| CTRI Number |
CTRI/2015/01/005387 [Registered on: 13/01/2015] Trial Registered Prospectively |
| Last Modified On: |
13/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
‘NASAL PACKING VERSUS NO PACKING AFTER SINUS SURGERY’ |
|
Scientific Title of Study
|
‘IS POSTOPERATIVE NASAL PACKING ESSENTIAL AFTER FUNCTIONAL ENDOSCOPIC SINUS SURGERY?’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghav Mehan |
| Designation |
PG Fellow – Rhinology |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of ENT Unit III, Room No 303, 3rd Floor,
CMC Hospital, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8489291133 |
| Fax |
|
| Email |
dr.raghavmehan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupa Vedantam |
| Designation |
Professor and Head, ENT III |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of ENT Unit III, Room No 303, 3rd Floor,
CMC Hospital, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
|
| Fax |
|
| Email |
rupavedantam@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupa Vedantam |
| Designation |
Professor and Head, ENT III |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of ENT Unit III, Room No 303, 3rd Floor,
CMC Hospital, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
|
| Fax |
|
| Email |
rupavedantam@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Institutional Review Board,
Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Institutional Review Board |
| Address |
Christian Medical College, Vellore |
| 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 Raghav Mehan |
Department of ENT Unit III |
Room no 303, 3rd Floor,
CMC Hospital
Vellore
TAMIL NADU |
8489291133
dr.raghavmehan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Ethics Committee, Silver, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic rhinosinusitis with or without polyposis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
No packing |
To leave one nasal cavity unpacked after functional endoscopic sinus surgery |
| Comparator Agent |
Packing |
To place Merocel nasal pack in one nasal cavity after functional endoscopic sinus surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral chronic rhinosinusitis with or without polyposis and a Lund-MacKay CT scan score difference of three or less between the left and right sides |
|
| ExclusionCriteria |
| Details |
a)Age less than 18 years
b)Unilateral chronic rhinosinusitis / nasal polyp
c)Previous history of endoscopic sinus surgery
d)Severe co-morbidities eg. uncontrolled systemic hypertension, uncontrolled diabetes mellitus
e)Haemoglobin concentration of less than 10 mg/dl
f)Abnormal blood coagulation profile
g)Any immunological or systemic disease affecting the nose
h)Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the post operative nasal symptoms between the packed and unpacked side of the same patient after FESS
2. To compare the post operative nasal endoscopic findings between the packed and unpacked side of the same patient after FESS
|
1. Post operative nasal symptoms will be evaluated everyday for one week after surgery and then on 4th and 12th post op week
2. Post operative nasal endoscopic findings will be evaluated at 1st, 4th and 12th post op week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To calculate the amount of blood loss from each side during FESS
2. Assessment of surgical outcome
|
1. Blood loss will be estimated immediately after completion of surgery
2. Surgical outcome will be evaluated at 4th and 12th post op week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
15/01/2015 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM: To assess the need of routine nasal packing after functional endoscopic sinus surgery (FESS) OBJECTIVES: PRIMARY OBJECTIVES: 1. To assess the difference in degree of postoperative bleeding from the packed and unpacked side of the same patient after FESS. 2. To assess the difference in degree of postoperative nasal blockage, pain and lateralized headache on the packed and unpacked side of the same patient after FESS. 3. To compare the early and late post operative nasal endoscopic findings between the packed and unpacked side of the same patient after FESS. SECONDARY OBJECTIVE: To suggest a protocol for determining the need for postoperative nasal packing after FESS |