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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.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2009/007
Date of registration: 17/07/2009
Primary sponsor: J.P.Marasinghe
Public title: Is suturing of the abdominal fat tissues in gynaecological surgery beneficial?
Scientific title: Comparison of sutured versus non-sutured subcutaneous fat tissues in abdominal surgery in Gynaecology; A prospective randomized controlled trial
Date of first enrolment: 1/8/2009
Target sample size: 144(72 in each group)
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={9F403947-32D1-46F1-8ABC-7CAA49BFEDDD}
Study type:  Interventional
Study design:  A prospective randomized study.  
Countries of recruitment
Sri Lanka
Contacts
Name: J.P.Marasinghe 
Address:  Colombo South Teaching Hospital, Kalubowila
Telephone: 0773834787
Email: jeevanmarasinghe@yahoo.com
Affiliation:  Senior Registrar in Obstetrics and Gynaecology
Name: J.P.Marasinghe 
Address:  Singhagiri, Helambawatawana, Nalladarankattuwa
Telephone: 0773834787
Email: jeevanmarasinghe@yahoo.com
Affiliation:  Senior Registrar in Obstetrics and Gynaecology
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Wound infection and other wound complications in gynaecological surgery
Intervention(s)
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.
Primary Outcome(s)
Wound infection and pain score
Secondary Outcome(s)
Pain score, Haematoma formation, seroma ,dehiscence and disruption, incisional hernia
Secondary ID(s)
None
Source(s) of Monetary Support
None
Secondary Sponsor(s)
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