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Completed

NCT Number: NCT05985239

Virtual Ileostomy Versus Diverting Ileostomy

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 virtual ileostomy versus conventional divertingileostomy after total mesorectal excision for rectal cancer.

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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

Observational

Primary location

Daping Hospital, Third Military Medical University

Chongqing, 400042, China

About this study

Diverting ileostomy (DI) is a common procedure performed in patients undergoing total mesorectal excision for rectal cancer to protect the anastomosis and reduce the risk of complications. Although DI remains one of the most common methods used in clinical practice to prevent anastomotic leakage, there is still considerable debate in clinical practice about whether to perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly increased the risk of non-elective readmissions and reinterventions as well as higher total costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia, peristomal abscess, and fistula, etc.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of rectal cancer confirmed by pathology
  • Age ≥ 18 years
  • Lap/robot 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)
  • 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
  • missing information

Treatment and study plan

VI

Procedure

Laparoscopic or robotic surgery with virtual ileostomy

DI

Procedure

Laparoscopic or robotic surgery with virtual ileostomy

Primary outcomes

  1. Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient

    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 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. Postoperative hospitalization days

    Time frame: Through study completion, an average of 1 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.

  2. Readmission rates

    Time frame: Through study completion, an average of 1 year

    Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of 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 the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.

  3. The number of hospitalizations

    Time frame: Through study completion, an average of 1 year

    Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of 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 the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.

  4. Duration of bearing the stoma (months)

    Time frame: Through study completion, an average of 1 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.

  5. First hospitalization costs

    Time frame: During hospitalization,approximately 7 days

    Patient hospitalization costs for radical resection of rectal cancer.

  6. Total hospitalization costs

    Time frame: Through study completion, an average of 1 year

    Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs 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 costs due to complications and reoperation since the data of low anterior resection for rectal cancer.

Other outcomes

  1. Whether patients undergo terminal ostomy after low anterior resection for rectal cancer.

    Time frame: Through study completion, an average of 1 year

    Hartmann's procedure or for example, abdominoperineal extirpation

  2. Patients with stoma (terminal/loop) at 6 months after initial surgery.

    Time frame: 6 months from the date of total mesorectal excision for rectal cancer

    Patients carrying stoma 6 months after low anterior resection for rectal cancer.

  3. The number of participants with virtual ileostomy converted to diverting ileostomy.

    Time frame: Through study completion, an average of 1 year

    The virtual stoma required bedside or secondary surgery for diverting ileostomy due to complications.

  4. The number of patients who required secondary abdominal surgery under general anesthesia due to complications

    Time frame: Through study completion, an average of 1 year

    Patients undergo second abdominal surgery for complications after low anterior resection for rectal cancer.

  5. Ghost ileostomy remove time

    Time frame: During hospitalization,approximately 7 days

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

  6. The number of patients with complications after low anterior resection for rectal cancer.

    Time frame: Through study completion, an average of 1 year

    Abdominal abscess,Anastomotic bleeding,Pelvic infection,Surgical incision infection, Peritonitis,Interventional drainage ,ileostomy wounds/abscesses/edema/dermatitis/ ulcers,Parastomal hernia ,Stoma prolapse,Anastomotic separation/poor healing, Anastomotic stenosis,Anastomotic leakage,Bowel obstruction,Anastomotic bowel necrosis ,Wound dehiscence / bleeding / sinus tract / abscess/fat liquefaction,Acute kidney injury ,Dehydration/output >1500 mL/day,Converted to permanent ileostomy,Intestinal fistula,Incisional hernia ,fecal incontinence.

  7. Adjuvant chemotherapy in patients after low anterior resection for rectal cancer.

    Time frame: 6 months from the date of total mesorectal excision for rectal cancer

    Whether the patient has completed chemotherapy.

Sponsors and collaborators

Lead sponsor

fan li

Other

Registry information

Official study title

Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Underwent Total Mesorectal Excision for Rectal Cancer: a Propensity-matched Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Oct 15, 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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