Comparative study of a barbed suture, polyglecaprone and stapler in Pfannenstiel incisions performed for benign gynaecological procedures
| ISRCTN | ISRCTN58129660 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58129660 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/06/2009
- Registration date
- 09/07/2009
- Last edited
- 11/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mehmet Murat Naki
Scientific
Scientific
Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Türkiye
| mmuratnaki@yahoo.com |
Study information
| Study design | Randomised controlled single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparative study of a barbed suture, polyglecaprone and stapler in Pfannenstiel incisions performed for benign gynaecological procedures: a randomised trial |
| Study objectives | Are there any differences between three suture materials on post-operative incision pain, patient satisfaction and scar cosmesis? Please note that as of 11/02/10 this trial has been updated to included participants aged 18-65. |
| Ethics approval(s) | Ethics Committee of the Dr. Lutfi Kirdar Kartal Research and Training Hospital approved on the 26th March 2009 (ref: 17/28.05.2009) |
| Health condition(s) or problem(s) studied | Benign gynaecological diseases/skin incision closure |
| Intervention | This trial is taking place at the Istanbul Dr. Lutfi Kirdar Kartal Research and Training Hospital, Department of Obstetrics and Gynaecology. Approximately 117 patients will be recruited, 39 patients in each of the following three groups: 1. Skin incision closure with a barbed suture (copolymer of glycolide and e-caprolactone) 2. Skin incision closure with intracutaneous polyglecaprone 3. Skin incision closure with stapler Patient allocation will be carried out as follows: A computer based randomisation will be prepared. The skin closure type will be printed on identical sheets of paper, which will be put into identical, consecutively numbered sealed opaque envelopes by a non-participating colleague. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain for skin incision (post-operative third day) |
| Secondary outcome measures | 1. Patient satisfaction (post-operative sixth day) 2. Scar cosmesis score (post-operative third month) |
| Overall study start date | 01/06/2009 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | Approximately 117 |
| Key inclusion criteria | 1. Women between ages of 18 - 45 years 2. Pfannenstiel incisions for benign gynaecological procedures 3. No previous lower abdominal incision Amended 11/02/10: 1. Women between ages of 18 - 65 years |
| Key exclusion criteria | 1. Previous lower abdominal incision 2. Diabetes mellitus 3. Body mass index more than 35 kg/m^2 4. Chronic alcholism |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Cihat Saran Sk. Cagdas Apt. No:11/3
Istanbul
34841
Türkiye
34841
Türkiye
Sponsor information
Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Mehmet Murat Naki
Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Türkiye
"ROR" |
https://ror.org/01c2wzp81 |
|---|
Funders
Funder type
Hospital/treatment centre
Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
