Clinical trial · Interventional
Endo-GIA Versus Endowrist Stapler in Intracorporeal Urinary Diversion in Robotic Assisted Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endo-GIA | Procedure | — | UNRESOLVED |
| Endowrist | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endo-GIA
- interventionNames
- Procedure: Endo-GIA
- type
- EXPERIMENTAL
- label
- Endo-wrist
- interventionNames
- Procedure: Endowrist
Primary outcomes (1)
- measure
- Postoperative bowel function
- timeFrame
- 90 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years old * The ability to understand Danish orally and in writing * undergoing robotic assisted cystectomy with intracorporeal ileal conduit Exclusion Criteria: \-
References
Publications (7)
- BACKGROUNDChoy 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 21901690
- BACKGROUNDKorolija 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 18609000
- BACKGROUNDChen C. The art of bowel anastomosis. Scand J Surg. 2012;101(4):238-40. doi: 10.1177/145749691210100403. PMID 23238497
- BACKGROUNDDal 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 28009143
- BACKGROUNDRussell 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 26341822
- BACKGROUNDJensen 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 21223476
- BACKGROUNDDucrotte 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 22236136