Evidence map›Paper›PMID 35422136›Full record

Trial reportThe Journal of urology2022

Bilateral Peritoneal Flaps Reduce Incidence and Complications of Lymphoceles after Robotic Radical Prostatectomy with Pelvic Lymph Node Dissection-Results of the Prospective Randomized Multicenter Trial ProLy.

Simon Gloger, Burkhard Ubrig, Anselm Boy, Sami-Ramzi Leyh-Bannurah, Stefan Siemer, Madeleine Arndt, Jens-Uwe Stolzenburg, Toni Franz, Matthias Oelke, Jörn H Witt

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06258486 (Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06258486 phase4unknown statusnot on this mapstarted 2024, after this paper: background citation

Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks

TypeinterventionalSponsorKaiser PermanenteRan2024 to 2026Enrolled100ConditionsLymphocele, Prostate CancerArmsICG injection, Non-Injection/Control, Prostatectomy with pelvic lymph node dissection
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 33 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Simon GlogerCenter for Minimally Invasive and Robotic Urology, Augusta Hospital Bochum, Witten/Herdecke University, Bochum, Germany.ORCID 0000-0003-1166-7778
Burkhard UbrigCenter for Minimally Invasive and Robotic Urology, Augusta Hospital Bochum, Witten/Herdecke University, Bochum, Germany.
Anselm BoyCenter for Minimally Invasive and Robotic Urology, Augusta Hospital Bochum, Witten/Herdecke University, Bochum, Germany.
Sami-Ramzi Leyh-BannurahDepartment of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau, Gronau, Germany.
Stefan SiemerDepartment of Urology, Saarland University, Homburg/Saar, Germany.
Madeleine ArndtDepartment of Urology, Saarland University, Homburg/Saar, Germany.
Jens-Uwe StolzenburgDepartment of Urology, University of Leipzig, Leipzig, Germany.
Toni FranzDepartment of Urology, University of Leipzig, Leipzig, Germany.
Matthias OelkeDepartment of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau, Gronau, Germany.
Jörn H WittDepartment of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau, Gronau, Germany.
St.-Antonius-Hospital Gronau · DEWitten/Herdecke University · DELeipzig University · DESaarland University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this study was to investigate the effect of a surgically constructed bilateral peritoneal flap (PIF) as an adjunct to robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection (PLND) on the incidence of lymphoceles. MATERIALS AND

methodsA total of 530 men with localized prostate cancer underwent a RARP with bilateral extended standardized PLND in a prospective randomized controlled trial. In group A, a PIF was created by suturing the margins of the bladder peritoneum to the ipsilateral endopelvic fascia at 2 points on each side. In group B, no PIF was created. The patients were followed 30 and 90 days after the surgery to assess the incidence, extent and treatment of lymphoceles.

resultsLymphoceles occurred in 22% of group A patients and 33% of group B patients (p=0.008). Symptomatic lymphoceles were observed in 3.3% of group A patients and 8.1% of group B patients (p=0.027). Lymphoceles requiring intervention occurred significantly less frequently in group A patients (1.3%) than in group B patients (6.8%, p=0.002). The median lymphocele size was 4.3 cm in group A and 5.0 cm in group B (p=0.055). No statistically significant differences were observed in minor or major complications unrelated to lymphocele, blood loss, or surgical time between groups A and B.

conclusionsBilateral PIFs in conjunction with RARP and PLND significantly reduce the total incidence of lymphoceles, the frequency of symptomatic lymphoceles and the rate of associated secondary interventions.

Indexed as

LymphoceleProstatic NeoplasmsRoboticsRobotic Surgical ProceduresHumansIncidenceLymph Node ExcisionMalePelvisPeritoneumProspective StudiesProstatectomyadenocarcinomalymph node excisionlymphocelepostoperative complicationsprostatic neoplasms

Identifiers

PMID35422136
PMCPMC9275839
OpenAlexW4223947238

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.