| BackgroundSmall bowel capsule endoscopy (SBCE) is a non-invasive diagnostic technique for digestive system emerging in recent years. It was first introduced in Nature by Iddan G. in 2000. SBCE is small and can be swallowed easily. Advantages of SBCE include its convenience, simplicity, lack of discomfort, non-invasive, safety and high efficiency. It does not affect patients’ normal life and work. There is no occurrence of cross infection during the examination of SBCE. It is suitable for patients with heart, lungs, brain, kidney and other viscera disease and those elderly patients with difficulty to tolerate the traditional endoscopy examinations. It is also suitable for those who are unwilling to undergo the traditional endoscopy examinations. It has little effects on the peristalsis of the digestive tract and fills the gaps in noninvasive and visual examination of the small intestine.It provides a fresh choice in diagnosis and treatment for the small intestine diseasess. It doesn’t need mechanical insertion and breaks through the traditional endoscopy in examination mode. It overcomes the disadvantages of the traditional endoscopy which has poor tolerance and is not suitable for the frail elderly and those with critical condition. It can examine the small intestine comprehensively and intuitively and increase the accuracy of the diagnosis of the small intestinal diseases greatly. In the entire process of examination the patients don’t have any pain, can act freely and don’t need to be hospitalized. It greatly expanded the examination channel of the digestive tract and can observe the small intestinal which the traditional endoscopy is difficult to do. Since its advent, it has been widely applied and is called the revolution and the development direction of endoscopy in the 21st-century. It has developed from a new exploratory examination technology into a first line diagnostic tool of the small intestine diseases.In the case of physiological or many pathological conditions, there is a large amount of chyme or feces in the digestive tract. To improve the image quality of SBCE, bowel preparation is required. The European Society for Gastrointestinal Endoscopy guidelines on SBCE recommending polyethylene glycol (PEG) based regimens as first-line small bowel preparations before SBCE.In some areas (such as China), medical resources are unevenly distributed. Occasionally, patients with unexplainable results are referred from local hospitals to superior medical institutions. Although those patients might have already undergone a colonoscopy at local hospital, physicians at the superior medical institution might advise them to undergo both SBCE and colonoscopies (considering that physicians in local hospital may lack clinical experience). In addition, patients with established Crohn disease may require both SBCE and colonoscopies during the course of the disease. This combination has become more common in recent years due to the increasing occurrence of some of the gastrointestinal diseases.Both SBCE and colonoscopy require bowel preparation, which may cause inconvenience even discomfort. To avoid repeated bowel preparation, many patients choose to undergo SBCE and colonoscopies on the same day.Many patients who undergo colonoscopies without sedation experience significant pain. Many patients prefer the use of sedation for colonoscopy. SBCE is small and the lifespan of the battery is limited. Theoretically, sedation may affect gastrointestinal motility and reduce the SBCE completion rate.As one of the most ultra short-acting sedative drugs, propofol has a short elimination half-life and takes effect quickly. Advantages of propofol include recovering in a short time, no obvious residual and accumulation, low incidence of nausea and vomiting. It has gained wide acceptance as a drug for sedation and is used extensively in the world.There are few reports on the effect of sedation on SBCE. To evaluate the effect of sedation on SBCE, we conducted a prospective review of patients who underwent SBCE and colonoscopies with or without sedation on the same day.Methods Study designThis was an observational study. The principal investigator and the steering committee designed the study and wrote the article. The study protocol was approved by the Institutional Review Boards of Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong province, China. Written informed consent was obtained from all patients prior to the procedure. From July 2014 to June 2015,18 to 65 years old patients who underwent SBCE and colonoscopies on the same day at Nanfang Hospital (Guangzhou, Guangdong province, China) were enrolled consecutively.PatientsFrom July 2014 to June 2015,18 to 65 years old patients who underwent SBCE and colonoscopies on the same day at Nanfang Hospital were enrolled consecutively. 181 patients were ultimately enrolled,64 of whom were assigned to the sedation group at their request. Inclusion criteriaThose patients who underwent SBCE and colonoscopies on the same day were enrolled.Exclusion criteria1.Contraindications of SBCE or colonoscopies:(1). Patients could not or refused to accept any abdominal surgery (once the capsule retention could not be removed by surgery); (2). Patients with oropharyngeal diseases affecting swallowing such as pharynx tumor and goiter; (3). Patients with the digestive tract dynamic obstacles such as esophageal achalasia and gastroparesis; (4). Patients with the digestive tract stenosis, obstruction or fistula for example digestive tract severe stenosis, obstruction or fistula caused by Crohn’s disease or digestive tract stenosis caused by chemical burns; (5). Patients known or suspected the digestive tract perforation; (6). Patients with all kinds of severe ischemic diseases, radioactive colonitis and acute enteritis for instance active bacterial dysentery or the acute phase of ulcerative colitis; (7). Patients with giant diverticulum; (8). Patients with the digestive tract malformation;(9). Patients with implanted electronic medical instrument such as cardiac pacemaker;(10). Pregnant woman; (11). Patients with mental disorder.2. Patients with serious diseases for example:cardiovascular diseases, liver diseases, kidney diseases, neurological diseases and respiratory system diseases;3. Diabetes mellitus with evidence of end-organ damage.4. Clinical hyperthyroidism or hypothyroidism. 5. Hypokalemia. 6. Irritable bowel syndrome.7. Use of prokinetic medications within 5 days prior to the procedure.8. Patients with a history of abdominal surgery.9. Patients<18 years old or> 65 years old.10. Patients with allergic to any ingredients of the drug used in the study.11. Patients participating in other clinical study in recent one month12. Refused to participate in the study.Bowel preparationPatients were instructed to eat a soft breakfast on the day before the procedure and to maintain a fluids-only diet starting at lunch time on the day prior to the procedure. Then, patients were asked to consume 4 L of PEG electrolyte solution. Specifically,2 L was consumed between 19:00 and 21:00 on the night before the procedure, and the remaining 2 L was consumed between 3:00 and 5:00 on the day of the procedure. Patients were encouraged to drink more clear liquids following the purgative to ensure adequate hydration and were instructed to take nothing by mouth after 5:00 AM on the day of the procedure. Endoscopy procedureBetween 8:00 AM and 9:00 AM patients wore recorder vest and swallowed SBCE, then acted freely. They recorded related symptoms on time, kept watch on the flashing lights of data logger and made sure the equipment running normally. Doctors checked if patients feel discomfortable from time to time. To avoid interferring the image signal, patients should not enter the strong magnetic field and exercise strenuously during examination. The location of the SBCE was checked by a workstation’s real-time monitoring system 2 hours later. If the SBCE was found to be present in the stomach, upper gastrointestinal endoscopy was performed to help the SBCE pass through the pylorus. Then, a conventional colonoscopy was performed before 12:00 AM by one of the five attending gastroenterologists, each with more than ten years of experience. Gastroenterologists assess the efficacy of bowel cleansing according to Boston criteria. In the sedation group, each patient received a continuous gravity-regulated infusion of intravenous normal saline. Before sedation, all patients received supplemental oxygen (2 L/min) by nasal cannula. An electrocardiogram was obtained, and pulse oximetry, heart rate and blood pressure were monitored. During endoscopy, patients with spontaneous breathing were sedated only with an initial bolus of propofol (1.5 mg/kg body weight, intravenously). Sedation was maintained with repeated doses of 10 to 20 mg propofol during insertion of the colonoscope by anaesthesiologists. Generally, no additional propofol was administered during the withdrawal phase.Doctors checked the position of the SBCE through the real-time monitoring system. After the battery of SBCE run out or SBCE passed through the ileocecal valve reaching the colon, doctors took the data loggers down then connected them to the workstation of the data processing. The image data was downloaded to the workstation. All SBCE videos were reviewed by two experienced gastroenterologists who were blinded to the group assignment. The disagreements on the reports were resolved by consensus.Approximately an hour after the procedure, all patients completed a questionnaire regarding their willingness to undergo a similar examination and rated their satisfaction and pain level according to a standard 10-cm visual analog scale. The visual analog scale consisted of a 10-cm line scaled from 0 (no pain) to 10 (very painful).Outcome measuresPatients’ data, including demographics, age, sex and body mass index, satisfaction and pain level were recorded. The primary endpoints of the study were SBCE completion rate and the small bowel transit time. Secondary endpoints were diagnostic yield, adverse events and the efficacy of bowel cleansing. The following events were considered adverse events:colon perforation, oxygen saturation under 85% for over 30 seconds, heart rate under 40/min and blood pressure lower than 80/50 mmHg, the need for mechanical ventilation, or any cardiorespiratory event requiring an anesthesiologist’s assistance. Statistical analysis181 patients were ultimately enrolled. Percentages were used to describe categorical variables; means (standard deviation) or medians (range) were used to describe continuous variables. For categorical variables, associations between 2 groups were evaluated with a chi-squared test (applying Fisher’s correction when necessary); for continuous variables, the 2-sample t test or the Mann-Whitney U test was used. All statistical analyses were performed using the IBM SPSS 18.0 software. All tests were performed with the a-level set to 0.05 (2-tailed).ResultsBetween July 2014 and June 2015, a total of 229 patients needed and chose to undergo SBCE and colonoscopies on the same day in Nanfang Hospital. Of these patients,48 patients were excluded:(1).10 patients< 18 years old; (2).13 patients> 65 years old; (3).4 Patients with a history of abdominal surgery; (4).2 patients with diabetes mellitus with evidence of end-organ damage; (5).10 patients taking prokinetic medications within 5 days prior to the procedure; (6).1 patient with hyperthyroidism; (7).8 patients refused to participate in the study. Therefore,181 patients were ultimately enrolled,64 of whom were assigned to the sedation group at their request.The baseline characteristics of the 2 groups were not significantly different. The mean±standard deviation ages of the sedation and nonsedation groups were 43.7±13.7 and 42.0±14.4 years, respectively (P=0.442). The mean± standard deviation body mass indexs of the sedation and nonsedation groups were 22.7±3.1 and 22.0±3.1, respectively (P=0.116). Men represented 73.4%(n=47) of the sedation group and 63.2%(n=74) of the nonsedation group (P=0.164).The bowel cleaning effect evaluation:Median scores of the efficacy of bowel cleansing were 7.5±1.0 in the sedation group and 7.4±1.1 in the nonsedation group (P=0.732). The numbers of remarkable effect, effect and inefficacy of the efficacy of bowel cleansing in the sedation group were 32,30 and 2 cases respectively. The total ineffective rate was 3.1%. The numbers of remarkable effect, effect and inefficacy of the efficacy of bowel cleansing in the nonsedation group were 63,48 and 6 cases respectively. The total ineffective rate was 5.1%. The efficacy of bowel cleansing between the sedation group and the nonsedation group were not significantly different (P=0.714). Gastrointestinal side effects evaluation:The numbers of I grade, II grade and III grade of gastrointestinal side effects in the sedation group were 10,36 and 18 cases respectively. The numbers of I grade, II grade and III grade of gastrointestinal side effects in the nonsedation group were 18, 72 and 27 cases respectively. There were no Ⅳ grade of gastrointestinal side effects in both groups. The incidence rates of gastrointestinal side effects between the sedation group and the nonsedation group were not significantly different (P= 0.966). Self-reported medication compliance:The numbers of I grade and II grade of medication compliance in the sedation group were 12 and 52 cases respectively. The numbers of I grade and II grade of medication compliance in the nonsedation group were 19 and 98 cases respectively. There were not significantly different in medication compliance between these two groups (P= 0.668).The indications for SBCE in the sedation group were listed below:16 (25.0%) patients with abdominal pain with suspected small bowel diseases,13 (20.3%) patients with assessment of abnormal findings on previous results (eg, laboratory tests, scans, and other procedures),12 (18.8%) patients with inflammatory bowel disease, 6 (9.4%) patients with obscure gastrointestinal bleeding (OGIB),5 (7.8%) patients with chronic diarrhea,4 (6.3%) patient with emaciation,2 (3.1%) patients with polyposis syndrome,2 (3.1%) patient with abnormal bowel movements,1 (1.6%) patients with abdominal distension,1 (1.6%) patient with iron-deficiency anemia,1 (1.6%) patients with Peutz-Jeghers syndrome, and 1 (1.6%) patient with history of obstructive symptoms without stricture.In the nonsedation group, the indications for SBCE were listed below:31 (26.5%) patients with inflammatory bowel disease,28 (23.9%) patients with abdominal pain with suspected small bowel diseases,24 (20.5%) patients with OGIB,13 (11.1%) patients with assessment of abnormal findings on previous results,7 (6.0%) patients with chronic diarrhea,5 (4.3%) patients with emaciation,3 (2.6%) patients with polyposis syndrome,2 (1.7%) patients with abdominal distension, and 1 (0.9%) patient with abnormal bowel movements,1 (0.9%) patient with iron-deficiency anemia,1 (0.9%) patients with Peutz-Jeghers syndrome, and 1 (0.9%) patient with history of obstructive symptoms without stricture.There was no difference in the overall SBCE completion rate between the sedation and nonsedation groups (84.4%[54/64] vs 87.2%[102/117], respectively, P=0.601). The median small-bowel transit time was 386.4±150.1 mins in the sedation group and 341.4±141.1 mins in the nonsedation group (P=0.046). The median small-bowel transit time of the subgroup of patients who completed the SBCE in the sedation and nonsedation groups were 350.3±122.4 and 308.5±109.2 mins, respectively (P=0.031). The median small-bowel transit time of the subgroup of patients who didn’t complete the SBCE in the sedation and nonsedation groups were 581.0±140.3 mins and 564.7±132.8 mins, respectively (P=0.772).Four patients in the sedation group and eight patients in the nonsedation group had gastroscopy-assisted SBCE, respectively (P=1.000). The diagnostic yields of the sedation group and the nonsedation group were 78.1% and 75.2%, respectively (P=0.660). The positive findings in the sedation group were listed below:ulcers (n=18,28.1%), followed by lymphangiectasia (n=9,14.1%), erosions (n=6,9.4%), red spots (n=4,6.3%), tumors (n=3,4.7%), follicular hyperplasia of the terminal ileum (n=3,4.7%), angioectasia (n=2,3.1%), polyps (n=2,3.1%), active bleeding (n=2,3.1%) and parasites (n=1,1.6%). In the nonsedation group, the positive findings were listed below:ulcers (n=29,24.8%), followed by erosions (n=19,16.2%), lymphangiectasia (n=10,8.5%), red spots (n=9,7.7%), active bleeding (n=6,5.1%), tumors (n=4,3.4%), polyps (n=3,2.6%), follicular hyperplasia of the terminal ileum (n=3,2.6%), parasite (n=2,1.7%), angioectasia (n=2,1.7%) and diverticulum (n=1, 0.9%).All patients completed the postprocedure questionnaires. Median satisfaction scores were 8.2±1.5 in the sedation group and 3.9±2.1 in the nonsedation group (P=0.000). The median pain scores were 1.4±1.1 in the sedation group and 6.3±2.0 in the nonsedation group (P=0.000). All of the patients in the sedation group and 28 (23.9%) patients in the nonsedation group reported willingness to have another examination performed in the same fashion. All colonoscopies were completed in the sedation group, while 1 patient in the nonsedation group did not complete the colonoscopy because of pain. In the sedation and nonsedation groups,78.1% and 4.3% of patients (satisfaction scores>8), respectively, were satisfied with the procedure (P=0.000).Adverse eventsNo SBCE device was retained in the gastrointestinal tract during the study. Only one patient in the sedation group suffered transient oxygen desaturation (< 85% oxygen saturation for longer than 30 seconds), which was addressed by increasing the oxygen flow rate and performing a jaw thrust maneuver. No patient required mechanical ventilation or endotracheal intubation. There were no cases of colon perforation during the study.ConclusionsSedation had no effect on the SBCE completion rate. Sedation increased small-bowel transit time but had no effect on the overall diagnostic yield of SBCE. When SBCE and colonoscopy performed on the same day, sedation can be safely and effectively used for colonoscopyic procedures and is associated with high rates of patient satisfaction, few side effects, and a high degree of patient acceptance. |
PDF Full Text Request