LAParoscopic Entry Technique in REnal Surgery

NCT03306238 | Unknown

• 1 other identifier: AMNCH-GU-2017-3
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Diseases

Keywords

laparoscopy/ key-hole; renal surgery; open/hasson; closed/veress

Outcome Measures

Primary Outcomes (1)

• Complications

  Minor and major complications assessed

  48 hours

Secondary Outcomes (1)

• Time to insertion

  30 minutes

Study Arms (2)

Open/Hasson

ACTIVE COMPARATOR

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

Closed/ Veress

ACTIVE COMPARATOR

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

Interventions

Open approach to port insertion PROCEDURE

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

Also known as: Hasson

Open/Hasson

Closed approach to port insertion PROCEDURE

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).

Also known as: Veress

Closed/ Veress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to undergo a general anaesthetic
• At least 18 years old
• Willing and able to give AN INFORMED CONSENT

You may not qualify if:

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

Sponsors & Collaborators

• The Adelaide and Meath Hospital, incorporating The National Children's Hospital: lead

Study Sites (1)

Adelaide and Meath hospital incorporating the NAtional Children's hospital

Dublin, 24, Ireland

RECRUITING

Related Publications (3)

• 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.

  PMID: 24103531 BACKGROUND

• 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.

  PMID: 16515961 BACKGROUND

• 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.

  PMID: 22336819 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Arun Z Thomas

  AMNCH, Tallaght hospital, Dublin 24

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arun Z Thomas, MCh, FRCS

CONTACT

0353879804873; arun.z.thomas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient and the investigator will not be informed of the type of approach they had. These will be marked as A and B with only the care povide/surgeon being aware of the actual approach. The investigator of complications and assessor of the case outcomes will collect data without the knowledge of the group the patient belongs to. The surgeon or car eprovider cannot be masked in this case due to technical limitations but they will not contribute towards analysing the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This is a randomised single blinded prospective trial comparing two similar groups directly to check for differnces in time to approach and complication rate

Study Record Dates

• First Submitted: September 23, 2017
• First Posted: October 11, 2017
• Study Start: November 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

IE (1)