Colonic NeoplasmsNCT03155165
Retroview™ Colonoscope and Lesion Detection Rate
An observational study of Colonic Neoplasms, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
Colonoscopy is considered the gold standard for colorectal polyp and cancer detection. However, even meticulous colonoscopy substantial numbers of colorectal polyps may be missed and carcinomas may not be prevented. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Retroview™ colonoscope
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEcuador
- Study dates
- 1 May 2017to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the gastroenterology unit (IECED). All of the participants will have a clear colonoscopy indication. Group A will include patients that have a polyp already seen in a previous colonoscopy and the colonoscopy is indicated for polypectomy. Group B will include the rest of indicated colonoscopies. The distribution in groups A and B is with no intention to compeer the groups but in order to avoid a bias because the patients already have a known lesion.
Who may be able to join
- Patients that agree to participate in the study.
- Able to understand and provide written informed consent.
- Colonoscopy indication for colorectal neoplasia screening or polyp surveillance.
- Colonoscopy indication for polypectomy.
- Colonoscopy indication for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging.
Who cannot join
- Age under 18 and over 80 years' old.
- Pregnancy
- Patients with heart disease, kidney, liver or severe metabolic disorder, who cannot tolerate sedation.
- Severe uncontrolled coagulopathy.
- Patients with difficulty understanding instructions of bowel preparation.
- Prior history of colon resection.
Show all 13Show fewer
- Patients with an ileostomy or a colostomy.
- Abdomen or pelvis radiation therapy.
- Known inflammatory bowel disease, polyposis syndrome or acute diverticulitis.
- Suspected colonic obstruction or history of previous obstruction.
- Gastrointestinal bleeding.
- Lack of acceptance by the patient.
- Bowel preparation will be evaluated using the Boston Bowel Preparation Scale. Patients with < 2 points in at least one of the three segments of the colon (rectum plus left-side colon, transverse colon plus left and right flexure, right-side colon) will be excluded from statistical analysis as well as those who after the beginning of the colonoscopy, had to be aborted because of an inability to reach the cecum by unfavorable anatomy or impassable tumors / stenosis.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Ecuadorian Institute of Digestive Diseases, Omnihospital
Guayaquil, Guayas, 090505
About this study
Official title: Retroview™ vs. Conventional Colonoscopy: it is Time to Change?
Colonoscopy is considered the gold standard for colorectal polyp and cancer detection. However, even meticulous colonoscopy substantial numbers of colorectal polyps may be missed and carcinomas may not be prevented. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with the higher miss rates noted for smaller polyps. The lesions missing rate depends on several factors as the location on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, a poor bowel preparation and inadequate endoscopy technique, particularly rapid colonoscope withdrawal. Using the commonly available 140º angle of view colonoscope, approximately 13% of the colonic surface is unseen. The incorporation of colonoscopes with a 170-degree wide angled could not improve adenoma detection rate. The introduction of high definition (HD) colonoscopes and visual image enhancement technologies as narrow band imaging (NBI, Olympus America, Center Valley, PA), i-SCAN™ (PENTAX of America, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization, but several studies proved no increase in adenoma detection rates. The Third Eye Retroscope (Avantis Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced via the accessory channel of a standard colonoscope. Allows retrograde views behind colonic folds and flexures simultaneously with the forward view of the colon. Although it was shown an increase in adenoma detection rate by 11%-25%, it has many disadvantages. It requires a separate processor and the device is disposable making the cost bigger. Occupies the working channel of the colonoscope which limits the ability to suction. If a polyp is seen the viewing device has to be removed in order to perform the polypectomy. The optic is not high definition and finally, the endoscopist has to get used to visualizing and processing two simultaneous video streams from the colonoscope and from the retroscope device.
Read the detailed description
The Retroview™ (PENTAX Medical, HOYA Co.) colonoscope has a short turning radius at the colonoscope tip, that allows a retroflexed view of the colon during withdrawal. This may allow for detection of polyps hidden behind flexures, folds and valves, from the cecum to the rectum. It offers many advantages like the ability to provide high definition views of the proximal aspects of colonic folds, flexures and valves with no additional equipment or device costs. The image is high definition and the colonoscope also incorporates i-SCAN technology. The suction/work channel of the colonoscope is available for therapeutic procedures. Polypectomy can be performed with the colonoscope in retroflexion, without losing views of the polyp. The only disadvantages are the higher consumed withdrawal time because the additional retroflexed withdrawal to the standard withdrawal and that a small portion of the colon is obscured by the shaft of the colonoscope in retroflexion that may be the reason why combined standard withdrawal with retroflexed withdrawal has proved to be better than retroflexed withdrawal alone.
The aim of this study is to determinate and compare the polyp / adenoma detection rate and lesion miss rate by performing a colonoscopy using conventional scopes vs PENTAX RetroView™ scope. As a secondary outcome, size of lesions will be measure in order to determinate if there is a difference between both technics.
MATERIALS AND METHODS
Setting: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Omni Hospital Academic Tertiary Center. We will include patients from December 2016 to July 2017. The study protocol and consent form has been approved by the Institutional Review Board and will be conducted according to the declaration of Helsinki. Patients will sign an informed consent.
Intervention: endoscopic technique The colonoscopy will be performed, in all cases, twice with 2 different scopes. One is a conventional HD colonoscope with I-Scan, tube diameter of 13.2 mm and total length 2023 mm (standard EC 3490LK, PENTAX, Montvale, NJ) and the other is the Retroview™ colonoscope with tube diameter of 11.6 mm and total length 2023 mm (EC-3490TLi, PENTAX, Montvale, NJ). The endoscopy images will be seen on a 27-inch, flat panel, HD LCD monitor (Radiance™ ultra SC-WU27-G1520 model). All of the participants will follow the same colonic preparation with 4 liters of polyethylene glycol (PEG) the day before and the bowel preparation will be evaluated using the Boston Bowel Preparation Scale. Two trained endoscopists on retroflex withdrawal will perform the colonoscopies. Both colonoscopies will be performed in tandem. First one endoscopist will perform the conventional colonoscopy using standard withdrawal technique and then the second endoscopist blinded to the first colonoscopy results, will perform the second colonoscopy with the Retroview scope and combination withdrawal (retroflexed + standard withdrawal). The endoscopist that will perform each colonoscopy will be chosen randomly. The minimum withdrawal time of 6 minutes that is recommended in literature will be respected in both cases. After the examination, the endoscopist will fill a questionnaire detailing each polyp / adenoma found including the size and location. The withdrawal time will be measured in both colonoscopies.
Statistical analysis: Baseline characteristics will be analyzed using Chi-square o Fisher Test for categorical variable and Mann-Whitney Test for continuing variables. If there are more than one polyp in one patients it will be considered individually for statistical purposes. A P value of less than 0.05 will be considered to be statistically significant. All the statistical analysis will be performed using SPSS software suite v.22.
Limitations: The protocol will be performed in only one center and by two endoscopists. There is no control group because the intention is to compare two endoscopy methods in the same setting.
- Conditions
- Colonic Neoplasms
- Being tested
- Retroview™ colonoscope
- Keywords
- Colonoscopy, Retroview™ colonoscope, retrofex colonoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroview™ colonoscopeDevice
The colonoscopy will be performed twice, with 2 different scopes, in tandem, by 2 endoscopists trained on retroflex withdrawal. First a conventional HD colonoscope with I-Scan will be used following the standard withdrawal technique and then the second endoscopist blinded to the first colonoscopy results, will perform the second colonoscopy using the Retroview™ scope with a combining withdrawal (retroflexed + standard withdrawal). The endoscopist that will perform each colonoscopy will be chosen randomly. After the examination, the endoscopist will fill a questionnaire detailing each polyp / adenoma found including the size and location.
| Study group | Role | What they receive |
|---|---|---|
| Group A Retroview™ colonoscope | Patients that have a polyp already seen in a previous colonoscopy and the colonoscopy is indicated for polypectomy will be submitted to a Retroview™ colonoscope Receives: Device: Retroview™ colonoscope | |
| Group B Retroview™ colonoscope | The rest of colonoscopies indicated will be submitted to a Retroview™ colonoscope Receives: Device: Retroview™ colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection rate with the standard colonoscope and Retroview™ scope.
Polyps found with standard colonoscope / total of polys found X 100; polyps found with Retroview™ scope / total of polys found X 100; The total of polyps found will be determinated by the combination of both technics (standard colonoscope and Retroview™ scope)
Measured: 8 month
Adenoma detection rate with the standard colonoscope and Retroview™ scope.
Adenomas found with standard colonoscope / total of adenomas found X 100; adenomas found with Retroview™ scope / total of adenomas found X 100. The total of adenomas found will be determinated by the combination of both technics (standard colonoscope and Retroview™ scope)
Measured: 8 month
Secondary outcomes (2)
Lesion miss rate with the standard colonoscope and Retroview™ scope.
Lesion miss rate: lesions missed / total of lesions (polyps and adenomas) X 100
Measured: 8 month
Number and size of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview ™ scope.
The number and size of lesions will be described in each patient with both procedures. The size will be measure using a standard biopsy catheter as comparison method.
Measured: 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 May 2017
- Primary completion31 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos A Robles-medranda, MD, Principal investigator, Ecuadorian Institute of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155165
- Sponsor's protocol ID
- DEC-19-2016
- Status last verified
- Feb 2019
- First submitted
- 19 Dec 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
PubMed 8247072Hixson LJ, Fennerty MB, Sampliner RE, Garewal HS. Prospective blinded trial of the colonoscopic miss-rate of large colorectal polyps. Gastrointest Endosc. 1991 Mar-Apr;37(2):125-7. doi: 10.1016/s0016-5107(91)70668-8.
PubMed 2032595Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustiere C, Grimaud JC, Barthelemy C, See J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy. 2008 Apr;40(4):284-90. doi: 10.1055/s-2007-995618.
PubMed 18389446Pickhardt PJ, Nugent PA, Mysliwiec PA, Choi JR, Schindler WR. Location of adenomas missed by optical colonoscopy. Ann Intern Med. 2004 Sep 7;141(5):352-9. doi: 10.7326/0003-4819-141-5-200409070-00009.
PubMed 15353426Robertson DJ, Greenberg ER, Beach M, Sandler RS, Ahnen D, Haile RW, Burke CA, Snover DC, Bresalier RS, McKeown-Eyssen G, Mandel JS, Bond JH, Van Stolk RU, Summers RW, Rothstein R, Church TR, Cole BF, Byers T, Mott L, Baron JA. Colorectal cancer in patients under close colonoscopic surveillance. Gastroenterology. 2005 Jul;129(1):34-41. doi: 10.1053/j.gastro.2005.05.012.
PubMed 16012932Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
PubMed 15300577Miller RE, Lehman G. Polypoid colonic lesions undetected by endoscopy. Radiology. 1978 Nov;129(2):295-7. doi: 10.1148/129.2.295.
PubMed 704840Soetikno RM, Kaltenbach T, Rouse RV, Park W, Maheshwari A, Sato T, Matsui S, Friedland S. Prevalence of nonpolypoid (flat and depressed) colorectal neoplasms in asymptomatic and symptomatic adults. JAMA. 2008 Mar 5;299(9):1027-35. doi: 10.1001/jama.299.9.1027.
PubMed 18319413Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
PubMed 15758907East JE, Saunders BP, Burling D, Boone D, Halligan S, Taylor SA. Surface visualization at CT colonography simulated colonoscopy: effect of varying field of view and retrograde view. Am J Gastroenterol. 2007 Nov;102(11):2529-35. doi: 10.1111/j.1572-0241.2007.01429.x. Epub 2007 Jul 19.
PubMed 17640320Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
PubMed 8978338McGill SK, Kothari S, Friedland S, Chen A, Park WG, Banerjee S. Short turn radius colonoscope in an anatomical model: retroflexed withdrawal and detection of hidden polyps. World J Gastroenterol. 2015 Jan 14;21(2):593-9. doi: 10.3748/wjg.v21.i2.593.
PubMed 25593483Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
PubMed 19136102Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM. Quality indicators for colonoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S16-28. doi: 10.1016/j.gie.2006.02.021. No abstract available.
PubMed 16564908Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol. 2003 Sep;98(9):2000-5. doi: 10.1111/j.1572-0241.2003.07662.x.
PubMed 14499778
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retroview™ vs. Conventional Colonoscopy: it is Time to Change?
- ClinicalTrials.gov ID
- NCT03155165
- Acronym / sponsor ID
- DEC-19-2016
- Conditions
- Colonic Neoplasms
- Keywords
- Colonoscopy, Retroview™ colonoscope, retrofex colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colonoscopy is considered the gold standard for colorectal polyp and cancer detection. However, even meticulous colonoscopy substantial numbers of colorectal polyps may be missed and carcinomas may not be prevented. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with the higher miss rates noted for smaller polyps. The lesions missing rate depends on several factors as the location on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, a poor bowel preparation and inadequate endoscopy technique, particularly rapid colonoscope withdrawal. Using the commonly available 140º angle of view colonoscope, approximately 13% of the colonic surface is unseen. The incorporation of colonoscopes with a 170-degree wide angled could not improve adenoma detection rate. The introduction of high definition (HD) colonoscopes and visual image enhancement technologies as narrow band imaging (NBI, Olympus America, Center Valley, PA), i-SCAN™ (PENTAX of America, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization, but several studies proved no increase in adenoma detection rates. The Third Eye Retroscope (Avantis Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced via the accessory channel of a standard colonoscope. Allows retrograde views behind colonic folds and flexures simultaneously with the forward view of the colon. Although it was shown an increase in adenoma detection rate by 11%-25%, it has many disadvantages. It requires a separate processor and the device is disposable making the cost bigger. Occupies the working channel of the colonoscope which limits the ability to suction. If a polyp is seen the viewing device has to be removed in order to perform the polypectomy. The optic is not high definition and finally, the endoscopist has to get used to visualizing and processing two simultaneous video streams from the colonoscope and from the retroscope device.
Detailed description
The Retroview™ (PENTAX Medical, HOYA Co.) colonoscope has a short turning radius at the colonoscope tip, that allows a retroflexed view of the colon during withdrawal. This may allow for detection of polyps hidden behind flexures, folds and valves, from the cecum to the rectum. It offers many advantages like the ability to provide high definition views of the proximal aspects of colonic folds, flexures and valves with no additional equipment or device costs. The image is high definition and the colonoscope also incorporates i-SCAN technology. The suction/work channel of the colonoscope is available for therapeutic procedures. Polypectomy can be performed with the colonoscope in retroflexion, without losing views of the polyp. The only disadvantages are the higher consumed withdrawal time because the additional retroflexed withdrawal to the standard withdrawal and that a small portion of the colon is obscured by the shaft of the colonoscope in retroflexion that may be the reason why combined standard withdrawal with retroflexed withdrawal has proved to be better than retroflexed withdrawal alone.
The aim of this study is to determinate and compare the polyp / adenoma detection rate and lesion miss rate by performing a colonoscopy using conventional scopes vs PENTAX RetroView™ scope. As a secondary outcome, size of lesions will be measure in order to determinate if there is a difference between both technics.
MATERIALS AND METHODS
Setting: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Omni Hospital Academic Tertiary Center. We will include patients from December 2016 to July 2017. The study protocol and consent form has been approved by the Institutional Review Board and will be conducted according to the declaration of Helsinki. Patients will sign an informed consent.
Intervention: endoscopic technique The colonoscopy will be performed, in all cases, twice with 2 different scopes. One is a conventional HD colonoscope with I-Scan, tube diameter of 13.2 mm and total length 2023 mm (standard EC 3490LK, PENTAX, Montvale, NJ) and the other is the Retroview™ colonoscope with tube diameter of 11.6 mm and total length 2023 mm (EC-3490TLi, PENTAX, Montvale, NJ). The endoscopy images will be seen on a 27-inch, flat panel, HD LCD monitor (Radiance™ ultra SC-WU27-G1520 model). All of the participants will follow the same colonic preparation with 4 liters of polyethylene glycol (PEG) the day before and the bowel preparation will be evaluated using the Boston Bowel Preparation Scale. Two trained endoscopists on retroflex withdrawal will perform the colonoscopies. Both colonoscopies will be performed in tandem. First one endoscopist will perform the conventional colonoscopy using standard withdrawal technique and then the second endoscopist blinded to the first colonoscopy results, will perform the second colonoscopy with the Retroview scope and combination withdrawal (retroflexed + standard withdrawal). The endoscopist that will perform each colonoscopy will be chosen randomly. The minimum withdrawal time of 6 minutes that is recommended in literature will be respected in both cases. After the examination, the endoscopist will fill a questionnaire detailing each polyp / adenoma found including the size and location. The withdrawal time will be measured in both colonoscopies.
Statistical analysis: Baseline characteristics will be analyzed using Chi-square o Fisher Test for categorical variable and Mann-Whitney Test for continuing variables. If there are more than one polyp in one patients it will be considered individually for statistical purposes. A P value of less than 0.05 will be considered to be statistically significant. All the statistical analysis will be performed using SPSS software suite v.22.
Limitations: The protocol will be performed in only one center and by two endoscopists. There is no control group because the intention is to compare two endoscopy methods in the same setting.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Retroview™ colonoscope | – | Device: Retroview™ colonoscopePatients that have a polyp already seen in a previous colonoscopy and the colonoscopy is indicated for polypectomy will be submitted to a Retroview™ colonoscope |
| Group B Retroview™ colonoscope | – | Device: Retroview™ colonoscopeThe rest of colonoscopies indicated will be submitted to a Retroview™ colonoscope |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the gastroenterology unit (IECED). All of the participants will have a clear colonoscopy indication. Group A will include patients that have a polyp already seen in a previous colonoscopy and the colonoscopy is indicated for polypectomy. Group B will include the rest of indicated colonoscopies. The distribution in groups A and B is with no intention to compeer the groups but in order to avoid a bias because the patients already have a known lesion.
Key inclusion criteria (5 listed)
- Patients that agree to participate in the study.
- Able to understand and provide written informed consent.
- Colonoscopy indication for colorectal neoplasia screening or polyp surveillance.
- Colonoscopy indication for polypectomy.
- Colonoscopy indication for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging.
Key exclusion criteria (13 listed)
- Age under 18 and over 80 years' old.
- Pregnancy
- Patients with heart disease, kidney, liver or severe metabolic disorder, who cannot tolerate sedation.
- Severe uncontrolled coagulopathy.
- Patients with difficulty understanding instructions of bowel preparation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retroview™ colonoscopeThe colonoscopy will be performed twice, with 2 different scopes, in tandem, by 2 endoscopists trained on retroflex withdrawal. First a conventional HD colonoscope with I-Scan will be used following the standard withdrawal technique and then the second endoscopist blinded to the first colonoscopy results, will perform the second colonoscopy using the Retroview™ scope with a combining withdrawal (retroflexed + standard withdrawal). The endoscopist that will perform each colonoscopy will be chosen randomly. After the examination, the endoscopist will fill a questionnaire detailing each polyp / adenoma found including the size and location. | Device | Group A Retroview™ colonoscope, Group B Retroview™ colonoscope |
Primary outcome
Polyp detection rate with the standard colonoscope and Retroview™ scope.
Time frame: 8 month
Polyps found with standard colonoscope / total of polys found X 100; polyps found with Retroview™ scope / total of polys found X 100; The total of polyps found will be determinated by the combination of both technics (standard colonoscope and Retroview™ scope)
Adenoma detection rate with the standard colonoscope and Retroview™ scope.
Time frame: 8 month
Adenomas found with standard colonoscope / total of adenomas found X 100; adenomas found with Retroview™ scope / total of adenomas found X 100. The total of adenomas found will be determinated by the combination of both technics (standard colonoscope and Retroview™ scope)
2 secondary outcomes
Lesion miss rate with the standard colonoscope and Retroview™ scope.
Time frame: 8 month
Number and size of lesions (adenomas and polyps) detected with the standard colonoscope and Retroview ™ scope.
Time frame: 8 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Results publication: PubMed 8247072Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
- Results publication: PubMed 2032595Hixson LJ, Fennerty MB, Sampliner RE, Garewal HS. Prospective blinded trial of the colonoscopic miss-rate of large colorectal polyps. Gastrointest Endosc. 1991 Mar-Apr;37(2):125-7. doi: 10.1016/s0016-5107(91)70668-8.
- Results publication: PubMed 18389446Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustiere C, Grimaud JC, Barthelemy C, See J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy. 2008 Apr;40(4):284-90. doi: 10.1055/s-2007-995618.
- Results publication: PubMed 15353426Pickhardt PJ, Nugent PA, Mysliwiec PA, Choi JR, Schindler WR. Location of adenomas missed by optical colonoscopy. Ann Intern Med. 2004 Sep 7;141(5):352-9. doi: 10.7326/0003-4819-141-5-200409070-00009.
- Results publication: PubMed 16012932Robertson DJ, Greenberg ER, Beach M, Sandler RS, Ahnen D, Haile RW, Burke CA, Snover DC, Bresalier RS, McKeown-Eyssen G, Mandel JS, Bond JH, Van Stolk RU, Summers RW, Rothstein R, Church TR, Cole BF, Byers T, Mott L, Baron JA. Colorectal cancer in patients under close colonoscopic surveillance. Gastroenterology. 2005 Jul;129(1):34-41. doi: 10.1053/j.gastro.2005.05.012.
- Results publication: PubMed 15300577Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
- Results publication: PubMed 704840Miller RE, Lehman G. Polypoid colonic lesions undetected by endoscopy. Radiology. 1978 Nov;129(2):295-7. doi: 10.1148/129.2.295.
- Results publication: PubMed 18319413Soetikno RM, Kaltenbach T, Rouse RV, Park W, Maheshwari A, Sato T, Matsui S, Friedland S. Prevalence of nonpolypoid (flat and depressed) colorectal neoplasms in asymptomatic and symptomatic adults. JAMA. 2008 Mar 5;299(9):1027-35. doi: 10.1001/jama.299.9.1027.
- Results publication: PubMed 15758907Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
- Results publication: PubMed 17640320East JE, Saunders BP, Burling D, Boone D, Halligan S, Taylor SA. Surface visualization at CT colonography simulated colonoscopy: effect of varying field of view and retrograde view. Am J Gastroenterol. 2007 Nov;102(11):2529-35. doi: 10.1111/j.1572-0241.2007.01429.x. Epub 2007 Jul 19.
- Results publication: PubMed 8978338Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
- Results publication: PubMed 25593483McGill SK, Kothari S, Friedland S, Chen A, Park WG, Banerjee S. Short turn radius colonoscope in an anatomical model: retroflexed withdrawal and detection of hidden polyps. World J Gastroenterol. 2015 Jan 14;21(2):593-9. doi: 10.3748/wjg.v21.i2.593.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Robles-medranda, MD principal investigator
Ecuadorian Institute of Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasms, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyp detection rate with the standard colonoscope and Retroview™ scope. (time frame: 8 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155165, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.