| CTRI Number |
CTRI/2023/11/060386 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Post surgery complications in newborns undergoing herniotomy surgery: a retrospective study. |
|
Scientific Title of Study
|
Post-operative complications in preterm neonates and neonates undergoing herniotomy surgery. |
| 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 Vrushali C Ponde |
| Designation |
Consultant and Head of the Department |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Childrens Hospital, First floor OT complex. 101-102 Mangal Ashirvad S V road santacruz
west, Mumbai 400054 Maharashtra, INDIA
Mumbai
MAHARASHTRA
400054
India
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
09819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrushali C Ponde |
| Designation |
Consultant and Head of the Department |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Childrens Hospital, First floor OT complex. 101-102 Mangal Ashirvad S V road santacruz
west, Mumbai 400054 Maharashtra, INDIA
Mumbai
MAHARASHTRA
400054
India
MAHARASHTRA
400054
India |
| Phone |
09819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali C Ponde |
| Designation |
Consultant and Head of the Department |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Childrens Hospital, First floor OT complex. 101-102 Mangal Ashirvad S V road santacruz
west, Mumbai 400054 Maharashtra, INDIA
Mumbai
MAHARASHTRA
400054
India
MAHARASHTRA
400054
India |
| Phone |
09819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Surya Children Hospital First floor OT complex. 101-102 Mangal Ashirvad S V road santacruz
west Mumbai 400054 |
|
|
Primary Sponsor
|
| Name |
Childrens Anaesthesia Services Mumbai |
| Address |
C/ O Surya Childrens Hopsital, S V Road, Santacruz West Mumbai-
400054 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srinitya Kullu |
Surya Children Hospital |
Department of Anaesthesia. First floor OT complex. 101-102 Mangal Ashirvad S V road santacruz west Mumbai 400054 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA |
9078489407
nityak9228@gmail.com |
| Dr Vrushali C Ponde |
Surya Children Hospital |
Department of
Anaesthesia. First floor
OT complex. 101-102
Mangal Ashirvad S V
road santacruz west
Mumbai 400054
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
09819886502
vrushaliponde@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Surya Hospital Academic Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Preterm and Term neonates and infants who underwent hernia surgery from the year April 2015 to July 2023. |
|
| ExclusionCriteria |
| Details |
Not meeting inclusion criteria, Incomplete records. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the incidence of postoperative apnoea in first 24 hrs. |
first 24 h postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate other perioperative adverse events like airway intervention, hypoxia, hypotension, hypothermia, & cardiac arrest in first 24 hrs.
Discharge from hospital. |
first 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="133" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2023 |
| Date of Study Completion (India) |
28/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Inguinal hernia is common in pre-term infants and requires early repair to avoid the risks of incarceration [1]. However, the risk of life-threatening apnea after surgery is significant in this group regardless of the anaesthetic technique used. There was high risk of postoperative apnea, to the extent of 49 %, while more recent reports demonstrated this rate to be closer to 5 %. [2] Cautious use of postoperative ICU monitoring for high-risk patients may be considered in resource limited health care system. [3] There is not much data and evidence comparing different regimens and methods of provision of anaesthesia [4] and cohort studies to look at the incidence of postoperative complications. We have planned this retrospective study to identify the incidence of postoperative complications and review our current practices. This will help us to improve our practices and patient care. After taking permission from ethics committee, the records of the preterm and term who underwent hernia surgery from the April 2015 to July 2023 will be checked. We expect to get a sample size of 200. The data include age, sex, birth weight, anaesthetic management, postoperative pain management, postoperative respiratory complications like apnea, airway intervention, hypoxia, cardiac arrest, hypotension, hypothermia, duration of ICU stay, and discharge from hospital will be extracted from the medical record database with due care not to disclose the identity of the patients. Inclusion criteria: Preterm and Term infants who underwent hernia surgery from the year April 2015 to July 2023. Exclusion criteria: Incomplete data References: 1. Ramachandran V, Edwards CF, Bichianu DC. Inguinal Hernia in Premature Infants. Neoreviews. 2020 Jun;21(6):e392-e403. 2. Özdemir, T., Arıkan, A. Postoperative apnea after inguinal hernia repair in formerly premature infants: impacts of gestational age, postconceptional age and comorbidities. Pediatr Surg Int. 2013;29, 801–804. 3. Murphy JJ, Swanson T, Ansermino M, Milner R. The frequency of apneas in premature infants after inguinal hernia repair: do they need overnight monitoring in the intensive care unit? J Pediatr Surg. 2008 May;43(5):865-8. 4. Ponde VC, Chavan DN, Desai AP, Gursale AA, Bedekar VV, Puranik KA. Avoidance of deep anesthesia and artificial airways in 1000 neonates and infants using regional anesthesia: A retrospective observational analysis. J Anaesthesiol Clin Pharmacol. 2020 Jul-Sep;36(3):386-390. |