| CTRI Number |
CTRI/2019/12/022347 [Registered on: 12/12/2019] Trial Registered Prospectively |
| Last Modified On: |
03/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prone vs Supine for perianal Surgery |
|
Scientific Title of Study
|
Lithotomy vs prone postion for perianal surgery- A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no 402, Academic Block,
AIIMS Bhbuaneswar,Sijua,Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no 402, Academic Block,
AIIMS Bhbuaneswar,Sijua,Patrapada, Bhubaneswar
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no 402, Academic Block,
AIIMS Bhbuaneswar,Sijua,Patrapada, Bhubaneswar
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS Bhubaneswar,Sijua,Patrapada,Bhubaneswar,Odisha |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pankaj Kumar |
AIIMS Bhubaneswar |
Room No 402, Academic Block,Department of General Surgery
Khordha
ORISSA |
9438884253
surg_pankaj@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K603||Anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lithotomy position |
Patient will be operated in lithotomy position |
| Intervention |
Prone position |
Perianal procedure will be done in prone position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years or older and scheduled to undergo perianal surgery for fistula in ano, haemorrhoids and fissure in ano.
|
|
| ExclusionCriteria |
| Details |
Patients with contraindications to any of the two positions and failed to understand or sign the informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Local Experienced Discomfort (LED) scale- physical stress
2.Subjective Mental Effort Questionnaire (SMEQ) - mental stress
3.Exposer of operative site will be measured in a scale of 1-5
|
At the end of the Surgery Outcome will be measured.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of surgery, procedure and position related complications and change in position will be noted separately for different type of surgeries.
Comfort level of patients will also be noted using LED scale if operated under local anaesthesia.
We will also document the number of patients who could not be included in the study due to contraindications to either of the positions. |
Just afterthe surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2019 |
| Date of Study Completion (India) |
18/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Perianal surgeries like hemorrhoids,fistula in ano,fissure in ano and anorectal abscess are operated
mostly in lithotomy position.In our experience lithotomy position is
uncomfortable to both the patients,surgeon and the assistant with regard to awkward position of
the patient with limited exposer and poor ergonomics
to the surgeon and assistant.Constant soiling of
the operative field with blood during dissection and poor exposer due to bulky gluteal muscle.The surgeon has to
bend and assistants have to twist and bend their body to properly handle the
operative site.This poor ergonomics
theoretically affects both the performance and physical health of the surgeon
and assistant.In contrast prone
position with leg split and buttocks kept apart by elastic tape provide
excellent exposer,better ergonomics and
under-vision exchange of instruments.Another theoretical
advantage is pooling of blood away from operative field.The literature is
sparse regarding advantages of these positions over each other. No guidelines exists
regarding preference of position based on anatomical location of perianal pathology.Both positions have
never been compared earlier with regard to surgeon comfort,patient comfort,ergonomics and position related
complications.
|