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Virtual Ileostomy Versus Conventional Loop Ileostomy

Primary Purpose

Rectal Neoplasms

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Virtual ileostomy
Diverting ileostomy
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring Virtual ileostomy, Diverting ileostomy, Rectal Neoplasms, Rectosigmoid junction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Daping hospital
  • Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual ileostomy

Diverting ileostomy

Arm Description

Laparoscopic or robotic surgery with virtual ileostomy

Laparoscopic or robotic surgery with diverting ileostomy

Outcomes

Primary Outcome Measures

Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
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 Outcome Measures

Postoperative hospitalization days
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.
Readmission rates
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.
The number of hospitalizations
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.
Duration of bearing the stoma (months)
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.
First hospitalization costs
Patient hospitalization costs for radical resection of rectal cancer.
Total hospitalization costs
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.

Full Information

First Posted
July 14, 2023
Last Updated
August 8, 2023
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05985252
Brief Title
Virtual Ileostomy Versus Conventional Loop Ileostomy
Official Title
Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection for Rectal Cancer: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Virtual ileostomy, Diverting ileostomy, Rectal Neoplasms, Rectosigmoid junction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual ileostomy
Arm Type
Experimental
Arm Description
Laparoscopic or robotic surgery with virtual ileostomy
Arm Title
Diverting ileostomy
Arm Type
Active Comparator
Arm Description
Laparoscopic or robotic surgery with diverting ileostomy
Intervention Type
Procedure
Intervention Name(s)
Virtual ileostomy
Intervention Description
Laparoscopic or robotic surgery with virtual ileostomy
Intervention Type
Procedure
Intervention Name(s)
Diverting ileostomy
Intervention Description
Laparoscopic or robotic surgery with diverting ileostomy
Primary Outcome Measure Information:
Title
Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
Description
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.
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
Secondary Outcome Measure Information:
Title
Postoperative hospitalization days
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Readmission rates
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
The number of hospitalizations
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Duration of bearing the stoma (months)
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
First hospitalization costs
Description
Patient hospitalization costs for radical resection of rectal cancer.
Time Frame
During hospitalization,approximately 7 days
Title
Total hospitalization costs
Description
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.
Time Frame
Through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Whether patients undergo terminal ostomy after low anterior resection for rectal cancer.
Description
Hartmann's procedure or for example, abdominoperineal extirpation
Time Frame
Through study completion, an average of 1 year
Title
Patients with stoma (terminal/loop) at 6 months after initial surgery
Description
Patients carrying stoma 6 months after low anterior resection for rectal cancer.
Time Frame
6 months from the date of low anterior resection for rectal cancer
Title
The number of participants with virtual ileostomy converted to diverting ileostomy
Description
The virtual stoma required bedside or secondary surgery for diverting ileostomy due to complications.
Time Frame
Through study completion, an average of 1 year
Title
The number of patients who required secondary abdominal surgery under general anesthesia due to complications
Description
Patient undergoes second abdominal surgery for complications after first surgery
Time Frame
Through study completion, an average of 1 year
Title
Ghost ileostomy remove time
Description
Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.
Time Frame
During hospitalization,approximately 7 days
Title
The number of patients with complications after low anterior resection for rectal cancer
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Adjuvant chemotherapy in patients after low anterior resection for rectal cancer.
Description
Whether the patient has completed chemotherapy.
Time Frame
6 months from the date of low anterior resection for rectal cancer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fan li
Phone
+86 023 68757958
Email
levinecq@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fan li
Organizational Affiliation
Daping Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping hospital
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Virtual Ileostomy Versus Conventional Loop Ileostomy

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