Robotic-assisted versus conventional laparoscopic surgery for endometrial cancer: long-term results of a randomized controlled trial - 18/09/24

Doi : 10.1016/j.ajog.2024.08.028

Elina Kivekäs, MD ^a,^b,^c,^⁎ , Synnöve Staff, MD, PhD ^a,^b,^c, Heini S.A. Huhtala, MSc ^d, Johanna U. Mäenpää, MD, PhD ^b,^c, Kari Nieminen, MD, PhD ^a,^b,^c, Eija I. Tomás, MD, PhD ^a,^c, Minna M. Mäenpää, MD, PhD ^a,^b,^c
^a Department of Obstetrics and Gynecology, Tampere University Hospital, Tampere, Finland
^b Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland
^c FICAN Mid
^d Faculty of Social Sciences, Tampere University, Tampere, Finland

^∗Corresponding author: Elina A. Kivekäs, MD.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Wednesday 18 September 2024

Abstract

Background

Robotic-assisted laparoscopy has become a widely and increasingly used modality of minimally invasive surgery in the treatment of endometrial cancer. Due to its technical advantages, robotic-assisted laparoscopic surgery offers benefits, such as a lower rate of conversions compared to conventional laparoscopy. Yet, data on long-term oncological outcomes after robotic-assisted laparoscopy is scarce and based on retrospective cohort studies only.

Objective

This study aimed to assess overall survival, progression-free survival, and long-term surgical complications in patients with endometrial cancer randomly assigned to robotic-assisted or conventional laparoscopy.

Study Design

This randomized controlled trial was conducted at the Department of Gynecology and Obstetrics of Tampere University Hospital, Finland. Between 2010 and 2013, 101 patients with low-grade endometrial cancer scheduled for minimally invasive surgery were randomized preoperatively 1:1 either to robotic-assisted or conventional laparoscopy. All patients underwent laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy. A total of 97 patients (49 in the robotic-assisted laparoscopy group and 48 in the conventional laparoscopy group) were followed up for a minimum of 10 years. Survival was analyzed using Kaplan-Meier curves, log-rank test, and Cox proportional hazard models. Binary logistic regression analysis was used to analyze risk factors for trocar site hernia.

Results

In the multivariable regression analysis, overall survival was favorable in the robotic-assisted group (hazard ratio 0.39; 95% confidence interval [CI], 0.15–0.99, P=.047) compared to the conventional laparoscopy group. There was no difference in progression-free survival (log-rank test, P=.598). The 3-, 5-, and 10-year overall survival were 98.0% (95% CI, 94.0–100) vs 97.9% (93.8–100), 91.8% (84.2–99.4) vs 93.7% (86.8–100), and 75.5% (64.5–87.5) vs 85.4% (75.4–95.4) for the conventional laparoscopy and the robotic-assisted groups, respectively. Trocar site hernia developed more often for the robotic-assisted group compared to the conventional laparoscopy group 18.2% vs 4.1% (odds ratio 5.42, 95% CI, 1.11–26.59, P=.028). The incidence of lymphocele, lymphedema, or other long-term complications did not differ between the groups.

Conclusion

The results of this randomized controlled trial suggest a minor overall survival benefit in endometrial cancer after robotic-assisted laparoscopy compared to conventional laparoscopy. Hence, the use of robotic-assisted technique in the treatment of endometrial cancer seems safe, though larger randomized controlled trials are needed to confirm any potential survival benefit. No alarming safety signals were detected in the robotic-assisted group since the rate of long-term complications differed only in the incidence of trocar site hernia.

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Key words : endometrial carcinoma, laparoscopy, lymphedema, lymphocele, oncological survival, port-site hernia, robotic, surgical outcome, trocar site hernia

Plan

Introduction

Materials and methods

Results

Comment

Principal findings

Results in the context of what is known

Clinical implications

Research implications

Strengths and limitations

Conclusions

CRediT authorship contribution statement

	The authors report no conflict of interest.
	E.A.K. has received funds from the Finnish Cultural Foundation. The foundation did not have any involvement in the study.
	Cite this article as: Kivekäs E, Staff S, Huhtala HSA, et al. Robotic-assisted versus conventional laparoscopic surgery for endometrial cancer: long-term results of a randomized controlled trial. Am J Obstet Gynecol 2024;XXX:XX–XX.
	The study was approved by the Ethics Committee of Tampere University Hospital (identification number ETL R10081; July 14, 2010).
	Date of clinical trial registration: August 18, 2011.
	Date of initial participant enrollment: December 1, 2010.
	Clinical trial identification number: ETL R10081 (URL of the registration site: ClinicalTrials.gov; NCT014 66777).
	Data availability: Data are available upon request from the corresponding author. To gain access, data requestors will need to sign a data access agreement. Data available: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), and study protocol. Investigators, who proposed the use of the data, have been approved by an independent review committee.