## Protocol Section
### Identification Module
**NCT ID:** NCT06424522

**Brief Title:** A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

**Official Title:** Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management

#### Organization Study ID Info
**ID:** OSU-22312
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03173
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-10-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ohio State University Comprehensive Cancer Center

#### Responsible Party

**Investigator Affiliation:** Ohio State University Comprehensive Cancer Center

**Investigator Full Name:** Alessandra

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.

**Detailed Description:** PRIMARY OBJECTIVE:

I. To compare two approved pathways for treatment of low anterior resection syndrome (LARS) - a retrograde enema program versus a medical management pathway.

SECONDARY OBJECTIVE:

I. The determination of feasibility to complete this treatment pathway.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

GROUP II: Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.

### Conditions Module

**Conditions:**

- Low Anterior Resection Syndrome

- Rectal Carcinoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

**Intervention Names:**

- Dietary Supplement: Dietary Fiber

- Procedure: Enema Administration

- Drug: Loperamide Hydrochloride

- Procedure: Physical Therapy

- Other: Questionnaire Administration

- Procedure: X-Ray Imaging

**Label:** Group I (RRE, medical managment)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

**Intervention Names:**

- Dietary Supplement: Dietary Fiber

- Drug: Loperamide Hydrochloride

- Procedure: Physical Therapy

- Other: Questionnaire Administration

**Label:** Group II (medical management)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group I (RRE, medical managment)

- Group II (medical management)

**Description:** Receive dietary fiber

**Name:** Dietary Fiber

**Other Names:**

- Fiber

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Group I (RRE, medical managment)

**Description:** Undergo RRE

**Name:** Enema Administration

**Other Names:**

- Enema

- Enema Injection

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Group I (RRE, medical managment)

- Group II (medical management)

**Description:** Receive loperamide hydrochloride

**Name:** Loperamide Hydrochloride

**Other Names:**

- Imodium

- Imodium A-D

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Group I (RRE, medical managment)

- Group II (medical management)

**Description:** Undergo pelvic floor physical therapy

**Name:** Physical Therapy

**Other Names:**

- Physiatric Procedure

- Physical Medicine Procedure

- Physical Therapeutics

- Physical Therapy Procedure

- Physiotherapy

- Physiotherapy Procedure

- PT

**Type:** PROCEDURE

#### Intervention 5

**Arm Group Labels:**

- Group I (RRE, medical managment)

- Group II (medical management)

**Description:** Ancillary studies

**Name:** Questionnaire Administration

**Type:** OTHER

#### Intervention 6

**Arm Group Labels:**

- Group I (RRE, medical managment)

**Description:** Undergo abdominal film x-ray

**Name:** X-Ray Imaging

**Other Names:**

- Conventional X-Ray

- Diagnostic Radiology

- Medical Imaging, X-Ray

- Plain film radiographs

- Radiographic Imaging

- Radiographic imaging procedure (procedure)

- Radiography

- RG

- Static X-Ray

- X-Ray

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire \[MSKCC BFI\]). Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

**Measure:** Fecal incontinence

**Time Frame:** Up to 1 year from start of treatment

**Description:** Will be assessed using LARS validated scoring tool. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

**Measure:** Effectiveness assessed using LARS validated scoring tool

**Time Frame:** Up to 1 year from start of treatment

#### Secondary Outcomes

**Description:** Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

**Measure:** Feasibility measured by Patient Satisfaction Survey

**Time Frame:** At 1 year from start of treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥ 18 years old
* LARS diagnosis
* Patients with history of rectal cancer

Exclusion Criteria:

* Patients presenting with significant stricture that need a definitive surgical management strategy; patients with minor or clinically negligible strictures can still be candidates. Patients who are able to pass the catheter and the balloon per rectum may be candidates after a digital rectal exam at their initial visit
* Patients with any chemo or radiation therapy in the last 6 months
* Patients who currently have colorectal cancer
* Patients with recurrent colorectal cancer
* Patients who have undergone a colorectal surgical procedure within the last three months
* Patients \< 18 years old
* Active sacral nerve simulator
* Altered mental status or mental disability that would alter ability to self-administer enema
* Any reason the research team believes the subject is not an appropriate candidate for this study (i.e., transportation issues, history of no-show appointments, lack of reliable communications, vulnerable population(s), etc.)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** OSUCCCClinicaltrials@osumc.edu

**Name:** The Ohio State Comprehensive Cancer Center

**Phone:** 800-293-5066

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Columbus

**Contacts:**

***Contact 1:***

- **Email:** Alessandra.gasior@osumc.edu

- **Name:** Alessandra C. Gasior, DO

- **Phone:** 614-722-3879

- **Role:** CONTACT

***Contact 2:***

- **Name:** Alessandra C. Gasior, DO

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Ohio State University Comprehensive Cancer Center

**State:** Ohio

**Zip:** 43210

#### Overall Officials

**Official 1:**

**Affiliation:** Ohio State University Comprehensive Cancer Center

**Name:** Alessandra C Gasior, DO

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** The Jamesline

**URL:** http://cancer.osu.edu

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000011183

- Term: Postoperative Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M3018

- Name: Low Anterior Resection Syndrome

- Relevance: HIGH

- As Found: Low Anterior Resection Syndrome

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000094123

- Term: Low Anterior Resection Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Ancestors

- ID: D000005765

- Term: Gastrointestinal Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M11139

- Name: Loperamide

- Relevance: HIGH

- As Found: Hydroxamic Acid

- ID: M4249

- Name: Antidiarrheals

- Relevance: HIGH

- As Found: Hydroxamic Acid

- ID: M6263

- Name: Coal Tar

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008139

- Term: Loperamide

- ID: D000000930

- Term: Antidiarrheals

### Misc Info Module

- Version Holder: 2024-05-31
