Evidence map›Paper›PMID 24398192›Full record

Trial reportJSLS : Journal of the Society of Laparoendoscopic Surgeons

Bladeless direct optical trocar insertion in laparoscopic procedures on the obese patient.

Andrea Tinelli, Antonio Malvasi, Ospan A Mynbaev, Daniel Alberto Tsin, Fausto Davila, Guillermo Dominguez, Emanuele Perrone, Farr R Nezhat

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JSLS : Journal of the Society of Laparoendoscopic Surgeons. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Laparoscopic entry techniques.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Trial
  4. Article
  5. Laparoscopic entry techniques: Which should you prefer?International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2023
    Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Direct Vision Entry with Integrated Insufflation.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Article
  12. Optimal Initial Trocar Placement for Morbidly Obese Patients.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Article
  13. Article
  14. Operative Gynecological Laparoscopy Under Conscious Sedation.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Observational
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Andrea TinelliDepartment of Obstetrics and Gynecology, Division of Experimental Endoscopic Surgery, Imaging, Technology and Minimally Invasive Therapy, Vito Fazzi Hospital, Piazza Muratore, 73100 Lecce, Italy. andreatinelli@gmail.com.
Antonio MalvasiDepartment of Obstetrics and Gynaecology, Santa Maria Hospital, Bari, Italy.
Ospan A MynbaevExperimental Researches and Modeling Division, Moscow State University of Medicine and Dentistry, Moscow, Russia.
Daniel Alberto TsinDepartment of Gynecology, Division of Minimal Invasive Endoscopy, The Mount Sinai Hospital of Queens, New York, NY, USA.
Fausto DavilaHospital Regional de Poza Rica, Sesver, Monterrey, Mexico.
Guillermo DominguezFundaciòn Hospitalaria, Buenos Aires, Argentina.
Emanuele PerroneDepartment of Gynecology and Obstetrics, University of Perugia, Perugia, Italy.
Farr R NezhatColumbia University College of Physicians and Surgeons, New York, NY, USA, Division of Gynecologic Oncology and the Department of Obstetrics and Gynecology, St. Luke's-Roosevelt Hospital Center, New York, NY, USA.
Columbia University · USOspedale Vito Fazzi · ITSanta Maria Nuova Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecently, we have shown advantages of a direct optical entry (DOE) using a bladeless trocar in comparison with the open Hasson technique (OHT) in older reproductive-age women with previous operations, as well as in comparison with Veress needle entry in reproductive-age and postmenopausal women.

objectivesA prospective multicenter randomized study to determine whether the DOE is feasible for establishing safe and rapid entry into the abdomen in comparison with those of the OHT in reproductive-age obese women.

methodsTwo types of surgical techniques were blindly applied in 224 obese reproductive-age women with benign neoplastic diseases of ovary and uterus. Namely, laparoscopic entry into the abdomen in 108 patients was performed by DOE and in 116 women by OHT. Following parameters (entry time in seconds needed to establish the intra-abdominal vision after pneumoperitoneum, blood loss, occurrence of vascular and/or bowel injuries) were compared during surgery as main outcomes.

resultsMain baseline characteristics of patients, including age (36.1 ± 4.5 vs 35.7 ± 5.8), body mass index (34.9 ± 5.1 vs 35.1 ± 4.9 kg/m(2)), and parity (2.1 ± 0.4 vs 1.9 ± 0.9), were not significantly different between the DOE and OHT groups (P > .05). While intraoperative parameters such as the entry time (71.9 ± 3.7 vs 215.1 ± 6.2 seconds) and blood loss value (9.7 ± 6.1 vs 12.2 ± 2.9 mL) were significantly reduced in the DOE group in comparison with those of OHT group (respectively, P < .0001 and < .01), there were also trends to slight decrease of the occurrence of the minor injuries, manifested as omental small vessels rupture (0 of 108 vs 4 of 116) and punctures and pinches of jejunal serosa (0 of 108 vs 3 of 116) in patients of the DOE group in comparison with those of OHT group (respectively, P = .0515 and = .0925).

conclusionsDOE reduced entry time and blood loss with trends to slightly decrease of the occurrence of the minor vascular and bowel injuries, thus enabling a possible alternative to OHT in obese women; however, further larger trials need to confirm the possible additional benefits of a DOE.

Indexed as

LaparoscopesAdultEquipment DesignFemaleHumansLaparoscopyObesityOvarian DiseasesProspective StudiesSurgical InstrumentsUterine Diseases

Identifiers

PMID24398192
PMCPMC3866054
OpenAlexW2034797579

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.