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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ghost ileostomy

Laparoscopic or robotic surgery with ghost ileostomy

Group Type EXPERIMENTAL

Ghost ileostomy

Intervention Type PROCEDURE

Laparoscopic or robotic surgery with ghost ileostomy

No ileostomy

Laparoscopic or robotic surgery with no ileostomy

Group Type ACTIVE_COMPARATOR

No ileostomy

Intervention Type PROCEDURE

Laparoscopic or robotic surgery with no ileostomy

Interventions

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Ghost ileostomy

Laparoscopic or robotic surgery with ghost ileostomy

Intervention Type PROCEDURE

No ileostomy

Laparoscopic or robotic surgery with no ileostomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes