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

NCT04688242 | Unknown Phase 2 DMC

• 1 other identifier: 2020ZSLYEC-187
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

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).

Conditions

Low Anterior Resection Syndrome

Keywords

rectal cancer; temporary ileostomy; low anterior resection syndrome; anal dilatation; gut microbiota

Outcome Measures

Primary Outcomes (1)

• Major LARS at 1 years after proctectomy

  Proportion of patients with Low anterior resection syndrome (LARS) score ≥30. LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).

  At 1 years after proctectomy

Secondary Outcomes (8)

• LARS score at 1 years after proctectomy

  At 1 years after proctectomy

• Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30 at 1 years after proctectomy

  At 1 years after proctectomy

• Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29 at 1 years after proctectomy

  At 1 years after proctectomy

• MSKCC BFI Score at 1 years after proctectomy

  At 1 years after proctectomy

• Presence of stoma at 1 years after proctectomy

  At 1 years after proctectomy

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Other: Anal dilatation per anus; Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus

Control Arm

NO INTERVENTION

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

Interventions

Anal dilatation per anus OTHER

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

Treatment Arm

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

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (2)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

the Fifth Affiliated Hospital, Sun Yat-Sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Ruoxu Dou, M.D.

CONTACT

+86-756-2528708; dourx@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients were randomized to the treatment group (anal dilatation plus probiotics) or the control group.

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 29, 2020
• Study Start: February 20, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 6, 2022

Record last verified: 2021-12

Locations

CN (2)