Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
Phase: NA
Conditions: Performance and Tolerance of Colonoscopy
Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

 
 
 
 
 
 
 
 
COVER PAGE 
 
Tittle of the Study: Does Using Abdominal Binder Really Benefit During Colonoscopy 
?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial 
NCT number: 04383132 
Document date: 04/19/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
       
 
 
 
 
Study Protocol 
 
Introduction  
 
Colonoscopy is considered the primary screening test for colorectal cancer screening 
worldwide (1). Researches show that by 2030, 24 million colonoscopy procedures will be 
required for colorectal cancer screening in the USA (2).  
Cecal intubation time (CIT) is one of the quality indicators in colonoscopies (3). Looping 
is the most common challenge endoscopists encounter, and this prolongs the CIT and can 
cause pain and several adverse events such as colon perforation and spleen injury (4). 
Position change and manual pressure are the best known two methods to prevent looping 
(5). In recent studies, various abdominal compression devices have been used to reduce 
CIT by reducing looping. In the systematic review and meta-analysis conducted in 2019, 
the limited number of trials on abdominal compression devices were studied and conflicting 
results were observed. Meanwhile, significant heterogeneity was detected among these 
studies (p=0.0006, I2=%83) (6). 
 
Objectives: Prolongation of cecal intubation time (CIT) directly affects the comfort of the 
patient and the colonoscopist. In this study, the effectiveness of using an abdominal binder 
(AB) during colonoscopy on procedure time and colonoscopy outcomes was investigated. 
We hypothesized that the use of AB would reduce the CIT and the need for auxiliary 
maneuvers by reducing the looping. 
1. Bénard F, Barkun AN, Martel M, et al. Systematic review of colorectal cancer screening guidelines for 
average-risk adults: Summarizing the current global recommendations. WJG. 2018 Jan 7;24(1):124–38.  
2. Joseph DA, Meester RGS, Zauber AG, et al. Colorectal Cancer Screening: Estimated Future Colonoscopy 
Need and Current Volume and Capacity. Cancer. 2016 Aug 15;122(16):2479–86.  
3. Ruiz-Rebollo ML, Alcaide-Suárez N, Burgueño-Gómez B, et al. Tasa de detección de adenomas e 
intubación cecal: indicadores de calidad de la colonoscopia. Gastroenterología y Hepatología. 2019 
Apr;42(4):253–5 
4. Wallace MB, Wang KK, Adler DG, et al. Recent Advances in Endoscopy. Gastroenterology. 2017 
Aug;153(2):364–81.  
5. Zhao S, Yang X, Meng Q, et al. Impact of the supine position versus left horizontal position on 
colonoscopy insertion: a 2-center, randomized controlled trial. Gastrointestinal Endoscopy. 2019 
Jun;89(6):1193-1201.e1 
6. Nishizawa T, Suzuki H, Higuchi H, et al. Effects of Encircled Abdominal Compression Device in 
Colonoscopy: A Meta-Analysis. J Clin Med. 2019 Dec 19;9(1):11. 
 
 
Methods 
 It is a randomized double-blind sham-device-controlled study 

Intervention Group: Patients randomized to Abdominal Binder Intervention Group 
will have the abdominal binder secured firmly between Spina iliaca anterior 
superior and subcostal area to the abdomen just prior the colonoscopy. 
Sham Group: Sham Group will have the abdominal binder secured firmly between 
Spina iliaca anterior superior and subcostal area to the abdomen just prior the 
colonoscopy but it will be loosened just prior the procedure 
 Inclusion criteria: The patients who performed the given bowel cleansing before 
the procedure and who were American Society of Anesthesiologists Class (ASA) ≤III 
 Exclusion criteria: Patients with known anesthesia or analgesic allergy, patients 
undergoing multiple procedures simultaneously, pregnant patients, patients with 
a history of colorectal surgery, patients with active inflammatory bowel disease, 
patients with a history of intra-abdominal malignancy, patients with liver cirrhosis 
or ascites, and patients with giant ventral hernia. 
 Outcomes: 
Primary outcome of this study is CIT.  
The main secondary outcomes are the cecal intubation length (CIL) (the length of 
the colonoscope needed to reach the cecum from the anus) and manual pressure and 
position change requirement during the procedure. Other secondary outcomes were 
the colonoscopy completion rate, the need for extra narcotic analgesic drugs, the 
pain and comfort level reported by the patient, and colonoscopy results. Patients 
whose colonoscopy procedure could not be completed (excessive looping, poor 
bowel cleansing, etc.) were excluded from the primary outcome analysis but were 
included in the secondary outcome analysis. Subgroup analysis was performed for 
age (≥60 and <60), gender (female and male), and obesity (obese and non-obese). 
No adverse events occurred in any of the procedures.  
 
 
 
 
 

 
 
 
 
Statistical Analysis Plan (SAP) 
 
  
In sample size calculation, CIT and SD were used with the help of literature data. It was 
found that 326 patients (163 per group) were required to detect a 60-second difference 
in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. Again, with the help 
of literature data, the frequency of the auxiliary maneuvers was estimated and it was 
calculated that 324 patients were required for a 20% reduction in the auxiliary 
maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients 
was expanded by 5%, and a total of 346 patients, 173 patients in each group, were 
included in the study. 
  
Descriptive statistical methods (mean, standard deviation, frequency, percentage, 
minimum, maximum) were used for evaluating the study data. The eligibility of the 
quantitative data to normal distribution was tested by Shapiro-Wilk test and graphical 
analyses. Independent t-test was used to compare normally distributed quantitative 
variables such as mean CIT and CIL between two groups. For the comparison of 
qualitative data (e.g., manual pressure and position change), Pearson chi-square test, 
Fisher's exact test, and Fisher-Freeman-Halton exact test were used. The statistical 
significance level was accepted as p<0.05. For statistical analyses, NCSS (Number 
Cruncher Statistical System) 2007 (Kaysville, Utah, USA) program was used. 
 
 
 
 
  
 
 
 
 

 
 
 
 
 
 
 
 
Informed Consent Form (ICF) 
 
1- Tittle of the Study: Does Using Abdominal Binder Really Benefit During Colonoscopy  
 
2-  Objectives: Colonoscopy procedure; It is the examination of the last part of the large 
intestine and small intestine with the help of a video camera by entering the tube from the 
anus. In this way, diseases of the large intestine (cancer, polyps, etc.) can be diagnosed and 
treated. The biggest challenge of the process; It is because of the technical difficulties 
experienced in the advancement of the hose in the intestine, which negatively affects the 
patient comfort and the procedure time is prolonged. The aim of this study is to investigate 
whether the abdominal corset worn before colonoscopy can be a solution to the technical 
difficulties experienced during the procedure. Abdominal corset will be used in addition to 
standard traditional methods (position change, hand-assisted pressure application to the 
abdomen, etc.). 
3- The Place (s) of the Research: Sehit Prof. Dr. İlhan Varank Training and Research 
Hospital 
 
4- Time Envisioned for You to Continue Research: 3 month 
 
 
5- Estimated Number of Volunteers Expected to Participate: 346  
 
6-All of the Methods to be Followed and Actions to be Taken: Before the colonoscopy 
procedure, a standard elastic abdominal binder will be attached to your abdominal area. At 
the end of the procedure, these binders will be removed and you will be asked to fill out a 
questionnaire showing your pain level. 
 
7-Possible Benefits: We think that you will feel less pain during the procedure as the 
procedure is easier, more comfortable and completed in a shorter time. 
 

8-Possible Disturbances and Risks That May Bring You: No risk situation is foreseen. 
 
9-Compensation (Insurance) and / Or Treatments to be Provided to the Volunteer: No 
compensation and / or treatment will be given to the volunteer. 
 
10-Payments for Transportation, Food and Expenses to be Made to the Volunteer: No 
transportation, meal or payment will be made to the volunteer. 
 
11-Participation in and Leaving Research: Participation in this research is entirely 
voluntary. You have the right not to participate in the study or to quit at any time. In 
addition, the responsible investigator may exclude you from the study if necessary. There 
will be no penalty or loss of benefits you are entitled to for not participating, leaving or 
dismissed from the study. You or your legal representative will be informed in a timely 
manner when new information regarding the research subject and that may affect your 
willingness to continue research is obtained. 
 
12-Responsibilities of Volunteers: You should not remove the binder that is worn before 
the procedure until the process is completed. You need to fill in a questionnaire showing 
the level of pain after the procedure. 
 
13- Confidentiality: Records that will reveal your identity will be kept completely 
confidential, will not be disclosed to the public, and your identity will be kept secret even 
if the results of the research are published. If you sign this form, people participating in the 
study (audiences, reviewers), ethics committee, institution and other relevant health 
authorities may have direct access to the original medical records of the volunteer, but this 
information will be kept confidential. 
 
14-Situations or Reasons for the Termination of the Volunteer's Participation in the 
Research: You have the right to leave the job at any time. 
 
15-Access to Post-Study Research Products: In case of publication of the study results, 
you can access medical academic sites on the internet (You can get the relevant internet 
addresses if you request). 
 

16-Contact Person: Dr. Beslen Göksoy ( Tel: +90 534 953 01 12 ) 
 
 
 
 
 
 
 
I,…………………………………………. I have read all the explanations on the Informed 
Consent Form. Written and verbal explanation about the above subject and purpose of the 
research was given to me by the physician named below. I fully understood the scope and 
purpose of the study I was asked to participate in, and my responsibilities as a volunteer. I 
had the opportunity to ask questions and discuss the work and got satisfactory answers. I 
was also told verbally about the possible risks and benefits of the study. I know that I have 
voluntarily participated in the research, that I can leave the study with or without 
justification at any time, and that I can be excluded from the research by the researcher 
regardless of my will, and my current treatment will not be negatively affected when I leave 
the study. 
 
In this conditions; 
 
1) I agree to participate in the said Clinical Trial of my own free will without any pressure 
or coercion. 
2) If necessary, my personal information can be accessed by the persons / institutions 
specified in the legislation, 
3) I consent to the information obtained in the study (provided that my identity information 
is kept confidential) to be used for publication, archiving and, if necessary, transferred 
outside our country for scientific contribution. 
 
 
Volunteer (In his own handwriting) 
Name and surname: 
Signature: 
Address: 

Telephone No, Fax No, if available: 
Date (day / month / year):…. /…. /…. 
 
For Those Under Guardianship or Guardianship 
Parent or Guardian (in his own handwriting) 
Name and surname: 
Signature: 
Address: 
Telephone No, Fax No, if available: 
Date (day / month / year):… /…. /…. 
 
The Researcher Participating in the Research Team and Making the Statements 
Name-Surname: Beslen Göksoy 
Signature: 
Date (day / month / year):… /…. /… ..