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

ISRCTN ISRCTN63623153
DOI https://doi.org/10.1186/ISRCTN63623153
Secondary identifying numbers N/A
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

Study designRandomised controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedThyroid disorders
InterventionAll 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 typeProcedure/Surgery
Primary outcome measureAll 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 measuresNot provided at time of registration
Overall study start date01/01/2001
Completion date01/03/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants94
Key inclusion criteriaThe 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 criteriaDoes not match inclusion criteria
Date of first enrolment01/01/2001
Date of final enrolment01/03/2002

Locations

Countries of recruitment

  • India

Study participating centre

DII/131, West Kidwai Nagar
New Delhi
110023
India

Sponsor information

Safdarjung Hospital - Vardhman Mahavir Medical College (India)
Hospital/treatment centre

DII/131, West Kidwai Nagar
New Delhi
110023
India

Phone +91 (0)11 26268336 104
Email chintamani@doctor.com
Website http://www.vmmc-sjh.nic.in/
ROR logo "ROR" https://ror.org/03zj0ps89

Funders

Funder type

Government

Safdarjung Hospital - Vardhman Mahavir Medical College (India) - a government aided institution

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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