| CTRI Number |
CTRI/2024/07/071000 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| 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 comparative study on surgery for pile mass in patients low and high grade pile mass |
|
Scientific Title of Study
|
Surgical outcome of open and closed hemorrhoidectomy in patient with grade III and grade IV hemorrhoids-A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithra C |
| Designation |
Postgraduate |
| Affiliation |
Aaarupadai Veedu Medical College |
| Address |
Room no-10,department of general surgery,C-block
Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry
Aarupadai Veedu Medical College and Hospital
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9944851119 |
| Fax |
|
| Email |
docpavithra24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.K.Ravichandran |
| Designation |
Professor and HOD |
| Affiliation |
Aaarupadai Veedu Medical College |
| Address |
Opd no-10,C block,department of general surgery
Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry
Aarupadai Veedu Medical College and Hospital
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9944851119 |
| Fax |
|
| Email |
general.surgery@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.K.Ravichandran |
| Designation |
Professor and HOD |
| Affiliation |
Aaarupadai Veedu Medical College |
| Address |
Opd No-10,C-block,department of general surgery
Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry
Aarupadai Veedu Medical College and Hospital
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9944851119 |
| Fax |
|
| Email |
general.surgery@avmc.edu.in |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College and hospital,Kirumampakkam,Pondicherry-607402,India |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical CollegePondicherry |
| Address |
Opd 10,C block,department of general surgery
Aarupadai Veedu Medical College,Pondicherry 607402 |
| Type of Sponsor |
Private 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 |
| PavithraC |
Aarupadai Veedu Medical College |
Aarupadai Veedu Medical College and hospital
Pondicherry 607402
Pondicherry
PONDICHERRY |
9944851119
docpavithra24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC INSTITUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K642||Third degree hemorrhoids, (2) ICD-10 Condition: K642||Third degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Closed hemmorhoidectomy |
Closed hemorhoidectomy in gr 3 and gr 4 hemorrhoids post operative pain fever wound closure |
| Intervention |
Open Hemorrhoidectomy |
Post operative pain ; post operative bleeding , infection , wound healing |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with grade III and grade IV hemorrhoids
2.Patient willing for consent and follow up |
|
| ExclusionCriteria |
| Details |
Hemorrhoids associated with other perianal conditions like fissure in ano, fistula in ano, perianal infections
Patients with irritable bowel disease
Hemorrhoids associated with malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare these techniques with respect to post operative complications such as pain, infection, wound healing rates
To compare the techniques with respect to Duration of surgery,Length of post-op hospital stay. |
Post-op
Day 1
Day 3
1 Week
2 Weeks
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients compared with respect to postoperative pain,bleeding and return to work |
Patients assesed on postoperative day 1,3,1week,1 month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/08/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hemorrhoidal disease is one the most common disorder requiring surgical intervention in almost 10% of cases. True prevalence in the general population is not well understood, partly duemany patients do not seek treatment. Hemorrhoids are columns of vascular connective tissue within the anal submucosa which aids in maintaining continence and bulk to anal canal. The pathophysiology is mostly unknown. The current concept is that haemorrhoids develop due todeterioration and decay of vascular cushions.The three main important hemorrhoidal columns are left lateral, right posterolateral and right anterolateral.Based of the location related to dentate line, there can be internalor external haemorrhoids.Interalhaemorrhoid are further divided on a scale from I to IV based onthe degree of prolapse which also guides in the management of the condition. |