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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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
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
 
 
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 
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