| CTRI Number |
CTRI/2026/03/105206 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
INTRODUCING A NOVEL SELF RETAINING ABDOMINAL DRAIN - DESIGN AND EFFICACY |
|
Scientific Title of Study
|
INTRODUCING A NOVEL SELF RETAINING ABDOMINAL DRAIN - DESIGN AND EFFICACY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kotamareddi Anuhya |
| Designation |
MS General Surgery Post Graduate |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA UNIVERSITY |
| Address |
Room no.423 , siruvani hostel,saveetha medical college and hospitals,Thandalam,Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9121019912 |
| Fax |
|
| Email |
dr.anu2403@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kotamareddi Anuhya |
| Designation |
MS General Surgery Post Graduate |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA UNIVERSITY |
| Address |
Room No. 423 , Siruvani Girls hostel, Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9121019912 |
| Fax |
|
| Email |
dr.anu2403@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kotamareddi Anuhya |
| Designation |
MS General Surgery Post Graduate |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA UNIVERSITY |
| Address |
Room no. 423, Siruvani Girls hostel,Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9121019912 |
| Fax |
|
| Email |
dr.anu2403@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kotamareddi Anuhya |
| Address |
Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrKotamareddi Anuhya |
Saveetha medical college and Hospital |
Department of General Surgery Saveetha medical college and hospital,Saveetha Nagar,Thandalam,Chennai-602105
Chennai
TAMIL NADU |
9121019912
dr.anu2403@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMCH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K389||Disease of appendix, unspecified, (2) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (3) ICD-10 Condition: K437||Other and unspecified ventral hernia with gangrene, (4) ICD-10 Condition: K436||Other and unspecified ventral hernia with obstruction, without gangrene, (5) ICD-10 Condition: K638||Other specified diseases of intestine, (6) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventionally used abdominal drain |
The conventional abdominal drain is compared with the new novel self retaining abdominal drain |
| Intervention |
Self retaining abdominal drain |
Patients undergoing abdominal surgeries with conventional drain will be intervened and a self retaining drain will be used instead |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who undergo abdominal surgery and are stable
Patients who are willing to participate |
|
| ExclusionCriteria |
| Details |
Patients who are not fit for surgery
Patients who are haemodynamically unstable
Patients who are not willing for the procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevention of infection at drain site
Reducing the hospital stay of the patient
Improve cosmetic results
Reduced pain score |
2weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve cosmetic results |
4 weeks |
|
|
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)
|
11/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Drain site pain and infection are a significant postoperative complication resulting in poor patient compliance and delayed Post operative recovery.The novel self-retaining abdominal drain offers multiple significant benefits that enhance both surgical practice and patient care. By incorporating a built-in retention mechanism, it ensures stable intraperitoneal positioning, greatly reducing the risk of accidental dislodgement—a common complication with conventional drains. This eliminates the need for suture fixation or external anchoring, thereby decreasing the risk of infection, skin irritation, and patient discomfort. The simplified design allows for easier placement and removal, streamlining the surgical workflow and saving valuable operative time. Additionally, improved patient mobility and reduced manipulation contribute to better postoperative outcomes
|