attempt success during the insertion of veress needle
Primary Outcome number of attempts during the insertion of veress needle
Primary Outcome Time to needle insertion during the insertion of veress needle
Secondary Outcome the incidence of complications hematoma, failure 0 during the insertion of veress needle
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university Elgomhoreya Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university Elgomhoreya Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhoreya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mahmoud abdelwaha Geihan street Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoryea
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD including study protocol, statistical plan, and results tables will be shared Clinical Study Report,Statistical Analysis Plan,Study Protocol within 6 months after end recritment persons or organizations covered by ethical committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information