Use of Abdominal Binder in Colonoscopies Performed by Trainees in Gastrointestinal Endoscopy: A Randomized, Double-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Mean Cecal Intubation Time
研究概览
简要总结
This randomized trial will be conducted to evaluate the effectiveness and safety of an abdominal binder use during colonoscopy performed by gastrointestinal endoscopy fellow trainees. The investigators hypothesized that the abdominal binder use would facilitate and increase the effectiveness of the colonoscopy for inexperienced operators.
详细描述
It will be a randomized, double-blind, sham-controlled study. The trial will be performed at a single-center, Hospital Central Norte PEMEX, a tertiary center with a gastrointestinal endoscopy fellow trainee program with more than 10 years of experience. This trial will be conducted in accordance with the most recent version of the Declaration of Helsinki. The trial has been approved by the local ethical committee and research committee with the number DCAS-SSS GSM-HCN-INV-0043-2022. Written informed consent will be obtained from all the patients before participation. This manuscript will be reported in accordance with CONSORT guidelines.
Prior to the procedure, age, sex, height, weight, waist circumference (WC), body mass index (BMI), and colonoscopy indication of all participants will be recorded. Once enrolled, patients will be randomized to either the abdominal binder (AB) group or the sham binder (SB) group in a 1:1 ratio. Randomization will be performed using a web-based computer system (Research Randomizer, Geoffrey C. Urbaniak and Scott Plous) by an independent statistician who had no other intervention in the study. An independent operator will print the randomization number and group for each participant (either the AB or SB group) in individual cards, which will be hidden in a locked black box by the same independent operator. Only the nurse, who will fit the abdominal binder to all the patients in a private space, will have access to the cards. Randomized data and cards will be concealed to study coordinators, endoscopists, clinical staff, and participants.
The abdominal binder to be used for the patients allocated in the AB group was the Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). Its price is $29.96. The device is manufactured in two sizes, One Size and X-Large. For the patients with a waist circumference >110 cm it will be used the X-Large model. The three belts that make up the binder will be fitted to all the participants. Once placed, the binder will be adjusted to be located between the subcostal border and the anterior superior iliac spine. The participants will be asked to confirm that the binder is fastened tightly but not uncomfortably. For the participants in the SB group the same binder will be fitted, but once the patient is sedated, it will be loosened by the same nurse. The participants will wear a non-transparent gown over the binder so that it will not be visible to the endoscopists.
Bowel preparation with 4 L of polyethylene glycol solution in split-dose (2 L in the afternoon of the day before and 5 h before the colonoscopy) will be used in all the participants. In this trial, all colonoscopy procedures will be performed by two second-year fellow trainees in gastrointestinal endoscopy.
A standard video-colonoscope (EC-3890Li, PENTAX Co., Tokyo, Japan) will be used. All the patients will be placed in the left lateral decubitus position. Manual abdominal compression and postural change will be conducted by a technician when required by the endoscopy trainee or the attending endoscopist. Endoscopist or anesthesiology will be allowed to remove the binder at any time during the procedure if they resolve it was necessary for safety. Air insufflation will be used during colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomization will be performed using a web-based computer system (Research Randomizer, Geoffrey C. Urbaniak and Scott Plous) by an independent statistician who had no other intervention in the study. An independent operator will print the randomization number and group for each participant (either the AB or SB group) in individual cards, which will be hidden in a locked black box by the same independent operator. Only the nurse, who will fit the abdominal binder to all the patients in a private space, will have access to the cards. Randomized data and cards will be concealed to study coordinators, endoscopists, clinical staff, and participants.
For the participants in the SB group the same binder will be fitted, but once the patient is sedated, it will be loosened by the same nurse. The participants will wear a non-transparent gown over the binder so that it will not be visible to the endoscopists.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults between the ages of 20-80
- •Participants with ASA I-III (American Society of Anesthesiologists Class)
- •Undergoing a colonoscopy at any of the study locations for:
- •I. CRC screening (first colonoscopy or 10 years follow up of negative exam). II. Surveillance (prior colonoscopy with polyps). III. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.
- •- Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure and describe adequate cleansing.
排除标准
- •Inability to provide informed consent.
- •Patients with known or suspected pregnancy.
- •Patients undergoing multiple procedures (e.g., upper and lower endoscopy).
- •Previous colon resection surgery.
- •History of problems with sedation or anesthesia.
- •Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- •Patients with a history of colorectal cancer or other intra-abdominal malignancy.
- •Patients with open or recent wounds or skin rash on the anterior abdominal wall.
- •History of cirrhosis or ascites.
- •Patients who are medically unstable (American Society of Anesthesiology Class IV or above).
结局指标
主要结局
Mean Cecal Intubation Time
时间窗: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum
次要结局
- Frequency of Intervention by the Attending Endoscopist(During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.)
- Frequency of Use of Abdominal Pressure(During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.)
- Colonoscopy Completion Rate(During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.)
- Number of Participants According to Colonoscopy Findings(During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.)
- Operator Perception of Patient Discomfort(Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure.)
- Frequency of Use of Position Change(During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.)
- Additional Analgesic Drug Required to Complete Procedure(During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes.)
- Length of Cecal Intubation(During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.)
- Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees(Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure.)
- Patient Pain at Discharge(At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure.)
- Patient Satisfaction at Discharge(At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure.)
- Additional Anesthetic Drug Required to Complete Procedure(During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes.)
研究者
Antonio Marmolejo
Principal investigator
Hospital Central Norte PEMEX