| CTRI Number |
CTRI/2020/08/027349 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
14/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of routine care Vs assisted recovery based care in patients undergoing surgical closure of intestinal opening on the abdominal wall. |
|
Scientific Title of Study
|
Comparison of Enhanced Recovery After Surgery (ERAS) pathway vs. Standard care in patients undergoing elective stoma reversal surgery- A Randomized 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 |
Madan S |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
JIPMER campus, Dhanavantri Nagar, Gorimedu, Puducherry - 605006
Pondicherry
PONDICHERRY
570023
India |
| Phone |
7204132686 |
| Fax |
|
| Email |
madanshivakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikram Kate |
| Designation |
Professor (Senior Scale) |
| Affiliation |
JIPMER |
| Address |
JIPMER campus, Dhanavantri Nagar, Gorimedu, Puducherry - 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikram Kate |
| Designation |
Professor (Senior Scale) |
| Affiliation |
JIPMER |
| Address |
JIPMER campus, Dhanavantri Nagar, Gorimedu, Puducherry - 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, Dhanavantri Nagar, Gorimedu, Puducherry - 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanavantri Nagar, Gorimedu, Puducherry - 605006 |
| 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 |
| MADAN S |
JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH (JIPMER) |
DHANAVANTRI NAGAR, GORIMEDU, PUDUCHERRY - 605006
Pondicherry
PONDICHERRY |
7204132686
madanshivakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR INTERVENTIONAL STUDIES, JIPMER |
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 |
| Intervention |
ERAS protocol based care in elective stoma reversal surgery |
-pre operative fasting duration will be kept less than 6 hrs
-Maltodextrin drink to be given to participant 2 hrs before surgery
-no mechanical bowel preparation in the participant
-avoidance of fluid overload in participant pre op
-avoidance of the use of opioid analgesics intra op
-avoidance of use of urinary catheter/drain/Ryles tube
-early ambulation within 6 hrs post op
-starting oral sips by 6 hrs post op and escalating it to oral clear liquids by 12 hrs and oral liquid diet by 24 hr |
| Comparator Agent |
Standard protocol based care in elective stoma reversal surgery |
-pre operatively patient is kept Nil by mouth for more than 6 hrs
-mechanical bowel preparation will be done
-fluid administration according to standard protocol of unit
-Intra op analgesic and opioid use according to standard protocol of unit
-use of urinary catheter/drain/Ryles tube based on discretion of operating surgeon
-post op ambulation and resumption of feeds according to standard protocol of unit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all eligible subjects between the age of 18 yrs - 60 yrs will be included in the study |
|
| ExclusionCriteria |
| Details |
-Age<18 years.
-ASA class 3 or 4.
-Patients requiring/planned for laparotomy for stoma reversal.
-Patients with neurological and/or renal disorders, cardiac illnesses, bed ridden patients and patients on steroids.
-Patients unable to understand/respond to verbal or written commands
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the length of hospitalization (LOH) in patients managed with ERAS protocol with that of patients managed by standard protocols in elective stoma reversal surgeries |
7 days LOH in control arm vs 5 days LOH in ERAS (study) arm |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of ileus and time to first bowel sound |
6 hrs in ERAS (study) arm vs more than 6 hrs in Control arm |
| time to first fluid diet and first solid diet |
oral sips by 6 hrs and escalation to clear liquids by 12 hrs and liquid diet by 24 hrs in ERAS (study arm)
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/10/2020 |
| 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="2"
Months="0"
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
|
Bowel surgeries, particularly needing intestinal anastomosis have conventionally been managed by prolonged abstinence from oral intake, usage of opioid analgesics, insertion of nasogastric tube and urinary catheter etc. ERAS protocol is a streamlined multimodal approach which utilizes various evidence-based modifications of the perioperative care elements with the aim of attenuating the physiological and psychological stress, thus accelerating patients’ recovery. Though ERAS protocol based management has yielded significant success in colorectal surgeries, not many studies have been conducted to compare ERAS protocol vs standard care in elective stoma closure surgeries.The study expects ERAS pathway management to be superior to conventional care for elective stoma reversal surgeries. Patient managed by ERAS pathway is expected to have shorter length of hospitalization (LOH), low morbidity/mortality/readmission rates which in turn will result in wider implementation of the protocol and lower burden on the healthcare system.If the ERAS protocol is found to be safe and feasible with shorter LOH, it may be uniformly implemented in all elective stoma closure surgeries.
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