LAParoscopic Entry Technique in REnal Surgery (LAPRES)

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Diseases
• Intervention / Treatment: Procedure: Open approach to port insertion; Procedure: Closed approach to port insertion

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 24
    • Recruiting
    • Adelaide and Meath hospital incorporating the NAtional Children's hospital
    • Contact: Arun Z Thomas, MCh, FRCS; Phone Number: 00353879804873; Email: arun.z.thomas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Other Names: Hasson
Active Comparator: 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	Procedure: 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 Names: Veress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Minor and major complications assessed	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to insertion	Record time taken to perform both approaches	30 minutes

Collaborators and Investigators

• Sponsor: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
• Investigators: Principal Investigator: Arun Z Thomas, AMNCH, Tallaght hospital, Dublin 24

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: September 23, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: renal surgery; laparoscopy/ key-hole; open/hasson; closed/veress
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: AMNCH-GU-2017-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No