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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

500

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

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)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Estimated)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Rectal Neoplasms

Clinical Trials on Ghost ileostomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe