| CTRI Number |
CTRI/2015/12/006404 [Registered on: 02/12/2015] Trial Registered Retrospectively |
| Last Modified On: |
02/12/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An experiment on comparison of routine surgical closure of ostomy after eight weeks with earlier ostomy closure between two to four weeks |
|
Scientific Title of Study
|
EARLY VERSUS CONVENTIONAL STOMA CLOSURE FOLLOWING BOWEL SURGERY- A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NELSON T |
| Designation |
JUNIOR RESIDENT, M.S GENERAL SURGERY |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF SURGERY,
JIPMER,
PONDICHERRY
JIPMER,
gorimedu,
pondicherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9789589298 |
| Fax |
|
| Email |
nelson.mbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIKRAM KATE |
| Designation |
PROFESSOR |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF SURGERY,JIPMER,
PONDICHERRY, INDIA-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VIKRAM KATE |
| Designation |
PROFESSOR |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF SURGERY,JIPMER,
PONDICHERRY, INDIA-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER,
PUDUCHERRY-605006
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 |
| NELSON T |
JIPMER |
DEPARTMENT OF SURGERY,JIPMER,
PONDICHERRY, INDIA-605006
Pondicherry
PONDICHERRY |
9789589298
nelson.mbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE(HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS WITH TEMPORARY STOMA WHO HAD UNDERGONE BOWEL SURGERY., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL STOMA CLOSURE |
STOMA CLOSURE DONE RANGED FROM 8-12 WEEKS FOLLOWING INDEX OPERATION. |
| Intervention |
EARLY STOMA CLOSURE |
STOMA CLOSURE DONE WITHIN 28 DAYS FOLLOWING INDEX OPERATION. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ALL CONSECUTIVE PATIENTS UNDERGOING TEMPORARY STOMA FOLLOWING BOWEL SURGERIES. |
|
| ExclusionCriteria |
| Details |
1.EMERGENCY STOMA REVISION
2. LAPAROSCOPIC BOWEL SURGERIES
3. SIGNS OF ACTIVE INFECTION OR ORGAN FAILURE IN POSTOPERATIVE PERIOD.
4. RADIOLOGICAL SIGNS OF ANASTOMOTIC LEAKAGE EVIDENT AT WATER SOLUBLE CONTRAST EXAMINATION BEFORE STOMA CLOSURE.
5.MALNOURISHED PATIENTS. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE FREQUENCY OF COMPLICATIONS IN THE EARLY AND CONVENTIONAL STOMA CLOSURE GROUP FOLLOWING BOWEL SURGERY. |
INTRAOPERATIVE AND POSTOPERATIVE PERIOD,4 WEEKS AND 12 WEEKS AFTER STOMA CLOSURE. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE HEALTH RELATED QUALITY OF LIFE AND ANALYSE THE COST TOWARDS STOMA CARE |
BEFORE AND AFTER STOMA CLOSURE |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2013 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients who underwent temporary stoma following bowel surgeries will be included in the randomised study from 2013-2015 after getting informed consent. Early stoma closure is done within 28 days following index operation whereas conventional stoma closure ranges from 8-12 weeks. Preoperatively patient’s quality of life will be assessed by modified health questionnaire of European Organisation for Research and Treatment of Cancer(EORTC) . Intraoperative complications like bleeding, laparotomy and postoperative complications like wound infection, anastomotic leak, intra abdominal abscess will be assessed between the two groups. Stratification of complications is done by Clavien-Dindo classification. Cost pertaining to stoma care and length of hospital stay will be analysed between the groups. Assessment for frequency of complications and quality of life would be done by 4 weeks at 1st follow-up and 12 weeks at 2nd followup after stoma closure. |