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
23 participants
INTERVENTIONAL
2021-12-09
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcome of Neoadjuvant Chemotherapy for Obstructive Colon Cancer
NCT04889820
The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
NCT03699761
CPET in Colorectal Surgery
NCT02298907
INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer
NCT01679756
Multicentric Study Comparing Carcinological and Functional Results of Surgery
NCT00502723
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will take place across 3 sites: Swansea Bay University Health Board (SBUHB); Aneurin Bevan University Health Board and Cardiff and Vale University Health Board. Surgeons at all three sites have experience with both interventional extra-peritoneal surgical technique and the most commonly used transperitoneal technique.
The investigators aim to recruit 60 participants over 12 months. Local recruitment will be co-ordinated by PIs and research teams. Recruitment is aimed to be equally distributed across all sites. Participants will be equally randomised by arm in each of the three sites: to receive the EP colostomy formation (Intervention) or the standard transperitoneal (TP) technique. Participants will remain blinded as to their treatment until the close of the study.
Data collection will be performed by the clinical and research teams, with support from PIs. Data will be stored centrally in REDCap (Research Electronic Data Capture) software.
The investigators will explore whether it is possible to establish a research infrastructure in which data can be collected and co-ordinated across sites and for patients to be followed up effectively. The investigators will also look to demonstrate standardisation of the operative technique for EP stoma formation and to determine which outcome measures a future trial should explore. This feasibility trial be evaluated against ACCEPT progression criteria.
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
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Trans-peritoneal
Surgery technique in the formation of permanent end colostomy
No interventions assigned to this group
Extra-peritoneal
Surgery technique in the formation of permanent end colostomy
Extra-peritoneal
Surgery procedure: a non-mesh prophylactic surgical technique to prevent PH
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Extra-peritoneal
Surgery procedure: a non-mesh prophylactic surgical technique to prevent PH
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able and willing to give informed consent to participate
* Elective patient for colorectal surgery requiring formation of permanent end colostomy (This may include patients undergoing surgery for rectal or anal cancer, inflammatory bowel disease, diverticular disease and functional bowel disorders)
* Suitable to receive both trans-peritoneal and extra-peritoneal techniques
Exclusion Criteria
* Having emergency surgery
* Previous or current abdominal wall stoma
* Intention to form loop colostomy, ileostomy or double-barrelled stoma
* Previous incisional hernia repair with disruption of abdominal wall layers
* Pregnant or breastfeeding (as determined by standard NHS procedures)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Swansea University
OTHER
Swansea Bay University Health Board
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gregory Taylor
Role: STUDY_DIRECTOR
Swansea Bay University Health Board
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiff and Vale University Health Board
Cardiff, , United Kingdom
Aneurin Bevan University Health Board
Newport, , United Kingdom
Swansea Bay University Health Board
Swansea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
291897
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.