Bladder CancerCIMMISNCT06928220
The Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence of Postoperative Complications Following Cystectomy With Ileal Conduit
A study testing cystectomy with ileal conduit, using mechanical bowel anastomosis and cystectomy with ileal conduit, using manual bowel anastomosis in people with Bladder Cancer and Anastomosis; Complications, run by Fundacio Puigvert at 1 site in Spain.
Trial summary
Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Anastomosis; Complications, Ileus Paralytic
- What is being tested?
- cystectomy with ileal conduit, using mechanical bowel anastomosis and cystectomy with ileal conduit, using manual bowel anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 19 Oct 2020to 7 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who consents to participate and signs the informed consent.
- Patient candidate for radical open cystectomy and ileal conduit.
Who cannot join
- Patient who is unable to complete the study questionnaires.
- 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..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Prospective, Randomized Clinical Trial Investigating the Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy With Ileal Conduit.
Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.
Read the detailed description
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
- Conditions
- Bladder Cancer, Anastomosis; Complications, Ileus Paralytic
- Being tested
- cystectomy with ileal conduit, using mechanical bowel anastomosis, cystectomy with ileal conduit, using manual bowel anastomosis
- Keywords
- bladder Cancer, Cystectomy, hand sewn anastamosis, stapled anastamosis, intestinal complications
- Medical subject headings
- Urinary Bladder Neoplasms, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystectomy with ileal conduit, using mechanical bowel anastomosisProcedure or surgery
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 anastomosisProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Manual anastamosis | Active comparator | Intestinal anastamosis will be performed manually Receives: Procedure: cystectomy with ileal conduit, using manual bowel anastomosis |
| Mechanical anastamosis | Active comparator | Intestinal anastamosis will be performed using stapling device Receives: Procedure: cystectomy with ileal conduit, using mechanical bowel anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start19 Oct 2020
- Primary completion4 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavel Gavrilov, Fundacio Puigvert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928220
- Sponsor's protocol ID
- 181184
- Acronym
- CIMMIS
- Status last verified
- Apr 2025
- First submitted
- 18 Jan 2021
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized Clinical Trial Investigating the Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy With Ileal Conduit.
- ClinicalTrials.gov ID
- NCT06928220
- Acronym / sponsor ID
- CIMMIS / 181184
- Conditions
- Bladder Cancer, Anastomosis; Complications, Ileus Paralytic
- Keywords
- bladder Cancer, Cystectomy, hand sewn anastamosis, stapled anastamosis, intestinal complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual anastamosis | Active comparator | Procedure: cystectomy with ileal conduit, using manual bowel anastomosisIntestinal anastamosis will be performed manually |
| Mechanical anastamosis | Active comparator | Procedure: cystectomy with ileal conduit, using mechanical bowel anastomosisIntestinal anastamosis will be performed using stapling device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who consents to participate and signs the informed consent.
- Patient candidate for radical open cystectomy and ileal conduit.
Key exclusion criteria (4 listed)
- Patient who is unable to complete the study questionnaires.
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cystectomy with ileal conduit, using mechanical bowel anastomosisAn ileal conduit will be the new storage area for urine once the bladder is removed. GIA Device will be used to perform bowel anastomosis | Procedure or surgery | Mechanical anastamosis |
| cystectomy with ileal conduit, using manual bowel anastomosisAn 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 | Procedure or surgery | Manual anastamosis |
Primary outcome
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.
Time frame: 1 year
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 secondary outcome
To evaluate the predictive factors of postoperative complications.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
Related trials for Bladder Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cystectomy with ileal conduit, using mechanical bowel anastomosis and cystectomy with ileal conduit, using manual bowel anastomosis in people with Bladder Cancer and Anastomosis; Complications, run by Fundacio Puigvert at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.