Comparing surgical techniques for removal of the groin lymph nodes in the treatment of vulvar cancer

Ligasure versus conventional surgery for inguinofemoral lymphadenectomy in vulval cancer patients: a multi-centre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15057626

Enrollment

Registered

2019-01-29

Start date

2017-09-15

Completion date

Unknown

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulval cancer Cancer Malignant neoplasm of vulva

Interventions

The inguinofemoral lymphadenectomy will be the standard procedure for both groins. For the intervention groin, the LigaSure device will be used to perform this surgical procedure and for the other gro

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female sex 2. Age = 18 years 3. Squamous cell carcinoma of the vulva with indication for bilateral inguinofemoral lymphadenectomy by separate groin incisions (also after SN procedure) 4. Able to visit the outpatient clinic

Exclusion criteria

Exclusion criteria: 1. Previous radiotherapy to vulva, groins and/or pelvis 2. Previous pelvic lymphadenectomy 3. Any histology other than squamous cell carcinoma 4. Patient with indication for inguinofemoral lymphadenectomy with ‘en bloc’ approach

Design outcomes

Primary

Measure	Time frame
The incidence of any short term complication (wound breakdown and/or wound infection and/or lymphocele) will be measured within 8 weeks after inguinofemoral lymphadenectomy.	—

Secondary

Measure	Time frame
1. Surgeon experience using LigaSure will be measured using a questionnaire containing SURG-TLX. 2. Patient experience (including the maximum and minimum postoperative pain measured by a visual analogue score (VAS) and restriction of daily activities scored between 0 (no restrictions) and 10 (completely restricted)) will be measured using a questionnaire by telephone between 6 and 8 weeks after surgery. 3. Operating time for inguinofemoral lymphadenectomy will be measured in minutes from incision to end of closure for each groin separately. 4. The volume drained per day in mililitres per 24 hours per groin will be measured during the period when the drain is in situ. 5. The duration of drainage in days. 6. The duration of hospital stay in days. 7. The frequency and duration of re-admission during the follow-up period of 8 weeks. 8. The percentage of primary wound healing 8 weeks after inguinofemoral lymphadenectomy. 9. The days wound care (number of days paid care is necessary) (intra- and extramural) is needed per groin during follow up. 10. The need and nature of intervention following any short term complication per groin.	—

Measure

Time frame

1. Surgeon experience using LigaSure will be measured using a questionnaire containing SURG-TLX. 2. Patient experience (including the maximum and minimum postoperative pain measured by a visual analogue score (VAS) and restriction of daily activities scored between 0 (no restrictions) and 10 (completely restricted)) will be measured using a questionnaire by telephone between 6 and 8 weeks after surgery. 3. Operating time for inguinofemoral lymphadenectomy will be measured in minutes from incision to end of closure for each groin separately. 4. The volume drained per day in mililitres per 24 hours per groin will be measured during the period when the drain is in situ. 5. The duration of drainage in days. 6. The duration of hospital stay in days. 7. The frequency and duration of re-admission during the follow-up period of 8 weeks. 8. The percentage of primary wound healing 8 weeks after inguinofemoral lymphadenectomy. 9. The days wound care (number of days paid care is necessary) (intra- and extramural) is needed per groin during follow up. 10. The need and nature of intervention following any short term complication per groin.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026