Virtual Ileostomy Versus Conventional Loop Ileostomy

Sponsor

fan li (Other)

Overall Status

Recruiting

CT.gov ID

NCT05985239

Collaborator

(none)

400

Enrollment

Location

9.9

Anticipated Duration (Months)

40.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms	Procedure: VI Procedure: DI

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection for Rectal Cancer: a Single-center Retrospective Study

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Virtual ileostomy Laparoscopic or robotic surgery with virtual ileostomy	Procedure: VI Laparoscopic or robotic surgery with virtual ileostomy
Diverting ileostomy Laparoscopic or robotic surgery with diverting ileostomy	Procedure: DI Laparoscopic or robotic surgery with virtual ileostomy

Arm

Intervention/Treatment

Virtual ileostomy

Laparoscopic or robotic surgery with virtual ileostomy

Procedure: VI

Laparoscopic or robotic surgery with virtual ileostomy

Diverting ileostomy

Laparoscopic or robotic surgery with diverting ileostomy

Procedure: DI

Laparoscopic or robotic surgery with virtual ileostomy

Outcome Measures

Primary Outcome Measures

Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient [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.

Secondary Outcome Measures

Postoperative hospitalization days [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.
Readmission rates [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.
The number of hospitalizations [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.
Duration of bearing the stoma (months) [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.
First hospitalization costs [During hospitalization,approximately 7 days]
Patient hospitalization costs for radical resection of rectal cancer.
Total hospitalization costs [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.

Other Outcome Measures

Whether patients undergo terminal ostomy after low anterior resection for rectal cancer. [Through study completion, an average of 1 year]
Hartmann's procedure or for example, abdominoperineal extirpation
Patients with stoma (terminal/loop) at 6 months after initial surgery. [6 months from the date of low anterior resection for rectal cancer]
Patients carrying stoma 6 months after low anterior resection for rectal cancer.
The number of participants with virtual ileostomy converted to diverting ileostomy. [Through study completion, an average of 1 year]
The virtual stoma required bedside or secondary surgery for diverting ileostomy due to complications.
The number of patients who required secondary abdominal surgery under general anesthesia due to complications [Through study completion, an average of 1 year]
Patients undergo second abdominal surgery for complications after low anterior resection for rectal cancer.
Ghost ileostomy remove time [During hospitalization,approximately 7 days]
Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.
The number of patients with complications after low anterior resection for rectal cancer. [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.
Adjuvant chemotherapy in patients after low anterior resection for rectal cancer. [6 months from the date of low anterior resection for rectal cancer]
Whether the patient has completed chemotherapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.