Is the type of surgery in the groin influencing the coming back of varicose veins in the long term?
| ISRCTN | ISRCTN23494731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23494731 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/01/2010
- Registration date
- 01/02/2010
- Last edited
- 01/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 Wolfgang Mouton
Scientific
Scientific
Krankenhausstrasse 12
Thun
3600
Switzerland
Study information
| Study design | Prospective randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Surgery as a trigger for neorevascularisation in recurrent saphenofemoral incompetence: a randomised trial of three different techniques |
| Study objectives | Surgery itself, and maybe the type of surgery, may trigger neorevascularistion in the groin when treating sapheno-femoral incompetence.The hypothesis is that one of the following three techniques is better - inducing less neorevascularisation - than the other two. If this would be the case this one technique should be preferred to the other two, worldwide. The three techniques are: 1. Dissection under ligation 2. Dissection with electrocoagulation 3. Ultrasonic dissection |
| Ethics approval(s) | Ethics Commission of the Regionalspital Thun approved on the 1st March 2002 (ref: 2:4;1.3) |
| Health condition(s) or problem(s) studied | Recurrent varicose veins |
| Intervention | The study was approved by the local Human Ethics Committee. All patients included in the study have informed pre-operative consent. 36 consecutive unselected patients underwent redo saphenous high ligation procedures during a period of thirteen months (1st April 2002 - 30th June 2003). The study population comprised 34 female patients and 2 males. The age ranged from 24 to 73 years (mean 53 years). Thirty-two patients had undergone at least one previous procedure in the groin. The patients were randomised to receive either dissection with ultrasound (Ultracision Harmonic Scalpel, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland) or electrocoagulation (Elektrotom Berchtold GmbH&Co, Tuttlingen, Germany) or sharp dissection with ligation of scar and lymphatic tissue using absorbable suture material (Vicryl, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland). The groin was reopened via a transverse incision. The femoral artery was visualised as a landmark, after which the femoral vein was dissected and recurrent veins ligated and divided. Fascia and subcutaneous tissue was closed in two layers and included a vacuum wound drain. The skin was closed with sutures. Operating time is around one hour per procedure. The drain was removed one day post-operatively. After three months a clinical and colour duplex ultrasonography investigation (Acuson Aspen, Acuson Corporation, Mountain View CA, USA) were carried out to detect lymphatic complications. After seven years a clinical and colour duplex ultrasonography investigation were carried out to detect and describe type and extent of neorevascularisation for the patients of all three treatment arms. |
| Intervention type | Other |
| Primary outcome measure | Clinical outcome and duplex sonography outcome at three months VDS: venous disability score VCSS: venous clinical severity score |
| Secondary outcome measures | Clinical outcome and duplex sonography outcome at seven years VDS: venous disability score VCSS: venous clinical severity score |
| Overall study start date | 01/04/2002 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Key inclusion criteria | 1. Consecutive randomised patients with re-do surgery for sapheno-femoral incompetence in the groin 2. Written informed consent 3. Adults greater than 16 years old, either sex |
| Key exclusion criteria | Does not want to take part in the study |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Krankenhausstrasse 12
Thun
3600
Switzerland
3600
Switzerland
Sponsor information
Regionalspital Thun (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Krankenhausstrasse 12
Thun
3600
Switzerland
"ROR" |
https://ror.org/00m7t6760 |
|---|
Funders
Funder type
Hospital/treatment centre
Regionalspital Thun (Switzerland) - paying incidental costs
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 |
