These remarkable images show the power of Clear Passage to clear bowel obstructions without surgery. Scheduled for emergency surgery, this patient had two obstructions in her intestine. On the left, we see “BEFORE” images of
- a 3-inch long ‘string stricture’ in the lower bowel that was about the thickness of a coffee straw, and
- an ‘hourglass obstruction’ in the upper bowel.
On the right, images taken AFTER Clear Passage (only) showed that the therapy cleared both obstructions – without surgery. In addition, you can see how much wider and more open the surrounding bowels are in the AFTER THERAPY images, than those in the BEFORE images. The AFTER images show much healthier, more functional bowels.
This landmark controlled study compared the rate of repeat small bowel obstructions (SBO) and quality of life among patients who received CP therapy vs. those who did not receive the therapy. During a three-year period, 103 patients were treated with the Clear Passage Approach® (CP). 90-day outcomes were compared to 136 patients who received no therapy – the usual standard of care. Click here for some of the most pertinent results.
After 90 days, 15% of patients who did not receive the therapy had repeat total SBO; less than 1% of the CP treated patients had SBO. In addition, the non-treated group underwent roughly three times more repeat surgeries than those who received CP.
Domains of diet, pain, gastrointestinal symptoms, quality of life and pain severity improved significantly (p<0.0001) for all CP treated patients. Statistical analysis showed a significant increase after CP therapy for all six measures of trunk mobility: flexion, extension, L&R sidebending, L&R rotation. (multiplicity adjusted P-values<0.05).
Results: Return to Surgery Rate
Expected rate without Clear Passage: 30% of patients will need another surgery.
With Clear Passage: Only 3% to 7% of patients need another surgery within 2 years.
With our strong commitment to measuring and publishing results scientifically, bowel obstructions presented several research challenges to us. For one thing, there are 21 feet (7 meters) of small intestine (bowel), vs. about four inches (10 cm) of fallopian tubes. Even more challenging, when a tube is blocked, the woman can still function in all other ways. When the bowel is blocked, the patient is in an immediate life-threatening position. The obstruction must clear, or the patient will die. Finally, there are many more co-morbidities in the abdomen and bowel – concurrent conditions we must consider before we put our hands on a person who suffers repeat bowel obstructions.
A major problem for these patients is that the surgery designed to cure or save them often creates new adhesions – that block the bowels months or years later. Repeat surgeries cause repeat obstructions, we (and surgeons) see this every day. No matter how caring and skilled your doctor, surgeons cannot prevent the adhesions that form naturally in the body as it heals from the surgery. Thus, repeat life-threatening obstructions become a way of life for many people. These are the people we tend to help the most.
As usual, we started with publishing interesting case studies, then built into larger groups. As we go to press, we are submitting a controlled study with over 200 subjects in it, half of whom received CPA after bowel obstructions (the Treatment Group), and half of whom did not (the Control Group.) Look for that study to be published in 2018.
The data on this page represents the latest clinical data we have as of the date of this writing. It includes “before and after” reports from independent physicians and tests that have been published and validated by independent scientists and physicians.
Success Rates Overview
Published studies and statistical data show strong evidence of the improvements that our non-surgical therapy achieves in people with recurring small bowel obstructions (SBO). These include cleared obstructions, cleared strictures, decreased need for medications, decreased pain and improved quality of life. More importantly, they show a dramatic decrease in the need for additional surgery versus the expected rate.
Following is a timeline summary of our investigation with these conditions.
Two recent studies authored by surgeons from Stanford and Washington University Medical Schools (respected medical research institutes) provide good insights into our ability to help people with abdominal adhesions and repeating bowel obstructions. Both of these studies were peer-reviewed and are PubMed Indexed, which denotes a high level of credibility and importance. You may view these and other published studies on our work at this URL.
“Before and after” x-rays show cleared obstructions
In this remarkable case study, “before and after therapy” films performed by a radiologic physician demonstrated total resolution of two different bowel obstructions (strictures) after the patient received our CP therapy. X-rays taken before and after therapy are shown below.
In the first set of images, a “string stricture” obstruction about three inches in length (the tiny coffee straw shaped bowel on the left image) was opened at the terminal ileum – the lower bowel where the small and large intestine meet. The MD radiologist described the results on the right image as “normal” after therapy (without obstruction.)
Lower Bowel Stricture and Obstruction Cleared
In the second set of images, an hourglass-shaped stricture obstruction in the jejunum (upper bowel) totally cleared after the patient received this therapy. Films show the obstruction on the left image before therapy, and a normal bowel in the image on the right, after therapy.
Upper Bowel Stricture and Obstruction Cleared
Controlled study compares bowel obstruction patients, with and without Clear passage
The same surgeons (both familiar with our work) also co-authored a Controlled Phase Two study which published in the World Journal of Gastroenterology the same month, examining patients with recurring bowel obstructions. That study addressed the difference between a Control Group who did not receive therapy (which is the norm) and a Therapy Group, which received the Clear Passage Approach. Among other findings, 15% of the Control Group had another total bowel obstruction within 90 days after the study ended compared to 1% of the group that received therapy. Detailed results are shown below:
This is considered a major Phase Two study. Below, we will take an in-depth look at the data – before and after the 90-day run of the study.
The Control Group (without CP therapy) had far less complex histories compared to the CP Treated Group. The authors stated that one would have expected worse results with the CP Treated Group. Here are the two groups as they entered the study:
Before CP Therapy
After CP Therapy
2008 – First SBO Patients Treated
When published studies showed we could open fallopian tubes blocked by adhesions, we developed therapy to clear the adhesions that cause bowel obstructions. Our success with these patients came quickly, inspiring us to begin to track data suitable for publication.
2013 – SBO Published Studies
We began publishing case studies about clearing bowel obstructions and adhesions via manual therapy using objective reports from independent physicians noting:
- Before and after x-rays showing cleared bowel obstruction;
- Before and after x-rays showing eliminated stricture (narrowing) in the bowel;
- A patient whose only nutrition was intravenous before therapy could eat normally following therapy.
Journal of Clinical Medicine, 2013
2014 –Validated Measurement Test Published
Some patients who have recurring SBOs have other symptoms; others do not. We published a scientifically validated questionnaire to measure common but serious quality of life issues for patients experiencing small bowel obstructions ‘before and after’ therapy. This test, now available to all physicians and scientists, helped give an overview of ‘quality of life’ changes for people who suffer repeat obstructions.
2015 – Measuring and Publishing Data on Quality of Life After Therapy
The independent data noted above generated interest in further studies. Subjective data, such as pain relief, is considered relevant when screened using a scientifically validated test, such as the one we published in 2014. We use it to measure:
- Pain presence
- Pain severity
- Gastrointestinal symptoms
- Quality of life
- Range of motion (prior surgical adhesions can bind the abdomen, restricting trunk mobility)
As a result, we can now identify the areas where we are most effective, shown below.
2015 – Present Data to 15,000 Physicians
We were invited to present our work to 15,000 international gastroenterologists at Digestive Disease Week in Washington D.C. Results of that pilot study were published in the journal Gastroenterology (May 2015). Scientists noted improvement in every domain of ‘quality of life’ measurable for patients with prior bowel obstructions, including:
- Pain decreased in 85% of patients;
- Gastrointestinal symptoms deceased in 73% of patients;
- Diet improved for 100% of patients who reported a severe impact on their diet before therapy, and in 50% of patients overall;
- 83% of patients who were taking medication for bowel function maintenance before therapy were able to completely stop their medication;
- Significant improvements in all six areas of trunk range of motion (flexion, extension, right and left side bending, right and left rotation)
Measuring Repeat Surgeries with and without Therapy
A vital concern for anyone who has ever undergone the terrible ordeal of bowel obstruction surgery is to avoid repeat hospitalization and surgery. Adding to this concern is the fact that abdominal surgery is the primary cause of bowel obstruction. Thus, post-surgical SBO patients worry they will have to undergo one or more repeat surgeries, leaving them in a cycle of obstruction-surgery-adhesions with no end in sight.
We have treated over 350 patients over the last eight years with concerns they would have to undergo another obstruction surgery. This large number allows us to start gathering long-term data on success rates, including percent of return surgeries in our patients compared to those who don’t receive our therapy.
We compiled the first of our long-term “return to surgery” rates from two sets of patients who received our therapy, and compared them to the norm (no therapy):
- Dataset #1 – Clinical data on our earliest bowel obstruction patients
- Dataset #2 – Scientific data published in a 2015 medical textbook
Repeat Surgeries without CPA Therapy
Repeat surgery within 30 days: According to U.S. government statistics, 18% of patients who undergo bowel obstruction surgery are readmitted to the hospital within 30 days after their surgery. Some of these repeat surgeries are due to infection from bowel contents that leaked into the abdominal cavity during the first surgery. Set free in a warm, dark, moist environment, the escaped bacteria can grow quickly, creating an internal infection that requires immediate repeat surgery, with antibiotics administered directly to the surgical site.
Repeat surgery within two years: Abdominal surgery is the primary cause of small bowel obstruction. Based on medical literature, the expected rate of repeat surgery after SBO surgery is 30% without therapy; repeat surgeries generally start within the first two years.
Repeat Surgeries with CPA Therapy
Dataset #1 – Initial Data
Repeat surgeries up to five years after therapy: Initial clinical data examines our first 69 Clear Passage bowel obstruction patients for up to five years (mean 2.2 years) after therapy in two areas:
- Repeat surgeries with and without compliance with our home program
- Conditions where we observed negative outcomes
In this Dataset, 7% of patients we treated who followed our home program required additional surgery after therapy – much better than the 30% rate without Clear Passage therapy. In examining the unsuccessful cases, we were able to identify factors that pre-dispose a person to negative outcomes – to improve our results.
While our initial results with therapy were several times better than surgery, we continued to improve upon them over the years, as we modified our therapy, introduced a home maintenance program, and screened better for patients we felt would not benefit our treatment.
Dataset #2 – Published Results
Repeat surgeries after therapy:
As our inquiries became more scientific, we created and published a validated test to get a broader view of our results. This test gave more definitive scientific results, which were published in the medical textbook “Intussusception and Bowel Obstruction” (Rice & King, 2015). This Dataset showed a 3% return for surgery in bowel obstruction patients up to 35 months (mean 19 months) after therapy. Based on medical literature, the expected rate for return surgery would have been 30% – ten times our number.
Conclusion: A Chance to Avoid Surgery
Whether our “return to surgery” rate is 7% or 3% or between the two, it is clear that we greatly improved on the 30% “surgical return rate” for patients who do not receive our therapy. As we near the end of our first decade of treating patients with recurring bowel obstructions, we assume our rates will remain stable — or improve.
Pre-Disposing Factors for Poor Results
Over the years, we have learned to screen for conditions that pre-dispose a person to negative results. Thus, we now examine each patient’s medical history for present or past conditions that could lead to negative outcomes, e.g. active infection, radiation enteritis (bowel inflammation due to radiation therapy for cancer) and uncontrolled inflammatory processes (e.g. Crohn’s disease uncontrolled by medication). To help our patients, we now delay or decline applicants with conditions that could lead to negative outcomes. Please consult us if you have concerns about possible contraindications.
Life After Therapy
If you have undergone bowel obstruction surgery, your intestines have been structurally compromised. It is impossible to return the internal abdominal structure you had before your first surgery. We cannot guarantee you will be able to eat all of the foods you ate before you began having obstructions. Some patients do; some do not.
Nevertheless, it is clear from the numbers above, and responses from the 400+ SBO patients we have treated to date, that the benefits of therapy and our home maintenance program are significant for most patients. The success rates of our therapy in eliminating the need for surgery and restoring quality of life are very encouraging.
We continue to follow our patients over time and collect outcome data, both long term and immediately following treatment. It is worthy to note that the initial results from the 400+ patients for whom we are presently gathering follow-up are equal or better than the numbers in the 69 patients above.