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1.
J Gastroenterol Hepatol ; 39(3): 457-463, 2024 Mar.
Article En | MEDLINE | ID: mdl-37984841

BACKGROUND AND AIM: The purpose of this randomized controlled study was to compare the characteristics of the CF-H290I (high-definition) colonoscope with those of the PCF-Q260JI (high-resolution) colonoscope in non-sedated patients with a history of abdominal or pelvic surgery in an effort to help endoscopists to select more effectively and objectively between the various colonoscopes. METHODS: A total of 397 patients who underwent colonoscopy at the Affiliated Wuxi People's Hospital of Nanjing Medical University, between August 2022 and October 2022 were randomized to a CF-H290I group (n = 198) or a PCF-Q260JI group (n = 199) using a computer-generated allocation method. We compared the adenoma detection rate (ADR), patient satisfaction with the examination, discomfort associated with colonoscopy including abdominal distension and pain, cecal intubation time, and patient willingness to undergo colonoscopy in the future between the CF-H290I and PCF-Q260JI groups. RESULTS: There was no statistically significant difference in the overall ADR between the CF-H290I and PCF-Q260JI groups (81 [40.9%] vs 63 [31.7%], Z = 3.674, P = 0.055). However, the ADRs in the transverse colon and left colon were significantly higher in the CF-H290I group (22 [11.1%] vs 6 [3.0%], Z = 9.588, P = 0.002 and 57 [28.8%] vs 37 [18.6%], Z = 5.212, P = 0.017, respectively). More sessile serrated lesions were detected in the CF-H290I group (52 [26.3] vs 30 [15.1%], Z = 7.579, P = 0.006). Patient satisfaction with colonoscopy was better in the PCF-Q260JI group (8.91 ± 1.09 vs 8.51 ± 1.44, t = -3.158, P < 0.01) with less likelihood of discomfort (23 [11.6%] vs 41 [20.7%], Z = 6.144, P = 0.013), The number of patients willing to undergo colonoscopy in the future was significantly greater in the PCF-Q260JI group (168 [84.4%] vs 149 [75.3%], Z = 5.186, P = 0.023). The cecal intubation time was significantly shorter in the CF-H290I group (256.09 ± 155.70 s vs 315.64 ± 171.64 s, P = 0.004). There were no complications such as perforation or bleeding in either group. CONCLUSION: The CF-H290I and PCF-Q260JI colonoscopes each have advantages when used in patients with a history of abdominal or pelvic surgery. The CF-H290I has higher ADRs in the transverse and left colon whereas the PCF-Q260JI is less painful and better accepted by patients. This study was approved by the Clinical Research Ethics Committee of Wuxi People's Hospital and was registered in the Chinese Clinical Trial Registry (ChiCTR2200063092).


Adenoma , Colonoscopy , Humans , Colonoscopy/adverse effects , Colonoscopy/methods , Cecum , Prospective Studies , Equipment Design , Colonoscopes/adverse effects , Pain/etiology
2.
J Card Surg ; 35(8): 2053-2055, 2020 Aug.
Article En | MEDLINE | ID: mdl-32652732

Colonoscopy is generally considered a safe procedure, with a low rate of complications. Although rare, the migration of the colonoscope may represent life-threatening events, requiring emergency treatment. We, herein, describe the case of an elective colonoscopy complicated by an irretrievable colonoscope that migrated, through a previous traumatic diaphragmatic hernia, in the chest cavity. This hernia was likely a chronic complication of a previous abdominal trauma. Several attempts to retrieve the scope were unsuccessful. After further investigations and collegial discussion, a left thoracotomy was performed, with the aim to retrieve the colonoscope and to reduce the hernia.


Colonoscopes/adverse effects , Colonoscopy/adverse effects , Foreign Bodies/surgery , Foreign-Body Migration/surgery , Thoracic Cavity , Thoracotomy/methods , Abdominal Injuries/complications , Aged , Hernia, Diaphragmatic/etiology , Humans , Male
4.
Gastrointest Endosc ; 91(3): 663-668, 2020 03.
Article En | MEDLINE | ID: mdl-31756315

BACKGROUND AND AIMS: Endocuff improves detection at colonoscopy but seems to impede terminal ileal (TI) intubation. We assessed the impact of Endocuff Vision (EV) on TI intubation using adult or pediatric colonoscopes and evaluated whether filling the cecum with gas versus water affected the impact of EV on TI intubation. METHODS: Using a prospectively recorded quality control database, we explored the impact of EV on TI intubation in ≤1 minute. We used adult and pediatric colonoscopes and tested the effect of filling the cecum with gas versus water. If the initial attempt failed, then the alternative (water vs gas) was tried as a rescue method. RESULTS: TI intubation in ≤1 minute occurred in 91% of colonoscopies without EV versus 65% with EV, but the use of the pediatric colonoscope with EV had a higher success rate for TI intubation in ≤1 minute compared with the adult colonoscope with EV (73% vs 57%, P = .043). TI intubation in ≤1 minute was more successful with EV when the cecum was filled with water rather than gas (74% vs 56%, P = .019), but the benefit of water filling was limited to the adult colonoscope with EV. When EV was in place, water filling was more successful as a rescue method of TI intubation (58% vs 21%, P = .011). CONCLUSIONS: EV adversely affects TI intubation, particularly for adult colonoscopes. Water filling of the cecum mitigates the impact of EV on TI intubation with adult colonoscopes.


Cecum/surgery , Colonoscopes , Colonoscopy , Aged , Clinical Competence , Colonoscopes/adverse effects , Colonoscopy/adverse effects , Colonoscopy/instrumentation , Colonoscopy/methods , Colonoscopy/standards , Equipment Design , Female , Gases , Humans , Ileum/surgery , Male , Middle Aged , Prospective Studies , Time Factors , Water
5.
J Clin Gastroenterol ; 53(10): 731-736, 2019.
Article En | MEDLINE | ID: mdl-31135633

GOALS: The goal of this study was to evaluate the safety and feasibility of routine segmental retroflexed withdrawal viewing (RV) of the colon with the RetroView colonoscope. MATERIALS AND METHODS: This was a prospective, single-center, 2-stage diagnostic trial. After cecal intubation, mucosal evaluation by forward viewing (FV) and RV was performed by segment (right, transverse, left, and sigmoid colon, and rectum). Lesions detected during FV were removed and/or marked before retroflexion. Safety and feasibility were measured through adverse event and technical success rates. All lesions detected and removed endoscopically were recorded. RESULTS: Two hundred twenty-five patients underwent colonoscopy with the RetroView colonoscope. Retroflexion by segment was successful in the right, transverse, left, and sigmoid colon, and rectum in 98.9%, 100%, 100%, 82.6%, and 100% of cases, respectively. The mean total procedure time was 16.6 minutes. Ninety-four lesions were detected through retroflexion evaluation, for an increase in the lesions' detection rate of 30.7%. The per-adenoma miss rate of standard colonoscopy (FV) was 35.71%. The adenoma detection rate (ADR) for FV was 16%, whereas, when performing FV and RV, the ADR increased to 24.9%. Adverse events were recorded in 0.4% of cases. Therapeutic procedures were performed successfully through the retroflexed position in 81/225 patients. CONCLUSIONS: Routine retroflexion evaluation of the colonic mucosa by segment using the RetroView colonoscope is safe and feasible. Retroflexion evaluation increases the detection rate of colonic lesions behind folds, including the number of adenomas per colonoscopy and ADR, offering a complete screening colonoscopy. All therapeutic procedures are feasible through retroflexion.


Adenoma/diagnosis , Colonic Polyps/diagnosis , Colonoscopes/adverse effects , Colonoscopy/instrumentation , Patient Safety , Adenoma/pathology , Colonic Polyps/pathology , Equipment Design , Female , Humans , Male , Middle Aged , Prospective Studies , Treatment Outcome
6.
Comput Methods Biomech Biomed Engin ; 22(1): 38-46, 2019 Jan.
Article En | MEDLINE | ID: mdl-30398066

Patient pain caused by a colonoscope is one of the main complications in completing a colonoscopy. Currently, randomized controlled trial (RCT) is one of the most used methods to evaluate the efficacy of small-caliber (SC) colonoscopes in reducing patient pain during a colonoscopy, compared with a standard colonoscope (SDC). However, many disturbing factors, including endoscopists' skills, characteristics of patients and new technical features of the colonoscope (passive bending and high force transmission shaft), limit the reliability and generalizability of each finding in current RCTs. This paper focuses on modeling the insertion of colonoscopes within colon models using an explicit finite element method (FEM). Such a numerical model could overcome the limitations in RCTs. At the same time, it is expected to evaluate the efficacy of the small-caliber colonoscopes in reducing patient pain during a colonoscopy, while considering the effects of patient characteristics, including age, region and gender. The simulation results in this work showed that: compared with the SDC, a SC colonoscope may be more helpful in reducing discomfort for older patients, patients with smaller colon diameters and females.


Colonoscopes/adverse effects , Colonoscopy/adverse effects , Numerical Analysis, Computer-Assisted , Pain/etiology , Adult , Animals , Colon/anatomy & histology , Colon/diagnostic imaging , Computer Simulation , Equipment Design , Female , Friction , Humans , Kinetics , Male , Middle Aged , Models, Anatomic , Reproducibility of Results , Swine
8.
Endoscopy ; 50(1): 63-68, 2018 01.
Article En | MEDLINE | ID: mdl-29132174

BACKGROUND AND STUDY AIMS: The adenoma detection rate (ADR) of conventional colonoscopy can still be improved. We conducted a prospective multicenter cohort study to assess the feasibility, safety, and diagnostic yield of the Extra Wide Angle View (EWAVE) colonoscope, which offers a 235° view obtained from a forward-viewing and two lateral backward-viewing lenses incorporated into one image. PATIENTS AND METHODS: The study was performed between November 2015 and June 2016. EWAVE colonoscopy was performed in patients with an increased risk of colorectal cancer by experienced and EWAVE-trained endoscopists (≥ 500 colonoscopies, ≥ 10 with the EWAVE system). RESULTS: A total of 193 patients underwent EWAVE colonoscopy. The cecal intubation rate was 97.4 %. EWAVE colonoscopy had a polyp detection rate (PDR) of 61.1 % (118 /193), ADR of 39.9 % (77 /193), and advanced ADR of 13.5 % (26 /193). No adverse events occurred. CONCLUSIONS: EWAVE colonoscopy is feasible and safe. The ADR appears comparable to those achieved with conventional colonoscopes in similar patient populations. To further elucidate the additional benefits of wide-angle-view colonoscopes, randomized trials would be required.


Adenoma/diagnostic imaging , Colonic Polyps/diagnostic imaging , Colonoscopes , Colonoscopy/instrumentation , Colorectal Neoplasms/diagnostic imaging , Aged , Cecum , Colonoscopes/adverse effects , Feasibility Studies , Female , Humans , Intubation, Gastrointestinal , Male , Middle Aged , Prospective Studies
9.
Surg Endosc ; 31(12): 5150-5158, 2017 12.
Article En | MEDLINE | ID: mdl-28488178

BACKGROUND: Ultrathin colonoscopes (UTC) reportedly produce less pain during colonoscopy than standard colonoscopes. The aim of this study was to assess the tolerability of an UTC compared with that of a pediatric colonoscope. METHODS: A total of 270 adult patients scheduled to undergo colonoscopy were randomized, with 134 allocated to the UTC group and 136 to the pediatric colonoscope group. Pain was assessed using a visual analog scale. For all procedures, sedation was administered only if requested. Overall pain, rate and time of cecal and terminal ileum intubation, number of patients requesting sedation, adenoma detection rates (ADR), and rate of complications were measured and analyzed. RESULTS: Among all patients, the medians of maximum pain and overall pain were significantly lower in the UTC group than in the pediatric colonoscope group (23 vs. 38, P < 0.001; 12 vs. 22, P = 0.0003, respectively). Significantly fewer patients requested sedation in the UTC group than in the pediatric colonoscope group (1.4 vs. 6.6%; P = 0.0269). No significant differences were seen in either the rate and time of successful cecal and terminal ileum intubation, or in other procedure-related outcomes, including ADR. CONCLUSIONS: Compared with a pediatric colonoscope, the UTC was associated with reduced overall and maximum pain during colonoscopy, with no difference in ADR.


Adenoma/diagnostic imaging , Colonic Neoplasms/diagnostic imaging , Colonoscopes , Colonoscopy/instrumentation , Adult , Aged , Aged, 80 and over , Colonoscopes/adverse effects , Colonoscopy/adverse effects , Colonoscopy/methods , Conscious Sedation , Female , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Pain/diagnosis , Pain/etiology , Pain/prevention & control , Pain Measurement , Prospective Studies , Single-Blind Method
10.
Endoscopy ; 49(4): 351-358, 2017 Apr.
Article En | MEDLINE | ID: mdl-27852099

Background and study aims Colonoscopy should reliably intubate the cecum with minimal patient discomfort and without complications. Use of thinner endoscopes to overcome pain during the procedure has shown promise. However, the use of thinner scopes could lead to excess looping and difficulty with therapeutic procedures. The aim of this meta-analysis was to analyze the performance of ultrathin colonoscopes (UTC) and standard colonoscopes for routine colonoscopy. Patients and methods We searched several electronic databases for all randomized controlled trials and nonrandomized (prospective) studies that compared the efficacies of UTC (diameter ≤ 9.8 mm) and standard colonoscopes. We used fixed effect or random effects models to compare cecal intubation rate, cecal intubation time, pain score, and polyp and adenoma detection rates using standard mean differences (SMD) or odds ratios (OR) with 95 % confidence intervals (CI). Results Seven studies (2191 patients) met the inclusion criteria. There was no significant heterogeneity among studies except for pain scores. The cecal intubation rate was higher with UTC (OR 2.30; 95 %CI 1.31 to 4.03). There was no difference in the cecal intubation time between UTC and standard colonoscopes. Pain scores were significantly lower with UTC than with standard colonoscopes (SMD - 0.59, 95 %CI - 0.93 to - 0.25). Polyp and adenoma detection rates were similar for both types of colonoscope. Conclusion Use of UTC appears to improve the cecal intubation rate and reduce abdominal pain but does not affect polyp detection. Future trials are needed to evaluate the therapeutic performance of UTC vs. standard colonoscopes.


Adenoma/diagnostic imaging , Colonoscopes/standards , Colonoscopy/instrumentation , Colorectal Neoplasms/diagnostic imaging , Intubation/statistics & numerical data , Abdominal Pain/etiology , Cecum , Colonic Polyps/diagnostic imaging , Colonoscopes/adverse effects , Colonoscopy/adverse effects , Equipment Design , Humans , Intubation/instrumentation , Time Factors
11.
Digestion ; 93(3): 234-47, 2016.
Article En | MEDLINE | ID: mdl-27119347

BACKGROUND: Colorectal cancer (CRC) is a common cause of cancer-related deaths. Early detection of precursor lesions in the adenoma-carcinoma sequence via colonoscopy can decrease mortality from CRC. SUMMARY: In this review article, we have summarized retrospective studies, prospective single center, multicenter studies and randomized controlled trials describing the efficacy of endocuff colonoscopy (EC), cap-assisted colonoscopy (CAC) and endorings colonoscopy (ERC). Indications, techniques, outcomes, limitations and complications reported are discussed. KEY MESSAGE: Use of colonoscope with cap, cuff or rings attached to its distal tip has been shown to increase the polyp detection rate and adenoma detection rate, predominantly for the small polyps (<1 cm) and proximal colon location. Evidence is uniform for EC and ERC but not for CAC. Benefits of shorter cecum intubation time, improved cecum intubation rates and decreased pain scores during colonoscopy done with assistance of cuff or cap has potential to decrease the number of incomplete colonoscopy and increase overall patient satisfaction, thus improving follow-up. In the absence of any additional adverse events, EC, CAC and ERC have potential to enhance the benefits of colonoscopy.


Adenoma/diagnosis , Carcinoma/diagnosis , Colonic Polyps/diagnosis , Colonoscopes , Colonoscopy , Colorectal Neoplasms/diagnosis , Clinical Studies as Topic , Colonoscopes/adverse effects , Colonoscopes/trends , Colonoscopy/adverse effects , Colonoscopy/methods , Colonoscopy/trends , Humans , Treatment Outcome
12.
Gastrointest Endosc ; 83(5): 998-1004.e1, 2016 May.
Article En | MEDLINE | ID: mdl-26391735

BACKGROUND AND AIMS: The self-propelled disposable colonoscope (SPDC) with a 360° view is designed to enhance visualization, minimize risks of perforation and infection transmission, and shorten operator training time associated with conventional colonoscopy (CC). We evaluated SPDC efficacy for cecal intubation and safety. METHODS: Prospective patients presenting for colorectal cancer screening underwent SPDC immediately followed by CC. Initial patients necessary for SPDC operators to achieve proficiency comprised the training cohort. Subsequent enrolled patients comprised the study cohort. SPDC colonoscopy was performed up to the cecum, where anatomic landmarks were photographed and mucosal suction marks were placed. During SPDC withdrawal, polyps were recorded and similarly marked. On the second pass (by using CC), any potential mucosal damage and suction marks from the SPDC as well as polyps were recorded. Main endpoints included SPDC cecal intubation rates, confirmed by anatomic landmarks and residual marks seen on subsequent CC, and frequency and severity of adverse events and mucosal damage with SPDC. The secondary endpoint was subjective procedure proficiency, evaluated by the operator based on the training cohort. The tertiary endpoint was documenting pathologies visualized with SPDC. RESULTS: Fifty-six of 58 enrolled subjects completed the study. Proficiency with SPDC was attained after 8 to 10 procedures. Cecal intubation was successful in 98.2% (55/56 subjects; 95% confidence interval [CI], 90.4%-99.9%), including 100% (95% CI, 90.7%-100%) of the study cohort and 94.4% (95% CI, 72.7%-99.9%) of the training cohort. No mucosal damage or adverse events were reported. SPDC detected 87.5% of polyps seen in tandem CC, including all polyps larger than 5 mm. CONCLUSIONS: SPDC was highly successful, simple to use, and safe in achieving complete colonoscopy (cecal intubation). ( CLINICAL TRIAL REGISTRATION NUMBER: 0692-12-TLV.).


Colonic Polyps/diagnostic imaging , Colonoscopes , Colonoscopy/instrumentation , Disposable Equipment , Adult , Aged , Anatomic Landmarks , Cecum , Clinical Competence , Colonoscopes/adverse effects , Colonoscopy/adverse effects , Female , Humans , Intestinal Mucosa/injuries , Intubation, Gastrointestinal , Learning Curve , Male , Middle Aged , Prospective Studies
15.
Endoscopy ; 47(5): 444-8, 2015 May.
Article En | MEDLINE | ID: mdl-25412088

BACKGROUND AND STUDY AIMS: Lesions may be missed during colonoscopy because of anatomical features such as mucosal folds. This feasibility study assessed the safety and efficacy of a novel colonoscope with extra-wide angle of view, which provides a simultaneous lateral-backward view to complement the forward view. PATIENTS AND METHODS: Consecutive patients undergoing colonoscopy using the prototype colonoscope were enrolled in this multicenter, single-arm study. The number of adverse events, and the first detection of adenomas during withdrawal by the lateral-backward view and the forward view were evaluated. RESULTS: A total of 47 patients underwent colonoscopy examination to the cecum. The mean insertion and withdrawal times were 6.4 ±â€Š4.9 minutes and 8.6 ±â€Š4.2 minutes, respectively. Of 47 detected polyps, 28 adenomatous polyps were found (mean size 3.3 ±â€Š3.1 mm). A total of 29 polyps (61.7 %) and 16 adenomatous polyps (57.1 %) were first detected with the lateral-backward view. The lateral-backward view first detected 5/6 adenomatous polyps (83.3 %) in the ascending colon and all (2/2) adenomatous polyps in the sigmoid colon. No adverse events occurred during the study. CONCLUSIONS: This exploratory study suggested that a novel colonoscope with extra-wide angle of view is safe and feasible, and has the potential to improve colorectal adenoma detection. TRIAL REGISTER: UMIN000016450.


Adenoma/diagnosis , Colonic Neoplasms/diagnosis , Colonic Polyps/diagnosis , Colonoscopes , Colonoscopy/instrumentation , Aged , Colon, Ascending , Colon, Sigmoid , Colonoscopes/adverse effects , Feasibility Studies , Female , Humans , Male , Middle Aged , Time Factors
16.
Endoscopy ; 46(10): 883-7, 2014 Oct.
Article En | MEDLINE | ID: mdl-25225962

BACKGROUND AND STUDY AIMS: Although colonoscopy is the gold standard for detecting colorectal cancer (CRC), adenomas and cancers are missed. We aimed to establish the safety and feasibility of use of a novel balloon-colonoscope. PATIENTS AND METHODS: Patients (40 - 75 years) referred for CRC screening, polyp surveillance, or diagnostic evaluation were enrolled in a prospective pilot cohort study whose primary endpoint was device safety. Additional endpoints included success of and time to cecal intubation, withdrawal and total procedure times, polyp detection rate (PDR), adenoma detection rate (ADR), and success of polypectomies. RESULTS: Among 50 patients (mean age 59.0 years, 27 women [54 %]), three were excluded (inadequate colon preparation, technical problem, abdominal hernia) and 47 were analyzed. Two patients experienced minor adverse events (diarrhea, abdominal pain). Cecal intubation rate was 47 /47 (100 %). Mean times, to reach cecum, withdrawal, and total procedure, were 4.3, 7.4, and 16.5 minutes, respectively. We identified 44 polyps (all successfully removed) in 25 /47 patients (PDR 53.2 %), 35 polyps (79.5 %) were 1 - 5 mm, 4 (9.1 %) 6 - 9 mm, and 5 (11.4 %) ≥ 10 mm. Of 44 polyps, 36 (81.8 %) were "adenomas"; 21/47 patients had ≥ 1 adenoma (ADR 44.7 %). CONCLUSIONS: The NaviAid G-EYE balloon-colonoscope appears safe and feasible to use. Comparative human studies are underway.Clinicaltrials.gov identifier: NCT01749722.


Adenoma/diagnosis , Colonic Polyps/diagnosis , Colonoscopes/adverse effects , Colonoscopy/adverse effects , Colonoscopy/instrumentation , Colorectal Neoplasms/diagnosis , Early Detection of Cancer/instrumentation , Abdominal Pain/etiology , Adenoma/surgery , Adult , Aged , Catheterization , Cecum , Colonic Polyps/pathology , Colonic Polyps/surgery , Diarrhea/etiology , Feasibility Studies , Female , Humans , Male , Middle Aged , Operative Time , Pilot Projects , Prospective Studies , Time Factors
17.
Gastrointest Endosc ; 79(5): 790-7, 2014 May.
Article En | MEDLINE | ID: mdl-24210653

BACKGROUND: Studies have estimated that cecal intubation failure occurs with conventional colonoscopy in about 10% of cases. Various methods have been adopted to improve the cecal intubation rate, including a transparent cap and special colonoscopes. OBJECTIVE: To assess the efficacy of using a cap-assisted gastroscope (E-cap) compared with a cap-assisted colonoscope (C-cap) for the complete examination of the colon in nonsedated patients with technically difficult sigmoid colons. DESIGN: Randomized, controlled study. SETTING: Tertiary-care referral center. PATIENTS: One hundred thirty-nine patients with technically difficult sigmoid colons were studied. INTERVENTION: Colonoscopy with either an E-cap (n = 69) or a C-cap (n = 70). MAIN OUTCOME MEASUREMENTS: Cecal intubation rate, cecal intubation time, patient-assessed pain score, and endoscopist-assessed pain score. RESULTS: The cecal intubation rate was significantly higher in the E-cap (65/69, 94.2%) than in the C-cap group (50/70, 71.4%; P < .0001). Patient-assessed pain (moderate to severe) was more frequently reported in the C-cap (14/70, 20.0%) than in the E-cap group (5/69, 7.2%; P = .029). Endoscopist-assessed pain (moderate to severe) was more frequently reported in the C-cap (13/70, 18.6%) than in the E-cap group (3/69, 7.2%; P = .009). For patients with a low body mass index (≤ 22 kg/m(2)), the cecal intubation rate was significantly higher in the E-cap (37/38, 97.4%) than in the C-cap group (15/29, 51.7%; P < .0001). LIMITATIONS: Single-center experience, lack of a gastroscope control group without a cap. CONCLUSION: The cap-assisted gastroscope is more tolerable and effective than cap-assisted colonoscope for the complete examination of the colon in patients with technically difficult sigmoid colons. ( CLINICAL TRIAL REGISTRATION NUMBER: KCT0000744.).


Colon, Sigmoid/anatomy & histology , Colonoscopes , Colonoscopy/instrumentation , Gastroscopes , Adult , Aged , Asian People , Body Mass Index , Cecum , Colonoscopes/adverse effects , Colonoscopy/adverse effects , Deep Sedation , Female , Gastroscopes/adverse effects , Humans , Intubation, Gastrointestinal , Male , Middle Aged , Operative Time , Pain/etiology , Pain Measurement
20.
Gastrointest Endosc ; 75(5): 1031-1036.e1, 2012 May.
Article En | MEDLINE | ID: mdl-22381532

BACKGROUND: Unsedated colonoscopy has potential benefits, including decreased costs and decreased risks. OBJECTIVE: To determine whether patient comfort during unsedated colonoscopy can be improved through the use of a magnetic endoscopic imaging (MEI) colonoscope compared with a standard colonoscope. DESIGN: Prospective, patient-blinded, randomized, controlled trial. SETTING: San Francisco Veterans Affairs Medical Center. PATIENTS: Veterans undergoing outpatient screening or surveillance colonoscopy. INTERVENTIONS: Use of a standard or MEI colonoscope during unsedated colonoscopy. MAIN OUTCOME MEASUREMENT: The primary outcome variable was patient perception of pain using a 7-point scale. The secondary endpoint was patient willingness to undergo a future unsedated colonoscopy. RESULTS: Of the 160 patients enrolled, 140 completed an unsedated colonoscopy in the study protocol. In a per-protocol analysis, the mean and median pain score was 3.12 (standard deviation 1.22) and 4 (interquartile range 2-4) for the standard colonoscope group and 3.06 (standard deviation 1.13) and 3 (interquartile range 2-4) for the MEI group, where 3 was mild pain (P = not significant). Overall, 80% of subjects were willing to undergo a future unsedated colonoscopy for screening or surveillance. In an intention-to-treat analysis, 80% of subjects (64/80) in the standard colonoscope arm and 79% in the MEI arm (63/80) were willing to undergo a future unsedated colonoscopy (P = not significant). LIMITATIONS: Single-center study of mostly male veterans. CONCLUSIONS: This patient-blinded, randomized, controlled trial did not demonstrate any difference in patient perception of pain or willingness to undergo unsedated examinations when using the MEI versus the conventional colonoscope. Unsedated colonoscopy is generally feasible and well tolerated and is associated with high patient satisfaction rates.


Colonoscopes , Colonoscopy/methods , Pain/etiology , Patient Satisfaction , Aged , Chi-Square Distribution , Colonoscopes/adverse effects , Deep Sedation , Female , Humans , Intention to Treat Analysis , Male , Middle Aged , Single-Blind Method , Statistics, Nonparametric
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