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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2009/007 |
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Date of registration:
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17/07/2009 |
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Primary sponsor: |
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Public title:
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Is suturing of the abdominal fat tissues in gynaecological surgery beneficial?
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Scientific title:
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Comparison of sutured versus non-sutured subcutaneous fat tissues in abdominal surgery in Gynaecology; A prospective randomized controlled trial |
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Date of first enrolment:
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1/8/2009 |
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Target sample size:
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144(72 in each group) |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={9F403947-32D1-46F1-8ABC-7CAA49BFEDDD} |
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Study type:
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Interventional |
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Study design:
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A prospective randomized study.
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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J.P.Marasinghe
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Address:
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Colombo South Teaching Hospital, Kalubowila
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Telephone:
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0773834787 |
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Email:
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jeevanmarasinghe@yahoo.com |
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Affiliation:
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Senior Registrar in Obstetrics and Gynaecology |
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Name:
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J.P.Marasinghe
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Address:
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Singhagiri, Helambawatawana, Nalladarankattuwa
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Telephone:
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0773834787 |
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Email:
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jeevanmarasinghe@yahoo.com |
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Affiliation:
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Senior Registrar in Obstetrics and Gynaecology |
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Key inclusion & exclusion criteria
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Inclusion criteria: All willing patients undergoing open gynaecological surgeries from the start of the study until the target number of patients are achieved.
Exclusion criteria: Patients with long term anticoagulation, diabetes and malignancy will be excluded.Patients who are not willing to participate will be excluded.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Wound infection and other wound complications in gynaecological surgery
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Intervention(s)
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Subcutaneous suturing of the subcutaneous fat tissue will be performed in nearly half of the patients in each group, determined using the envelope method (‘Suture Yes’ or ‘Suture No’). The envelopes will be opened by the operating surgeon in the operation theater just before surgery.
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Primary Outcome(s)
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Wound infection and pain score
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Secondary Outcome(s)
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Pain score, Haematoma formation, seroma ,dehiscence and disruption, incisional hernia
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Source(s) of Monetary Support
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None
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