An interventional study of Virtual ileostomy in Rectal Cancer, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are:
Participants will:
This study is a national multicenter, large-sample, randomized controlled study
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's planned enrollment of 620 is above the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 120 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.
Procedure: Virtual ileostomy
Diverting ileostomy (DI) is a common fecal diversion procedure performed in patients undergoing total mesorectal excision (TME) procedure for rectal cancer to protect the anastomosis and reduce the risk of complications.
A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.
Comprehensive Complication index (CCI) at the 6th postoperative month
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 6 month from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications
Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative
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: 5 year
First postoperative complications
First postoperative complications(including abdominal abscess, peritonitis, anastomotic leakage, anastomotic bleeding, pelvic infection, surgical incision infection, peritonitis, anastomotic stenosis, intestinal obstruction, peri-wound complications, incisional hernia, and others) 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: From the date of randomization until the date of discharge, an average of 7 to 14 days
Stoma-related complications
Wounds/abscesses/edema/dermatitis/ulcers around the diverting Ileostomy; parastomal hernia; stoma prolapse; acute kidney injury; dehydration/output \>1500 mL/day； other stoma-related complications
Time frame: Through study completion, an average of 5 year
Complications after ileostomy closure
Anastomotic leakage； intestinal anastomotic leakage； anastomotic stenosis; bowel obstruction; other wound complications （Wound dehiscence/bleeding/sinus tract/abscess/fat liquefaction）; burst abdomen (dehiscence of abdominal fascia); incisional hernia; fecal incontinence; reoperation; other complications
Time frame: Through study completion, an average of 5 year
Postoperative hospitalization days(Initial and all subsequent hospitalizations)
Patients in the virtual stoma group who did not have a second surgery due to complications recorded days of postoperative hospitalization after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record days of postoperative hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Time frame: Through study completion, an average of 5 year
The number of hospitalizations(Initial and all subsequent hospitalizations)
Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalizations after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Time frame: Through study completion, an average of 5 year
Duration of bearing the stoma (months)
If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the duration of bearing the stoma since the data of surgery of diverting ileostomy.
Time frame: Through study completion, an average of 5 year
Total hospitalization costs(Initial and all subsequent hospitalizations)
Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs after the first surgery for rectal cancer, if the virtual stoma group required bedside or secondary surgery for converted to diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the costs due to complications and reoperation since the data of the first surgery for rectal cancer.
Time frame: Through study completion, an average of 5 year
Number of participants with terminal ostomy
Hartmann's procedure or for example, abdominoperineal extirpation，and transverse colostomy
Time frame: Through study completion, an average of 5 year
Number of Participants with unscheduled secondary surgery
Patients performed unscheduled secondary surgery due to complications.
Time frame: Through study completion, an average of 5 year
The rate at which virtual ileostomy was converted to diverting ileostomy
The virtual ileostomy group required bedside or secondary surgery to convert to diverting ileostomy due to complications
Time frame: Through study completion, an average of 5 year
Virtual ileostomy remove time(days)
Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.
Time frame: During hospitalization,approximately 14 days
Bile acid concentration of drainage fluid
The investigators are monitoring the concentration of bile acids in the first postoperative drainage fluid.
Time frame: During hospitalization,approximately 7 days
Number of participants with stoma (terminal/loop) at 6 months after initial surgery
Patients carrying stoma 6 months after the first surgery for rectal cancer
Time frame: 6 months from the date of first surgery for rectal cancer
Interventional drainage rate
Patient requires interventional drainage due to complications.
Time frame: Through study completion, an average of 5 year
Fecal Incontinence Scale(Wexner Score)
The defecation function of all postoperative patients. Wexner score range is 0-20 points, with 0 points indicating normal and 20 points indicating complete incontinence.
Time frame: Through study completion, an average of 5 year
Quality of life(EORTC QLQ-C30)
The quality of life of all patients was assessed using relevant scales\[EORTC (The European Organization for Reasearch and Treatment of Cancer) QLQ-C30(Quality of Life Questionnare-Core 30)\]. The EORTC QLQ-C30 (V3. O) consists of 30 entries, which can be divided into 15 domains, including 5 functional domains (physical, role, cognitive, emotional, and social functions), 3 symptom domains (fatigue, pain, nausea, and vomiting), 1 overall health/quality of life domain, and 6 individual entries (each as a domain). EORTC QLQ-C30 has a total of 30 entries. Among them, entries 29 and 30 are divided into seven levels, ranging from 1 to 7 points based on their answer options; the other entries are divided into 4 levels: none(1 point), a little（2 points）, more（3 points）, many（4 points）. The QLQ-C30 scale is reversed except for items 29 and 30 (the higher the value, the worse the quality of life).
Time frame: Through study completion, an average of 5 year
Disease free survival (DFS)
Disease free survival
Time frame: Through study completion, an average of 5 year
Overall survival (OS)
Overall survival
Time frame: Through study completion, an average of 5 year
Rate of permanent ileostomy
Patients who underwent diverting Ileostomy were converted to permanent ileostomy.
Time frame: From the date of first surgery,an average of 3 year
Completion of intended perioperative or adjuvant chemotherapy
Completion of intended perioperative or adjuvant chemotherapy
Time frame: Through study completion, an average of 5 year
Low anterior resection syndrome for rectal cancer
The investigators use LARS scale to evaluate the patient's defecation function.The LARS rating scale consists of 5 questions: voiding incontinence, fluid voiding incontinence, frequency of voiding, voiding aggregation, and voiding urgency. 0-20 is classified as no LARS, 21-29 is classified as mild LARS, 30-42 is classified as severe LARS.
Time frame: Through study completion, an average of 5 year
Quality of life for fecal incontinence
The Fecal Incontinence Quality of Life Scale (FIQL) is mainly used to evaluate the quality of life of patients with fecal incontinence. It includes four main aspects: lifestyle changes, psychological coping/behavioral limitations, depression/self-perception, and social embarrassment. The FIQL is analyzed as a total score; the higher the patient's score, the higher the patient's quality of life.
Time frame: Through study completion, an average of 5 year
Permanent ileostomy rate
Patients with diverting ileostomy who underwent sphincter-saving surgery for rectal cancer were converted to permanent ileostomy.
Time frame: 3 years from the date of first surgery for rectal cancer
Mortality
30-day mortality
Time frame: 30 days from the date of first surgery for rectal cancer
Plan to share: No
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