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

January 17, 2024 updated by: fan li

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ghost ileostomy
Laparoscopic or robotic surgery with ghost ileostomy
Procedure: Ghost ileostomy
Laparoscopic or robotic surgery with ghost ileostomy
Active Comparator: No ileostomy
Laparoscopic or robotic surgery with no ileostomy
Procedure: No ileostomy
Laparoscopic or robotic surgery with no ileostomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
First hospitalization costs
Time Frame: During hospitalization,approximately 7 days
Patient hospitalization costs for total mesorectal excision of rectal cancer.
During hospitalization,approximately 7 days
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.
Through study completion, an average of 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
During hospitalization,approximately 7 days
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 .
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
fan li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ghost 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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