LAParoscopic Entry Technique in REnal Surgery (LAPRES)

The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Status: Unknown

Conditions: Kidney Diseases

Treatments: Procedure: Closed approach to port insertion; Procedure: Open approach to port insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT03306238

AMNCH-GU-2017-3

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Open/Hasson

Active Comparator group

Description:

This group will undergo initial laparoscopic port insertion by the open or Hasson approach and then undergo the remaining laparoscopic surgery as usual

Treatment:

Procedure: Open approach to port insertion

Closed/ Veress

Active Comparator group

Description:

This group will undergo initial laparoscopic port insertion by the closed or Veress approach and then undergo the remaining laparoscopic surgery as usual

Treatment:

Procedure: Closed approach to port insertion