| 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 (in lay language) | Is suturing of the abdominal fat tissues in gynaecological surgery beneficial? | |
| Acronym, if any | None | |
| Brief title, if any | Subcutaneous suturing in Gynaecological surgery | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Wound infection and other wound complications in gynaecological surgery | |
| 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. ? | |
| Study design | A prospective randomized study. | |
| 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. | |
| Target number / sample size | 144(72 in each group) | |
| Primary outcome(s) | Wound infection and pain score | |
| Primary outcome(s) - time of assessment(s) | 48 to 72 hours after surgery | |
| Secondary outcome(s) | Pain score, Haematoma formation, seroma ,dehiscence and disruption, incisional hernia | |
| Secondary outcome(s) - time of assessment(s) | 48 to 72 hours and in 30 to 45 days after surgery | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/08/2009 | |
| Anticipated end date | 15/12/2009 | |
| Recruitment status | Completed | |
| State of ethics review approval | Ethical clearance was obtained from the ethical clearance commitee,Teaching Hospital, Colombo South (No-110) | |
| Funding source(s) | None | |
| Applicant's Email | jeevanmarasinghe@yahoo.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | 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 |
|
| Contact Person for Public Queries | J.P.Marasinghe Senior Registrar in Obstetrics and Gynaecology Colombo South Teaching Hospital, Kalubowila 0773834787 jeevanmarasinghe@yahoo.com |
|
| Secondary Study Sponsor(s), (if any) | None |
|
