LAParoscopic Entry Technique in REnal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Kidney Diseases

Intervention / Treatment
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* Procedure: Open approach to port insertion
* Procedure: Closed approach to port insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomised single blinded prospective trial comparing two similar groups directly to check for differnces in time to approach and complication rate
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open/Hasson<br>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<br>* 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<br>* Other names: Hasson;|
| Active Comparator: Closed/ Veress<br>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<br>* 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).<br>* Other names: Veress;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy/ key-hole, renal surgery, open/hasson, closed/veress