Clinical Trials Directory

Trials / Completed

CompletedNCT05461248

Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
The First Hospital of Jilin University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREstoma drainage reinfusion1 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.
PROCEDUREStandard of Care - No Return of Stoma DrainNo Return of Stoma Drain

Timeline

Start date
2022-08-01
Primary completion
2024-05-30
Completion
2024-05-30
First posted
2022-07-18
Last updated
2024-11-22

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05461248. Inclusion in this directory is not an endorsement.