NCT03385798

Brief Summary

The study is a randomized clinical trial (RCT) including patients undergoing robotic assisted cystectomy with intracorporeal ileal conduit at four large university hospitals in Denmark. If included, the patients will be randomized 1:1 to two study arms: 1) Standard arm with current procedure where intracorporeal bowel anastomosis is performed with the 60 mm EndoGIA stapler, or 2) Experimental arm where the bowel anastomosis will be performed totally robotic with the Endowrist Intuitive robotic stapler with 2 subsequent elongated 45 mm magazines for the side-to-side anastomosis. Primary outcome will be postoperative bowel function where a better bowel recovery is anticipated in the experimental Endowrist arm whereas serious complications are expected to be non-inferior to the current standard.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

December 21, 2017

Last Update Submit

May 30, 2023

Conditions

Bladder Cancer

Keywords

Endo-GIA StaplerEndowrist Stapler

Outcome Measures

Primary Outcomes (1)

  • Postoperative bowel function

    Primary outcome will be postoperative bowel function where a better bowel recovery is anticipated in the experimental Endowrist arm whereas serious complications are expected to be non-inferior to the current standard.

    90 days

Study Arms (2)

Endo-GIA

ACTIVE COMPARATOR
Procedure: Endo-GIA

Endo-wrist

EXPERIMENTAL
Procedure: Endowrist

Interventions

EndowristPROCEDURE

Anastomosis made by Endowrist

Endo-wrist
Endo-GIAPROCEDURE

Anastomosis made by Endo-GIA

Endo-GIA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old
  • The ability to understand Danish orally and in writing
  • undergoing robotic assisted cystectomy with intracorporeal ileal conduit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (7)

  • Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD004320. doi: 10.1002/14651858.CD004320.pub3.

    PMID: 21901690BACKGROUND

  • Korolija D. The current evidence on stapled versus hand-sewn anastomoses in the digestive tract. Minim Invasive Ther Allied Technol. 2008;17(3):151-4. doi: 10.1080/13645700802103423.

    PMID: 18609000BACKGROUND

  • Chen C. The art of bowel anastomosis. Scand J Surg. 2012;101(4):238-40. doi: 10.1177/145749691210100403.

    PMID: 23238497BACKGROUND

  • Dal Moro F, Haber GP, Wiklund P, Canda AE, Balbay MD, Stenzl A, Zattoni F, Palou J, Gill I, Catto JW. Robotic intracorporeal urinary diversion: practical review of current surgical techniques. Minerva Urol Nefrol. 2017 Feb;69(1):14-25. doi: 10.23736/S0393-2249.16.02780-6. Epub 2016 Aug 31.

    PMID: 28009143BACKGROUND

  • Russell KW, O'Holleran BP, Bowen ME, Mone MC, Scaife CL. The Barcelona Technique for Ileostomy Reversal. J Gastrointest Surg. 2015 Dec;19(12):2269-72. doi: 10.1007/s11605-015-2929-6. Epub 2015 Sep 4.

    PMID: 26341822BACKGROUND

  • Jensen JB, Pedersen KV, Olsen KO, Bisgaard UF, Jensen KM. Mini-laparotomy approach to radical cystectomy. BJU Int. 2011 Oct;108(7):1125-30. doi: 10.1111/j.1464-410X.2010.09958.x. Epub 2011 Jan 11.

    PMID: 21223476BACKGROUND

  • Ducrotte P, Causse C. The Bowel Function Index: a new validated scale for assessing opioid-induced constipation. Curr Med Res Opin. 2012 Mar;28(3):457-66. doi: 10.1185/03007995.2012.657301. Epub 2012 Feb 16.

    PMID: 22236136BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

December 21, 2017

First Posted

December 29, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)