First operation in the groin to treat varicose veins: a comparison of two different surgical techniques with regards to reducing lymphatic complications
| ISRCTN | ISRCTN48980066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48980066 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/07/2008
- Registration date
- 11/07/2008
- Last edited
- 19/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wolfgang Mouton
Scientific
Scientific
Spital Thun STS AG
Department of Surgery
Krankenhausstrasse 12
Thun
3600
Switzerland
Study information
| Study design | Prospective randomised controlled 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 | Primary surgery for saphenofemoral incompetence: a randomised controlled trial to compare two techniques to reduce lymphatic complications |
| Study objectives | The aim of this study was to prospectively compare two surgical techniques in primary high ligation such as sharp dissection with ligation of lymphatic tissue versus dissection with electrocoagulation in regard to the incidence of lymphocoele and lymphatic fistula. It is exspected that maybe sharp dissection with ligation of lymphatic tissue shows less lymphatic complications and would be therefore to be recommended. |
| Ethics approval(s) | Ethics approval received from the Ethikkommission des Spital Thun STS AG (Switzerland) on the 1st December 2004 (ref: 3:16;27.9). |
| Health condition(s) or problem(s) studied | Saphenofemoral incompetence |
| Intervention | Patients get operated on for symptomatic varicose vein disease classified C2 to C6 according clinical, aetiological, anatomical, pathological elements (CEAP). The CEAP classification is the common standard for classification of venous disorders and is widely used. All patients included in the study had informed preoperative consent. 134 consecutive unselected patients underwent bilateral primary saphenous high ligation procedures during a period of three and half years. The patients were randomised to receive either sharp dissection with ligation of lymphatic tissue using absorbable suture material (Vicryl, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland) or dissection with electrocoagulation (Elektrotom Berchtold GmbH&Co, Tuttlingen, Germany). The groin was opened via a transverse incision. The long saphenous vein up to the femoral vein was visualised, side branches ligated and the long saphenous vein flush-ligated with absorbable suture material. After the stripping of the long saphenous vein no wound drain was inserted and subcutaneous tissue was closed in one layer. The skin was closed with intracutaneous sutures. The wound was observed for lymphatic fistula and formation of a lymphocoele. |
| Intervention type | Other |
| Primary outcome measure | The wound was observed for lymphatic fistula and formation of a lymphocoele. After one and ten days a clinical investigation was carried out to detect lymphatic complications. |
| Secondary outcome measures | Further follow-up data were assessed by the means of the electronic patient record (EPR) (e.g., adverse events, complications, etc). Statistical focus was on three parameters, all being defined in terms of a patient undergoing the two methods of operation: p1 = probability of complications with method 1 p2 = probability of complications with method 2 p3 = probability of complications with just one of the two methods of operations Differences were considered significant at an a level of 0.05, the software used was S-Plus Professional 6.2 (Insightful Corp., Seattle, USA). |
| Overall study start date | 01/01/2005 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Initial target was at least 100 patients and therefore at least 200 procedures |
| Key inclusion criteria | 1. Pre-operative written consent 2. Adults (greater than 16 years), either sex 3. The patient had to be operated on both areas of the groin |
| Key exclusion criteria | Previously operated groin by arterial or venous operation. |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Spital Thun STS AG
Thun
3600
Switzerland
3600
Switzerland
Sponsor information
Spital Thun STS AG (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
Krankenhausstrasse 12
Thun
3600
Switzerland
| Website | http://www.spitalstsag.ch |
|---|---|
"ROR" |
https://ror.org/00m7t6760 |
Funders
Funder type
Other
Investigator initiated and funded (Switzerland)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2009 | Yes | No |
