Transperitoneal vs Extraperitoneal Retroperitoneal Lymph Node Dissection: A Prospective Randomized Controlled Trial

Testis Cancer Surgery Study

T
Timothy Masterson

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
116 participants needed
1 Location

Brief description of study

We intend to compare an alternative way of performing cancer surgery for those who have testis cancer. This alternative technique is called extraperitoneal RPLND which has been published in retrospective studies. Its benefits, however, remain to be proved in a prospective study.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

 
  • This is a prospective, randomized controlled study where patients undergoing primary RPLND and PC-RPLND will be enrolled and assigned to either the TP or EP approach.
  • After Institutional Review Board approval, patients who meet the criteria will be offered enrollment into the trial during a clinic visit. Informed consent will be obtained.
  • On the day of surgery, patients will undergo either TP or EP RPLND per randomization.
  • The dissection template is based on the clinician’s discretion, but it should be at a minimum of a modified template.
  • The primary endpoint is the rate of ileus within 30 days. The secondary endpoints include operative time, opioid consumption, time to first flatus, lymph node yield, and length of stay.
  • Opioid consumption, including intravenous and oral narcotic medications, will be converted to morphine equivalents for comparison.
  • The variations in the incidence of ileus in previous literature may be due to different definitions from institution to institution. A systematic review and international survey suggest postoperative ileus (POI) as the interval from surgery until the passage of flatus/stool AND tolerance of an oral
  • diet; and prolonged POI as two or more of nausea/vomiting, inability to tolerate an oral diet over 24 h, absence of flatus over 24 h, distension, radiologic confirmation occurring on or after day 4 postoperatively without prior resolution of POI [15]. 
     

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic germ cell tumor, GCT, Cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

  • ASA 1-4
  • Metastatic germ cell tumor (GCT) with indication for primary RPLND or PC-RPLND [1, 16]
  • Retroperitoneal lymph node size < 10 cm

Exclusion Criteria

  • Patients with previous RPLND
  • Requirement of retrocrural dissection
  • Requirement of aortic resection
  • Requirement of intraperitoneal procedures
  • History of neurogenic bowel
  • History of opioid dependence

This study investigates two different surgical techniques for treating testis cancer, focusing on retroperitoneal lymph node dissection (RPLND). The study compares the transperitoneal (TP) and extraperitoneal (EP) approaches. RPLND is a surgery to remove lymph nodes from the back of the abdomen. The purpose is to see if the EP approach offers any benefits over the TP approach, as some studies suggest it might.

Participants will be randomly assigned to undergo either the TP or EP RPLND surgery. The study will measure outcomes like the time it takes for the patient to pass gas (flatus) after surgery, how long the surgery takes, and how much pain medication is needed. The study will also look at how long patients stay in the hospital and how many lymph nodes are removed. This information will help understand the differences between the two surgical methods.

  • Who can participate: Adults with metastatic germ cell tumors needing primary RPLND or PC-RPLND can participate. Candidates must have retroperitoneal lymph nodes smaller than 10 cm and meet ASA physical status classification 1-4.
  • Study details: Participants will undergo surgery using either the transperitoneal or extraperitoneal approach, based on random assignment. The main focus will be on recovery indicators such as time to pass gas and hospital stay length.
Updated on 23 Dec 2025. Study ID: UROL-IUSCCC-0939, 28248
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only