Clinical trials: Stoma Complications
Surgical Site Infection, Difference in Surgical Site Infection According to Gender and Age Groups
COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B…
- Trial name
- NCT04757623
- Testing
- Purse string closure of Ileostomy
- Where
- 2 sites in Pakistan
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Combined Military Hospital, Pakistan
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
Intestinal Stoma Site Hemorrhage, Intestinal Stoma Leakage
The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma
Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as…
- Conditions
- Intestinal Stoma Site Hemorrhage, Intestinal Stoma Leakage, Life Style, Healthy
- Trial name
- NCT06385613
- Testing
- Mobile-based stoma care education group
- Where
- Turkey (Türkiye)
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Ataturk 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
Incisional Hernia, Surgical Site Infection
Prophylactic Mesh Reinforcement for Stoma Closure
In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (SSIH),incidence of surgical site infection …
- Conditions
- Incisional Hernia, Surgical Site Infection, Postoperative Pain, Hospital Stay, Length of Stay in Hospital From Surgery to Discharge
- Trial name
- OASIS (NCT06157645)
- Testing
- Prolene mesh
- Where
- Egypt
- Volunteers
- 62 people
- Sponsor
- Assiut University
Neoplasms Malignant, Rectal Cancer
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair.
- Conditions
- Neoplasms Malignant, Rectal Cancer, Hernia Incisional, Surgery
- Trial name
- ProMeLAR (NCT05939687)
- Testing
- mesh, non-mesh
- Where
- Russia
- Volunteers
- 142 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Incisional Hernia, Ileostomy - Stoma
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak.
- Trial name
- NCT06511414
- Testing
- duramesh, Control
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Northwestern University
Stoma Site Infection, Ileostomy - Stoma
Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy
Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy and colostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose…
- Conditions
- Stoma Site Infection, Ileostomy - Stoma, Colostomy Stoma
- Trial name
- PRIC (NCT04974931)
- Testing
- PREVENA Incision Management System
- Where
- Ireland
- Volunteers
- 50 people
- Sponsor
- St. James's Hospital, Ireland
Peristomal Skin Complication
Preliminary Evaluation of CASTLE Barrier Prototype UK
The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.
- Trial name
- NCT01530087
- Testing
- CASTLE barrier
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Hollister Incorporated
Ileostomy - Stoma, Ileostomy; Complications
Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study
In this study 100 patients due to undergo surgery that will result in an ostomy will be provided with the Alfred SmartBag system.
- Trial name
- NCT03982875
- Testing
- Alfred SmartBag
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- 11 Heath and Technologies Limited
Intestinal Obstruction, Gastroschisis
Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis
Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine.
- Conditions
- Intestinal Obstruction, Gastroschisis, Enterocolitis, Necrotizing, Hirschsprung Disease
- Trial name
- StomaPed (NCT04213976)
- Testing
- Ileostomy
- Where
- 5 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
Rectal Cancer
Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)
This study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after LARfor rectal cancer.
- Trial name
- NCT04359498
- Where
- 8 sites in United States, Canada
- Volunteers
- 372 people
- Sponsor
- Safeheal
Ileostomy - Stoma, Ileostomy; Complications
Stimulation of the Efferent Loop Before Loop Ileostomy Closure
The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay
- Conditions
- Ileostomy - Stoma, Ileostomy; Complications, Stoma Ileostomy, Ileus Paralytic
- Trial name
- NCT03424447
- Testing
- efferent limb stimulation
- Where
- Spain
- Volunteers
- 140 people
- Sponsor
- Hospital de Basurto
Diverticulum, Colon, Colorectal Neoplasms
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- RETROPRESS (NCT01301417)
- Testing
- ColonRing™
- Where
- United States
- Volunteers
- 171 people
- Sponsor
- novoGI
Peristomal Skin Complication
Investigation of a New Stoma Product for People With a Stoma
The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects.
- Trial name
- CP288 (NCT04101318)
- Testing
- Non-Conformité Européene marked product, Conformité Européene marked competitor products
- Where
- Norway
- Volunteers
- 79 people
- Sponsor
- Coloplast A/S
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 - Stoma, Ileostomy; Complications
Evaluating Ileostomy Hydration Protocol
This is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at Robert Packer Hospital.
- Conditions
- Ileostomy - Stoma, Ileostomy; Complications, Dehydration
- Trial name
- NCT04669964
- Testing
- Intravenous Hydration
- Where
- United States
- Sponsor
- The Guthrie Clinic