Contact information
Type
Scientific
Primary contact
Dr Chintamani
ORCID ID
Contact details
DII/131
West Kidwai Nagar
New Delhi
110023
India
+91 (0)11 26886405
chintamani7@rediffmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To study the role of drains after thyroid surgery and monitor the fluid collection in thyroid bed.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Thyroid disorders
Intervention
All patients included in the study were randomly allocated to drain and non-drain group on the basis of computer generated random number table. The surgeon was informed of the group just before the closure of the wound. In the drain group a closed suction drain with negative pressure (Romovac®) was brought out through a separate wound. Ultrasound of the neck using B mode with linear frequency of 7.5 MHz was performed in both groups between 24 to 48 hours of surgery and seventh postoperative day. Volume of fluid collection in the operative bed was calculated by measuring the maximum diameter in three dimensions. The volume of fluid collected in the suction drain was measured separately. The drains were removed in all the patients after 48 hours. All patients were observed for any postoperative respiratory distress, change in voice, wound collection, tingling sensation, tetany etc.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
All patients were observed for any postoperative respiratory distress, change in voice, wound collection, tingling sensation, tetany etc. The specimens were subjected to histopathological examination for final confirmation of diagnosis. Using two sample t-test all the data was statistically analyzed for any significant difference in the two groups for:
1. Fluid collection in thyroid bed on day one and day seven
2. Size of nodule and amount of fluid collection
3. Complication rate
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
01/03/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The study was carried out on 94 patients who underwent thyroid surgeries in a single unit. Patients with cervical lymph nodes metastases requiring neck dissection and those with clinical or laboratory indicators of coagulation disorders were excluded from the study. No patient was excluded on the basis of size of the gland, difficulty in surgery, surgery involving both lobes and re-operation in the neck.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
94
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/2001
Recruitment end date
01/03/2002
Locations
Countries of recruitment
India
Trial participating centre
DII/131, West Kidwai Nagar
New Delhi
110023
India
Sponsor information
Organisation
Safdarjung Hospital - Vardhman Mahavir Medical College (India)
Sponsor details
DII/131
West Kidwai Nagar
New Delhi
110023
India
+91 (0)11 26268336 104
chintamani@doctor.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Safdarjung Hospital - Vardhman Mahavir Medical College (India) - a government aided institution
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/pubmed/15946379
Publication citations
-
Results
Khanna J, Mohil RS, Chintamani, Bhatnagar D, Mittal MK, Sahoo M, Mehrotra M, Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153]., BMC Surg, 2005, 5, 11, doi: 10.1186/1471-2482-5-11.