Clinical trials: Ileostomy; Complications
Wound Infection
A Randomized Trial of Ostomy Closure Techniques
Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clean-contaminated operative…
- Trial name
- NCT01713452
- Testing
- Purse string closure, Primary closure
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- University of Minnesota
Stoma - Ileostomy, Stoma Colostomy
Vıdeo-Assısted Stoma Care Traınıng Gıven To Patıents Wıth Stoma Adaptıng To Stoma and Complıcatıons
Objective: The aim of this study is to evaluate the effects of video-assisted stoma care training given to patients with stoma on postoperative anxiety, stoma compliance and complications.
- Conditions
- Stoma - Ileostomy, Stoma Colostomy, Stoma, Education of Patients
- Trial name
- NCT06672211
- Testing
- video-supported training
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people
- Sponsor
- Hatay Training and Research Hospital
Diverting Ileostomy, Middle and Low Rectal Cancer
Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery
Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.
- Conditions
- Diverting Ileostomy, Middle and Low Rectal Cancer, Functional Outcome, Stoma Complications
- Trial name
- NCT04776421
- Testing
- Diverting ileostomy
- Volunteers
- 300 people
- Sponsor
- The First Hospital of Jilin 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
Incisional Hernia of Anterior Abdominal Wall
Phasix Mesh Underlay During Loop Ileostomy Closure
This prospective study will evaluate whether placement of long-acting absorbable Phasix mesh during loop ileostomy closure reduces the development of an incisional hernia at the ileostomy closure site in patients with a BMI…
- Trial name
- NCT07871630
- Testing
- Long-acting absorbable mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Corewell Health West
Inflammatory Bowel Diseases, Ileostomy
Malnutrition Associated With Complications After Ileostomy Reversal
An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body.
- Trial name
- NCT03909542
- Where
- United States
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Rectal Neoplasms, Low Anterior Resection
Use of One Kind of Controllable Tube Ileostomy in the Low 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 low anterior resections(LAR).
- Trial name
- CTI (NCT02012023)
- Testing
- Low anterior resection, tube ileostomy, loop ileostomy
- Where
- China
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Ileostomy - Stoma
Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications
The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing readmission rates of subjects with new ileostomies in the first 30 days post-operatively.
- Trial name
- NCT02694757
- Testing
- Ostom-i device
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Massachusetts General Hospital
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
Rectal Cancer, Ulcerative Colitis
Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Short Bowel Syndrome
- Trial name
- NCT02266849
- Testing
- Loperamide
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Odense University Hospital
Incisional Hernia
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer
- Trial name
- ILEOMESH (NCT02896686)
- Testing
- Control CT, Clinical Follow Up, Reinforcement with Light Polypropylene Mesh
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Hospital Universitari Joan XXIII de Tarragona.
Ileostomy; Complications
"Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study
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
- NCT06010043
- Testing
- Suturing of ileostomy using "Dumpling suture method", Suturing of ileostomy using Traditional suture method
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Surgical Wound Infection
Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure
1. Introduction: The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%).
- Trial name
- NCT02574702
- Testing
- application of a contralateral drainage (Penrose ® device)
- Where
- Spain
- Volunteers
- 78 people
- Sponsor
- Corporacion Parc Tauli
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
Surgery, Stoma Ileostomy
Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care.
- Trial name
- Tapas (NCT03971513)
- Testing
- Trans abdominal plane
- Where
- 2 sites in France
- Volunteers
- 149 people
- Sponsor
- University Hospital, Clermont-Ferrand
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 Cancer Patients, Anastomotic Leakage
CRP/CT-Guided Selective Ileostomy After LAR
This single-center, parallel-group randomized controlled trial compared routine diverting loop ileostomy with a postoperative CRP/CT-guided selective ileostomy strategy in adults undergoing laparoscopic low anterior resection for…
- Conditions
- Rectal Cancer Patients, Anastomotic Leakage, Low Anterior Resection
- Trial name
- less stoma (NCT07722533)
- Testing
- Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy, routine follow up
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Alexandria University
Ileostomy - Stoma, Ileostomy; Complications
Laparoscopic Surgery of Rectal Cancer and Ileostomy
Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of…
- Conditions
- Ileostomy - Stoma, Ileostomy; Complications, Leakage, Anastomotic
- Trial name
- NCT04169425
- Testing
- elective diverting ileostomy
- Volunteers
- 150 people
- Sponsor
- Campus Bio-Medico University
Ileostomy Closure, Gum Chewing
Chewing Gum vs Honey in Postoperative Recovery After Ileostomy Reversal: A Study Comparing Their Effects on Bowel Function, Complications, and Hospital Stay
Title: Comparison of the effect of chewing gum and honey on postoperative recovery and complications in ileostomy reversal - a pilot randomized controlled trial Background: Ileostomy reversal is associated with postoperative…
- Conditions
- Ileostomy Closure, Gum Chewing, Honey, Postoperative Recovery
- Trial name
- NCT07144969
- Testing
- Honey, gum chewing
- Where
- Pakistan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mayo Hospital Lahore
Ileostomy, Colorectal Surgery
Early vs Standard Ileostomy Reversal
This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes.
- Trial name
- NCT07601594
- Testing
- Ileostomy reversal
- Where
- Pakistan
- Volunteers
- 90 people
- Sponsor
- Gulab Devi Hospital