| CTRI Number |
CTRI/2024/05/066860 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the Role of bioresorbable membranes in patients undergoing abdominal surgeries by placing this membrane in the abdominal cavity which will reducie the post operative adhesions formed leading to decrease in incidence of intestinal obstructions and the bowel injury during redosurgeries |
|
Scientific Title of Study
|
Role of sodium hyaluronate and carboxy methylcellulose based bioresorbable membranes in decreasing intraabdominal adhesions |
| 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 Vinkle Panjoria |
| Designation |
Junior Resident |
| Affiliation |
PGIMER , CHANDIGARH |
| Address |
Dept. of General Surgery
PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160011
India |
| Phone |
9816973881 |
| Fax |
|
| Email |
Vinklepanjoria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Cherring Tandup |
| Designation |
Associate Professor |
| Affiliation |
PGIMER , CHANDIGARH |
| Address |
Dept. of General Surgery
PGIMER ,Chandigarh
Chandigarh
CHANDIGARH
160011
India |
| Phone |
8196991007 |
| Fax |
|
| Email |
Ctandup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinkle Panjoria |
| Designation |
Junior Resident |
| Affiliation |
PGIMER , CHANDIGARH |
| Address |
Dept of General Surgery
PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160011
India |
| Phone |
9816973881 |
| Fax |
|
| Email |
Vinklepanjoria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of General Surgery, PGIMER , CHANDIGARH , Pin -160012
India |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Chandigarh
Pin- 160012
India |
| 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 Vinkle panjoria |
PGIMER |
Dept. of General surgery
5th Floor , Nehru building
Chandigarh
Chandigarh
CHANDIGARH |
9816973881
Vinklepanjoria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER CHANDIGARH, INSTITUTIONAL ETHICS COMMITTEE, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No membrane would be placed at the stoma site |
Bioresorbable membrane would not be placed at the stoma site. And the second surgery which is stoma reversal would be done at 6-8 weeks from the index surgery |
| Intervention |
Placement of sodium hyaluronate and carboxymethylcellulose based bioresorbable membrane under the stoma . |
During stoma formation a bioreorbable membrane would pe placed beneath the stoma site which will reduce the adhesion formation and thus help in reducing complications during the second surgery for stoma reversal which would be done at 6-8 weeks following index surgery. So the total duration would be 6-8 weeks |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving consent for the study who will undergo a temporary stoma formation in which stoma closure would be done in 6-8weeks |
|
| ExclusionCriteria |
| Details |
Permanent stoma formation.
Patient with prior history of abdominal TB and inflammatory bowel disease.
Patients in which stoma reversal is not possible in 6-8weeks |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of this bioresorbable membrane in reducing the severity of postoperative intraabdominal adhesions |
During 2nd surgery i.e 6-8 weeks post index surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the decrease in operating time during surgery for stoma reversal |
During 2nd surgery i.e 6-8weeks post index surgery |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Vinklepanjoria@gmail.com].
- For how long will this data be available start date provided 18-04-2024 and end date provided 18-04-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Patient presenting to emergency or admitted in ward with any condition of intestines requiring a temporary stoma formation in which stoma reversal can be done in 6-8weeks post the stoma formation will be considered . In these patients a bioresorbable membrane would be placed beneath the stoma which will act as a barrier and reduce the formation of adhesions . Now during the stoma reversal surgery the adhesions formed would be noted and compared with the counterparts in which the membrane was not placed |