The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000715976
Ethics application status
Approved
Date submitted
5/07/2011
Date registered
11/07/2011
Date last updated
11/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of applying perianal local anesthetics on patient comfort during visual examination of the last part of large intestine
Scientific title
No effect of perianal application of topical anesthetics on patient comfort during non-sedated sigmoidoscopy: a randomized, placebo-controlled clinical trial
Secondary ID [1] 262549 0
Nil
Universal Trial Number (UTN)
U1111-1122-5893
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing sigmoidoscopy without any sedation 268214 0
Condition category
Condition code
Oral and Gastrointestinal 268342 268342 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 268419 268419 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomized to 3 groups according to perianal application of different topical agents 30 minutes before the procedure as follows:
Group 1 - 5 mL of vaseline application (placebo)
Group 2 - 5 mL of 2% lidocaine gel
Group 3 - 5 ml of 2.5% lidocaine plus 2.5% prilocaine cream
Intervention code [1] 266887 0
Treatment: Drugs
Comparator / control treatment
Vaseline was used as lubricant in the control group
Control group
Placebo

Outcomes
Primary outcome [1] 269115 0
Patient anxiety: assessed by STAI Iand II scales
Timepoint [1] 269115 0
Before and after sigmoidoscopy
Primary outcome [2] 269116 0
Pain: assessed by Visual analogue Scale
Timepoint [2] 269116 0
Just before the procedure; at the time when scope is inserted, during the procedure at intervals of 5 minutes; at the time when scope is removed, before discharge
Secondary outcome [1] 276956 0
Nil
Timepoint [1] 276956 0
Nil

Eligibility
Key inclusion criteria
ASA I-II patients undergoing sigmoidoscopy without sedation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were use of anti-anxiety medicine within 48 hours before the procedure, cognitive dysfunction, past history of having lower endoscopy or anal/colorectal or gynecological surgery and complaint of pain at the anal area precluding examination.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization was used to keep the sample size of the groups similar and block size was set to 3. Random Allocation Software (Ver. 1.0.0) was used to allocate the patients into groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3691 0
Turkey
State/province [1] 3691 0

Funding & Sponsors
Funding source category [1] 267362 0
Hospital
Name [1] 267362 0
Mesa Hospital
Address [1] 267362 0
Yasam Caddesi No:5
06510, Sogutozu, Ankara
Country [1] 267362 0
Turkey
Primary sponsor type
Individual
Name
Prof. Mehmet Ayhan KUZU
Address
Ankara University, Faculty of Medicine
Department of Surgery
06100, Samanpazari, Ankara
Country
Turkey
Secondary sponsor category [1] 266429 0
None
Name [1] 266429 0
Address [1] 266429 0
Country [1] 266429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269344 0
Ethics Committee of Ankara University School of Medicine
Ethics committee address [1] 269344 0
Ankara Universitesi Tip Fakultesi
Morfoloji Yerleskesi
Sihhiye 06100 Ankara, TURKIYE
Ethics committee country [1] 269344 0
Turkey
Date submitted for ethics approval [1] 269344 0
Approval date [1] 269344 0
15/10/2008
Ethics approval number [1] 269344 0
Ethics committee name [2] 269381 0
Ministry of Health of Turkey Ethics Committee of General Directorate of Pharmaceuticals and Pharmacy
Ethics committee address [2] 269381 0
Sogutozu Mahallesi 2176. Sokak No:5
06520 Cankaya, Ankara, TURKIYE
Ethics committee country [2] 269381 0
Turkey
Date submitted for ethics approval [2] 269381 0
Approval date [2] 269381 0
20/09/2010
Ethics approval number [2] 269381 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32823 0
Address 32823 0
Country 32823 0
Phone 32823 0
Fax 32823 0
Email 32823 0
Contact person for public queries
Name 16070 0
Hasan Kutluk Pampal
Address 16070 0
Gazi Universitesi Tip Fakultesi
Anesteziyoloji ve Reanimasyon AD
06500, Besevler, Ankara
Country 16070 0
Turkey
Phone 16070 0
+905325569624
Fax 16070 0
Email 16070 0
hpampal@gazi.edu.tr
Contact person for scientific queries
Name 6998 0
Hasan Kutluk Pampal
Address 6998 0
Gazi Universitesi Tip Fakultesi
Anesteziyoloji ve Reanimasyon AD
06500, Besevler, Ankara
Country 6998 0
Turkey
Phone 6998 0
+905325569624
Fax 6998 0
Email 6998 0
hpampal@gazi.edu.tr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary