Virtual Ileostomy Versus Conventional Loop Ileostomy

August 8, 2023 updated by: fan li, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection 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 versus conventional loop ileostomy after low anterior resection for rectal cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Diverting ileostomy (DI) is a common procedure performed in patients undergoing low anterior resection 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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China, 400042
        • Daping Hospital
      • Chongqing, China
        • Daping Hospital, Third Military Medical University

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 low to intermediate level rectal cancer, with the lower margin of anastomosis <10cm from the anus.
  • age ≥18 years and ≤80 years.
  • the surgical procedure is anterior rectal resection (LAR).
  • intraoperative virtual or conventional ileostomy was performed.

Exclusion Criteria:

  • BMI >30 kg/m².
  • 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 prior to 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: Virtual ileostomy
Laparoscopic or robotic surgery with virtual ileostomy
Procedure: Virtual ileostomy
Laparoscopic or robotic surgery with virtual ileostomy
Active Comparator: Diverting ileostomy
Laparoscopic or robotic surgery with diverting ileostomy
Procedure: Diverting ileostomy
Laparoscopic or robotic surgery with diverting 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 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.
An average of 1 year from the date of low anterior resection 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
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.
Through study completion, an average of 1 year
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.
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 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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
First hospitalization costs
Time Frame: During hospitalization,approximately 7 days
Patient hospitalization costs for radical resection of rectal cancer.
During hospitalization,approximately 7 days
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.
Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year
Patients with stoma (terminal/loop) at 6 months after initial surgery
Time Frame: 6 months from the date of low anterior resection for rectal cancer
Patients carrying stoma 6 months after low anterior resection for rectal cancer.
6 months from the date of low anterior resection for rectal cancer
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.
Through study completion, an average of 1 year
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
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.
During hospitalization,approximately 7 days
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.
Through study completion, an average of 1 year
Adjuvant chemotherapy in patients after low anterior resection for rectal cancer.
Time Frame: 6 months from the date of low anterior resection for rectal cancer
Whether the patient has completed chemotherapy.
6 months from the date of low anterior resection for rectal cancer

Collaborators and Investigators

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

Sponsor

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

Investigators

  • Principal Investigator: fan li, Daping Hospital, Third Military Medical University

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)

October 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-RCT

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 Virtual ileostomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe