Endo-GIA Versus Endowrist Stapler in Intracorporeal Urinary Diversion in Robotic Assisted Radical Cystectomy
NCT ID: NCT03385798
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2018-01-01
2023-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction
NCT03280459
Robotic Radical Cystectomy Outcomes
NCT04900558
Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
NCT02665156
Study Comparing Open Radical Cystectomy With Robot-assisted Cystectomy in Patients With Bladder Cancer
NCT03977831
The Effect of Pneumoperitoneum (Raised Pressure in the Peritoneal Cavity) During Robotic Kidney/Prostate Cancer Surgery.
NCT04755452
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In Denmark, approximately 400 radical cystectomies are performed yearly with the majority of procedures performed as a laparoscopic robot assisted procedure. This includes urinary diversion by means of intracorporeal procedure.
During current standard intracorporeal urinary diversion, an Endo-GIA stapler is handled by the assisting surgeon and not by the main surgeon as the Endo-GIA stapler is not integrated into the robot.
The traditional Endo-GIA anastomosis is made as a side-by-side anastomosis with two 60 mm magazines: one for the side-to-side anastomosis and one for closing the end.
Any reduction in the lumen of the anastomosis will clinically affect post-operative bowel function. It is known that at all cystectomy patients have intestinal paralysis / lack of normal bowel function in the first days postoperatively. It is thus plausible that a wider anastomosis will be able to reduce the duration of this in favor of the patient's post-operative nutrition, postoperative length of stay and convalescence.
A stapler integrated in the robot (Endowrist stapler from Intuitive) is available. This has several advantages: it is operated by the robotic surgeon and not by the assistant, it is more flexible, and faster mobility. These advantages provide the possibility of precisely removing a minimal intestinal segment by the final transverse stapling. The biggest disadvantage of the robot-operated Endowrist staple is that it is not available in a 60 mm version but only in 45 mm, thus giving only an anastomosis of approximately the same lumen as using a 60 mm Endo-GIA staple but not better.
An opportunity to make a more spacious anastomosis would be to "prolong" the longitudinal stapling as to the side-to-side anastomosis between the intestinal segments. This requires precise and coordinated handling of bowel graspers and staplers to make a complete elimination of the risk of anastomosis leakage, which in this respect is an advantage of robot-operated staples with the Endowrist stapler rather than an assistant handled stapler with Endo-GIA.
Both Endo-GIA and Endowrist stapler are approved for clinical use according to the procedures described.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Endo-GIA
Endo-GIA
Anastomosis made by Endo-GIA
Endo-wrist
Endowrist
Anastomosis made by Endowrist
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endowrist
Anastomosis made by Endowrist
Endo-GIA
Anastomosis made by Endo-GIA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The ability to understand Danish orally and in writing
* undergoing robotic assisted cystectomy with intracorporeal ileal conduit
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jørgen Bjerggaard Jensen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jørgen Bjerggaard Jensen
Professor, MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aarhus University Hospital
Aarhus, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Chen C. The art of bowel anastomosis. Scand J Surg. 2012;101(4):238-40. doi: 10.1177/145749691210100403.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UFE-1-10-72-78-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.