| CTRI Number |
CTRI/2024/10/075342 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study comparing efficacy of plain Piles surgery with Piles surgery plus cutting of internal part of anal continence control muscle in treatment of Piles. |
|
Scientific Title of Study
|
A Comparative study of efficacy of Open Haemorrhoidectomy versus Open Haemorrhoidectomy with Internal Sphincterotomy in Management of Haemorrhoids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avulareddygari Ajay Kumar |
| Designation |
PG RESIDENT |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of General Surgery,Victoria Hospital,Bangalore Medical College and Research Institute.
Bangalore
KARNATAKA
560018
India |
| Phone |
9550114363 |
| Fax |
|
| Email |
ajay4reddy72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kemparaj T |
| Designation |
PROFESSOR |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of General Surgery,Victoria Hospital,Bangalore Medical College and Research Institute.
Bangalore
KARNATAKA
560002
India |
| Phone |
9448455040 |
| Fax |
|
| Email |
dkemprajt@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kemparaj T |
| Designation |
PROFESSOR |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of General Surgery,Victoria Hospital,Bangalore Medical College and Research Institute.
Bangalore
KARNATAKA
560002
India |
| Phone |
9448455040 |
| Fax |
|
| Email |
dkemprajt@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery,Victoria Hospital,Bangalore Medical College and Research Institute,Fort,Krishna Rajendra Road,Bangalore,Karnataka-560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research |
| Address |
Department of General Surgery,Victoria Hospital,Bangalore Medical College and Research Institute,Fort,Krishna Rajendra Road,Bangalore,Karnataka-560002 |
| 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 |
| Dr Avulareddygari Ajay Kumar |
Bangalore Medical College and Research Institute |
Department of General Surgery,Victoria Hospital,Bangalore Medical College and Research Institute,Fort,Krishna Rajendra Road,Bangalore,Karnataka-560002
Bangalore
KARNATAKA |
9550114363
ajay4reddy72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open Hemorrhoidectomy |
Open Hemorrhoidectomy is done to treat patients with Grade 3 and Grade 4 Hemorrhoids |
| Intervention |
Open Hemorrhoidectomy with Internal Sphincterotomy |
Open Hemorrhoidectomy combined with Internal Sphincterotomy done to treat patients with Grade 3 and Grade 4 Hemorrhoids |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the above age criteria
2.Patients with clinical and investigations supporting the diagnosis of Grade 3 and Grade 4 Hemorrhoids
3.Patients giving informed consent for surgical excision of hemorrhoids by milligan morgan open hemorrhoidectomy |
|
| ExclusionCriteria |
| Details |
1.Inflammatory Bowel Disease
2.Fissure in ano
3.Recurrent Hemorrhoids
4.Fistula in ano
5.Malignancy
6.Cirrhosis and Portal Hypertension
7.Pregnancy
8.Patients not giving consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain assessed using Visual Analogue |
Post Operative Day 1 ,Day 2 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urinary Retention |
upto 3 postoperative days |
| Bleeding per rectum post operatively |
pto 3 postoperative days |
| duration of hospital stay |
those staying 3 or less than 3 days or those sgtaying more than 3 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 disorders of the anus which are dilated anal cushions occupying 3,7,11Oclock positions .There are various treatment modalities for treatment of hemorrhoids such as open ,closed, stapled ,laser hemorrhoidectomy etc.. But Open Hemorrhoidectomy named after Milligan Morgan is the most commonle performed method in developing nations owing to its ease of procedure and no technical limitations.The main drawback of Open Hemorrhoidectomy is severe post operative pain in the early postoperative period ,others such as bleeding ,urinary retention are also seen.The most important cause for the above complications is spasm of internal sphincter muscle that gets exposed after hemorrhoidectomy. Studies have shown that adding internal sphincterotomy along with open hemorrhoidectomy significantly reduces post operative complications .Hence my study aims to prove the same . |