What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include bowel preparation methods like Fleet Enemas and Pico Salax, chemotherapy, and radiation therapy. Fleet Enemas can cause local irritation, cramping, and discomfort. Pico Salax, an oral mechanical bowel preparation, may lead to dehydration, electrolyte imbalances, and gastrointestinal discomfort such as bloating and cramping. Chemotherapy often results in side effects like nausea, vomiting, fatigue, and peripheral neuropathy. Radiation therapy can cause skin irritation, fatigue, and gastrointestinal issues such as diarrhea and bowel discomfort.

What prior FDA approvals exist?

FDA-approved treatments for colorectal cancer include a variety of chemotherapy agents and targeted therapies. Common chemotherapy drugs include 5-fluorouracil (5-FU), often combined with leucovorin, oxaliplatin, and irinotecan. Targeted therapies such as bevacizumab, cetuximab, and panitumumab are also approved for use in specific cases. While the context does not provide specific FDA approvals for bowel preparation methods like Fleet Enemas or Pico Salax, these are standard practices for ensuring bowel cleanliness prior to procedures like transanal endoscopic surgery (TES).

What other types of research exist?

Currently, there are no specific novel alternatives to Fleet Enemas and Pico Salax mentioned in the provided context for colorectal cancer patients. Both methods remain standard for bowel preparation. Patients should consult their healthcare provider for the most up-to-date and personalized recommendations.

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Enema vs Oral Bowel Prep for Surgical Preparation (TESEO Trial)

Phase 4

Recruiting

Led By Katerina Neumann

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons

Be older than 18 years old

Must not have

Chronic steroid use

Clear diagnosis of congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up a one-time pre-op assessment for each patient the morning of surgery

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial compares two methods of bowel cleaning for patients having rectal surgery. One method uses Fleet enemas, which are inserted into the rectum, while the other uses Pico Salax, a drink. The goal is to determine which method provides better visibility and cleanliness for the surgery.

Who is the study for?

This trial is for individuals under 75 years old with colorectal cancer who are scheduled for transanal endoscopic surgery at the QEII Health Sciences Center. Candidates must be able to self-administer enemas and not have conditions like inflammatory bowel disease, previous pelvic radiation, congestive heart failure, or chronic constipation.

What is being tested?

The study compares two methods of bowel preparation before rectal surgery: Fleet Enema versus Pico-Salax oral solution. It aims to determine which one better cleanses the rectum by using a modified Ottawa Bowel Prep Scale.

What are the potential side effects?

Potential side effects may include discomfort from administering an enema, dehydration or electrolyte imbalance due to bowel cleansing agents, abdominal cramping, nausea, and possible irritation of the anus or rectum.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific rectal surgery in Halifax by a trained surgeon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use steroids for a long-term condition.

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I have been diagnosed with congestive heart failure.

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I have inflammatory bowel disease.

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I am over 75 years old.

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I cannot give myself enemas.

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I cannot tolerate standard bowel preparations for medical reasons.

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My chronic constipation isn't managed well with diet or softeners.

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I had or will have a surgery involving a scope through the anus along with another procedure.

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I take Lasix or a similar water pill every day.

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I am scheduled for another surgery through the anus for the same issue.

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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ a one-time intra-operative assessment for each patient

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~a one-time intra-operative assessment for each patient

This trial's timeline: 3 weeks for screening, Varies for treatment, and a one-time intra-operative assessment for each patient for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of bowel preparation

Secondary study objectives

Ability to close the surgical defect

Patient tolerability of preparation

Post-operative complications

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: Fleet EnemaActive Control1 Intervention

Patient is to administer one sodium bisphosphate (Fleet) enema at home 2 hours prior to arrival for surgery and a second enema one hour prior to arrival for surgery. Each 120 mL application of rectally administered enema contains 19g of monobasic sodium phosphate and 9 g of dibasic sodium phosphate. Patient is to follow standard packaging instructions from the manufacturer.

Group II: Pico SalaxActive Control1 Intervention

Patient is to take Pico Salax oral bowel preparation which is a combination product consisting of 10 mg picosulfate sodium, 3.5 g magnesium oxide, and 12 g citric acid per sachet the day prior to surgery. Patient is to take 2 doses of this product, as per standard packaging instructions from the manufacturer. Specifically patient is to take the first packet contents dissolved in 150 mL water at 3pm the day before surgery. Patient is to take the second packet dissolved in 150 mL water at 8pm the day before surgery. Patient should drink 2-3L of clear liquids after each dose, for a total of 4-6L.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, surgical resection, and bowel preparation methods. Chemotherapy agents like oxaliplatin and S-1 work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and grow. Surgical resection involves physically removing the tumor from the colon or rectum, which is often necessary for localized cancer. Bowel preparation methods, such as Fleet enemas and Pico Salax, are used to cleanse the bowel before surgery to ensure clear visibility and reduce the risk of infection. These treatments are crucial for colorectal cancer patients as they aim to eliminate cancer cells, prevent recurrence, and prepare the body for effective surgical intervention.

Rectal Cancer Risk and Survival After Total Colectomy for IBD: A Population-Based Study.Assessing the Quality of Rectal Cancer Pathology Reports in National Surgical Adjuvant Breast and Bowel Project Protocol R-04/NRG Oncology.Regional Variation in Laparoscopy Use for Elective Colon Cancer Treatment in Canada: The Importance of Fellowship Training Sites.