| CTRI Number |
CTRI/2024/02/062876 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Stapled versus open haemorrhoidectomy of Milligan morgan technique |
|
Scientific Title of Study
|
STAPLED HAEMORRHOIDECTOMY VERSUS OPEN HAEMORRHOIDECTOMY (MILLIGAN MORGAN) FOR GRADE IV HAEMORRHOID |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujoy Mukherjee |
| Designation |
Professor ,General surgery |
| Affiliation |
Rohilkhand Medical College and Hospital,Bareilly |
| Address |
Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly
Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly Bareilly UTTAR PRADESH 243006 India |
| Phone |
9927991062 |
| Fax |
|
| Email |
dr_joy22001@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sujoy Mukherjee |
| Designation |
Professor, General surgery |
| Affiliation |
Rohilkhand Medical College and Hospital,Bareilly |
| Address |
Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly Bareilly UTTAR PRADESH 243006 India |
| Phone |
9927991062 |
| Fax |
|
| Email |
dr_joy22001@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mamta Kumari Arun |
| Designation |
Junior Resident, General surgery |
| Affiliation |
Rohilkhand Medical College and Hospital,Bareilly |
| Address |
Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly Ac girls hostel Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly Bareilly UTTAR PRADESH 243006 India |
| Phone |
6306365459 |
| Fax |
|
| Email |
mratmala@outlook.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical College |
|
|
Primary Sponsor
|
| Name |
Rohilkhand medical college |
| Address |
Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rohilkhand Medical College and Hospital Suresh Sharma Nagar Bareilly |
Rohilkhand Medical College and Hospital, Suresh Sharma Nagar, Bareilly |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujoy Mukherjee Professor General Surgery |
Rohilkhand Medical College & Hospital, Bareilly |
Rohilkhand Medical College and Hospital Suresh Sharma Nagar Bareilly Bareilly UTTAR PRADESH |
9927991062
dr_joy22001@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RMCH, Bareilly, U.P. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open haemorrhoidectomy procdure in grade IV haemorrhoids |
Stapled haemorrhoidectomy is to be done and study about time taken in surgical procedure, bleeding during surgery,pain after surgery,duration of hospital stay and complications are compared with the standard open haemorrhoidectomy procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients of 18 years and above with Grade IV haemorrhoids admitted in the department of surgery of Rohilkhand Medical College and Hospital Bareilly, Uttar Pradesh. |
|
| ExclusionCriteria |
| Details |
1. Patients with colorectal malignancy anal fistula,
2. Acute haemorrhoidal oedema, Perianal sepsis.
3. Patients with acute or chronic diarrhoea or inflammatory bowel disease.
4. Patients with previous history of surgery for haemorrhoids, a pre-existing sphincteric injury, or complete rectal prolapse, or perianal dermatosis.
5. Patients with symptomatic incontinence, diabetes, anaemia, malnutrition, or immunodeficiency; patients with serious heart, liver, or kidney disease, or blood coagulation dysfunction;
6. Pregnant or menstruating
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the stapled and open haemorrhoidectomy Milligan morgan in grade 4 haemorrhoid |
1-After surgery to 10th day
2-2 weeks after surgery
3-4 weeks after surgery 4-
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study demography, time taken for sugery |
One year |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2024 |
| Date of Study Completion (India) |
02/02/2025 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Haemorrhoids or piles are the most frequently presenting anorectal disorder. They are considered to be the most common cause of bleeding per rectum1. Piles are symptomatic anal cushions. They are more common when intraabdominal pressure is raised, e.g. in obesity, constipation and pregnancy. Primarily, they occur in the 3, 7 and 11 o’clock positions with the patient in the lithotomy position.2 External haemorrhoids are aggregations of congested inferior haemorrhoidal plexus covered by perianal skin; while, internal haemorrhoids originate from the sub-epithelial plexus of the anal canal above the dentate line3.The symptoms include discomfort, itching, mucous discharge, bleeding, pain, and prolapse associated with a feeling of fullness and incomplete evacuation4. Internal hemorrhoids are classified into 4 grades, Grade I- Prominent haemorrhoidal vessels with no prolapse, Grade II-Prolapse which reduce spontaneously, Grade III- Prolapse and have to be manually reduced, Grade IV- Permanently prolapsed4. The treatment options for symptomatic haemorrhoids vary from conservative medical management, to various surgical techniques depending on the grade of haemorrhoids. The nonsurgical options include rubber band ligation, injection sclerotherapy, cryotherapy, infrared coagulation, laser therapy, and diathermy coagulation.5 Most nonoperative procedures are reserved for firstand second-degree haemorrhoids. Operative options are clamp and cautery haemorrhoidectomy, open hemorrhoidectomy, closed haemorrhoidectomy, submucosal haemorrhoidectomy, whitehead circumferential haemorrhoidectomy, stapled haemorrhoidopexy, radiofrequency ablation suture fixation haemorrhoidopexy, pile suture’ method, bipolar diathermy haemorrhoidectomy and the LigaSure haemorrhoidectomy. Operative haemorrhoidectomies are reserved mainly for third and fourth-degree haemorrhoids.6 Haemorrhoidectomy is indicated in grade III and grade IV haemorrhoids. Milligan-Morgan open haemorrhoidectomy is the most popular surgical technique in management of 3rd and 4th grade haemorrhoids and is considered the gold standard. However, some early and late post-operative complications like anal pain, acute retention of urine, anal stenosis and incontinence has been reported. In 1998, Longo provided an initial description for the correction of prolapsed haemorrhoids by applying a circular stapling device. The important concept underlying this technique involved drawing up the haemorrhoidal tissue, and reducing the redundant mucosa, interfering with the branches of the superior haemorrhoidal artery. Patients, therefore, eliminate the painful skin wound. Haemorrhoidal prolapse is corrected by relocating the pile masses into the anal canal and by decreasing the venous engorgement with division of the feeding arteries and redundant mucosa. Through this method, resultant stapled mucosa anastomosis is formed in the rectum, approximately 30 millimetres proximal to the dentate line where sensitive receptors are sparse. The precise treatment of haemorrhoids is still topic of considerable debate. There are only limited studies on Grade IV Haemorrhoids, which provide evidence comparing the methods of Stapled Haemorrhoidectomy versu |