Comparison of robotic and laparoscopic surgery trials in 2025: a cross-sectional analysis of the national clinical trials registry

Introduction

Background

The first successful laparoscopic appendectomy was performed by Dr. Kurt Semm in the 1980s, which invited both awe and profound skepticism by surgeons globally (1). Over the next two decades, the benefits of laparoscopic technique would become widely accepted, and in many cases the preferred operative approach, catapulting the field of minimally invasive surgery (MIS) (2). The first widely used surgical robot, the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA, USA), was then approved by the U.S. Food and Drug Administration (FDA) for general laparoscopic procedures in 2000 and has since seen increased use among various surgical specialties (2,3). Within the field of MIS, robotic-assisted surgery has been touted to offer surgeons certain advantages over laparoscopy such as better field visualization, improved ergonomics, and enhanced dexterity though some data is contradictory (2-4).

Knowledge gap

Prospective clinical trials remain the gold standard in the hierarchy of research. Many landmark studies have historically defined laparoscopic surgery: the Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC) trial in 2007 demonstrated laparoscopic outcomes of colorectal carcinoma resection were non-inferior to open approaches (5), and a review on several recent studies has shown laparoscopy to be both safe and feasible for pancreatic resections (6). In contrast, while the percentages of robotic surgery trials have certainly grown, with early prostatectomy trials demonstrating functional superiority and direct technique comparisons with the robotic platform showing non-inferiority [e.g., Robotic-assisted Surgery Compared with Laparoscopic Resection Surgery for Rectal Cancer (ROLARR) and Robot-assisted vs. VATS Lobectomy (RVlob) trials], much of the published data on robotic surgery outcomes are retrospective in nature (7-9). This underrepresentation in prospective robotic trials has been attributed to various challenges researchers face when pursuing surgical trials, which are resource-intensive and subject to ethical issues with blinding and recruitment (10-13). Additionally, disparities appear to exist in which MIS disciplines conduct and publish prospective studies, with a recent review concluding that urologic and orthopedic fields publish the highest proportion of randomized controlled trials (9).

Rationale

The technical advancements and widespread use of laparoscopic and robotic surgery raise questions on the current status of modern MIS studies. ClinicalTrials.gov, a national trial registry, provides a unique opportunity to evaluate the surgical trial pipeline. The registry has been interrogated to evaluate trial characteristics for several surgical specialties (14-17), but MIS trials have not been previously analyzed. Furthermore, ClinicalTrials.gov uniquely mandates registration of active trials, which have provided insights into the treatment activity for various diseases (18,19). Identifying and summarizing the activity of ongoing contemporary clinical trials may highlight research priorities as well as potential gaps within the field of MIS.

Objectives

To this end, the objective of this study was to determine if laparoscopic trials continue to overshadow prospective robotic surgery studies using modern data from ClinicalTrials.gov. We then compare patterns of trial interventions by operative approach (i.e., laparoscopic vs. robotic-assisted surgery) and evaluate differences among MIS subspecialties. We present this article in accordance with the STROBE reporting checklist (available at https://ales.amegroups.com/article/view/10.21037/ales-25-38/rc).

Methods

Study design and trial inclusion

This is a cross-sectional study of prospective interventional clinical trials reported on ClinicalTrials.gov, a publicly accessible trial registry and results database that is maintained by the U.S. National Library of Medicine. Interventional studies conducted in the U.S. are legally mandated to be registered on ClinicalTrials.gov, but studies conducted around the world can be included on an elective basis (20). The registry was accessed on January 1, 2025. To build a data set for this analysis, MIS trials were identified by using the search terms “laparoscopy”, “robotic surgery” and “minimally invasive surgery” as well as registry-specific synonyms (Appendix 1). We included active trials in Phase I, II, III, and IV. To focus on active, ongoing MIS studies, trials that were marked as completed, suspended, or withdrawn were excluded.

Study variables

We extracted the following variables from the data provided on ClinicalTrials.gov: national clinical trial (NCT) number, study title, study status, brief summary, study type, study design, study phase, enrollment number, interventions, and primary outcome. The studies that populated from the search were then individually screened for non-MIS-related trials. Included trials were separated into laparoscopic and robotic groups based on information regarding the MIS approach used in the trial description and interventional arms of the study. Trials were then categorized based on the goal of the study intervention:

• Treatment: the intervention under study incorporates surgical management in the treatment of a disease or condition (i.e., operative vs. non-operative management of cancer);
• Perioperative complications: the intervention is evaluating known procedure-related complications (e.g., urinary retention, nerve injury); and
• Pain control: the intervention is assessing postoperative pain and/or opioid requirements;
• Technique: a current or novel surgical approach is being studied.

In addition, the surgical subspecialties that were represented by each operative approach (laparoscopy vs. robotic) were identified based on available data.

Study outcomes

The primary outcome was the proportion of laparoscopic surgery trials compared to robotic-assisted surgery trials. Secondary outcomes included a comparison of study interventions (treatment, perioperative complications, pain control, technique) and subspecialty focuses.

Statistical analysis

Descriptive statistics were used to summarize trial interventions and reported as frequencies and percentages. Chi-square and Fisher’s exact test was used to compare categorical variables. Mann-Whitney U test was used for non-parametric comparisons and reported as medians with interquartile ranges (IQR). Statistical significance was defined as P<0.05.

Results

MIS trials by operative approach

A total of 153 trials were identified using the outlined registry search strategy; 28 were unrelated to MIS and were excluded. The remaining 125 MIS trials were included for analysis (Figure 1). Laparoscopy was 2.5 times more represented than robotic surgery in the 2025 clinical trial pipeline (89 vs. 36 trials). The number of participants per trial were similar between MIS methods [97 (IQR, 55–158) vs. 100 (IQR, 64–204), P=0.27]. A greater proportion of laparoscopic trials utilized randomization in their protocols (88% vs. 61%, P<0.001), were in later trial phases (72% vs. 28% in Phase III or IV, P<0.001), and were twice as likely to be conducted outside of the U.S. (80% vs. 38%, P<0.001). In terms of specific geographic location, 29% (n=26) of laparoscopic trials were conducted in Asia, 27% (n=24) in North America, 24% (n=21) in Africa, 19% (n=17) in Europe, and 1% (n=1) in South America. Meanwhile, 81% (n=29) of prospective robotic studies were based in North America, 14% (n=5) in Asia, and the remaining 5% (n=2) in Europe.

Figure 1 Flow chart diagram of minimally invasive surgery trial inclusion.

MIS trials by study intervention

Across all MIS trials, 39% (n=49) of interventions focused on pain control, 26% (n=33) evaluated surgical technique, 22% (n=28) were treatment-centered, and the remaining 15 (12%) addressed procedure-related complications. Pain control interventions included assessing opioid versus non-opioid perioperative analgesia (NCT05597878) or more novel approaches such as the efficacy of intraperitoneal ondansetron on postoperative pain (NCT06632184). Trials addressing technique varied widely: one trial evaluated intraoperative imaging techniques for prostate adenocarcinoma (NCT05960149), while another compared laparoscopic versus open approaches of orchiopexy (NCT05845515). Studies aimed at treating disease largely focused on oncologic outcomes such as rates of cancer progression after neoadjuvant chemotherapy and rates of survival. Few focused on preventing known perioperative complications, with many studies aimed at postoperative nausea and urinary retention prophylaxis. Trial intervention data is summarized in Table 1.

When comparing interventions by MIS approach, most laparoscopic trials were aimed at addressing postoperative pain (43%) while robotic trials were primarily treatment-focused (42%).

MIS trials by subspecialty

A wide variety of MIS subspecialties were represented in the pipeline. General surgery, gynecology, and colon and rectal surgery were the most represented overall at 25 (20%), 20 (16%) and 18 (14%) total trials, respectively. Figure 2 summarizes the distribution of trial characteristics by surgical specialty.

Figure 2 Comparison of MIS trial characteristics by surgical subspecialty. MIS, minimally invasive surgery.

Inter-specialty variations were evident when stratified by operative approach. Of the 89 laparoscopy trials, 24 (27%) involved general surgery, 20 (22%) focused on gynecology, and 18 (20%) on colorectal conditions. Most general surgery trials evaluated perioperative outcomes for gallbladder disease, while gynecology studies assessed hysterectomy interventions for both benign and malignant conditions. Colorectal trials were mainly cancer focused. Meanwhile, of the 36 robotic surgery studies, 11 (31%) were conducted for otolaryngology (ENT), 8 (22%) were urologic, and 7 (19%) involved cardiothoracic diseases. These trials were primarily oncologic and focused on head and neck (NCT06445114), prostate (NCT05753046, NCT05946603), and lung cancer (NCT05918783, NCT032570815), respectively.

Comparison of MIS study interventions by subspecialty

Among general surgery trials, 12 (48%) focused on pain control measures after laparoscopic surgery (NCT06088082, NCT06714279, NCT06666985). Similarly, most gynecologic (12 of 20; 60%) and bariatric (8 of 12; 67%) studies focused on perioperative pain measures. All 11 ENT trials by contrast were entirely dedicated to assessing oncologic treatments for head and neck cancers (NCT04277858, NCT01590355). Nine of the 15 (60%) surgical oncologic and hepatobiliary cancer trials focused on intraoperative techniques, including lymph node mapping with fluorescent tracers (NCT04973475, NCT05618821). Similarly, trials in urology were split between postoperative pain management (7 of 16; 44%) and techniques (8 of 16; 50%) aimed at intraoperative nerve preservation (NCT06446648, NCT05960149). Studies on perioperative complications were sparse: 4 (33%) bariatric surgery trials focused on postoperative nausea after gastric sleeve (NCT05516953, NCT05620641) and 7 (28%) conducted by general surgery were aimed at nausea after laparoscopic cholecystectomy (NCT06017167, NCT05988671, NCT06288035). Study endpoints categorized by surgical subspecialty are summarized in Table 2.

Discussion

Key findings

The goal of this study was to compare MIS (i.e., laparoscopic vs. robotic surgery) trials using a comprehensive clinical trial registry as well as to characterize study interventions across MIS subspecialties. We found that laparoscopy largely outnumbers robotic surgery studies 2.5-to-1, which is akin to historical trends cited in the literature (9,10). In general, modern MIS trials are largely prioritizing interventions aimed at reducing postoperative pain. While laparoscopy is well represented within general surgery, focusing primarily on pain and opioid requirements, ENT trials account for the greatest number of robotic studies and are aimed exclusively at cancer treatment. To our knowledge, this is the first study to identify and compare ongoing MIS trial activity in the clinical trial pipeline.

Explanation of findings

Nearly half of MIS trials focused on either postoperative analgesia or surgery-related complications, mirroring Robinson and colleagues’ recent systematic review that concluded published randomized studies primarily focused on minor clinical events (21). These findings perhaps reflect the many challenges associated with conducting minimally invasive-focused prospective studies. MIS trials are resource-intensive, requiring dedicated personnel and training with operative care unique to robotic and laparoscopic surgery (10,13). The significantly higher costs specific to robotic approaches are its own barrier that critics argue may not justify comparison with either laparoscopic or open techniques (22). To effectively circumvent the costly and lengthy clinical trial process, robotic surgery systems have largely relied on their FDA approved status as general surgical tools (3). The 510(k) process has allowed for widely expanded indications for robotic surgery where medical devices obtain clearance based on slight modifications to predicate data (23,24). This regulatory mechanism, along with the large proportion of modern trials focusing on outcomes of pain management, does raise concerns about the quality of data supporting the effectiveness of surgical robots in MIS outcomes.

Comparison with similar research

A review by Long et al. looked at publications from 1999 to 2023 and revealed urology as a leader in robotic surgery clinical trials (9). The present study shows that urology had slightly fewer ongoing trials compared to ENT (n=8 vs. n=11, respectively) but still comprised a sizable percentage of robotic studies. We noted the focus of the ENT trials were on oropharyngeal cancers, for which transoral robotic surgery has become an increasingly preferred approach of modern practice due to lower morbidity rates compared to open neck surgery (25). As a result, research is focusing on robotic surgery’s role on oncologic outcomes such as recurrence rates and pathological complete response. Much like ENT, robotic-assisted radical prostatectomy has become a standard surgical approach for prostate cancer and has therefore driven considerable research investment, especially regarding factors such as erectile function and urinary incontinence (26). In contrast to ENT and urology, our analysis revealed that general surgery had the fewest robotic trials in spite of an over 40-fold increase in robotic-assisted procedures like inguinal and ventral hernia repairs (27). This suggests that prospective research activity has not paralleled clinical use. This could be due to the increased cost associated with robotic surgery, which has been shown to be less cost-effective in procedures such as the cholecystectomy for which the laparoscopic approach is the preferred approach (28).

Implications and actions needed

The findings of this analysis provide insights into the utility of monitoring MIS studies in the trial pipeline. The predominance of trials focused on postoperative pain reveals a growing emphasis on reducing opioid requirements after surgery, which is in tune with enhanced recovery after surgery guidelines (29). This current focus on researching postoperative pain raises the question of why surgical techniques and treatment-related outcomes are not being evaluated more in MIS. The precise reasons are likely multifactorial. Participant blinding is a unique challenge, as both surgeon and patient may be aware of the surgical intervention under study (30). Ethical dilemmas may also exist when comparing treatments, particularly when a technique is considered experimental or believed to be superior to the comparison arm of a trial (11,12). Cost and logistical barriers may be present due to the significant investment in resources needed to conduct a surgical trial, from operative and personnel expenses to the postoperative care required (13). Together, these factors may serve to hinder pursuit of these “higher stakes” MIS studies that certainly require commitment to rigorous study design and pre-planning.

Strengths and limitations

This study has limitations worth mentioning. Our analysis only consisted of registered trials, meaning that unpublished or unregistered studies were not captured in our search. ClinicalTrials.gov also allows for a 2-year period with no updates before a study status is listed as unknown, which may overestimate the number of ongoing trials. We also only included studies in Phase I–IV and must acknowledge there are trials without FDA-defined phases. Additionally, since international researchers are not required to register their studies in this registry, there may be trials that went unrepresented, especially those conducted outside of major trial registries or in regions with less stringent reporting requirements. We also acknowledge that certain specialties, including robotic surgery, may be particularly affected by underreporting as trials in this field sponsored by industry may not be consistently registered in public databases. However, all U.S.-based trials are by law captured via ClinicalTrials.gov, and most international trials are also registered. To that end, the novelty of this analysis and use of ClinicalTrials.gov are major strengths as this registry is comprehensive, publicly accessible, and provides insights into ongoing trial activity.

Conclusions

A review of prospective MIS studies reveals that laparoscopy-focused clinical trials are clearly prioritized over robotic approaches. General surgery represents most laparoscopic trials, with a predominant focus on pain control and postoperative opioid requirements. For robotic trials, ENT and urology are currently leading, which reflects the technology’s transformative management and widespread adoption of head and neck as well as prostate cancers, respectively. These findings reflect the current priorities in the field of MIS research and reflect the utility of interrogating clinical trial registries.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://ales.amegroups.com/article/view/10.21037/ales-25-38/rc

Peer Review File: Available at https://ales.amegroups.com/article/view/10.21037/ales-25-38/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://ales.amegroups.com/article/view/10.21037/ales-25-38/coif). J.T.D. serves as an unpaid editorial board member of Annals of Laparoscopic and Endoscopic Surgery from November 2024 to December 2026. M.K. serves as Chief Medical Officer for Medtronic. G.R.V. has received consulting fees from Veracyte, Inc. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. Litynski GS. Kurt Semm and the fight against skepticism: endoscopic hemostasis, laparoscopic appendectomy, and Semm's impact on the "laparoscopic revolution". JSLS 1998;2:309-13.
2. Alkatout I, Mechler U, Mettler L, et al. The Development of Laparoscopy-A Historical Overview. Front Surg 2021;8:799442. [Crossref] [PubMed]
3. Hazey JW, Melvin WS. Robot-assisted general surgery. Semin Laparosc Surg 2004;11:107-12. [Crossref] [PubMed]
4. Muaddi H, Hafid ME, Choi WJ, et al. Clinical Outcomes of Robotic Surgery Compared to Conventional Surgical Approaches (Laparoscopic or Open): A Systematic Overview of Reviews. Ann Surg 2021;273:467-73. [Crossref] [PubMed]
5. Jayne DG, Guillou PJ, Thorpe H, et al. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol 2007;25:3061-8. [Crossref] [PubMed]
6. van Hilst J, de Graaf N, Abu Hilal M, et al. The Landmark Series: Minimally Invasive Pancreatic Resection. Ann Surg Oncol 2021;28:1447-56. [Crossref] [PubMed]
7. Yaxley JW, Coughlin GD, Chambers SK, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet 2016;388:1057-66. [Crossref] [PubMed]
8. Jayne D, Pigazzi A, Marshall H, et al. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA 2017;318:1569-80. [Crossref] [PubMed]
9. Long X, Chen J, Li J, et al. The current status and global trends of clinical trials related to robotic surgery: a bibliometric and visualized study. J Robot Surg 2024;18:193. [Crossref] [PubMed]
10. Marshall JC. Clinical trials in surgical infection. Br J Surg 2017;104:e11-3. [Crossref] [PubMed]
11. Davies L, Beard D, Cook JA, et al. The challenge of equipoise in trials with a surgical and non-surgical comparison: a qualitative synthesis using meta-ethnography. Trials 2021;22:678. [Crossref] [PubMed]
12. Lim CT, Roberts HJ, Collins JE, et al. Factors influencing the enrollment in randomized controlled trials in orthopedics. Contemp Clin Trials Commun 2017;8:203-8. [Crossref] [PubMed]
13. Pawlik TM, Sosa JA, editors. Clinical Trials (Success in Academic Surgery). 2nd ed. Cham: Springer; 2020.
14. Kendall N, Pennington Z, Hamouda AM, et al. Compliance and factors affecting reporting of spinal stenosis and spinal-fusion-related clinical trials to ClinicalTrials.gov. J Clin Neurosci 2025;135:111148. [Crossref] [PubMed]
15. Peng C, Jia H, Hu J, et al. Characteristics and publication status of minimally invasive glaucoma surgery trials registered in ClinicalTrials.gov, 2007-2024: a cross-sectional study. BMJ Open 2025;15:e095854. [Crossref] [PubMed]
16. Menezes AS, Barnes A, Scheer AS, et al. Clinical research in surgical oncology: an analysis of ClinicalTrials.gov. Ann Surg Oncol 2013;20:3725-31. [Crossref] [PubMed]
17. Witsell DL, Schulz KA, Lee WT, et al. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov. Otolaryngol Head Neck Surg 2013;149:692-9. [Crossref] [PubMed]
18. Cummings JL, Zhou Y, Lee G, et al. Alzheimer's disease drug development pipeline: 2025. Alzheimers Dement (N Y) 2025;11:e70098. [Crossref] [PubMed]
19. Jones CW, Woodford AL, Platts-Mills TF. Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis. BMJ Open 2020;10:e041276. [Crossref] [PubMed]
20. Clinical Trials Registration and Results Information Submission. Final rule. Fed Regist 2016;81:64981-5157.
21. Robinson NB, Fremes S, Hameed I, et al. Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020: A Systematic Review. JAMA Netw Open 2021;4:e2114494. [Crossref] [PubMed]
22. Broholm M, Onsberg Hansen I, Rosenberg J. Limited Evidence for Robot-assisted Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Surg Laparosc Endosc Percutan Tech 2016;26:117-23. [Crossref] [PubMed]
23. Lefkovich C, Rothenberg S. Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device. PLoS One 2023;18:e0283442. [Crossref] [PubMed]
24. Liebeskind AY, Chen AC, Dhruva SS, et al. A 510(k) ancestry of robotic surgical systems. Int J Surg 2022;98:106229. [Crossref] [PubMed]
25. Sload R, Silver N, Jawad BA, et al. The Role of Transoral Robotic Surgery in the Management of HPV Negative Oropharyngeal Squamous Cell Carcinoma. Curr Oncol Rep 2016;18:53. [Crossref] [PubMed]
26. Du Y, Long Q, Guan B, et al. Robot-Assisted Radical Prostatectomy Is More Beneficial for Prostate Cancer Patients: A System Review and Meta-Analysis. Med Sci Monit 2018;24:272-87. [Crossref] [PubMed]
27. Sheetz KH, Claflin J, Dimick JB. Trends in the Adoption of Robotic Surgery for Common Surgical Procedures. JAMA Netw Open 2020;3:e1918911. [Crossref] [PubMed]
28. Singh A, Panse NS, Prasath V, et al. Cost-effectiveness analysis of robotic cholecystectomy in the treatment of benign gallbladder disease. Surgery 2023;173:1323-8. [Crossref] [PubMed]
29. Langnas EM, Matthay ZA, Lin A, et al. Enhanced recovery after surgery protocol and postoperative opioid prescribing for cesarean delivery: an interrupted time series analysis. Perioper Med (Lond) 2021;10:38. [Crossref] [PubMed]
30. Evaniew N, Carrasco-Labra A, Devereaux PJ, et al. How to Use a Randomized Clinical Trial Addressing a Surgical Procedure: Users' Guide to the Medical Literature. JAMA Surg 2016;151:657-62. [Crossref] [PubMed]