| CTRI Number |
CTRI/2018/01/011088 [Registered on: 02/01/2018] Trial Registered Prospectively |
| Last Modified On: |
01/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Acute uncomplicated appendicitis in children - Is surgery the preferred option? |
|
Scientific Title of Study
|
Conservative treatment with antibiotics versus emergency appendectomy for management of acute nonperforated appendicitis in children: 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 |
Dr Bikasha Bihary Tripathy |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Pediatric Surgery,
All India Institute of Medical Sciences, Bhubaneswar
Department of Pediatric Surgery,
All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884102 |
| Fax |
|
| Email |
bbtripathy.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikasha Bihary Tripathy |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Pediatric Surgery,
All India Institute of Medical Sciences, Bhubaneswar
Department of Pediatric Surgery,
All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884102 |
| Fax |
|
| Email |
bbtripathy.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bikasha Bihary Tripathy |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Pediatric Surgery,
All India Institute of Medical Sciences, Bhubaneswar
Department of Pediatric Surgery,
All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884102 |
| Fax |
|
| Email |
bbtripathy.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Cell, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India PIN 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Bhubaneswar, Odisha, India |
| Type of Sponsor |
Government medical college |
|
|
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 Bikasha Bihary Tripathy |
All India Institute of Medical Sciences, Bhubaneswar |
Department of Pediatric Surgery
Khordha
ORISSA |
9438884102
bbtripathy.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Non-Perforated Appendicitis in Children, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A.Conservative Management Group (CMx) |
Broad spectrum intravenous antibiotics (Ceftriaxone 50 mg/kg/dose 12 hourly, Amikacin 7.5 mg/kg/dose 12 hourly and Metronidazole 10 mg/kg/dose 8 hourly) along with bowel rest (maintenance Intravenous fluids as per body weight, Nil by mouth) will be given to children in CMx group. They will be monitored clinically for amelioration of symptoms and signs. Whenever there will be any deterioration in conservative management emergency surgery will be undertaken. Once the laboratory test for inflammatory markers stabilizes the children in CMx group will be discharged with oral antibiotics for 5 days. Follow up assessment for feasibility, safety, recurrences and other significant complications will be done at 1 month, 3 months and 1 year or SOS. |
| Comparator Agent |
B.Emergency Surgical Management Group (SMx) |
Emergency Laparoscopic appendectomy as per Institute protocol will be done in SMx group. Also whenever there will be any deterioration in conservative management group emergency surgery will be undertaken. Follow up assessment for any significant complications will be done. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 3 to 14 years both male and female.
2.Symptoms of Pain Abdomen, Anorexia, Nausea, Vomiting, Fever.
3.Signs of Focal Peritonitis (Guarding, Rebound tenderness) in Right Iliac Fossa (RIF).
4.Laboratory Findings of ↑ Total Leukocyte Count, ↑ Neutrophil count, ↑ CRP, ↑ LRG.
5.Abdominal Ultrasonogram s/o noncompressible nonperistaltic tubular structure ≥ 6 mm in AP diameter in RIF, probe tenderness in RIF, hyperechoic pericaecal fat & free fluid.
6.Abdominal CT scan suggestive of acute nonperforated appendicitis |
|
| ExclusionCriteria |
| Details |
1.History of Recurrent Appendicitis
2.History of Chronic , Intermittent abdominal pain
3.Diffuse abdominal tenderness on clinical evaluation
4.Generalized Septicemia , Other Systemic illnesses
5.Abdominal Ultrasonography s/o Appendicolith, Appendicular Perforation ,Periappendicular Abscess or Phlegmon , Pan-peritonitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The feasibility and safety of the Conservative Management (CMx) with Antibiotics in children with acute Nonperforated Appendicitis. |
1st Month - Feasibility assessment
6th Month - Mid-recruitment review
1 year - Final assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Length of Stay in the Hospital
b)Cost of Treatment
c)Perforation Rate in CMx group
d)Lump formation in CMx group
e)Appendicular Abscess in CMx group
f)Intraoperative Complications in SMx group
g)Wound Complications in SMx group
h)Negative Appendectomy Rate in SMx group
i)Disability Days for the Child and Parents
j)Missed School Days
k)Measures of Quality of Life (PedsQLTM survey)
l)Health Care Satisfaction (1 to 10 score)
m)Recurrence Rate of Appendicitis in CMx group |
All the children enrolled in the CMx group will be called / telephoned for follow up at 1 month, 3 months and 1 year interval. |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
08/01/2018 |
| 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
|
After Completion of the Study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Although non-operative treatment for uncomplicated appendicitis is now an accepted approach, there are few reports in children. The major advantage of antibiotic treatment is the avoidance of surgery and its complications; the potential disadvantage is the fact that, by not removing inflamed appendix, parents will be concerned about recurrent appendicitis every time a child develops abdominal pain in the future. Data on conservative treatment of nonperforated appendicitis in children are scanty. Few retrospective study published had unclear diagnostic and treatment criteria. Of note, there have been no randomized controlled trials investigating the nonoperative treatment of acute appendicitis in children. The current study is a randomized controlled trial to evaluate the feasibility and safety of conservative management with antibiotics alone (CMx group) and to compare with the results of emergency surgery (SMx group) in children with acute nonperforated appendicitis admitted to our hospital for a period of 1 year. We plan to enroll 106 children by non probability consecutive sampling method. Each patient will be assigned with a serial number according to their time and date (sequence) of hospitalization. Based on the computer generated table of random numbers with sealed envelope technique they will be randomized into either CMx group or SMx group as per their serial number. Emergency Laparoscopic appendectomy will be done in the SMx group as per Institute protocol. Intravenous broad spectrum antibiotics (Ceftriaxone, Amikacin and Metronidazole) and bowel rest (IV fluids, nil by mouth) will be given in CMx group till the amelioration of symptoms and signs and corroboration with laboratory test (markers of inflammation). They will be discharged with oral antibiotic for 5 days. If there will be any deterioration in clinical condition then emergency surgery will be done in those patients. Follow up at 1 month, 3month and 1 year will be undertaken to assess the feasibility, safety and recurrence rate in the conservative management (CMx) approach and to compare the incidences of significant complications between both the modalities of management. |