Is routine drainage necessary after thyroid surgery - a randomised controlled trial
ISRCTN | ISRCTN63623153 |
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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
Scientific
DII/131, West Kidwai Nagar
New Delhi
110023
India
Phone | +91 (0)11 26886405 |
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chintamani7@rediffmail.com |
Study information
Study design | Randomised controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/01/2001 |
Completion date | 01/03/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
110023
India
Sponsor information
Safdarjung Hospital - Vardhman Mahavir Medical College (India)
Hospital/treatment centre
Hospital/treatment centre
DII/131, West Kidwai Nagar
New Delhi
110023
India
Phone | +91 (0)11 26268336 104 |
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chintamani@doctor.com | |
Website | http://www.vmmc-sjh.nic.in/ |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 19/05/2005 | Yes | No |