Clinical trials: Ileostomy; Complications
Ileostomy; Complications, Ileostomy - Stoma
The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy
Each year a large number of patients undergo ileostomy surgery, a procedure in which a portion of the small intestine is attached to a hole in the abdominal wall, allowing for digested material to pass into a disposable bag worn…
- Conditions
- Ileostomy; Complications, Ileostomy - Stoma, Ileostomy Malfunction, Ileostomy Underactive
- Trial name
- NCT03424954
- Testing
- EpxOstomy
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- St. Louis University
Presence of Ileostomy
Need for Subcutaneous Wound Drains in Ileostomy Reversal
The purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.
- Trial name
- DRASTAR (NCT01050686)
- Testing
- insertion of subcutaneous wound drain, no insertion of subcutaneous wound drain
- Where
- Germany
- Volunteers
- 102 people
- Sponsor
- Charite University, Berlin, Germany
Rectal Cancer
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery
Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death.
- Trial name
- LessStoReS (NCT02279771)
- Testing
- transanal anastomotic reinforcement, protective ileostomy group, a circular anal dilator (CAD)
- Where
- Italy
- Volunteers
- 140 people
- Sponsor
- Donato F Altomare
Colorectal Cancer, Quality of Life
Peristomal Skin Complications and Quality of Life
This study is a single blind semi-experimental study. Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.
- Conditions
- Colorectal Cancer, Quality of Life, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT04375930
- Testing
- STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dokuz Eylul University
Ileostomy - Stoma, Ileus
Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.
The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage.
- Conditions
- Ileostomy - Stoma, Ileus, Rectal Cancer, Surgical Complication
- Trial name
- Ileostim (NCT05302557)
- Testing
- Ileostomy stimulation
- Where
- Spain
- Volunteers
- 68 people
- Sponsor
- Universidad de León
Ileostomy - Stoma
Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.
- Trial name
- NCT03953170
- Testing
- Teduglutide
- Where
- United States
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Ileostomy; Complications
A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma
Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the…
- Trial name
- NCT05985499
- Testing
- Suturing of ileostomy using "Dumpling suture method", Suturing of ileostomy using Traditional suture method
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Colorectal Surgery, Colorectal Cancer
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an…
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma
- Trial name
- COLO-BT (NCT05826743)
- Testing
- COLO BT™, Stoma Creation
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- JSR Medical Co., Ltd.
Rectal Cancer, Total Mesorectal Excision
Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.
The purpose of this study is to asses the safety and efficacy of early stoma closure (2-3 weeks after total mesorectal excision) vs late closure (16-24 weeks after mesorectal excision).
- Conditions
- Rectal Cancer, Total Mesorectal Excision, Ileostomy - Stoma, Ileostomy; Complications
- Trial name
- TIMES (NCT05284864)
- Testing
- Stoma closure
- Where
- 9 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Hospital Universitario La Fe
Bowel Obstruction, Bowel Ischemia
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of…
- Conditions
- Bowel Obstruction, Bowel Ischemia, Diverticulitis, Abnormality of the Gastrointestinal Tract
- Trial name
- NCT04709445
- Testing
- ICG-NIRF Imaging plus ingress and egress analysis
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Ileostomy - Stoma, Short Bowel Syndrome
Osmolality of Oral Supplements and Ileostomy Output
This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intestinal aquaporin expression in eight…
- Conditions
- Ileostomy - Stoma, Short Bowel Syndrome, Sodium Depletion, Nutritional Deficiency
- Trial name
- NCT03348709
- Testing
- Isoosmolar, Hyperosmolar
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- University of Aarhus
Stoma Colostomy, Stoma Ileostomy
Outcomes of Midline Stoma
Ileostomy or colostomy is a common surgical procedure used for diverting the lower gastrointestinal content away from distal pathology or anastomotic insufficiency.
- Trial name
- NCT07616830
- Testing
- Midline stoma
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Assiut University
LARS - Low Anterior Resection Syndrome
The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal
Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation…
- Trial name
- NCT07082699
- Testing
- antegrade enema, retrograde enema
- Volunteers
- 72 people
- Sponsor
- Sichuan Cancer Hospital and Research Institute
Colostomy Stoma, Ileostomy - Stoma
Needle-Aspirated Compression Dressing Following Ostomy Reversal
Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections.
- Conditions
- Colostomy Stoma, Ileostomy - Stoma, Surgical Site Infection, Wound Complication
- Trial name
- NCT03703661
- Testing
- Needle-Aspirated Negative Pressure Dressing, Control
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Colorectal Cancer, Bladder Cancer
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer…
- Conditions
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer
- Trial name
- PRISMS (NCT04492007)
- Testing
- Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Ileostomy
A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
The traditional positioning and surgical methods for temporary ileostomy no longer meet the requirements of minimally invasive surgery: (1) Conventional stoma positioning often leads to the trocar incision being too close to the…
- Trial name
- FUSION (NCT06604052)
- Testing
- Reduced-Port Fusion Surgery, Traditional surgery
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ileostomy; Complications, Ileostomy - Stoma
The Cascade Feasibility Pilot (Ileostomy)
Existing interventions including improving communication and self-care to improve readmission of patients undergoing high risk colorectal surgery involving new ileostomy formation has shown limited results.
- Trial name
- NCT05048329
- Testing
- Non-invasive continuous remote monitoring with structured escalation pathway, Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Endeavor Health
Short Bowel Syndrome, Short Gut Syndrome
A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the symptoms of Short Bowel Syndrome and reduce the…
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Bowel
- Trial name
- NCT02242656
- Testing
- Opium Tincture USP Deodorized
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
Peristomal Skin Complication
Preliminary Evaluation of CASTLE Barrier North American Prototype
The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.
- Trial name
- NCT01413672
- Testing
- Use of CASTLE barrier
- Where
- 5 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Hollister Incorporated
Rectal Neoplasms
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer
Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing anterior resections.
- Trial name
- NCT01980238
- Testing
- cannula ileostomy, loop ileostomy, LAR
- Where
- China
- Volunteers
- 300 people
- Sponsor
- First Affiliated Hospital of Zhejiang University