Trial no.:
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PACTR201510000999192 |
Date of Approval:
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16/01/2015 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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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
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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 |
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Anticipated date of last follow up |
30/01/2016 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
200 |
Actual target sample size (number of participants) |
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Recruitment status |
Recruiting |
Publication URL |
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