Evidence map›Paper›PMID 24028441›Full record

Trial reportTrials2013

Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial.

Luciana Silveira Campos, Leo Francisco Limberger, Airton Tetelbom Stein, Antonio Nocchi Kalil

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01258413 (Laparoscopic vs Abdominal Radical Hysterectomy With Pelvic Lymphadenectomy in Patients With Early Cervical Cancer), which is not on this map. Cited by 24 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 13 pooled it
–field-weighted citation impact
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.

NCT01258413 phase3completednot on this map

Laparoscopic vs Abdominal Radical Hysterectomy With Pelvic Lymphadenectomy in Patients With Early Cervical Cancer: A Randomized Clinical Trial

TypeinterventionalSponsorHospital Nossa Senhora da ConceicaoRan1999 to 2009Enrolled30ConditionsCervical Cancer, Postoperative PainArmsLaparoscopic Radical Hysterectomy + pelvic lymphadenectomy, Abdominal radical hysterectomy
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  10. Robot-assisted surgery in gynaecology.The Cochrane database of systematic reviews · 2019
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  13. Robot-assisted surgery in gynaecology.The Cochrane database of systematic reviews · 2014
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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

4 authors.

Luciana Silveira CamposServiço de Ginecologia do Hospital Nossa Senhora da Conceição, Av Francisco Trein, 596, Bairro Cristo Redentor CEP, Porto Alegre 91350-200, Brazil. dlu@terra.com.br.
Leo Francisco Limberger
Airton Tetelbom Stein
Antonio Nocchi Kalil

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-randomised studies have suggested that the postoperative complications of (Campos LS, Limberger LF, Stein AT, Kalil AN) laparoscopic radical hysterectomy are similar to those in abdominal radical hysterectomy. However, no study evaluating postoperative pain comparing both techniques has been published thus far. Our objective was to compare pain intensity and other perioperative outcomes between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in early cervical cancer.

methodsThis single centre, randomised, controlled trial enrolled 30 cervical cancer patients who were clinically staged IA2 with lymph vascular invasion and IB according to the FIGO (International Federation of Gynaecology and Obstetrics) classification, and underwent LRH or ARH between late 1999 and early 2004. Postoperative pain, as measured by a 10-point numerical rate scale, was considered the primary endpoint. Postoperative pain was assessed every six hours during a patient's usual postoperative care. Perioperative outcomes were also registered. Both surgical techniques were executed by the same surgical team. Secondary outcomes included intraoperative and other postoperative surgicopathological factors and 5-year survival rates.

resultsIA2 patients with lymphatic vascular space invasion and IB cervical cancer patients were randomised to either the LRH group (16 patients) or the ARH group (14 patients). Four patients (25%) in the LRH group and 5 patients (36%) in the ARH group presented with transoperative or serious postoperative complications. All of the transoperative complications occurred in the LRH group. The relative risk of presenting with complications was 0.70; CI 95% (0.23-2.11); P = 0.694. LRH group mean pain score was significantly lower than ARH after 36 h of observation (P = 0.044; mean difference score: 1.42; 95% CI: 0.04-2.80). The survival results will be published elsewhere.

conclusionsLRH provided lower pain scores after 36 h of observation in this series. The perioperative and serious postoperative complications ratios were comparable between the groups.

trial registrationNCT01258413.

Indexed as

AdultBrazilDisease-Free SurvivalEarly Detection of CancerFeasibility StudiesFemaleHumansHysterectomyLaparoscopyMiddle AgedNeoplasm InvasivenessNeoplasm StagingPain MeasurementPostoperative PainProspective StudiesQuality of Life

Identifiers

PMID24028441
PMCPMC3856515

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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.