Development of Dysplasia in the Pelvic Pouch in Patients With Ulcerative

Status Completed

Clinical Trial Summary

The purpose of this study is to study development of dysplasia in the ileal mucosa among patients with Ulcerative Colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.

Clinical Trial Description

Objective Some of the rare complications reported in patients with an ileal pouch-anal anastomosis (IPAA) after colectomy for chronic ulcerative colitis are dysplasia and carcinoma. The supposed pathway is for the ileal pouch mucosa to go through adaptational changes then to progress through the phases of chronic pouchitis, dysplasia and subsequently to adenocarcinoma. The purpose of this study is to study development of dysplasia in the ileal mucosa among patients with Ulcerative Colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.

Methods In a cohort of 680 patients having IPAA with a median follow-up time of 18 years, 75 patients with risk factors for dysplasia were identified. Sixty-five patients were eligible for inclusion, fifty-six patients accepted to participate in the study. Patients are invited for clinical examination, endoscopy with macroscopic evaluation as well as mucosal biopsies. The biopsies are reviewed and evaluated by two independent pathologists, experienced in colonic pathology, concerning morphological changes, dysplasia and potential carcinoma Results Architectural structural changes, inflammation and reactive atypia is noted in the rectal cuff and ileal pouch. So far, none of the biopsies showed genuine dysplasia after a follow up for 18 years (Range 12-23 years). In this respect there is full agreement between the two pathologists.

Further microscopic evaluation are planned for the rest of the participating patients. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01764542
Study type	Interventional
Source	Sahlgrenska University Hospital, Sweden
Contact
Status	Completed
Phase	N/A
Start date	February 2010
Completion date	February 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05583916` - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery	N/A
Completed	`NCT03213314` - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies	N/A
Enrolling by invitation	`NCT05534490` - Surgery and Functionality in Older Adults	N/A
Recruiting	`NCT04792983` - Cognition and the Immunology of Postoperative Outcomes
Recruiting	`NCT04612491` - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting	`NCT04444544` - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed	`NCT04204785` - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions	N/A
Completed	`NCT03432429` - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed	`NCT04176822` - Designing Animated Movie for Preoperative Period	N/A
Recruiting	`NCT05370404` - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:	N/A
Not yet recruiting	`NCT05467319` - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS	Phase 3
Recruiting	`NCT04602429` - Children's Acute Surgical Abdomen Programme
Completed	`NCT03124901` - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor	N/A
Completed	`NCT04595695` - The Effect of Clear Masks in Improving Patient Relationships	N/A
Recruiting	`NCT06103136` - Maestro 1.0 Post-Market Registry
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Completed	`NCT04059328` - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting	`NCT03697278` - Monitoring Postoperative Patient-controlled Analgesia (PCA)	N/A
Completed	`NCT03355547` - Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis
Recruiting	`NCT04776954` - Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Development of Dysplasia in the Pelvic Pouch in Patients With Ulcerative Colitis (UC) and Risk Factors

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms