Understanding the risks and complications of surgery for penile cancer near the groin area

ISRCTN	ISRCTN16003816
DOI	https://doi.org/10.1186/ISRCTN16003816
CIV-ID	CIV-24-09-049274
Sponsor	Region Skåne
Funders	Gösta Jönssons foundation, Hillevi Fries foundation, The foundation for urological research and Region Skåne (USVE)

Submission date: 22/11/2025
Registration date: 01/12/2025
Last edited: 24/11/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Penile cancer is a rare disease that mostly affects older men. The main risk factors are Human Papilloma Virus (HPV), chronic inflammation, penile intraepithelial neoplasia and smoking. Penile cancer can spread to lymph nodes in the groin. Patients with penile cancer spread to the groin are treated with inguinal lymph node dissection. A drain is put in the groin to drain excess fluid from the groin after surgery. The drain is removed when there is less than 50 ml in drain per day in two consecutive days.

Inguinal lymph node dissection puts the patient at risk of complications such as lymphorrea, seroma, infection, bleeding and lymphocele. The aim of this study will investigate if the time with drain and risk of complications can be reduced using a vessel sealing device called LigaSure Exact Dissector(LS) during surgery compared to standard of care (SOC).

Who can participate?
Penile cancer patients that are operated with inguinal lymph node dissection in Sweden, Norway or Denmark can participate in the study.

What does the study involve?
The study participants are randomized to either LS och SOC. Information from the surgery and during follow up of 10-14 months are collected using forms and volume measurements of scrotum and lower limbs.

What are the possible benefits and risks of participating?
The advantage of participating in the trial is that, if we can demonstrate that the LigaSure Exact Dissector reduces complications compared to the surgical technique we use today, future patients will benefit from your participation. For you personally, there is also an advantage in taking part in the study, as you will be thoroughly followed up regarding any potential complications.
The risk associated with participating in the trial is that you may experience an intrusion of privacy because medical record information concerning your condition, the surgery, and any complications will be collected. The collected study data will be handled in a coded/pseudonymised manner.

Where is the study run from?
The study is run from Skåne University hospital in Malmö Sweden.

When is the study starting and how long is it expected to run for?
The study starts in January 2026 and will run for 5 years.

Who is funding the study?
This clinical trial is funded by the Gösta Jönssons foundation, the Hillevi Fries foundation, The foundation for urological research and Region Skåne (USVE).

Who is the main contact?
Axel Gerdtsson, PhD, MD, Dept of urology, Skåne university hospital, Malmö, Sweden is the main contact.
axel.gerdtsson@skane.se

Contact information

Dr Axel Gerdtsson
Principal investigator, Public, Scientific

VO Urologi, Jan Waldenströmsgata 5
Malmö
20502
Sweden

ORCID ID	0000-0003-4033-5078
Phone	+46 40-331000
Email	axel.gerdtsson@skane.se

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Basic science, Device feasibility, Treatment
Participant information sheet	48540 Patientinformation_The COMPLY study_V1_250912.pdf
Scientific title	Complications in inguinal lymph node dissection for patients with penile cancer
Study acronym	COMPLY
Study objectives	Primary objective: To assess if time (days) until inguinal drain removal is shorter with LS compared to SOC. Secondary objectives: 1. To assess whether LS (ligasure technique) reduces surgical site complications compared to SOC (standard of care). 2. To measure the complication rate using the Clavien-Dindo classification up to 90 days after surgery. 3. To determine if LS is superior to SOC in terms of shorter operating time and lower total drain volume. 4. To investigate whether LS is superior to SOC in reducing the proportion of patients with lower limb lymphedema at 3–5 months and 10–14 months after ILND (inguinal lymph node dissection). 5. To assess whether LS is superior to SOC in reducing the proportion of patients with scrotal lymphedema at 3–5 months and 10–14 months after ILND. 6. To quantify and evaluate scrotal and lower limb lymphedema using CT scans. 7. To assess whether scrotal volume measurement with a caliper gauge and lower limb volume with the V8 method are equivalent to measurements obtained from CT scans. 8. To evaluate whether LS affects health-related quality of life (HrQoL) less than SOC at 3–5 months and 10–14 months after ILND compared to baseline. 9. To determine if LS is cost-effective by calculating the incremental cost-effectiveness ratio (ICER) at 3–5 months and 10–14 months.
Ethics approval(s)	Approved 17/11/2025, Etikprövningsmyndigheten Stockholm avdelning 1 medicin (Box 2110, Uppsala, 75002, Sweden; +46 104750800; registrator@etikprovning.se), ref: 2025-07419-01
Health condition(s) or problem(s) studied	Penile cancer patients operated with inguinal lymph node dissection.
Intervention	Subjects will be randomly assigned 1:1 to either the control group, that will undergo the standard of care (SOC) or the intervention group that will be operated with LigaSure Exact Dissector (LS). The study subjects will undergo inguinal lymph node dissection according to the randomization. Preservation of the fascia lata and saphenous vein will be done when possible. The wound will be closed according to local guidelines. The following situations are accepted for subjects randomized to LS, ligature/clips on vessels exceeding 7mm, dissection of the saphenous vein or femoral artery using bipolar scissor, electrocautery of bleeding not suitable or unavailable for the LS device. The LS will be compared to standard of care “SOC”, which comprises all methods for vessel sealing except LS. The method/s of use of in SOC is up to the surgeon’s preference. The randomization process will be in RedCAP. The inclusion/exclusion criteria for the study must be answered in order to get the the randomization result. The patients are stratified on the study site. This means that around 50% of the patients at each site will be randomized to intervention and 50% to SOC. Every site has 4 sealed envelopes to use for randomization If the RedCAP can't be reached.
Intervention type	Drug/Device
Phase	Phase IV
Drug / device / biological / vaccine name(s)	LigaSure Exact Dissector
Primary outcome measure(s)	Time from inguinal lymph node dissection to drain removal (less than 50 ml of drain fluid, in two consecutive days) measured using patient records at up to 60 days Surgical site complication rate ,wound infection, lymphocele, lower limb lymphedema on the same side as the ILND performed measured using chart record at up to 90 days The 90-day complication rate measured using chart record at up to 90 days Operating time measured using minutes at day 1 Total drain volume measured using ml at up to 60 days Volume measurement of lower limbs measured using V8-method and CT-scan at 0, 3-5 and 10-14 months. Scrotal volume measured using caliper gauge and CT-scan at 0, 3-5 and 10-14 months Total HrQoL-score measured using Lymph edema quality of life (LYMQOL) at 0, 3-5 and 10-14 months Calculation of ICER measured using EQ-5D-5L at 0, 3-5 and 10-14 months. Lymphedema measured using Increment of 10% in excess volume (swollen limb/scrotum volume-normal limb/scrotum volume) of lower limbs or scrotum compared to baseline on either: -CT-scan of lower limb or scrotum. -scrotal volume measured with caliper gauge -lower limb volume measurement using V8 method -received treatment for lymphedema (compression stockings) at up to 14 months
Key secondary outcome measure(s)
Completion date	12/05/2031

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Male
Target sample size at registration	116
Key inclusion criteria	1. Diagnosis of penile cancer 2. Scheduled to be operated with inguinal lymph node dissection 3. Able and willing to fill in forms electronically or in paper form at the clinic with the assistance of the study nurse 4. Written informed consent
Key exclusion criteria	1. <18 years 2. Unable to understand the subject information according to the investigator’s judgement 3. Pacemaker or other implanted devices as medically judged by the Investigator NOT to be applicable with LigaSure Exact Dissector use
Date of first enrolment	12/01/2026
Date of final enrolment	12/01/2030

Locations

Countries of recruitment

Denmark
Norway
Sweden

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1	12/09/2025	24/11/2025	No	Yes
Protocol file	version 1	25/09/2025	24/11/2025	No	No
Statistical Analysis Plan	version 1	25/09/2025	24/11/2025	No	No

Additional files

48540 Patientinformation_The COMPLY study_V1_250912.pdf: Participant information sheet
48540 Protocol and SAP Prövningsplan_The COMPLY study_V1_250925.pdf: Protocol file
48540 Protocol and SAP Prövningsplan_The COMPLY study_V1_250925.pdf: Statistical Analysis Plan

Editorial Notes

24/11/2025: Trial's existence confirmed by Etikprövningsmyndigheten Stockholm avdelning 1 medicin.