Evidence map›Paper›PMID 25840895›Full record

Trial reportSurgical endoscopy2016

The new robotic TELELAP ALF-X in gynecological surgery: single-center experience.

Francesco Fanfani, Giorgia Monterossi, Anna Fagotti, Cristiano Rossitto, Salvatore Gueli Alletti, Barbara Costantini, Valerio Gallotta, Luigi Selvaggi, Stefano Restaino, Giovanni Scambia

3 registry-linked trialsAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 3% 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.

NCT04570176 nacompletednot on this mapstarted 2020, after this paper: background citation

Clinical Trial Protocol of Primary Study on Efficacy and Safety of Telesurgery for Patients With Tumors of the Urinary System Using Chinese Independently Developed "MicroHand" Surgical Robot System

TypeinterventionalSponsorThe Affiliated Hospital of Qingdao UniversityRan2020 to 2021Enrolled1ConditionsRenal Cell Carcinoma, Bladder Cancer, Adrenal TumorArmsadrenalectomy for adrenal adenoma
NCT04803487 early_phase1completednot on this mapstarted 2019, after this paper: background citation

Robotic Cholecystectomy Using the Newly Developed Chinese Robotic Surgical System-Micro Hand S: A Controlled, Randomized, Prospective Clinical Study

TypeinterventionalSponsorThe Affiliated Hospital of Qingdao UniversityRan2019 to 2020Enrolled82ConditionsCholecystitis, GallstoneArmsrobot-assisted cholecystectomy
NCT04804163 early_phase1completednot on this mapstarted 2021, after this paper: background citation

Research on the Effectiveness and Safety of Remote Surgery of Domestic Surgical Robot System for Urinary System Diseases

TypeinterventionalSponsorThe Affiliated Hospital of Qingdao UniversityRan2021 to 2021Enrolled47ConditionsRenal Cell Carcinoma, Adrenal Tumor, Nonfunctioning KidneyArmstelesurgery by domestic robot
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

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  17. Robotic surgery using SenhanceJournal of robotic surgery · 2020
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Francesco FanfaniDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy. francesco.fanfani@rm.unicatt.it.
Giorgia MonterossiDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Anna FagottiMinimally Invasive Gynecology, St. Maria Hospital, University of Perugia, Terni, Italy.
Cristiano RossittoDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Salvatore Gueli AllettiDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Barbara CostantiniDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Valerio GallottaDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Luigi SelvaggiDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Stefano RestainoDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Giovanni ScambiaDivision of Gynecologic Oncology, Department of Women and Child Health, Catholic University of the Sacred Heart, Rome, Italy.
Università Cattolica del Sacro Cuore · ITUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures.

methodsBetween September 2013 and May 2014, 146 patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and early stage malignant uterine disease were prospectively included.

resultsMedian age was 52 years (range 19-79 years), and median BMI was 23.7 (range 17.3-34.0 kg/m(2)). Sixty-two patients (32.5%) underwent mono/bilateral salpingo-oophorectomy or cyst removal (Group A), four patients (2.7%) myomectomy (Group B), 46 patients (31.5%) total hysterectomy (Group C), and 34 (23.3%) endometrial cancer staging (Group D). Median docking time was 7 min (range 3-36). Median OT was 35 min (range 17-145) in the Group A, 40 min (range 10-50) in the Group B, 133 min (range 58-320) in the Group C, and 160 min (range 69-290) in the Group D. Reduction in OT over the study period for hysterectomy (p < 0.001) and adnexal surgery (p < 0.002) was observed. We registered two laparoscopic conversion (3.2%) in the Group A and two (4.3 %) in the Group C. In the Group D, we showed one (2.9%) laparoscopic and two (5.8%) laparotomic conversions. One patient (2.17%) in the Group C was readmitted in the early postoperative period for severe vaginal bleeding.

conclusionsWe report the first series of a novel robotic approach for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, TELELAP ALF-X is feasible and safe. Further studies are mandatory to define the benefits, advantages, and costs of this new robotic approach with respect to others minimally invasive approaches.

Indexed as

Gynecologic Surgical ProceduresRobotic Surgical ProceduresAdultAgedAged, 80 and overFemaleGenital Diseases, FemaleHumansItalyMiddle AgedOperative TimePatient Outcome AssessmentProspective StudiesYoung AdultGynecologyMinimally invasive surgeryRobotic surgeryTELELAP ALF-X

Identifiers

PMID25840895
OpenAlexW1990290414

What OpenQuestion holds

Textmetadata
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.