| CTRI Number |
CTRI/2025/11/097080 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of postoperative outcomes: Chivate procedure vs Stapled hemorrhoidopexy in Grade II and III hemorrhoids. |
|
Scientific Title of Study
|
A Randomized controlled Trial Comparing the Postoperative Outcomes of the Chivate Procedure versus Stapled Hemorrhoidopexy in patients with Grade II and III Hemorrhoids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aelan |
| Designation |
Junior Resident |
| Affiliation |
All india institue of medical sciences Vijaypur, Jammu |
| Address |
Department of General Surgery, All india institute of medical sciences Vijaypur, Jammu
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9785007246 |
| Fax |
|
| Email |
aelan@aiimsjammu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Dogra |
| Designation |
Assistent Professor |
| Affiliation |
Post Graduate |
| Address |
Department of General Surgery, All india institute of medical sciences Vijaypur, Jammu
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9622218999 |
| Fax |
|
| Email |
varun.dogra@aiimsjammu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aelan |
| Designation |
Junior Resident |
| Affiliation |
All india institue of medical sciences Vijaypur, Jammu |
| Address |
Department of General Surgery, All india institute of medical sciences Vijaypur, Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9785007246 |
| Fax |
|
| Email |
aelan@aiimsjammu.edu.in |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences vijaypur, Jammu |
|
|
Primary Sponsor
|
| Name |
Dr Meeta Gupta |
| Address |
Academics Dean, aiims jammu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aelan |
All india institute of medical sciences, Jammu |
Department of General Surgery, All india institute of medical sciences Vijaypur, Jammu
Jammu
JAMMU & KASHMIR |
9785007246
aelan@aiimsjammu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue ethics comittee, AIIMS Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chivate procedure |
The Chivate procedure is novel method for hemorrhoidopexy from India, is now gaining popularity for its cost effectiveness, simplicity and minimal pain. The technique is based on the principles of hemorrhoidopexy combined with suture ligation of the hemorrhoidal tissues under regional anaesthesia |
| Comparator Agent |
Stapled Hemorrhoidopexy |
Stapled Hemorrhoidopexy (SH) is nearly minimally invasive and results in lesser discomfort. This procedure involves circumferential excision of a band of rectal mucosa and submucosa lying above the hemorrhoid with a circular stapler, carrying upward the prolapsed hemorrhoid tissue in an alternate direction while cutting off blood supply to it |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18–60 years of age diagnosed with Grade II or III internal haemorrhoids included under ASA Grade I–II surgical risk category and willing to provide written informed consent are included in the study. |
|
| ExclusionCriteria |
| Details |
1)Patient with External Haemorrhoids
2)Patients with history of previous anorectal surgery
3)Coexisting anal conditions (such as anal fissures or fistulas)
4)Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the proportion of patients achieving complete cessation of hemorrhoidal symptoms — including bleeding, prolapse, pain during defecation, between the Chivate Procedure and Stapled Hemorrhoidopexy groups. |
To assess the proportion of patients achieving complete cessation of hemorrhoidal symptoms — including bleeding, prolapse, pain during defecation, anal discomfort postoperatively between the Chivate Procedure and Stapled Hemorrhoidopexy groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the length of hospital stay among patients undergoing the Chivate Procedure versus Stapled Hemorrhoidopexy for Grade II & III internal hemorrhoids at AIIMS Vijaypur. |
1.To assess the length of hospital stay among patients undergoing the Chivate Procedure versus Stapled Hemorrhoidopexy for Grade II & III internal hemorrhoids at AIIMS Vijaypur.1.To assess the length of hospital stay among patients undergoing the Chivate Procedure versus Stapled Hemorrhoidopexy for Grade II & III internal hemorrhoids at AIIMS Vijaypur. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/11/2025 |
| 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 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
|
Though
performed widely, Stapled Hemorrhoidopexy come under scrutiny due to its
recurrence rates and costs, especially in resource-poor areas like India. The
Chivate procedure is appealing as a low-cost option and technically feasible in
health care system. There are some areas where good quality randomized
controlled trials (RCTs) directly contrasting the two are lacking, especially
in the Indian context [13]. With the growing case numbers now being
reported in the Jammu region, a comparative investigation into the efficacy,
postoperative outcomes, pain scoring, complications, and recurrence rate
between the Chivate procedure and Stapled Hemorrhoidopexy are much needed. This
data would prove to be critical for evidence-based decision-making and thus
inform institutional and state-level policies and guidelines. The aim of this
study is to fill the lacuna by evaluating postoperative outcomes using
standardized measures to provide sound evidence to further improve clinical
practice in proctologic surgery. |