Evidence map›Paper›PMID 31586602›Full record

Trial reportAmerican journal of obstetrics and gynecology2020

Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial.

Andreas Obermair, Rebecca Asher, Rene Pareja, Michael Frumovitz, Aldo Lopez, Renato Moretti-Marques, Gabriel Rendon, Reitan Ribeiro, Audrey Tsunoda, Vanessa Behan and 17 more

Erratum issuedAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 72 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 6 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.

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

72 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Morbidity of radical surgery and postoperative radiotherapy in cervical cancer.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Review
  14. Review
  15. ROCC/GOG-3043: a randomized controlled trial of robotic versus open surgery for early-stage cervical cancer.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2025
    Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Andreas ObermairQueensland Centre for Gynaecological Cancer Research, University of Queensland, Centre for Clinical Research, RBWH, Herston, QLD Australia. Electronic address: Obermair@powerup.com.au.
Rebecca AsherNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, Sydney, NSW Australia.
Rene ParejaDepartment of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogotá and Clínica de Oncología Astorga, Medellín, Colombia.
Michael FrumovitzDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
Aldo LopezDepartment of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.
Renato Moretti-MarquesGynecologic Oncology Division, Oncologic Center, Hospital Israelita Albert Einstein, São Paulo-SP, Brazil.
Gabriel RendonInstituto de Cancerologia-Las Americas, Medellín, Colombia.
Reitan RibeiroDepartment of Surgery, Erasto Gaertner Hospital, Curitiba, Brazil.
Audrey TsunodaDepartment of Surgery, Erasto Gaertner Hospital, Curitiba, Brazil.
Vanessa BehanQueensland Centre for Gynaecological Cancer Research, University of Queensland, Centre for Clinical Research, RBWH, Herston, QLD Australia.
Alessandro BudaUnit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza MB, Italy.
Marcus Q BernadiniDepartment of Gynecologic Oncology, Princess Margaret Cancer Center, Ontario, Canada.
Hongqin ZhaoDepartment of Gynecology, First Affiliated Hospital of Wenzhou Medical College, Ouhai, Wenzhou, China.
Marcelo VieiraDepartment of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, Brazil.
Joan WalkerDepartment of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma, Norman, OK.
Nick M SpirtosDivision of Gynecologic Oncology, Women's Cancer Center of Nevada, LV.
Shuzhong YaoDepartment of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Naven ChettyDepartment of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane, QLD, Australia.
Tao ZhuDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
David IslaDepartment of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico.
Mariano TamuraGynecologic Oncology Division, Oncologic Center, Hospital Israelita Albert Einstein, São Paulo-SP, Brazil.
James NicklinDepartment of Gynaecologic Oncology, Royal Brisbane and Women's Hospital and The University of Queensland, Brisbane, QLD, Australia.
Kristy P RobledoNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, Sydney, NSW Australia.
Val GebskiNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, Sydney, NSW Australia.
Robert L ColemanDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
Gloria SalvoDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
Pedro T RamirezDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundStandard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer is either nonrandomized or retrospective.

objectiveThe purpose of this study was to compare the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer. STUDY

designThe Laparoscopic Approach to Carcinoma of the Cervix trial was a multinational, randomized noninferiority trial that was conducted between 2008 and 2017, in which surgeons from 33 tertiary gynecologic cancer centers in 24 countries randomly assigned 631 women with International Federation of Gynecology and Obstetrics 2009 stage IA1 with lymph-vascular invasion to IB1 cervical cancer to undergo minimally invasive (n = 319) or open radical hysterectomy (n = 312). The Laparoscopic Approach to Carcinoma of the Cervix trial was suspended for enrolment in September 2017 because of an increased risk of recurrence and death in the minimally invasive surgery group. Here we report on a secondary outcome measure: the incidence of intra- and postoperative adverse events within 6 months after surgery.

resultsOf 631 randomly assigned patients, 536 (85%; mean age, 46.0 years) met inclusion criteria for this analysis; 279 (52%) underwent minimally invasive radical hysterectomy, and 257 (48%) underwent open radical hysterectomy. Of those, 300 (56%), 91 (16.9%), and 69 (12.8%) experienced at least 1 grade ≥2 or ≥3 or a serious adverse event, respectively. The incidence of intraoperative grade ≥2 adverse events was 12% (34/279 patients) in the minimally invasive group vs 10% (26/257) in the open group (difference, 2.1%; 95% confidence interval, -3.3 to 7.4%; P=.45). The overall incidence of postoperative grade ≥2 adverse events was 54% (152/279 patients) in the minimally invasive group vs 48% (124/257) in the open group (difference, 6.2%; 95% confidence interval, -2.2 to 14.7%; P=.14).

conclusionFor early cervical cancer, the use of minimally invasive compared with open radical hysterectomy resulted in a similar overall incidence of intraoperative or postoperative adverse events.

Indexed as

AdenocarcinomaBlood Loss, SurgicalBlood TransfusionBody Mass IndexCarcinoma, AdenosquamousCarcinoma, Squamous CellConversion to Open SurgeryFemaleHumansHysterectomyIntraoperative ComplicationsLaparoscopyLength of StayLymph Node ExcisionMiddle AgedOperative Timecervical cancercomplicationhysterectomyLACClaparoscopic hysterectomyminimally invasive surgerypostoperative adverse eventradical hysterectomyrobotic hysterectomy

Identifiers

PMID31586602
PMCPMC7181470

What OpenQuestion holds

Textmetadata
LicenceTDM
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.