Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome

NCT ID: NCT04688242

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2023-12-31

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 administered per anus before ileostomy reduction in relieving postoperative bowel dysfunction known as low anterior resection syndrome (LARS).

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 low anterior resection syndrome (LARS). Literatures and our previous data have demonstrated that diverting ileostomy is an independent risk factor for major LARS. This is a randomized, phase 2 trial in patients with rectal cancer who underwent sphincter-preserving proctectomy and ileostomy. This study will explore the effects of anal dilatation plus probiotics administered per anus in relieving the symptoms of LARS.

Conditions

Low Anterior Resection Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.

Group Type: EXPERIMENTAL

Anal dilatation per anus

Intervention Type: OTHER

Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus

administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus

Intervention Type: DRUG

Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus

Control Arm

No anal dilatation or probiotics per anus was allowed, from 2 weeks after proctectomy until reduction of ileostomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Anal dilatation per anus

Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus

Intervention Type: OTHER

administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus

Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. A voluntarily signed and dated informed consent form;

2. ECOG Performance status is 0 or 1;

3. Age at enrollment is of 18 to 80 years old.;

4. R0 sphincter-preserving proctectomy and temporary ileostomy for rectal cancer;

5. The distance from anastomosis to anal verge is ≤7cm;

6. Both the anastomosis and the ileostomy is intact at 2 weeks follow-up after proctectomy;

7. Baseline LARS score before proctectomy is <30;

8. The preoperatively predicted LARS (POLARS) score after proctectomy is ≥28.

Exclusion Criteria

1. R1/R2 resection or untreated metastases;

2. 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;

3. Severe morbidity with life expectancy less than 2 years;

4. Any toxicity of CTCAE grade 2 or above due to previous treatment that have not resolved, except for anemia, alopecia, skin pigmentation;

5. Anastomotic leak within 2 weeks after proctectomy, suspected by clinical symptoms, digital rectal examination, or imaging;

6. Complications of the ileostomy within 2 weeks after proctectomy, leading to premature takedown of the stoma (within 2 months after surgery);

7. Any medical condition that may affect the safety and compliance of the subject.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

the Fifth Affiliated Hospital, Sun Yat-Sen University

Zhuhai, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruoxu Dou, M.D.

Role: CONTACT

dourx@mail.sysu.edu.cn

+86-756-2528708

Facility Contacts

Rongkang Huang, M.D.

Role: primary

huangrk3@mail.sysu.edu.cn

020-13480218647

Ruoxu Dou, M.D.

Role: primary

dourx@mail.sysu.edu.cn

020-13342808275

Other Identifiers

2020ZSLYEC-187

Identifier Type: -

Identifier Source: org_study_id