Clinical trials: Stoma
Colo-rectal Cancer, Rectal Prolapse
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been…
- Conditions
- Colo-rectal Cancer, Rectal Prolapse, Colostomy Stoma, Colorectal Disorders
- Trial name
- NCT05321134
- Testing
- Single port robotic colorectal surgical procedure
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of California, Davis
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
Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being…
- Trial name
- ILEO (NCT03941522)
- Testing
- Early discharge from hospital
- Where
- 2 sites in Canada
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Ostomy
Effectiveness of Remote Self-care Education for Ostomy Patients
The primary aim of this study is to evaluate whether remote education is as effective as in-person education in improving self-care behaviors of ostomy patients.
- Trial name
- SELF-STOMA (NCT05796544)
- Testing
- Remote self-care education, In-person self-care education
- Where
- 5 sites in Italy
- Volunteers
- 384 people
- Sponsor
- University of Rome Tor Vergata
Ileostomy - Stoma
A New Method for Ileostomy Output Collection Using an Intestinal Tampon
The goal of this interventional study is to learn if a specialized absorbent intestinal tampon can effectively collect ileostomy output.
- Trial name
- NCT06897163
- Testing
- Specialized Absorbent Intestinal Tampon
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Ampa Medical
Stoma Care, Nursing Education
Immersive Virtual Reality Training for Stoma Care
This study investigates the effectiveness of immersive virtual reality (VR) training in stoma care on nurses' knowledge, skills, self-efficacy, and learning satisfaction.
- Trial name
- IVRT_SC (NCT07677592)
- Testing
- immersive virtual reality training program, traditional classroom lecture
- Where
- Taiwan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Colostomy - Stoma, Stoma Reversal Procedure
Pediatric Colostomy Reversal: Traditional Care vs. Enhanced Recovery After Surgery
The goal of this clinical trial is to learn whether using an Enhanced Recovery After Surgery (ERAS) protocol helps children recover faster after colostomy reversal compared with traditional care.
- Conditions
- Colostomy - Stoma, Stoma Reversal Procedure, ERAS
- Trial name
- NCT07206836
- Testing
- Enhanced Recovery after Surgery Protocol, Traditional Care Protocol
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Children Hospital Faisalabad
Ileus, Bowel Obstruction
Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients. Stomas are frequently created in conjunction with major colorectal surgery.
- Trial name
- NCT01911793
- Testing
- Stoma Tube
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cedars-Sinai Medical Center
Stoma Ileostomy
Evaluation of the Peel Force of New Adhesives From the Skin
This study investigates the impact and adhesion of new adhesives to the skin.
- Trial name
- NCT03200444
- Testing
- Standard adhesive 1, Standard adhesive 2, Standard adhesive 3
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
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
Ileostomy - Stoma, Rectal Neoplasms
Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy
In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection.
- Trial name
- NCT06344923
- Testing
- Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing, Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Qilu Hospital of Shandong University
Ileostomy - Stoma
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
- Trial name
- NCT03416023
- Testing
- TIES® (Transcutaneous Implant Evacuation System)
- Where
- 4 sites in Sweden, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Ostomycure AB
Parastomal Hernia
Stoma Hernia Intraperitoneal Full-Thickness Skin
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
- Trial name
- SHIFT (NCT03667287)
- Testing
- Repair of parastomal hernia
- Where
- 2 sites in Sweden
- Volunteers
- 90 people
- Sponsor
- Umeå University
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
Ileostomy, Rectal Cancer
The Stoma Closure Before or After Adjuvant Therapy Trial
This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it).
- Trial name
- STOMAD (NCT04372992)
- Testing
- Timing of stoma closure
- Where
- 28 sites in Italy
- Volunteers
- 14 people
- Sponsor
- Ospedale Umberto I di Torino
Colostomy Stoma
Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment.
- Trial name
- NCT05466721
- Testing
- Hydrustoma C3, Coloplast Alterna
- Where
- 6 sites in Portugal
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Hydrumedical
Surgical Stomas
Construction and Evaluation of a Stoma Patient Continuous Care Network
Construct a professional network platformof continuous care for patients with enterostomy and evaluate its availability， Eventually, patients with enterostomy will have access to care outside the hospital.
- Trial name
- NCT04682028
- Testing
- professional care, coventional care
- Where
- China
- Volunteers
- 200 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Rectal Neoplasms, Ostomy
Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy
The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.
- Conditions
- Rectal Neoplasms, Ostomy, Neoplasms
- Trial name
- LIVELOC (NCT05745909)
- Testing
- Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy, Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy
- Where
- Russia
- Volunteers
- 150 people
- Sponsor
- Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
Rehabilitation
Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients
This is a randomized, controlled trial aiming to assess the effects of preoperative education using stoma appliance on stoma self-care, quality of life, anxiety, and depression levels in colorectal cancer patients with a stoma.
- Trial name
- NCT05958433
- Testing
- Rehabilitation with stoma appliance
- Volunteers
- 170 people
- Sponsor
- Assiut University
Ostomy
Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients.
- Trial name
- Stomie 3D (NCT04326335)
- Testing
- Felt-tip marking, Felt-tip marking + 3D printed ostomy button
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Departemental Vendee