Status:
UNKNOWN
Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborating Sponsors:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Low Anterior Resection Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is randomized, phase 2 trial in patients with rectal cancer undergoing sphincter-preserving proctectomy and temporary ileostomy, to explore the effects of anal dilatation plus probiotics administ...
Detailed Description
Approximately 60-90% of patients undergoing sphincter-sparing proctectomy complain of postoperative bowel dysfunction including incontinence, frequency, clustering, and urgency, collectively known as ...
Eligibility Criteria
Inclusion
- A voluntarily signed and dated informed consent form;
- ECOG Performance status is 0 or 1;
- Age at enrollment is of 18 to 80 years old.;
- R0 sphincter-preserving proctectomy and temporary ileostomy for rectal cancer;
- The distance from anastomosis to anal verge is ≤7cm;
- Both the anastomosis and the ileostomy is intact at 2 weeks follow-up after proctectomy;
- Baseline LARS score before proctectomy is \<30;
- The preoperatively predicted LARS (POLARS) score after proctectomy is ≥28.
Exclusion
- R1/R2 resection or untreated metastases;
- Any synchronous or metachronous malignancies, except for cancers that have received curative treatment and have not recurred for more than 5 years, or carcinoma in situ that have been cured by appropriate treatment;
- Severe morbidity with life expectancy less than 2 years;
- Any toxicity of CTCAE grade 2 or above due to previous treatment that have not resolved, except for anemia, alopecia, skin pigmentation;
- Anastomotic leak within 2 weeks after proctectomy, suspected by clinical symptoms, digital rectal examination, or imaging;
- Complications of the ileostomy within 2 weeks after proctectomy, leading to premature takedown of the stoma (within 2 months after surgery);
- Any medical condition that may affect the safety and compliance of the subject.
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04688242
Start Date
February 20 2021
End Date
December 31 2023
Last Update
December 6 2022
Active Locations (2)
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1
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
2
the Fifth Affiliated Hospital, Sun Yat-Sen University
Zhuhai, Guangdong, China, 519000