Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

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