Is routine drainage necessary after thyroid surgery - a randomised controlled trial

ISRCTN	ISRCTN63623153
DOI	https://doi.org/10.1186/ISRCTN63623153
Protocol serial number	N/A
Sponsor	Safdarjung Hospital - Vardhman Mahavir Medical College (India)
Funder	Safdarjung Hospital - Vardhman Mahavir Medical College (India) - a government aided institution

Submission date: 31/01/2005
Registration date: 04/02/2005
Last edited: 24/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chintamani
Scientific

DII/131, West Kidwai Nagar
New Delhi
110023
India

Phone	+91 (0)11 26886405
Email	chintamani7@rediffmail.com

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To study the role of drains after thyroid surgery and monitor the fluid collection in thyroid bed.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/03/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	94
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/2001
Date of final enrolment	01/03/2002

Locations

Countries of recruitment

India

Study participating centre

DII/131, West Kidwai Nagar

New Delhi
110023
India

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	19/05/2005		Yes	No