Condition category
Surgery
Date applied
31/01/2005
Date assigned
04/02/2005
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (RomovacĀ®) 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 measures

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

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

http://www.vmmc-sjh.nic.in/

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

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/pubmed/15946379

Publication citations

  1. 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.

Additional files

Editorial Notes