Home » Trials » SLCTR/2009/007
Comparison of sutured versus non-sutured subcutaneous fat tissues in abdominal surgery in Gynaecology; A prospective randomized controlled trial
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SLCTR Registration Number
SLCTR/2009/007
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Comparison of sutured versus non-sutured subcutaneous fat tissues in abdominal surgery in Gynaecology; A prospective randomized controlled trial
Public Title of Trial
Is suturing of the abdominal fat tissues in gynaecological surgery beneficial?
Disease or Health Condition(s) Studied
Wound infection and other wound complications in gynaecological surgery
Scientific Acronym
None
Public Acronym
None
Brief title
Subcutaneous suturing in Gynaecological surgery
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
109-115 (Ethics Review Committee of the Colombo South Teaching Hospital)
What is the research question being addressed?
Suturing of subcutaneous fat tissue during surgical wound closure remains a discussed problem. The aim of this prospective randomized study was to investigate the necessity of suturing subcutaneous fat tissue in elective open gynaecological abdominal surgery. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
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.
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.
Primary outcome(s)
|
1.
Wound infection and pain score |
[ 48 to 72 hours after surgery ] |
Secondary outcome(s)
|
1.
Pain score, Haematoma formation, seroma ,dehiscence and disruption, incisional hernia |
[ 48 to 72 hours and in 30 to 45 days after surgery ] |
Target number/sample size
144 (72 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2009-08-01
Anticipated end date
2009-12-15
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2009-07-05
Approval number
109
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Colombo South Teaching Hospital |
| Institutional Address: | Kalubowila, Dehiwala, Sri Lanka |
| Telephone: | +94-11-2769726 |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
J.P. Marasinghe
Senior Registrar in Obstetrics and Gynaecology
Singhagiri, Helambawatawana, Nalladarankattuwa
0773834787
jeevanmarasinghe@yahoo.com
Contact Person for Public Queries
J.P. Marasinghe
Senior Registrar in Obstetrics and Gynaecology
Singhagiri, Helambawatawana, Nalladarankattuwa
0773834787
jeevanmarasinghe@yahoo.com
Primary study sponsor/organization
J.P.Marasinghe
Singhagiri, Helambawatawana, Nalladarankattuwa
0773834787
jeevanmarasinghe@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
