igasure versus conventional surgery for inguinofemoral lymphadenectomy in vulvar cancer patients; MAMBO-IC

Recruiting

Conditions: vulvar squamous cell carcinoma
vuvlar cancer
10038588

Registration Number: NL-OMON44496

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Female sex;
- Age * 18 years;
- Squamous cell carcinoma of the vulva with indication for bilateral inguinofemoral lymphadenectomy by separate groin incisions (also after SN procedure);
- Able to visit the outpatient clinic;
- Signed informed consent

Exclusion Criteria

- Patient not willing to sign and/or return the informed consent form;
- Previous radiotherapy to vulva, groins and/or pelvis;
- Previous pelvic lymphadenectomy;
- Any histology other than squamous cell carcinoma;
- Patient with indication for inguinofemoral lymphadenectomy with *en bloc* approach.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The differences in the incidence of short term complications (wound infection,<br /><br>wound breakdown and lymphocele) after IFL using LigaSure versus the<br /><br>conventional method. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are;<br /><br><br /><br>* To determine the surgeon* experience using LigaSure<br /><br>* To determine the operating time for inguinofemoral lymphadenectomy<br /><br>* To determine the volume drained per day during the period when the drain is<br /><br>in situ<br /><br>* To determine the duration of drainage in days<br /><br>* To determine the duration of hospital stay<br /><br>* To determine the frequency and duration of re-admission during the follow-up<br /><br>period of 8 weeks;<br /><br>* To determine the percentage of primary wound healing 8 weeks after<br /><br>inguinofemoral lymphadenectomy;<br /><br>* To assess the days wound care (number of days paid care is necessary) (intra-<br /><br>and extramural) needed per groin during follow up;<br /><br>* To assess the need and nature of intervention following any short term<br /><br>complication</p><br>