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Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

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ClinicalTrials.gov Identifier: NCT04776421
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Quan Wang, The First Hospital of Jilin University

Study Description
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Brief Summary:
Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.

Condition or disease Intervention/treatment
Diverting Ileostomy Middle and Low Rectal Cancer Functional Outcome Stoma Complications Procedure: Diverting ileostomy

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Registration Study on Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery in Middle and Low Rectal Cancer
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
ileostomy group Procedure: Diverting ileostomy
Diverting ileostomy


Outcome Measures
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Primary Outcome Measures :
  1. comprehensive complication index [ Time Frame: 1 year ]
    comprehensive complication index, CCI


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 1 year ]
    Postoperative complications based on Clavien-Dindo

  2. Incidence of anastomotic leakage [ Time Frame: 1 year ]
  3. Incidence of anastomotic stenosis [ Time Frame: 1 year ]
  4. Stoma-related complications [ Time Frame: 3 months ]
  5. Complications related to ileostomy reversal [ Time Frame: three months after ileostomy reversal ]
  6. Overall Survival [ Time Frame: three years after the operation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Middle and low rectal cancer patients
Criteria

Inclusion Criteria:

Necessary conditions: meet one of the following conditions

  1. Difficult pelvis: narrow pelvis (diameter of ischial tuberosity <10 cm, diameter of ischial spine <12 cm) 13 or BMI≥30kg/m2 or tumor diameter≥5cm2.
  2. To receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or ESD
  3. The anastomosis is below the level of the levator ani muscle: such as ISR, TaTME surgery, etc.

Other conditions:

  1. Age: 18 to 75 years old, male or female;
  2. Preoperative biopsy pathological diagnosis of rectal adenocarcinoma;
  3. Received MRI evaluation before surgery, and the distance between the lower edge of the tumor and the anal edge is no more than 10cm;
  4. The clinical stage is T1-3N0-2M0;
  5. Undertake elective laparoscopic TME for colon-rectal or colon-anal anastomosis
  6. ECOG score 0-2;
  7. Heart, lung, liver, and kidney functions can tolerate surgery;
  8. Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.

Exclusion Criteria:

  1. Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
  2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
  3. Neighboring organs need to be combined with organ removal
  4. ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
  5. Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
  6. Have a history of severe mental illness;
  7. Pregnant or lactating women;
  8. Those with a history of taking hormone drugs;
  9. Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776421


Contacts
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Contact: Quan Wang, Prof. +86-431-81875602 wquan@jlu.edu.cn
Contact: Weihua Tong +86-431-81875602 tongwh@jlu.edu.cn

Sponsors and Collaborators
The First Hospital of Jilin University
Investigators
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Principal Investigator: Quan Wang, Prof. Jilin University First Hospital
More Information
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Responsible Party: Quan Wang, Head of Department, The First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT04776421    
Other Study ID Numbers: STARS-RC02
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases