Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stoma drainage reinfusion
Standard of Care - No Return of Stoma Drain
Sponsored by
About this trial
This is an interventional supportive care trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Age: 18~75 years old, male or female;
- The pathological diagnosis of preoperative biopsy was rectal adenocarcinoma;
- The clinical stage is T1-4aN0-2M0;
- No distant multiple metastasis;
- ECOG score 0-2;
- Heart, lung, liver and kidney function can tolerate surgery;
- The clinical diagnosis of middle-low rectal cancer, the lower edge of the tumor is within 10cm from the anal verge, the patients who are to undergo radical rectal resection and prophylactic ileostomy in stage I and intestinal closure in stage II;
- Patients and their families can understand and be willing to participate in this clinical study, and sign the informed consent.
Exclusion Criteria:
- Past history of malignant colorectal tumor or recent diagnosis with other malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery;
- Adjacent organs need combined organ resection;
- ASA grade ≥ grade IV and/or ECOG performance status score > 2 points;
- Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases who cannot tolerate surgery;
- Have a history of serious mental illness;
- Pregnant or lactating women;
- Those who have a history of taking hormone drugs;
- Patients with other clinical and laboratory conditions considered by the researchers should not participate in the trial;
- There are signs of infection 1 week before the operation, the body temperature is higher than 37.5℃, and the blood WBC is higher than 10.0×109/L;
- There is a history of antibiotic use 1 week before surgery (excluding preoperative shock drugs);
- Preoperative neoadjuvant patients.
Sites / Locations
- Jilin University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Conventional group
Arm Description
The stoma drainage fluid was reinfused once a week for 2 months after radical rectal surgery. For each reinfusion, eat liquid food the day before, collect 400-600mL of stoma discharge on the same day (if the stoma fluid is too small, it can be mixed with warm water), and use an enema bag to reinfuse from the patient's anus. Generally, the flow rate is controlled at about 100mL/min.
The conventional group received no additional intervention.
Outcomes
Primary Outcome Measures
Incidence of low anterior resection syndrome
Incidence of low anterior resection syndrome one month after surgery
Secondary Outcome Measures
Incidence of low anterior resection syndrome
Incidence of low anterior resection syndrome 3 months after stoma reversal
Wexner score
The Wexner score includes 6 dimensions, including sanitary pads, solids, and liquids, with a total score of 20. The score is proportional to the patient's degree of anal incontinence.
Quality of life score
The EORTCQLQ-C30 scale is a cross-cultural and cross-country QOL-C30 (Quality of Life Questionnare-Core 30) launched by the European Organization for Research on Cancer Treatment (EORTC: The European O-rganization for Reasearch and Treatment of Cancer) in 1993. ), to evaluate QOL from a multi-dimensional perspective, which can better reflect the connotation of QOL, and has been applied to the measurement of QOL of cancer patients in many European countries and regions.
Full Information
NCT ID
NCT05461248
First Posted
July 14, 2022
Last Updated
July 14, 2022
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT05461248
Brief Title
Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
Official Title
An Exploratory Study on the Recovery of Intestinal Flora and Intestinal Function by Preventing Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Jilin 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
To analyze the occurrence of defecation complications, rectal function, and quality of life indicators after sphincter-preserving surgery for middle and low rectal cancer, the stoma exudate was collected before the stoma was restored, and the defecation complications, rectal function and quality of life indicators were evaluated. The effect of anal reinfusion of stoma discharge on the recovery of intestinal function in patients.
Detailed Description
Previous studies have shown that the mucosa and villi of the left intestinal segment will atrophy after intestinal bypass, the absorption capacity will decrease, and the rhythmic contraction will disappear. Some studies have shown that irrigation through the anorectal cavity may help prevent and treat colorectal anastomotic fistulas and improve the postoperative life of patients. Based on this, it is hypothesized that the stimulation of stomal exudate anal reinfusion to the empty intestinal segment through the anus may help to promote the recovery of intestinal function and intestinal flora disturbance after stoma retraction.
In response to this hypothesis, in this study, we intend to carry out a prospective and observational study on patients with stoma resection, aiming to investigate whether the stimulation of stoma discharge and anal reinfusion of stoma drainage through the anus before resection has any effect on the anus. It is beneficial to the recovery of intestinal function, reducing the occurrence of complications and improving the imbalance of intestinal flora, providing high-level clinical evidence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The experimental group collected stoma exudates and used an enema bag to infuse them from the anus.
The control group was not reinfused.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The stoma drainage fluid was reinfused once a week for 2 months after radical rectal surgery. For each reinfusion, eat liquid food the day before, collect 400-600mL of stoma discharge on the same day (if the stoma fluid is too small, it can be mixed with warm water), and use an enema bag to reinfuse from the patient's anus. Generally, the flow rate is controlled at about 100mL/min.
Arm Title
Conventional group
Arm Type
Sham Comparator
Arm Description
The conventional group received no additional intervention.
Intervention Type
Procedure
Intervention Name(s)
stoma drainage reinfusion
Intervention Description
1 month after radical rectal surgery, the stoma drainage fluid was reinfused once a week for 2 months. For each reinfusion, eat liquid food the day before, collect 400-600mL of stoma discharge on the same day (if the stoma fluid is too small, it can be mixed with warm water), and use an enema bag to reinfuse from the patient's anus. Generally, the flow rate is controlled at about 100mL/min.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care - No Return of Stoma Drain
Intervention Description
No Return of Stoma Drain
Primary Outcome Measure Information:
Title
Incidence of low anterior resection syndrome
Description
Incidence of low anterior resection syndrome one month after surgery
Time Frame
one month after surgery
Secondary Outcome Measure Information:
Title
Incidence of low anterior resection syndrome
Description
Incidence of low anterior resection syndrome 3 months after stoma reversal
Time Frame
3 months after stoma reversal
Title
Wexner score
Description
The Wexner score includes 6 dimensions, including sanitary pads, solids, and liquids, with a total score of 20. The score is proportional to the patient's degree of anal incontinence.
Time Frame
3 months after stoma reversal
Title
Quality of life score
Description
The EORTCQLQ-C30 scale is a cross-cultural and cross-country QOL-C30 (Quality of Life Questionnare-Core 30) launched by the European Organization for Research on Cancer Treatment (EORTC: The European O-rganization for Reasearch and Treatment of Cancer) in 1993. ), to evaluate QOL from a multi-dimensional perspective, which can better reflect the connotation of QOL, and has been applied to the measurement of QOL of cancer patients in many European countries and regions.
Time Frame
3 months after stoma reversal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18~75 years old, male or female;
The pathological diagnosis of preoperative biopsy was rectal adenocarcinoma;
The clinical stage is T1-4aN0-2M0;
No distant multiple metastasis;
ECOG score 0-2;
Heart, lung, liver and kidney function can tolerate surgery;
The clinical diagnosis of middle-low rectal cancer, the lower edge of the tumor is within 10cm from the anal verge, the patients who are to undergo radical rectal resection and prophylactic ileostomy in stage I and intestinal closure in stage II;
Patients and their families can understand and be willing to participate in this clinical study, and sign the informed consent.
Exclusion Criteria:
Past history of malignant colorectal tumor or recent diagnosis with other malignant tumors;
Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery;
Adjacent organs need combined organ resection;
ASA grade ≥ grade IV and/or ECOG performance status score > 2 points;
Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases who cannot tolerate surgery;
Have a history of serious mental illness;
Pregnant or lactating women;
Those who have a history of taking hormone drugs;
Patients with other clinical and laboratory conditions considered by the researchers should not participate in the trial;
There are signs of infection 1 week before the operation, the body temperature is higher than 37.5℃, and the blood WBC is higher than 10.0×109/L;
There is a history of antibiotic use 1 week before surgery (excluding preoperative shock drugs);
Preoperative neoadjuvant patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Wang, Prof.
Phone
0431-81875602
Email
wquan@jlu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Li
Email
lm17@mails.jlu.edu.cn
Facility Information:
Facility Name
Jilin University First Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
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