LAParoscopic Entry Technique in REnal Surgery

Kidney Diseases Clinical Trial

— LAPRES  

Official title:

Laparoscopic Entry Technique in Renal Surgery: a Randomised Controlled Trial Comparing Open (Hasson) Versus Closed (Veress) Techniques.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306238
• Other study ID #: AMNCH-GU-2017-3
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2017
• Last updated: December 19, 2017
• Start date: November 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
• Contact: Arun Z Thomas, MCh, FRCS
• Phone: 0353879804873
• Email: arun.z.thomas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomised controlled trial to evaluate safety and efficacy of two different port site entry techniques in laparoscopic renal surgery: open method (Hasson) and closed method (Veress). It will involve 300 adult patients undergoing elective laparoscopic renal surgery in Tallaght hospital under two Consultant urologists.

Description:

Surgical specialties commonly using laparoscopic techniques like gynecology and general surgery have extensively compared the various available techniques of port insertion (1). There is very little known regarding the safest entry technique for the initial port in laparoscopic renal surgery. Results from other surgical specialties cannot simply be extrapolated to this type of laparoscopic surgery due to difference in entry site and patient position with renal surgery. Hence, this randomised controlled trial will be performed in a urological unit with two laparoscopic renal surgeons to compare two commonly used techniques of initial trocar insertion: the closed method and the open method.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Able to undergo a general anaesthetic

• At least 18 years old

• Willing and able to give AN INFORMED CONSENT

Exclusion Criteria:

• patient refusal obese patients BMI >40mg/m2 previous laparotomy

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
Ireland	Adelaide and Meath hospital incorporating the NAtional Children's hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. Review. Update in: Cochrane Database Syst Rev. 2015;8:CD006583. — View Citation

Angioli R, Terranova C, De Cicco Nardone C, Cafà 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Minor and major complications assessed	48 hours
Secondary	Time to insertion	Record time taken to perform both approaches	30 minutes