| CTRI Number |
CTRI/2020/12/029973 [Registered on: 22/12/2020] Trial Registered Prospectively |
| Last Modified On: |
16/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARATIVE STUDY OF OPEN PILES SURGERY VERSUS STAPLER PILES SURGERY |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF STAPLER HEMORRHOIDOPEXY VERSUS MILLIGAN- MORGAN HEMORRHOIDECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHAY M PHILIP |
| Designation |
POST GRADGUATE STUDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY
FATHER MULLER ROAD KANKANADY ROAD
MANGALORE 575002
DEPARTMENT OF GENERAL SURGERY
FATHER MULLER ROAD KANKANADY ROAD
MANGALORE 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971978098 |
| Fax |
|
| Email |
abhaymphilip@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAKESH RAI A |
| Designation |
PROFESSOR |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DON BOSCO HOSTEL ROOM NO 318 FATHER MULLER ROAD KANKANADY
DEPARTMENT OF GENERAL SURGERY
FATHER MULLER ROAD KANKANADY
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971978098 |
| Fax |
|
| Email |
dr.rakeshrai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABHAY M PHILIP |
| Designation |
POST GRADGUATE STUDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL SURGERY
FATHER MULLER ROAD KANKANADY
MANGALORE
DEPARTMENT OF GENERAL SURGERY
FATHER MULLER ROAD KANKANADY
MANGALORE
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971978098 |
| Fax |
|
| Email |
abhaymphilip@gmai.com |
|
|
Source of Monetary or Material Support
|
| FATHER MULLER MEDICAL COLLEGE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 |
| Abhay M Philip |
father muller medical college |
father muller medical college
DEPARTMENT OF GENERAL SURGERY
father muller road kankanady
mangalore 575002
Dakshina Kannada
KARNATAKA |
8971978098
abhaymphilip@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| father muller medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• The patients with hemorrhoidal disease (grade I- IV) were included in each group.
• Age >18 years
|
|
| ExclusionCriteria |
| Details |
• Not willing to consent for the study
• History of inflammatory bowel disease
• Associated with anal canal fissure or fistula
• Previous hemorrhoidal surgery
• Patients on anti-coagulant medications
• Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To assess the pain score using visual analogue score at 6th hour , 12th hour and 24 hour post operatively |
• To assess the pain score using visual analogue score at 6th hour , 12th hour and 24 hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To determine the operating time
• To determine the mean duration of hospital stay. |
• INTRAOPERATIVE DAY 1
DISCHARGE DAY 2 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hemorrhoids are one of the most common benign anorectal problems
worldwide. Hemorrhoidectomy remains the most definitive procedure for treating
hemorrhoidal disease. Various techniques for excision are available. Numerous
controlled studies have already demonstrated that satplerhemorrhoidopexy is
associated with less postoperative pain and quicker recovery. Motivated by
results of these studies, we decided to conduct an observational study in
Father Muller Medical College Hospital, Mangalore to compare the short term
results of stapler hemorrhoidopexy and Milligan-Morgan in terms of
post-operative pain, operating time. Our aim was to contribute to the literature
with this study. |