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.: PACTR201510000999192 Date of Approval: 16/01/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title VDT TRIAL
Official scientific title A RANDOMISED CONTROL TRIAL ON THE COMPARISON OF TWO DIFFERENT CLOSED ENTRY TECHNIQUES IN GYNAECOLOGICAL LAPAROSCOPIC SURGERY
Brief summary describing the background and objectives of the trial Laparoscopy, the art of examining the abdominal cavity and its contents, requires insertion of a cannula through the abdominal wall, distention of the abdominal cavity with gas or air (pneumoperitoneum), and visualization and examination of the abdomen¿s contents with an illuminated telescope. It is currently widely used in the practice of medicine, for both diagnostic and therapeutic purposes. Gaining access into the abdomen is a major challenge of laparoscopy particularly for insertion of surgical instruments via small incisions. It is therefore obvious that laparoscopic procedures are not risk free since laparoscopic entry is blind. However, complications arising from laparoscopic surgery are rare but commonly occur when attempting to gain access to the peritoneal cavity. Thus, the majority of complications associated with laparoscopy occur at the time of entry, opinion is divided as to the safest entry technique. Although the Veress needle (VN) is widely used for insufflation of the peritoneum, direct trocar (DT) insertion is becoming more popular even though there is no clear consensus as to the optimal method of entry into the peritoneal cavity. A lot of complications have been reported because of the use of VN, and none of such studies has been published in Nigeria. Additionally, in a recent Cochrane systematic review by Ahmad et al, they concluded that randomised controlled trials of adequate power are required to detect a significant reduction in risks of major complications using different entry techniques. We therefore aim to conduct a prospective, randomized control trial for the comparison of the safety and benefit of direct trocar insertion (DTI) versus Veress needle followed by primary trocar insertion (VN) techniques among non obese women in our institution to identify the duration of the procedure, volume of gas used, costs, ease of performance, and frequency of complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VDT trial
Disease(s) or condition(s) being studied Laparoscopy entry techniques,Obstetrics and Gynecology,Surgery
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 23/01/2015
Actual trial start date
Anticipated date of last follow up 30/01/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Veres needle once STAT The technique for the Veres needle entry will be started with a 1-cm incision was made vertically into the inferior aspect of the umbilicus, and a Veress needle sheathed by an expandable polymeric sleeve (VersaStep Long Insufflation Needle; Covidien, Mansfield, MA, USA) was inserted in the incision. The angle for the Veress needle insertion will be 45¿ for non obese 100
Experimental Group Direct Trocar once STAT The technique of DT entry will be started with an intra-umbilical skin incision wide enough to accommodate the diameter of a sharp trocar/canal system. The anterior abdominal wall will be adequately elevated by hand, and the trocar will be inserted directly into the abdominal cavity at 90¿ angle, aiming towards the pelvic hollow. After removal of the sharp trocar, the laparoscope will be inserted 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women undergoing diagnostic operative or mixed laparoscopy performed by trained laparoscopic gynaecologists. Women with major abdominal distension WOMEN suspicious of malignancy or malignancy at the histopathological examination. 18 Year(s) 65 Year(s) Female
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
No 16/09/2014 NAUTH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
49 NNEWI ONITSHA ROAD NNEW 435001 Nigeria
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 26/03/2015 NAUTH ETHICAL REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL,nNEWI ONITSHA ROAD, PMB 5025 NNEWI NNEWI 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time of umbilical incision Start of procedure
Primary Outcome time at telescope withdrawal (B); (3) amount of gas in liters (volume of CO2 required); (4) number of attempts required to achieve successful insertion; (5) overall operative time (from time A to time B; stopwatch started at time A and stopped at time B = overall duration of the procedure in minutes), and (6) occurrence of any complications. Start and during procedure
Primary Outcome mortality, vascular injury (major vessels and abdominal wall vessels), visceral (bladder or bowel) injury, gas embolism, solid organ injury, failed entry and conversion to the alternate DTI or open technique following failure and evidence of adhesion within the peritoneal cavity. throughout procedure
Secondary Outcome extraperitoneal insufflation and trocar site bleeding. During procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LIFE SPECIALIST HOSPITAL, LIMITED,NNEWI IKEMBA DRIVE NNEWI 435001 Nigeria
Nnamdi Azikiwe University Teaching Hospital, Nnewi 49, NNEWI ONITSHA ROAD NNEWI 435001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
LIFE SPECIALIST HOSPITAL IKEMBA DRIVE NNEWI 435001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR GEORGE ELEJE NNEWI ONITSHA ROAD, NAUTH NNEWI NNEWI 435001 Nigeria Charities/Societies/Foundation
Secondary Sponsor PROF JOSEPH IKECHEBELU IKEMBA DRIVE NNEWI 435001 Nigeria Charities/Societies/Foundation
Secondary Sponsor DR GEORGE ELEJE NNEWI ONITSHA ROAD, NAUTH NNEWI NNEWI 435001 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
PROF JOSEPH IKECHEBELU IKEMBA DRIVE NNEWI 435001 Nigeria
DR OKAFOR CHIDIMMA DONATUS IKEMBA DRIVE NNEWI 435001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GEORGE ELEJE georgel21@yahoo.com +2348068117444 49 Nnewi onitsha road
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria LECTURER AND CONSULTANT, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, NNAMDI AZIKIWE UNIVERSITY,
Role Name Email Phone Street address
Public Enquiries CHUKWUEMEKA EZEAMA nicemekt@yahoo.com +2348037167284 NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL
City Postal code Country Position/Affiliation
NNEWI 435001 Nigeria DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, NNAMDI AZIKIWE UNIVERSITY, NNEWI CAMPUS, NIGERIA
Role Name Email Phone Street address
Scientific Enquiries JOSEPH IKECHEBELU ji.ikechebelu@unizik.edu.ng +2348034044189 IKEMBA DRIVE
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria PROFESSOR AND CONSULTANT: DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, NNAMDI AZIKIWE UNIVERSITY
REPORTING
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