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Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.
Currently, no specific trial compares hand-sewn intestinal anastomosis with mechanical stapled anastomosis in patients undergoing radical cystectomy with ileal conduit.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual anastamosis | Active Comparator | Intestinal anastamosis will be performed manually |
|
| Mechanical anastamosis | Active Comparator | Intestinal anastamosis will be performed using stapling device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cystectomy with ileal conduit, using mechanical bowel anastomosis | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the superiority of manual intestinal suturing versus mechanical suturing, defined as a lower incidence of postoperative digestive complications in patients undergoing radical cystectomy with ileal conduit. | Compare the incidence of gastrointestinal complications according to the type of suturing used in the creation of the ileo-ileal anastomosis in patients undergoing radical cystectomy with ileal conduit during the hospital admission period and at one-year follow-up. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the predictive factors of postoperative complications. | Identify the predictive factors of postoperative complications during hospital admission and at one-year follow-up, both overall and according to the type of suturing. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacio Puigvert | Barcelona | Barcelona | 08025 | Spain |
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| cystectomy with ileal conduit, using manual bowel anastomosis | Procedure | 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 |
|
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D045823 | Ileus |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015653 | Cystectomy |
| D014547 | Urinary Diversion |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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