| CTRI Number |
CTRI/2024/08/072331 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Study to look for the effect of ERAS protocol on stress response index in patient who underwent Radical Cholecystectomy |
|
Scientific Title of Study
|
Effect of enhanced recovery after surgery(ERAS) protocol on the stress response index in patient who underwent radical cholecystectomy with general anaesthesia |
| 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 Soumya Sankar Nath |
| Designation |
Professor (JR Grade) |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Anesthesiology And CCM, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, LUCKNOW
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9648935430 |
| Fax |
|
| Email |
soumyanath@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Soumya Sankar Nath |
| Designation |
Professor (JR Grade) |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Anesthesiology and CCM, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9648935430 |
| Fax |
|
| Email |
soumyanath@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vishal Pandey |
| Designation |
Resident |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Dr S C Rai Hostel, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
8853048385 |
| Fax |
|
| Email |
pandey.vishal68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti khand, Gomtinagar, Lucknow, Uttar Pradesh,226010, India |
|
|
Primary Sponsor
|
| Name |
Dr Ram Manohar Lohia Institute of Medical Sciences Lucknow |
| Address |
Vibhuti Khand, Gomati Nagar,
Lucknow, 226010 |
| 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 Somya Sankar Nath |
Dr Ram Manohar Lohia Institute of Medical Sciences |
Department pf anaesthesiology and CCM Lucknow UTTAR PRADESH |
9648935430
soumyanath@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIECES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS group |
1.Via tablet proper education will be given to patients about anaesthetic & surgical procedure and patient’s record will be examined
2-Preoperative carbohydrate loading will be done
3-Intraoperatively balanced salt solution shall be administered at a @4ml/kg/hr
4-Higher Fi02 (60%) shall be administered intra-operatively
5-Postoperative discontinuation of IV fluid half an hour after surgery
6-Patients will be encouraged to move their limbs every 5 min and further allowed to recover in semi-recumbent position
7-No abdominal drain shall be left
|
| Comparator Agent |
Non ERAS group |
1-Patients records will be examined and all the procedure will be explained to the patients
2- Fasting advice 6 hours for solid food & milk and 2 hours for clear fluid prior to surgery
3-Intra operative and post operative fluid management will be done
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients between 18-70 years, of either gender, who are willing to consent for participation in the study
2. Patients with confirmed carcinoma of gall bladder without metastasis and posted for radical Cholecystectomy
3. American Society of Anesthesiologists (ASA) physical classes I and II.
|
|
| ExclusionCriteria |
| Details |
1.Patient’s s refusal to give consent
2.Diabetes mellitus
3.Patient having gall bladder carcinoma but not advised radical cholecystectomy as plan of treatment
4.Patients with metastasis
5.Patients with any contraindication to insertion of epidural catheter, like patient’s refusal, coagulopathy, anatomical deformities of the spine, infection at the site of insertion.
6.Patient refused to cease smoking/ consume alcohol or ceased smoking/alcohol consumption for less than 4 weeks.
7.Intra-abdominal drain
8.Uncorrected anemia
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Enhanced rate of recovery in patients undergone Radical Cholecystectomy
2.Reducing the overall complication rates without affecting the readmission rates.
|
48 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Decrease hospital length of stay.
2.Decrease time of return bowel function
3.Predicting which agent & timing is ideal for preoperative venous thromboembolism prophylaxis
4.Getting to know about the ideal combination of medication & modalities for postoperative analgesia
5.Knowing about the optimal timing of urinary catheter removal
6.Preferred combination of antiemetics in the post operative period
7.Reducing cost for the patient’s treatment
8.Early mobilization of the patient
|
48 hours |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
20/08/2024 |
| 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="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
|
The
basic components of the ERAS protocol include pre-operative counselling to
psychologically prepare the patient for the surgery, avoidance of fasting,
preoperative nutrition including carbohydrate loading upto two hours prior to
surgery, analgesic regimes including epidural and non-opioid analgesia,
mobilization and resumption of enteral feeding. There is ample evidence that ERAS
protocol hastens postoperative recovery leading to improved outcome, including
early oral intake, early mobilization, shorter hospital stay and, thus, higher
satisfaction among patients. Carbohydrate loading,
suggested by ERAS protocol reduces the postoperative stress induced insulin
resistance and also minimizes nitrogen and protein losses. It promotes faster
recovery through faster return of bowel function, shorter length of hospital
stays (LOS), and thus, better perioperative feeling of well-being.
ERAS protocol had been widely
studied in laparoscopic cholecystectomies (LC). Yu Tianyang MM et al in a
retrospective study on 126 patients reported that the ERAS group had
significantly earlier time to first flatus, time to first ambulation, time to
solid intake compared with the traditional group. Further, the ERAS group had
significantly lower postoperative lung and abdominal cavity infection compared
to the traditional group.Udayasankar M et al (2020) performed a prospective
randomized controlled study in 50 patients reported lower anxiety prior to surgery
and at 6 hours postoperatively. Hunger, thirst and fatigue were also decreased
with better overall perioperative experience. Zhang N et al (2020)
performed a retrospective analysis of 445 patients who underwent LC with
biliary duct exploration and found that the WBC count and CRP levels were
significantly lower among those who underwent LC with ERAS protocol than those
without ERAS protocol one day after surgery. Flatus time, length of hospital
stays after surgery, incidence of nausea, incisional pain and vomiting were
lower in the ERAS group compared to the non-ERAS group. Nair A et al (2023) did a systematic
review and meta-analysis and reported that the LOS, time to first flatus was
found to be significantly shorter in the ERAS group than the control group, for
both LC and LC with CBD exploration. Among patients who underwent LC,
incidences of PONV and pain scores were lower in ERAS group compared to
conventional group.
Among
abdominal open surgeries, ERAS protocols have been studied in colo-rectal,
vascular, thoracic and radical cystectomies surgeries. but
there is no report in literature, about the effects of ERAS protocols in
radical cholecystectomies. ERAS society published the guidelines for
perioperative care in elective abdominal and pelvic surgeries in LMIC in 2022
to improve the perioperative care and to promote data driven, evidence-based
care.
Carcinoma of gall
bladder (CaGB) is quite rampant in India and it accounts for 10% of the global
case load of CaGB. It has a predilection for female gender and ranks among
three top cancers among women of North and North-eastern India. The age standardized
rate (ASR) for CaGB in women of North and north-east India are 11.8/100,000
population and 17.1/100,000 population, respectively.[9] Radical
cholecystectomy with en bloc hepatic resection and regional lymph node
resection, is the recommended method of managing non-metastatic CaGB.[10] Radical cholecystectomy is
defined as the resection of the gallbladder and gallbladder fossa and is usually combined with a
supraduodenal lymphadenectomy for the treatment of gallbladder cancer. The
extent of the hepatic resection may include nonanatomic parenchymal resection
of the gallbladder fossa to a standard segment IVb/V resection with data suggesting
superior survival from segment IVb/V resection over standard
cholecystectomy. The goal of the resection is complete resection of all
histopathologic disease, which may necessitate resection of the common hepatic
duct/common bile duct if clearance of all disease cannot be obtained by
division at the cystic duct/common hepatic duct junction. |