No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer
ConditionRectal Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
Sponsorfan li
About this trial
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 group versus no ileostomy group after total mesorectal excision for rectal cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pathologically confirmed rectal cancer.
age ≥18 years and ≤80 years.
intraoperative ghost ileostomy or no stoma was performed.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ghost ileostomy
Procedure/SurgeryLaparoscopic or robotic surgery with ghost ileostomy
No ileostomy
Procedure/SurgeryLaparoscopic or robotic surgery with no ileostomy
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Ghost ileostomyExperimental treatment 1 intervention
Group B: No ileostomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
Time frame
An average of 1 year from the date of total mesorectal excision for rectal cancer until the date of when the patient's condition is stabilized without complicationsSecondary outcomes
1
Postoperative hospitalization days
If the ghost ileostomy group required bed rest or a second surgery for ileostomy due to complications or no stoma group required a second surgery due to complications, the number of days of hospitalization due to complications and/or reoperation since total mesorectal excision for rectal cancer was recorded.
Time frame
Through study completion, an average of 1 year2
Readmission rates
Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.
Time frame
Through study completion, an average of 1 year3
The number of hospitalizations
Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.
Time frame
Through study completion, an average of 1 year4
First hospitalization costs
Patient hospitalization costs for total mesorectal excision of rectal cancer.
Time frame
During hospitalization,approximately 7 daysOther outcomes
1
Whether patients undergo terminal ostomy after total mesorectal excision for rectal cancer.
Hartmann's procedure or for example, abdominoperineal extirpation
Time frame
Through study completion, an average of 1 year2
The number of participants with ghost ileostomy converted to diverting ileostomy
The ghost stoma required bedside or secondary surgery for diverting ileostomy due to complications.
Time frame
Through study completion, an average of 1 year3
The number of patients who required secondary abdominal surgery under general anesthesia due to complications
Patient undergoes second abdominal surgery for complications after first surgery
Time frame
Through study completion, an average of 1 year4
Ghost ileostomy remove time
Duration of days from the date of total mesorectal excision of rectal cancer to ghost stoma removed.
Time frame
During hospitalization,approximately 7 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
fan li
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor institution
Source ClinicalTrials.gov
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