Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2017-11-01
2019-12-31
Brief Summary
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Detailed Description
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Background Since its introduction in 1991 by Clayman, laparoscopic renal surgery has become very popular and is widely used for both benign and malignant renal operations such as radical, simple and partial nephrectomies, pyeloplasties, nephro-ureterectomies (2). The overall reported major and minor complication rate of laparoscopic renal surgery is 9.5% and 1.9% respectively (2). Initial entry by trocar insertion is the most hazardous part of the laparoscopic procedure. Opinion regarding the safest entry technique is divided. The two most commonly used techniques of port entry include open and closed (3). An open technique, as first described by Hasson, involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope. One of the closed technique involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity). Finally the laparoscope is passed through the trocar once the obturator is removed. Previous meta-analyses in laparoscopic surgery from gynaecological and general surgical operations have not been able to support one technique over the other due to insufficient evidence.to our knowledge (3), there are no randomised controlled trials comparing these two techniques in laparoscopic renal surgery. During laparoscopic renal surgery, the patient is placed in a lateral flank position with the table flexed. The initial port of entry can be either at the umbilicus or lateral to it. This position is unique to urological surgery and hence can have different implications to the initial trocar insertion technique.
The objective is to compare the open method (Hasson) and closed method (Veress) of laparoscopic port site entry in renal surgery
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Open/Hasson
This group will undergo initial laparoscopic port insertion by the open or Hasson approach and then undergo the remaining laparoscopic surgery as usual
Open approach to port insertion
This involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope
Closed/ Veress
This group will undergo initial laparoscopic port insertion by the closed or Veress approach and then undergo the remaining laparoscopic surgery as usual
Closed approach to port insertion
This involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity).
Interventions
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Open approach to port insertion
This involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope
Closed approach to port insertion
This involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* Willing and able to give AN INFORMED CONSENT
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Adelaide and Meath Hospital, incorporating The National Children's Hospital
OTHER
Responsible Party
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Arun Thomas
Principal investigator
Principal Investigators
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Arun Z Thomas
Role: PRINCIPAL_INVESTIGATOR
AMNCH, Tallaght hospital, Dublin 24
Locations
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Adelaide and Meath hospital incorporating the NAtional Children's hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Arun Z Thomas, MCh, FRCS
Role: primary
References
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Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.
Pareek G, Hedican SP, Gee JR, Bruskewitz RC, Nakada SY. Meta-analysis of the complications of laparoscopic renal surgery: comparison of procedures and techniques. J Urol. 2006 Apr;175(4):1208-13. doi: 10.1016/S0022-5347(05)00639-7.
Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
Other Identifiers
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AMNCH-GU-2017-3
Identifier Type: -
Identifier Source: org_study_id