Clinical Trials Directory

Trials / Completed

CompletedNCT02508909

Videoscopic Ilioinguinal Lymphadenectomy for Melanoma

Videoscopic Ilioinguinal Lymphadenectomy for Groin Lymph Node Metastases From Melanoma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Istituto Oncologico Veneto IRCCS · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.

Detailed description

Videoscopic ilioinguinal dissection is a two-stage procedure. Dissection is performed using an ultrasound dissector. The inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the Sartorius muscle). After subcutaneous inflation, a formal inguinal lymph node (LN) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. The specimen is extracted using an endobag from the incision of SLNB, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive LNs. The iliac step starts with open insertion in the pro-peritoneal space of a Hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. After creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac LNs removed. Afterwards, the obturator LNs are dissected off the obturator nerve. LNs are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. Two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. Intra-operative and early post-operative outcome (lenght of stay, complications, number of LNs) is recorded. Follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life

Conditions

Interventions

TypeNameDescription
PROCEDUREVideoscopic ilioinguinal dissectionInguinal dissection is performed after subcutaneous inflation via three ports. Iliac dissection is obtained through a pro-peritoneal access.

Timeline

Start date
2011-09-01
Primary completion
2015-01-01
Completion
2015-01-01
First posted
2015-07-27
Last updated
2015-07-27

Source: ClinicalTrials.gov record NCT02508909. Inclusion in this directory is not an endorsement.