The Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence of Postoperative Complications Following Cystectomy With Ileal Conduit
NCT ID: NCT06928220
Last Updated: 2025-04-15
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
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COMPLETED
NA
120 participants
INTERVENTIONAL
2020-10-19
2025-04-07
Brief Summary
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Detailed Description
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At Fundació Puigvert, approximately one hundred radical cystectomies with ileal conduit are performed annually. Due to the lack of evidence regarding the superiority of either intestinal anastomosis technique, the decision to use hand-sewn versus stapled anastomosis depends on the surgeon's expertise, without considering the potential impact of each technique on postoperative complication rates, surgical time, or functional outcomes.
Currently, no well-designed surgical trials demonstrate differences between hand-sewn and mechanical stapled anastomosis in radical cystectomy regarding intraoperative and postoperative complications. For this reason, the investigators will conduct a trial to assess the impact of each anastomosis technique
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Manual anastamosis
Intestinal anastamosis will be performed manually
cystectomy with ileal conduit, using manual bowel anastomosis
An ileal conduit will be the new storage area for urine once the bladder is removed.
Vycryl suture will be used to perform manual bowel anastomosis
Mechanical anastamosis
Intestinal anastamosis will be performed using stapling device
cystectomy with ileal conduit, using mechanical bowel anastomosis
An ileal conduit will be the new storage area for urine once the bladder is removed.
GIA Device will be used to perform bowel anastomosis
Interventions
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cystectomy with ileal conduit, using mechanical bowel anastomosis
An ileal conduit will be the new storage area for urine once the bladder is removed.
GIA Device will be used to perform bowel anastomosis
cystectomy with ileal conduit, using manual bowel anastomosis
An ileal conduit will be the new storage area for urine once the bladder is removed.
Vycryl suture will be used to perform manual bowel anastomosis
Eligibility Criteria
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Inclusion Criteria
* Patient candidate for radical open cystectomy and ileal conduit.
Exclusion Criteria
* Patient who has a life expectancy of less than 1 year.
* Candidate patients for other urinary diversions other than ileal conduit as a first option
* Candidate patients for laparoscopic or robotic cystectomy..
18 Years
ALL
No
Sponsors
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Fundacio Puigvert
OTHER
Responsible Party
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Pavel Gavrilov
Consultant surgeon
Locations
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Fundacio Puigvert
Barcelona, Barcelona, Spain
Countries
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Other Identifiers
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181184
Identifier Type: -
Identifier Source: org_study_id
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