Clinical trials: Stoma Complications
Incisional Hernia
Reducing the Incidence of Incisional Hernia After Stoma Closure Using a Prophylactic Mesh
Background: Preliminary studies have shown that application of a prophylactic mesh during stoma closure reduces the incidence of incisional hernia at site of stoma closure.
- Trial name
- PROMESH (NCT04510558)
- Testing
- Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position, Stoma closure without mesh
- Where
- Switzerland
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Nurse's Role, Patient Compliance
The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Lesions
To explore the effect of the Stoma Mobile application-based training method on the psychosocial adjustment, self-efficacy, and development of peristomal skin complications in individuals with a stoma.
- Conditions
- Nurse's Role, Patient Compliance, Peristomal Skin Complication, Self Efficacy
- Trial name
- NCT05664503
- Testing
- Assigned Interventions STOMA-M
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Istanbul University
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
Stoma Ileostomy, Surgical Wound
The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery
Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear.
- Conditions
- Stoma Ileostomy, Surgical Wound, Negative Pressure Wound Therapy, Postoperative Wound Infection
- Trial name
- NCT04088162
- Testing
- Postoperative Negative Pressure Wound Therapy KCI NANOVA
- Where
- 2 sites in Poland
- Volunteers
- 70 people
- Sponsor
- Michał Pędziwiatr
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
TME, Rectal Cancer Surgery
REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of…
- Conditions
- TME, Rectal Cancer Surgery, Low Rectal Cancer, Middle Rectal Cancer
- Trial name
- RELOAD (NCT07463261)
- Testing
- Without a preventive stoma, With a preventive stoma
- Where
- 7 sites in Russia
- Volunteers
- 442 people
- Sponsor
- ANO Scientific and Practical Club for the Development of Modern Medical Technologies
Stoma Ileostomy, Ileostomy; Complications
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy…
- Trial name
- NCT06461559
- Testing
- antegrade infusion of ileostomy content
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Diego
Rectal Cancer, Anastomotic Leakage
Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection
The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior…
- Trial name
- SC-Stoma (NCT07605611)
- Testing
- Somatostatin, Clear Liquid Diet, Prophylactic Diverting Stoma
- Where
- 3 sites in China
- Volunteers
- 72 people
- Sponsor
- Tongji Hospital
Incisional Hernia, Parastomal Hernia
Hernia Prevention in Stomas
Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or…
- Trial name
- NCT00907842
- Testing
- Parietex Parastomal Mesh
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- Marc Schreinemacher
Incisional Hernia
PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial
Rationale: Approximately 7000 stomata are created in the Netherlands every year. The occurrence of a parastomal herniation is high, with a reported incidence of 4-48%.
- Trial name
- PROMISS (NCT03750942)
- Testing
- Adhesix® monofilament polypropylene mesh (Bard Davol)
- Where
- Netherlands
- Volunteers
- 130 people
- Sponsor
- Maastricht University Medical Center
Ileostomy - Stoma, Rectal Cancer
Early Ileostomy Closure for Rectal Cancer Patients in North America
Our preliminary work demonstrates that there is buy-in from both patients and surgeons with regards to early ileostomy closure (EIC) for select rectal cancer patients undergoing restorative proctectomy (RP) and diverting loop…
- Trial name
- NCT05027737
- Testing
- Early Ileostomy Closure
- Where
- 4 sites in Canada
- Volunteers
- 118 people
- Sponsor
- Jewish General Hospital
Ostomy, Enterocutaneous Fistula
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients.
- Trial name
- NCT06524401
- Testing
- Limpet, Control
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- HealthPartners Institute
Anastomotic Complication, Anastomotic Leak Small Intestine
Open Abdomen and Delayed Anastomosis After Anastomotic Dehiscences to Avoid Stomas
Phase III clinical trial to evaluate the efficacy of the open abdomen as bridging therapy to perform transit reconstruction in patients with anastomotic dehiscence.
- Conditions
- Anastomotic Complication, Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine
- Trial name
- STOP-STOMA (NCT05233995)
- Testing
- Damage Control Surgery
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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
Stoma Closure, Postoperative Pain
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure
After stoma closure, pain remains an important problem affecting patient recovery. A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed…
- Conditions
- Stoma Closure, Postoperative Pain, Quality of Recovery
- Trial name
- r-PVB III (NCT07571902)
- Testing
- Revised-Paravertebral Nerve Block
- Volunteers
- 250 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Feeding Tube Complication
Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
The purpose of the study is to collect safety and efficacy data on the performance of the study stoma site accessory when used to prevent abdominal wall leakage for patients with a long term feeding tube.
- Trial name
- SSA (NCT05288556)
- Testing
- Placement of stoma site enteral feeding tube accessory
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Eric Yudelevich
Parastomal Hernia, Rectal Surgery
A Prospective Randomized Controlled Trial Comparing Extraperitoneal Stoma Creation Via the Arcuate Line Approach Versus Conventional Transperitoneal Stoma Formation for the Prevention of Parastomal Hernia
This study is a prospective, randomized controlled trial designed to compare two surgical techniques for stoma creation in patients undergoing colorectal surgery.
- Conditions
- Parastomal Hernia, Rectal Surgery, Stoma Complications, Extraperitoneal Stoma
- Trial name
- NCT07056868
- Testing
- extraperitoneal colostomy, transperitoneal colostomy
- Volunteers
- 200 people
- Sponsor
- Qilu Hospital of Shandong University
Ostomy - Ileostomy or Colostomy, Stoma Complications
Suture Choice for Ostomy Creation
The goal of this clinical trial is to learn whether chromic gut or polyglactin 910 suture results in fewer stoma complications when used to mature an enterostomy in patients undergoing planned ostomy creation.
- Conditions
- Ostomy - Ileostomy or Colostomy, Stoma Complications, Stoma Site Dermatitis, Stoma Site Infection
- Trial name
- NCT07900711
- Testing
- Chromic Gut Suture, Polyglactin 910 Suture
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Southern California
Low Anterior Resection Syndrome
The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure
This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional…
- Trial name
- NCT06569966
- Testing
- preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon
- Where
- China
- Volunteers
- 154 people
- Sponsor
- The Affiliated Hospital of Qingdao University
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