Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Virtual ileostomy
- Registration Number
- NCT06633133
- Lead Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Brief Summary
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:
* Is the virtual ileostomy a safe and effective alternative to the ileostomy?
* Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma.
Participants will:
* Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer
* Continuous follow-up of their complications after the first surgery
- Detailed Description
This study is a national multicenter, large-sample, randomized controlled study
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 620
- Diagnosis of rectal cancer confirmed by pathology
- Age ≥ 18 years
- Total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis：1.anterior resection (AR/ PME), 2. low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)
- Signed informed consent
- Ability to understand the nature and risks of participating in the trial
- Emergency surgery, open surgery
- ASA score >3points
- Patients with combined complete intestinal obstruction
- Long-term history of using immunosuppressants 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 before 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
- Modified Bacon procedure(Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis)
- Due to an intraoperative accident the surgeon felt that a diverting ileostomy was necessary.
- Currently participating in other clinical trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual ileostomy Virtual ileostomy 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.
- Primary Outcome Measures
Name Time Method Comprehensive Complication index (CCI) at the 6th postoperative month 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 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.
- Secondary Outcome Measures
Name Time Method Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative 5 year 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.
First postoperative complications From the date of randomization until the date of discharge, an average of 7 to 14 days 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.
Stoma-related complications Through study completion, an average of 5 year 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
Complications after ileostomy closure Through study completion, an average of 5 year 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
Postoperative hospitalization days(Initial and all subsequent hospitalizations) Through study completion, an average of 5 year 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.
The number of hospitalizations(Initial and all subsequent hospitalizations) Through study completion, an average of 5 year 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.
Duration of bearing the stoma (months) Through study completion, an average of 5 year 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.
Total hospitalization costs(Initial and all subsequent hospitalizations) Through study completion, an average of 5 year 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.
Number of participants with terminal ostomy Through study completion, an average of 5 year Hartmann's procedure or for example, abdominoperineal extirpation，and transverse colostomy
Number of Participants with unscheduled secondary surgery Through study completion, an average of 5 year Patients performed unscheduled secondary surgery due to complications.
The rate at which virtual ileostomy was converted to diverting ileostomy Through study completion, an average of 5 year The virtual ileostomy group required bedside or secondary surgery to convert to diverting ileostomy due to complications
Virtual ileostomy remove time(days) During hospitalization,approximately 14 days Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.
Bile acid concentration of drainage fluid During hospitalization,approximately 7 days The investigators are monitoring the concentration of bile acids in the first postoperative drainage fluid.
Number of participants with stoma (terminal/loop) at 6 months after initial surgery 6 months from the date of first surgery for rectal cancer Patients carrying stoma 6 months after the first surgery for rectal cancer
Interventional drainage rate Through study completion, an average of 5 year Patient requires interventional drainage due to complications.
Fecal Incontinence Scale(Wexner Score) Through study completion, an average of 5 year 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.
Quality of life(EORTC QLQ-C30) Through study completion, an average of 5 year 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).
Disease free survival (DFS) Through study completion, an average of 5 year Disease free survival
Overall survival (OS) Through study completion, an average of 5 year Overall survival
Rate of permanent ileostomy From the date of first surgery,an average of 3 year Patients who underwent diverting Ileostomy were converted to permanent ileostomy.
Completion of intended perioperative or adjuvant chemotherapy Through study completion, an average of 5 year Completion of intended perioperative or adjuvant chemotherapy
Low anterior resection syndrome for rectal cancer Through study completion, an average of 5 year 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.
Quality of life for fecal incontinence Through study completion, an average of 5 year 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.
Permanent ileostomy rate 3 years from the date of first surgery for rectal cancer Patients with diverting ileostomy who underwent sphincter-saving surgery for rectal cancer were converted to permanent ileostomy.
Mortality 30 days from the date of first surgery for rectal cancer 30-day mortality
Trial Locations
- Locations (1)
Daping Hospital, Third Military Medical University
🇨🇳Chongqing, China