Preoperative Assessment of Bowel Cleansing Adequacy in Colonoscopy

20230245300 ยท 2023-08-03

    Inventors

    Cpc classification

    International classification

    Abstract

    A method of analyzing stool material captured during a preoperative bowel cleansing preparation to assess the adequacy of said preoperative bowel cleansing by color-comparison with a known specimen.

    Claims

    1. A method for preoperative assessment of bowel cleansing adequacy for a preoperative colon procedure, comprising the acts of a. providing education to a patient at time of scheduling said preoperative colon procedure, wherein said education comprises of desired stool color from photographs of stool receptacles showing acceptable and unacceptable colors, wherein said acceptable stool color is one of the following: lighter than a light yellow having a very light shade of yellow-green; lighter than HEX color value #FFFFE0, and HEX #FFFFE0; b. obtaining a stool sample, c. capturing a first image of said stool sample, d. locating a second image having color data from a resource storing said acceptable stool color, wherein said acceptable stool color is one of the following: lighter than a light yellow having a very light shade of yellow-green; lighter than HEX color value #FFFFE0, and HEX #FFFFE0; e. comparing said first image with said second image for color equivalency, f. evaluating said comparison with a resource corresponding to each of a plurality of stool colors, said image data information having color information matching color information g. generating test results based on said comparison for professional assessment.

    2. The method of claim 1, wherein comparing said first image with said second image is performed digitally.

    3. The method of claim 1, wherein said step of evaluation is based on an automatic evaluation of said acceptable stool color being one of the following: lighter than a light yellow having a very light shade of yellow-green; lighter than HEX color value #FFFFE0, and HEX #FFFFE0.

    4. A method of analyzing stool material captured during a preoperative bowel cleansing preparation to assess the adequacy of a cleanse, said method comprising the steps of (a) scheduling a colonoscopic procedure with a patient, (b) providing said patient with an electronic mail address, (c) instructing said patient said preoperative bowel cleansing preparation necessary for success of said colonoscopic procedure, (d) instructing said patient said stood material must at least one of clear and yellowish approximately two hours prior to said colonoscopic procedure, (e) on day of said colonoscopic procedure instructing said patient to make an image of said stood material, (f) transmitting said image by patient via internet to said electronic mail address, (g) receipt of said image, (h) forwarding said image to a medical professional, (i) comparing said image with a reference specimen by said medical professional, (j) determining adequacy of said preoperative bowel cleansing preparation disclosed by said image, (k) advising said patient results of said preoperative bowel cleansing preparation, (l) if said image discloses inadequacy of said preoperative bowel cleansing preparation, (m) instructing said patient to perform additional preparation prior to said colonoscopic procedure; (n) Repeating said additional preparation as needed.

    5. The method of claim 4 further including the step of administration of at least one enema by said medical professional at place of said colonoscopic procedure.

    6. The method of claim 4 wherein the step of comparing said image with said reference specimen is performed with a digital computer.

    7. The method of claim 4 wherein the step of comparing said image with said reference specimen is performed using Camtasia software.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0039] FIG. 1 is a photo sent to a patient with procedure instructions

    [0040] FIG. 2 is a color chart

    DETAILED DESCRIPTION OF THE INVENTION

    [0041] The present invention is a method for color-based assessment of a preoperative colon procedure preparation, comprising the acts or steps: [0042] a. executing said preoperative colon procedure preparation, [0043] b. obtaining a stool sample, [0044] c. capturing a first image of said stool sample, [0045] d. locating a second image having color data from a resource storing a range of stool color information, [0046] e. comparing said first image with said second image for color equivalency, [0047] f. evaluating said comparison with a resource corresponding to each of a plurality of stool colors, said image data information having color information matching color information [0048] g. generating test results based on said matching.

    [0049] The present invention is a result of extensive, two-phased experimentation. This first phase was a determination of the color of a photograph of the patient's bowel movement sufficient to achieve a high degree of confidence that that said patient's bowel movement was indicative of an adequate bowel cleansing.

    [0050] Furthermore, to arrive at the color standard of the present invention which is used to educate the patient or the color used to assess photographs sent by the patient, clarity in addition to color was considered. A number of experiments were conducted similar or equivalent to the following to achieve a consistent outcome. More particularly in order to develop the color/clarity standard a number of different concentrations of stool and liquid aspirated during routine colonoscopies were compared to each other. Post operatively the Boston Scale was used to assess postoperative bowel preparation.

    [0051] More specifically, the predictive result related to the adequacy preparation of the present invention were compared to the actual adequacy from postoperative assessment of the condition of the bowel during the medical procedure using the Boston Bowl Preparation scale.

    [0052] Clarity in photographic equipment is required to adjust the color images so as to more accurately reflect the item being photographed. In addition to a typical 256-color palette, a transparency specification is employed. An example of such a transparency specification is a GIF89a (graphics interchange format version 89a). A trial of various clarity standards was also required to properly select the color image. Photographs sent by a patient affix the color and clarity for each photograph as metadata. The color standard imposed by the present invention integrates clarity with color without need for a separate clarity standard.

    [0053] The present invention benefits from significant experiment using black and white photos of the bowel preparation, adjusting shades and density. Black-and-white images were found not to result in a statistically significant improvement of bowel preparation. Different concentration of stool in the post preparation liquid lead to darker colors. Only when a specific yellow color or lighter color was achieved by the patient preoperatively, did the inventor determine there was a significant drop in repeat colonoscopy procedures.

    [0054] The second phase was the use of an educational and motivational program which would result in a statistically significant improvement in the preoperative assessment of bowel-cleaning adequacy. In addition, staff education of the patient making the cleansing preparation, and comparing their last bowel movement with the yellow color above, led to statistically significant improvements in bowel preparation and successful colonoscopies. This education comprises in-person and telephone communications which both stressed the need to achieve the desired color in the patient's photograph as in the reference image provided at the time of scheduling or pre-procedure consultation. The results from this process were compared with sending photographs and instructions to patients which was statistically as effective, which result was nonobvious.

    [0055] More specifically, an experiment was conducted involving 30 patients who were instructed on the necessity to reach the color of stool prior to leaving their home, a statistically significant increase in successful colonoscopies to 99% was achieved.

    [0056] Stool color analysis is well documented and understood. For example, normal stool color is brown. If stool is black or clay-colored, maroon, or red, it is generally agreed that a medical problem is leading to this. The color of stool due to preoperative preparations is also known. A medical professional is normally able to assess when a stool sample indicates a bowel is relatively adequately prepared for the operative procedure.

    [0057] The prior art is not helpful for the present invention because camera sensors do not have the same spectral response as human eyes. The standards noted in the prior art have a stool-color standard denoting adequacy of preoperative cleansing did not consider the variations introduced by variables such as bowl tint, camera lens, rim lighting, and other factors.

    [0058] The reference color provided to a patient could be adjusted to consider the variation in color perception in an individual patient. Reference colors may need to be exaggerated or lightened, for example, to compensate for the lab-color standard for determining adequacy may be adjusted to account for the color-perception or other visual impairments of the patent to achieve said 95% confidence.

    [0059] In nearly every case, there are sensors that respond to red, green, and blue, but the human-eye response is very different from that of camera sensors. The present invention depends on camera sensors from a wide variety of photographic equipment; consequently, the present invention required the discovery of a stool-standard color which may be used to educate the patient and evaluate photographs sent by said patient. Generally, the experimentation necessary to identify said color standard was achieved in the following manner.

    [0060] The photograph's color which results in a high degree of confidence that the preoperative assessment of bowel-cleaning was adequate, differs between the actual color in situ and the color captured by a photographic representation thereof. Such differences result from, including, the tint of the bowl, lighting conditions, the particular sensor in the camera or mobile phone. Experimentation was performed to compensate for said differences in the transmitted images. Said experimentation was necessary to achieve at least a 95% confidence that images were adequate based on at least 100 random images of stool samples. In particular, an experiment was conducted wherein more than 100 random images of stool-sample photographs sent by patients were analyzed. Colors selected as the standard for the invention represented the color wherein at least 95% of the assessments were adequate when compared to reference photographs.

    [0061] Using a subject patient who has performed a preparation protocol, a photograph is taken and transmitted of a stool sample left in a bowl. Then a medical professional made a visual assessment for adequacy. From the photograph of the sample, the color was selected and hypothesize that said color indicates adequate cleansing. Another 100 photographs of stool-sample colors were compared to develop a proprietary standard to make the assessment whether the pre-procedure cleansing was adequate or inadequate.

    [0062] Then the notes of the professional performing the actual colonoscopy on the subject were examined for whether the colon presented as having been adequately cleansed during the preoperative protocol. This process was repeated, comparing reference photographs to select reference colors that are at least 95% predictive in practice.

    [0063] Various other modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the claims are not intended to be limited to the implementations shown herein, but are to be accorded the widest scope consistent with this disclosure, the principles and the novel features disclosed herein.

    [0064] Certain features that are described in this specification in the context of separate embodiments also can be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment also can be implemented in multiple embodiments separately or in any suitable sub-combination.

    [0065] Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.