BACKGROUND AND OBJECTIVES: Enhanced Recovery After Surgery (ERAS) guidelines for Radical Cystectomy (RC) were published over ten years ago. Aim of this systematic review is to update ERAS recommendations for patients undergoing RC and to give an expert opinion on the relevance of each single ERAS item. METHODS: A systematic review was performed to identify the impact of each single ERAS item on RC outcomes. Embase and Medline (through Pubmed) were searched systematically. Relevant articles were selected and graded. For each ERAS item, a level of evidence was determined. An e-Delphi consensus was then performed amongst an international panel with renowned experience in RC to provide recommendations based on expert opinion. KEY FINDINGS AND LIMITATIONS: Preoperative medical optimization and avoiding bowel preparation are highly recommended. Robotic-assisted RC with intracorporeal urinary diversion is moderately recommended and can help in applying other ERAS items, such as early mobilization. Medical thromboprophylaxis should be administered and nasogastric tube should be removed at the end of surgery. Perioperative fluid restriction as well as opioid-sparing anesthesia protocols should be implemented. Generally, consensus was reached on most ERAS items, with the exception of epidural anesthesia (no consensus), resection site drainage (consensus against), and type of urinary drainage. Limitations include the lack of a multidisciplinary approach to the present consensus, giving however a highly specialized surgical opinion on ERAS. CONCLUSIONS: and clinical implications: The current study updates ERAS recommendations for patients undergoing RC and suggests application of ERAS by a panel of experts in the field.
- MeSH
- Early Ambulation MeSH
- Surgeons MeSH
- Cystectomy * methods MeSH
- Urinary Diversion methods MeSH
- Humans MeSH
- Urinary Bladder Neoplasms surgery MeSH
- Robotic Surgical Procedures MeSH
- Practice Guidelines as Topic MeSH
- Enhanced Recovery After Surgery * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Systematic Review MeSH
BACKGROUND: Robot-assisted minimally invasive esophagectomy (RAMIE) is increasingly adopted in centers worldwide, with ongoing refinements to enhance results. This study aims to assess the current state of RAMIE worldwide and to identify potential areas for improvement. METHODS: This descriptive study analyzed prospective data from esophageal cancer patients who underwent transthoracic RAMIE in Upper GI International Robotic Association (UGIRA) centers. Main endpoints included textbook outcome rate, surgical techniques, and perioperative outcomes. Analyses were performed separately for intrathoracic (Ivor-Lewis) and cervical anastomosis (McKeown), divided into three time cohorts (2016-2018, 2019-2020, 2021-2023). A sensitivity analysis was conducted with cases after the learning curve (> 70 cases). RESULTS: Across 28 UGIRA centers, 2012 Ivor-Lewis and 1180 McKeown procedures were performed. Over the time cohorts, textbook outcome rates were 39%, 48%, and 49% for Ivor-Lewis, and 49%, 63%, and 61% for McKeown procedures, respectively. Fully robotic procedures accounted for 66%, 51%, and 60% of Ivor-Lewis procedures, and 53%, 81%, and 66% of McKeown procedures. Lymph node yield showed 27, 30, and 30 nodes in Ivor-Lewis procedures, and 26, 26, and 34 nodes in McKeown procedures. Furthermore, high mediastinal lymphadenectomy was performed in 65%, 43%, and 37%, and 70%, 48%, and 64% of Ivor-Lewis and McKeown procedures, respectively. Anastomotic leakage rates were 22%, 22%, and 16% in Ivor-Lewis cases, and 14%, 12%, and 11% in McKeown cases. Hospital stay was 13, 14, and 13 days for Ivor-Lewis procedures, and 12, 9, and 11 days for McKeown procedures. In Ivor-Lewis and McKeown, respectively, the sensitivity analysis revealed textbook outcome rates of 43%, 54%, and 51%, and 47%, 64%, and 64%; anastomotic leakage rates of 28%, 18%, and 15%, and 13%, 11%, and 10%; and hospital stay of 11, 12, and 12 days, and 10, 9, and 9 days. CONCLUSIONS: This study demonstrates favorable outcomes over time in achieving textbook outcome after RAMIE. Areas for improvement include a reduction of anastomotic leakage and shortening of hospital stay.
- MeSH
- Esophagectomy * methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Minimally Invasive Surgical Procedures methods MeSH
- Esophageal Neoplasms * surgery pathology MeSH
- Follow-Up Studies MeSH
- Postoperative Complications epidemiology MeSH
- Prognosis MeSH
- Prospective Studies MeSH
- Registries * MeSH
- Robotic Surgical Procedures * methods MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: The integration of robotic technology into surgical procedures has gained considerable attention for its promise to enhance a variety of clinical outcomes. Robotic deep inferior epigastric perforator (DIEP) flap harvest has emerged as a novel approach for autologous breast reconstruction. This systematic review aims to provide a comprehensive overview of the current techniques, outcomes, and complications of robotic DIEP flap surgery. METHODS: A systematic literature search was conducted after PRISMA 2020 guidelines across databases including PubMed, Embase, Google Scholar, and Web of Science from 2000 to 2023. Articles exploring robotic DIEP flap harvest for breast reconstruction were assessed to compare operative techniques, clinical outcomes, and complications. The risk of bias was evaluated using ROBINS-I and the Newcastle-Ottawa scale. RESULTS: Fourteen studies involving 108 patients were included. Three studies used a totally extraperitoneal (TEP) technique, whereas 11 studies used a transabdominal preperitoneal (TAPP) approach. Preoperative planning utilized computed tomography angiography and magnetic resonance angiography imaging. The mean robotic operative time was 64 minutes, with total operative times averaging 574 minutes for TAPP and 497 minutes for TEP. The mean length of stay was 5 days, and the mean fascial incision length was 3 cm. Overall complication rate was 14.9%, with no significant difference compared with conventional DIEP flap procedures. CONCLUSION: Robotic DIEP flap harvest is a promising technique that may reduce postoperative pain and limiting abdominal donor site morbidity. Potential limitations include longer operative times, variable hospital stays, and increased costs.
- MeSH
- Epigastric Arteries * transplantation MeSH
- Operative Time * MeSH
- Length of Stay MeSH
- Humans MeSH
- Mammaplasty * methods MeSH
- Tissue and Organ Harvesting methods MeSH
- Perforator Flap * blood supply MeSH
- Postoperative Complications prevention & control MeSH
- Robotic Surgical Procedures * methods MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Systematic Review MeSH
Roboticky asistovaná radikální prostatektomie je standardní metodou léčby lokalizovaného karcinomu prostaty. Přesto zůstávají pozdní funkční komplikace jako stresová inkontinence moči, erektilní dysfunkce a striktury hrdla močového měchýře zásadními faktory ovlivňujícími kvalitu života pacientů. Tento článek se zabývá možnostmi prevence těchto komplikací prostřednictvím optimalizace chirurgických technik a individualizované rehabilitační péče. Důraz je kladen na šetrné operační postupy, zachování klíčových anatomických struktur a důslednou pooperační péči a fyzioterapii. Výsledky studií ukazují, že kombinace těchto přístupů může významně přispět ke zlepšení pooperačních výsledků a urychlit návrat pacientů k běžnému životu. Komplexní přístup zahrnující precizní chirurgické metody, systematickou rehabilitaci a edukaci pacientů je nezbytný pro minimalizaci nežádoucích účinků a maximalizaci kvality života po operaci.
Robot-assisted radical prostatectomy is the standard treatment for localized prostate cancer. However, late functional complications such as stress urinary incontinence, erectile dysfunction, and bladder neck strictures continue to be critical factors affecting patients' quality of life. This article explores strategies to prevent these complications through optimized surgical techniques and individualized rehabilitation care. Emphasis is placed on minimally invasive surgical approaches, preservation of key anatomical structures, and comprehensive postoperative management, including physiotherapy, pharmacological support, and technical aids. Studies indicate that combining these approaches can significantly improve postoperative outcomes and accelerate patients' return to daily life. A comprehensive approach integrating precise surgical methods, systematic rehabilitation, and patient education is essential to minimizing adverse effects and maximizing quality of life after surgery.
- MeSH
- Erectile Dysfunction etiology prevention & control MeSH
- Humans MeSH
- Postoperative Complications prevention & control MeSH
- Prostatectomy * methods adverse effects MeSH
- Robotic Surgical Procedures MeSH
- Urinary Incontinence, Stress etiology prevention & control MeSH
- Urethral Stricture etiology prevention & control MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Publication type
- Review MeSH
Tento článek zpracovává téma nových trendů a technologií v urologii, a to konkrétně v oblasti telemedicíny a umělé inteligence. Nejprve stručně pojednává o přínosech telemedicíny a jak mění pohled na vztah mezi lékařem a pacientem. Podrobněji se pak text věnuje především umělé inteligenci, jež se v současnosti dostává do popředí zájmu laické i odborné veřejnosti. Její potenciál v urologii je testován v mnoha studiích, především se zaměřením na uroonkologii, v menší míře pak také v oblasti benigních urologických onemocnění. Článek se snaží identifikovat nejvýznamnější pokroky v této rychle se rozvíjející oblasti, a zároveň předkládá současné limity jejího zapojení do klinické praxe.
This article explores the emerging trends and technologies in urology, focusing on telemedicine and artificial intelligence. It provides a brief overview of the benefits of telemedicine and its impact on the patient-physician interactions. The article subsequently explores in detail the use of artificial intelligence, which is currently gaining considerable interest from both general public and medical professionals. Its potential in urology has been tested in a number of clinical studies, particularly in the field of uro-oncology and, to a lesser extent, in benign urological diseases. The aim of this article is to identify the key advances in this rapidly evolving field, while also highlighting the current limitations of its implementation into clinical practice.
- MeSH
- Deep Learning MeSH
- Humans MeSH
- Robotic Surgical Procedures MeSH
- Machine Learning MeSH
- Telemedicine MeSH
- Artificial Intelligence MeSH
- Urologic Neoplasms diagnosis therapy MeSH
- Urology * trends MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
Úvod: U idiopatické retroperitoneální fibrózy dominuje zavzetí ureterů do retroperitoneální fibrotické masy (zejména ve střední části ureterů), což vede k rozvoji (dolicho-) megaureterů s následnou progredující renální insuficiencí. Levá strana bývá postižena dříve. Řešením je ovlivnění etiopatogeneze onemocnění (zejména kortikoidní léčba) a derivace horních cest močových. Je možné provést buď trvalý stenting obou ureterů se všemi svými nevýhodami, či jejich deliberaci, která se historicky prováděla otevřeně ze střední laparotomie, nověji miniinvazivně. V práci hodnotíme výsledky miniinvazivní (laparoskopické, resp. roboticky asistované) deliberace a prezentujeme video robotické varianty. Soubor: V období 2001–2024 bylo k oboustranné deliberaci indikováno devět nemocných – tři muži (33 %) a šest žen; průměrný věk 58,5 ± 6,9 (48,8–69,6) roků; body mass index (BMI) 28,9 ± 5,8 (19,5–38,1). První čtyři řešení laparoskopicky, pět poté roboticky asistovaně. U dvou (22,2 %) nemocných nebylo možno uretery z těžkých fibrotických změn uvolnit (jeden z laparoskopie ponechán na stentech, druhý řešený roboticky asistovaně, provedena otevřená nefrektomie u ledviny s 8,6 % funkce a otevřená druhostranná deliberace – ze střední laparotomie). Doba operace obou stran (bez otevřeného výkonu) byla 154,0 ± 33,5 (100–201) min. Video: Ukazuje deliberaci obou ureterů roboticky asistovaně. Je užit čtyřramenný systém da Vinci Xi, poloha na boku 70°. Začínáme postiženější levou stranou. S Veres jehlou vytvořeno kapnoperitoneum tlakem 12 mm Hg, pupkem zaveden asistentský port 11 mm, za kontroly zraku zavedeny čtyři robotické 8mm porty. Kamera 30°, ProGraspTM, bipolární grasper MarylandTM, monopolární nůžky. Otevřeno parakolicky peritoneum, nalezen ureter a deliberován od dolního pólu ledviny až pod ilické cévy. Pod deliberovaný močovod vloženo mediální peritoneum a fixováno k laterálnímu okraji stehem či Hem-o-lok® L klipy. Ponechán port v pupku, změněna poloha a identicky proveden výkon i vpravo. Dutina břišní nedrénována. Ureterální stenty odstraněny za 3–6 týdnů. Výsledky: U 8 nemocných, kde bylo možno uretery deliberovat (15 močovodů, z toho 1 otevřeně), je známo dlouhodobé sledování všech 15 močovodů, u nich není nutný další stenting ureterů, horní cesty močové jsou sonograficky bez dilatace a nedochází k rozvoji renální insuficience. Doba sledování je v průměru 63,9 ± 64,3 (1–158) měsíců. U 8 kombinováno s kortikoidní terapií, která vedla vždy k výrazné regresi fibrotických hmot. Závěr: Deliberace močovodů při morbus Ormond je proveditelná miniinvazivně (laparoskopicky či roboticky asistovaně) u 77,8 % s překvapivě dobrými dlouhodobými výsledky umožňujícími uchránit horní cesty močové a vyhnout se dlouhodobému stentingu (ve 100 %). Robotické variantě dáváme nyní jednoznačně přednost.
Introduction: In idiopathic retroperitoneal fibrosis, ureteral involvement of the retroperitoneal fibrotic mass (especially in the middle part of the ureters) dominates, leading to the development of (dolicho-) megaureters with subsequent progressive renal insufficiency. The left side tends to be affected earlier. The solution is to influence the etiopathogenesis of the disease (especially corticoid treatment) and diversion of the upper urinary tract. Either permanent stenting of both ureters with all its disadvantages or ureterolysis. Historically open via midline laparotomy, more recently minimally invasive. In this paper we evaluate the results of minimally invasive (laparoscopic or robotic assisted) ureterolysis. Abstract: Between 2001 and 2024, nine patients were indicated for bilateral ureterolysis. Three men (33%) and six women. Mean age 58.5±6.9 (48.8-69.6) years. Body mass index (BMI) 28.9±5.8 (19.5-38.1). First four laparoscopically, subsequent five robotic assisted. In two (22.2%) patients ureters could not be released from severe fibrotic changes (one laparoscopy left with stents, the other robotically assisted open nephrectomy in a kidney with 8.6% function and open secondary ureterolysis - via midline laparotomy). The bilateral operation time (without open surgery) was 154.0±33.5 (100-201) min. Video: Shows the robotic-assisted bilateral ureterolysis. The 4-arm daVinci Xi system is used, 70° lateral position. Starting with the more affected left side. With Veres needle, capnoperitonum pressure of 12 mmHg created, 11 mm assisted port inserted through umbilicus, four robotic 8mm introduced under visual control. Camera 30°, ProGraspTM, bipolar grasper MarylandTM, monopolar scissors. Paracolic peritoneum opened, ureter found and liberated from the lower pole of the kidney to below the iliac vessels. Medial peritoneum inserted under the deliberated ureter and fixed to the lateral margin with suture or Hem-o-lok® L clips. The port in the umbilicus was left, the position was changed and the procedure was performed identically on the right side. The abdominal cavity was not drained. Ureteral stents removed in 3-6 weeks. Results: In the eight patients where ureters could be liberated (15 ureters, 1 open), long-term follow-up is known for all 15 ureters, no further ureteral stenting is required, the upper urinary tract is sonographically free of dilatation and no renal insufficiency developed. The mean follow-up time is 63.9±64.3 (1-158) months. In eight cases, combined corticosteroid therapy always resulted in significant regression of fibrotic masses. Conclusion: Liberation of ureters in morbus Ormond is feasible minimally invasively (laparoscopically or robotically assisted) in 77.8% with surprisingly good long-term results allowing preservation of the upper urinary tract and avoiding long-term stenting (in 100%). The robotic option is now clearly preferred.
Cíl: Cílem práce je porovnat perioperační výsledky robotické (RAPN) a otevřené resekce ledviny (OPN) hodnocené dle komplexity tumorů pomocí RENAL nefrometrického skóre. Soubor pacientů a metody: Do retrospektivní studie byli zařazeni pacienti operovaní v letech 2010–2020. Porovnány byly demografické údaje (věk, body mass index, Charlson comorbidity index), perioperační údaje (krevní ztráty, délka hospitalizace, komplikace, ischemie) a pooperační výsledky (histopatologický nález a renální funkce). Výsledky: Hodnoceno bylo 563 pacientů – 306 OPN a 257 RAPN. Pacienti, kteří podstoupili OPN, byli starší (průměr 64,3 vs. 61,6 let; p = 0,01), měli vyšší průměrné RENAL skóre (7,2 vs. 6,3; p < 0,01) a měli více komorbidit (p < 0,01). Ischemie byla u RAPN využita méně (60,8 vs. 65,8 %; p = 0,25), u RAPN byla o 3,5 min delší (průměrně 17,5 vs. 14 min; p = 0,014). Operace byla v průměru o 7 min delší u RAPN (100,2 vs. 92,9 min; p = 0,007), ale ve skupině se střední komplexitou (n = 279) rozdíl zjištěn nebyl (p = 0,19). U RAPN byly průměrné krevní ztráty o polovinu menší (149,9 vs. 301,9 ml; p < 0,001), doba hospitalizace byla kratší (5,2 vs. 6,8 dní; p < 0,01), stejně jako využití jednotky intenzivní péče (17 vs. 84 %; p < 0,01). Míra pozitivních chirurgických okrajů byla nižší u RAPN (p = 0,04). Celková míra komplikací byla u RAPN a OPN srovnatelná (12,7 vs. 11,9 %; p = 0,79), u OPN ale byl vyšší poměr závažných komplikací (Clavien-Dindo ≥ 3b) tvořící 20,5 vs. 11 %. Pooperačně došlo u RAPN k menšímu poklesu glomerulární filtrace u všech skupin (p = 0,04). Závěr:RAPN vykazuje lepší výsledky než OPN v míře krevních ztrát, zachování renálních funkcí, délky hospitalizace a míře využití intenzivní péče. Je také patrný trend v nižším výskytu závažných komplikací a pozitivních chirurgických okrajů.
Major statement: Partial nephrectomy is currently the standard treatment for cT1 renal tumors. Although the robotic approach (RAPN) does not clearly demonstrate superiority over open surgery (OPN), it has gained popularity. This study aims to compare the perioperative, functional, and oncological outcomes of these modalities. Summary: Objective: The study aims to compare the perioperative outcomes of robot-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN), assessed according to tumor complexity using the RENAL nephrometric score. Patients and methods: The retrospective study included patients operated on between 2010 and 2020. Demographic data (age, body mass index, Charlson Comorbidity index, and gender), perioperative data (blood loss, length of hospitalization, complications, length of ischemia), and postoperative outcomes (histopathological findings and renal function) were compared. Results: 563 patients were evaluated, 306 OPN and 257 RAPN. Patients who underwent OPN were older (mean 64.3 vs. 61.6 years; P = 0.01), had a higher mean RENAL score (7.2 vs. 6.3; P < 0.01), and had more comorbidities (P < 0.01). Ischemia was used less in RAPN (60.8 vs. 65.8 %; P = 0.25) but was 3.5 min longer in RAPN (mean 17.5 vs. 14 min; P = 0.014). The operation was, on average, 7 min longer in RAPN (100.2 vs. 92.9 min; P = 0.007), but in the moderate complexity group (N = 279), no difference was found (P = 0.19). In the RAPN group, the average blood loss was half of that in the OPN group (149.9 vs. 301.9 ml; P < 0.001), the length of hospital stay was shorter (5.2 vs. 6.8 days; P < 0.01), as was the use of the intensive care unit (17 vs. 84%; P < 0.01). The rate of positive surgical margins was lower in RAPN (P = 0.04). The overall complication rate was comparable between RAPN and OPN (12.7 vs. 11.9%; P = 0.79), but OPN had a higher rate of serious complications (Clavien-Dindo ≥ 3b) at 20.5 vs. 11%. Postoperatively, RAPN had a smaller decrease in glomerular filtration rate in all groups (P = 0.04). Conclusion: RAPN shows better results than OPN regarding blood loss, preservation of renal function, length of hospital stay, and intensive care utilization. There is also a trend toward lower rates of serious complications and positive surgical margins.
- MeSH
- Carcinoma, Renal Cell surgery pathology MeSH
- Humans MeSH
- Kidney Neoplasms * surgery pathology MeSH
- Nephrectomy methods MeSH
- Postoperative Complications MeSH
- Retrospective Studies MeSH
- Robotic Surgical Procedures MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Comparative Study MeSH
The objective of this study is to undertake a narrative review of the oncological adequacy of mediastinal lymphadenectomy performed via robot-assisted thoracic surgery (RATS) in comparison with video-assisted thoracic surgery (VATS) and thoracotomy for non-small cell lung cancer (NSCLC). The focus of the review is on lymph node yield, nodal station dissection, and nodal upstaging rates. A narrative review of literature published in the last decade was conducted using PubMed, Cochrane, and Web of Science databases. Studies examining mediastinal lymphadenectomy outcomes for RATS, VATS, or thoracotomy were included in the discussion. The analysis of 19 studies from diverse geographical regions showed that in six out of nine comparative studies, RATS demonstrated superior lymph node retrieval compared to VATS, with statistically significant differences. RATS achieved comparable or superior nodal station dissection rates and showed particular advantages in upstaging from clinical N0 to pathological N2 status. Additionally, RATS demonstrated favourable perioperative outcomes with reduced morbidity and mortality rates compared to conventional approaches. RATS represents a reliable and oncologically sound approach to mediastinal lymphadenectomy, with potential advantages over conventional techniques. Its enhanced visualization and precision make it an increasingly utilised option for NSCLC treatment in centres with robotic capabilities.
- MeSH
- Thoracic Surgery, Video-Assisted methods MeSH
- Humans MeSH
- Lymph Node Excision * methods MeSH
- Mediastinum surgery MeSH
- Lung Neoplasms * surgery pathology MeSH
- Carcinoma, Non-Small-Cell Lung * surgery pathology MeSH
- Robotic Surgical Procedures * methods MeSH
- Thoracotomy methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
BACKGROUND: The oncologic safety of minimally invasive simple hysterectomy in low-risk cervical cancer has not been explored by an adequately powered clinical trial. PRIMARY OBJECTIVE: This study aims to evaluate whether minimally invasive simple hysterectomy affects disease-free survival in low-risk early-stage cervical cancer. STUDY HYPOTHESIS: Minimally invasive simple hysterectomy represents an oncologically safe approach in selected patients with low-risk cervical cancer. TRIAL DESIGN: This is a single-arm trial with stopping rules. All patients must undergo cervical conization. Patients with clear conization margins or absence of residual macroscopic disease at imaging after conization (re-conization is mandatory if these criteria are not met) are submitted to minimally invasive (laparoscopy or robot-assisted laparoscopy) simple hysterectomy with sentinel lymph node biopsy algorithm. Adjuvant therapy is given in case of tumor-involved surgical margins, and/or metastatic lymph nodes, and/or substantial lymphovascular space invasion with depth of stromal infiltration >2/3 (or tumor-free distance ≤3 mm). MAJOR INCLUSION/EXCLUSION CRITERIA: The major inclusion criteria are: squamous cell carcinoma, human papillomavirus-related adenocarcinoma, adenosquamous carcinoma of the uterine cervix; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (≤2 cm) with depth of infiltration ≤10 mm on conization specimen; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (≤2 cm) with depth of infiltration ≤50% at pre-conization magnetic resonance imaging scan or "expert" ultrasound scan. Women are not eligible if they have evidence of metastatic disease, contra-indications to surgery and/or lymph node assessment, or fertility sparing desire. PRIMARY ENDPOINT: The primary end point is 3-year disease-free survival of patients who undergo minimally invasive simple hysterectomy. SAMPLE SIZE: A sample size of 974 patients will give a power of 80% at a significance level of 2.5% (1-sided) to reject the null hypothesis of a 3-year recurrence rate of 2.4%, assuming a 3-year recurrence rate of 1.2%. A maximum of 14 recurrences at 3 years should be observed to reject the null hypothesis. A stopping rule based on the number of recurrences observed at different timepoints will be implemented to avoid a higher recurrence rate with the study procedure. The trial will also be stopped if no recurrences are observed in the first 400 patients followed up for 2 years. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The enrolment will last 60 months. After the surgery, the follow-up time will be ≥3 years. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT06416748) and as ENGOT/MITO trial (ENGOT-cx23).
- MeSH
- Adult MeSH
- Hysterectomy * methods MeSH
- Conization MeSH
- Laparoscopy methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Minimally Invasive Surgical Procedures methods MeSH
- Uterine Cervical Neoplasms * surgery pathology MeSH
- Robotic Surgical Procedures methods MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
