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NCT Number: NCT06225609

No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer

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 ghost ileostomy group versus no ileostomy group after total mesorectal excision for rectal cancer.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

So far, there are no relevant reports on ghost ileostomy among the Asian population, and all studies are small sample studies.In the past decades, with the advent of circular stapling devices, many middle and low rectal cancers have chosen new sphincter-saving procedures (such as ISR and Ta TME). Nevertheless, when the incidence rate of AL remains high, is diverting ileostomy applicable? Is ghost ileostomy applicable to rectal cancer in the context of new surgical procedures such as pelvic floor reconstruction, perineal drainage, anastomotic reinforcement and robotic surgery? Is this delayed stoma safe and feasible with the increase of preoperative neoadjuvant therapy? Therefore, our study proposes to summarize the review of the complications of GI and no stoma to explore the safety and effectiveness of GI in clinical practice.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pathologically confirmed rectal cancer.
  • age ≥18 years and ≤80 years.
  • intraoperative ghost ileostomy or no stoma was performed.

Exclusion criteria

  • ASA score >3.
  • Patients with coexisting complete intestinal obstruction.
  • History of long-term use of immunosuppressive drugs 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.

Treatment and study plan

Ghost ileostomy

Procedure

Laparoscopic or robotic surgery with ghost ileostomy

No ileostomy

Procedure

Laparoscopic or robotic surgery with no 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

    If the ghost ileostomy group required bed rest or a second surgery for ileostomy due to complications or no stoma group required a second surgery due to complications, the number of days of hospitalization due to complications and/or reoperation since total mesorectal excision for rectal cancer was recorded.

  2. Readmission rates

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

    Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.

  3. The number of hospitalizations

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

    Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.

  4. First hospitalization costs

    Time frame: During hospitalization,approximately 7 days

    Patient hospitalization costs for total mesorectal excision of rectal cancer.

  5. Total hospitalization costs

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

    Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the costs total mesorectal excision for rectal cancer, if the ghost ileostomy and no stoma groups 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 total mesorectal excision for rectal cancer.

Other outcomes

  1. Whether patients undergo terminal ostomy after total mesorectal excision for rectal cancer.

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

    Hartmann's procedure or for example, abdominoperineal extirpation

  2. The number of participants with ghost ileostomy converted to diverting ileostomy

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

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

  3. 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

    Patient undergoes second abdominal surgery for complications after first surgery

  4. Ghost ileostomy remove time

    Time frame: During hospitalization,approximately 7 days

    Duration of days from the date of total mesorectal excision of rectal cancer to ghost stoma removed.

  5. The number of patients with complications after total mesorectal excision 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,Intestinal fistula,Incisional hernia .

Sponsors and collaborators

Lead sponsor

fan li

Other

Registry information

Official study title

Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jan 26, 2024
Registry last updated
Jan 26, 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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