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NCT Number: NCT06633133

Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

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

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daping Hospital, Third Military Medical University

Chongqing, 400042, China

Location status: Recruiting

Location contact

fan li, PhD

CONTACT

[email protected]

+86 023 68757958

About this study

This study is a national multicenter, large-sample, randomized controlled study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Virtual ileostomy

Procedure

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 outcomes

  1. Comprehensive Complication index (CCI) at the 6th postoperative month

    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

    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 outcomes

  1. Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative

    Time frame: 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.

  2. First postoperative complications

    Time frame: 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.

  3. Stoma-related complications

    Time frame: 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

  4. Complications after ileostomy closure

    Time frame: 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

  5. Postoperative hospitalization days(Initial and all subsequent hospitalizations)

    Time frame: 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.

  6. The number of hospitalizations(Initial and all subsequent hospitalizations)

    Time frame: 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.

  7. Duration of bearing the stoma (months)

    Time frame: 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.

  8. Total hospitalization costs(Initial and all subsequent hospitalizations)

    Time frame: 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.

  9. Number of participants with terminal ostomy

    Time frame: Through study completion, an average of 5 year

    Hartmann's procedure or for example, abdominoperineal extirpation，and transverse colostomy

  10. Number of Participants with unscheduled secondary surgery

    Time frame: Through study completion, an average of 5 year

    Patients performed unscheduled secondary surgery due to complications.

  11. The rate at which virtual ileostomy was converted to diverting ileostomy

    Time frame: 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

  12. Virtual ileostomy remove time(days)

    Time frame: During hospitalization,approximately 14 days

    Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.

  13. Bile acid concentration of drainage fluid

    Time frame: During hospitalization,approximately 7 days

    The investigators are monitoring the concentration of bile acids in the first postoperative drainage fluid.

  14. Number of participants with stoma (terminal/loop) at 6 months after initial surgery

    Time frame: 6 months from the date of first surgery for rectal cancer

    Patients carrying stoma 6 months after the first surgery for rectal cancer

  15. Interventional drainage rate

    Time frame: Through study completion, an average of 5 year

    Patient requires interventional drainage due to complications.

  16. Fecal Incontinence Scale(Wexner Score)

    Time frame: 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.

  17. Quality of life(EORTC QLQ-C30)

    Time frame: 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).

  18. Disease free survival (DFS)

    Time frame: Through study completion, an average of 5 year

    Disease free survival

  19. Overall survival (OS)

    Time frame: Through study completion, an average of 5 year

    Overall survival

  20. Rate of permanent ileostomy

    Time frame: From the date of first surgery,an average of 3 year

    Patients who underwent diverting Ileostomy were converted to permanent ileostomy.

  21. Completion of intended perioperative or adjuvant chemotherapy

    Time frame: Through study completion, an average of 5 year

    Completion of intended perioperative or adjuvant chemotherapy

  22. Low anterior resection syndrome for rectal cancer

    Time frame: 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.

  23. Quality of life for fecal incontinence

    Time frame: 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.

  24. Permanent ileostomy rate

    Time frame: 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.

  25. Mortality

    Time frame: 30 days from the date of first surgery for rectal cancer

    30-day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

fan li, PhD

CONTACT

[email protected]

18696539200

Sponsors and collaborators

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other

Registry information

Official study title

Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Oct 9, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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