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Trial Title:
Virtual Ileostomy Versus Conventional Loop Ileostomy
NCT ID:
NCT05985252
Condition:
Rectal Neoplasms
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Virtual ileostomy
Diverting ileostomy
Rectal Neoplasms
Rectosigmoid junction
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Virtual ileostomy
Description:
Laparoscopic or robotic surgery with virtual ileostomy
Arm group label:
Virtual ileostomy
Intervention type:
Procedure
Intervention name:
Diverting ileostomy
Description:
Laparoscopic or robotic surgery with diverting ileostomy
Arm group label:
Diverting ileostomy
Summary:
This study aimed at comparing the Comprehensive Complication Index (CCI), readmission
rates, postoperative hospitalization days, duration of bearing the stoma (months),
hospitalization costs, the number of hospitalizations with ghost ileostomy versus
conventional loop ileostomy after low anterior resection for rectal cancer.
Detailed description:
Diverting ileostomy (DI) is a common procedure performed in patients undergoing low
anterior resection for rectal cancer to protect the anastomosis and reduce the risk of
complications. Although DI remains one of the most common methods used in clinical
practice to prevent anastomotic leakage, there is still considerable debate in clinical
practice about whether to perform a routine ileostomy. Despite temporary ileostomy fecal
diversion can reduce the development of abdominal abscesses, wound inflammation,
peritonitis, and sepsis after the occurrence of AL, however, it not only failed to reduce
the incidence of AL but significantly increased the risk of non-elective readmissions and
reinterventions as well as higher total costs. Meanwhile, stoma significantly increase
the risk of stoma-related complication such as small bowel obstruction, postoperative
ileus, dehydration from high-output stoma culminating in acute kidney injury, electrolyte
imbalance, stoma stenosis/ necrosis, parastomal hernia, peristomal abscess, and fistula,
etc.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed low to intermediate level rectal cancer, with the lower
margin of anastomosis <10cm from the anus.
- age ≥18 years and ≤80 years.
- the surgical procedure is anterior rectal resection (LAR).
- intraoperative virtual or conventional ileostomy was performed.
Exclusion Criteria:
- BMI >30 kg/m².
- ASA score >3.
- Patients with coexisting complete intestinal obstruction.
- History of long-term use of immunosuppressive drugs or glucocorticoids.
- Combined severe cardiac disease: with congestive heart failure or NYHA cardiac
function ≥ grade 2. Patients with a history of myocardial infarction or coronary
artery surgery within 6 months prior to the procedure.
- chronic renal failure (requiring dialysis or glomerular filtration rate <30 mL/min).
Intraoperative combined multi-organ resection.
- Combined cirrhosis of the liver.
- Intraoperative findings of incomplete anastomosis and positive insufflation test.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Daping hospital
Address:
City:
Chongqing
Zip:
400042
Country:
China
Facility:
Name:
Daping Hospital, Third Military Medical University
Address:
City:
Chongqing
Country:
China
Start date:
October 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Agency class:
Other
Source:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05985252
