Unexpected results from randomized clinical trials. Or are they?

In a recent editorial, Chien (1) asked “How should we deal with unexpected results from randomized trials?” But why use the term “unexpected” at all? Indeed, before Ramirez et al.’s study was published in the New England Journal of Medicine (2), there was no robust evaluation of disease-free or overall survival rates in women with early-stage cervical cancer (FIGO stage IA1 to IB1) treated with the use of either laparatomy or minimal-access surgery (laparoscopic or robot-assisted). In that randomized clinical trial, which included patients with early-stage cervical cancer assigned to either minimally invasive surgery (n = 319) or open surgery (n = 312), minimally invasive radical hysterectomy was associated with lower rates of disease-free and overall survival than open abdominal radical hysterectomy.
Source: Fertility and Sterility - Category: Reproduction Medicine Authors: Tags: Inklings Source Type: research

Related Links:

The Laparoscopic Approach to Cervical Cancer (LACC) trial [1] keeps stirring emotions and discussions [2 –6]. The LACC trial can be criticized [7] because the surgical proficiency and the adequacy of the laparoscopic radical hysterectomy was not adequately evaluated, because radicality was not appropriately assessed, and because of the poorly defined inclusion of type II and type III surgery. However , our impression is that the main reason for this ongoing debate is because the LACC trial was a randomized controlled trial (RCT) and because many of us do not like or are not ready to accept the results.
Source: The Journal of Minimally Invasive Gynecology - Category: OBGYN Authors: Tags: Letter to the Editor Source Type: research
Publication date: Available online 3 July 2019Source: Journal of Minimally Invasive GynecologyAuthor(s): Sadikah Behbehani, Elena Suarez-Salvador, Matthew Buras, Paul Magtibay, Javier MagrinaABSTRACTObjectiveTo review early operative mortality (
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
Authors: Kim M, Kong TW, Kim S, Kim SC, Kim YB, Kim JW, Park JY, Suh DH, Shim SH, Lee KH, Lee SJ, Lee JK, Lim MC Abstract On the basis of emerging data and the current understanding of minimally invasive surgery (MIS) for radical hysterectomy (RH) in women with cervical cancer, the Korean Society of Gynecologic Oncology, Korean Society of Obstetrics and Gynecology, and Korean Society of Gynecologic Endoscopy and Minimally Invasive Surgery support the following recommendations: According to the recently published phase III Laparoscopic Approach to Cervical Cancer (LACC) trial-a prospective randomized clinical trial-...
Source: Journal of Gynecologic Oncology - Category: OBGYN Tags: J Gynecol Oncol Source Type: research
Publication date: Available online 3 July 2019Source: Journal of Minimally Invasive GynecologyAuthor(s): Sadikah Behbehani, Elena Suarez-Salvador, Matthew Buras, Paul Magtibay, Javier MagrinaAbstractObjectiveTo review early operative mortality (
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
We present two cases of primary SRCCC that were treated with robot-assisted laparoscopic radical hysterectomy (RALRH). Case 1 had stage IB2 cervical adenocarcinoma, in which signet ring cell (SRC) was predominant. As adjuvant chemotherapy was not successful, she twice underwent surgical excision of recurrent tumors in pararectal lymph node and periureteral space 11  months and 27 months after RALRH, respectively. There were only SRCs observed in recurrent tumors. Case 2 had stage IB1 cervical adenocarcinoma, in which SRCs were detected only in the biopsy specimen, and no relapse occurred at 15 months after R...
Source: International Cancer Conference Journal - Category: Cancer & Oncology Source Type: research
Authors: Bogani G, Rossetti D, Ditto A, Martinelli F, Chiappa V, Leone C, Leone Roberti Maggiore U, Lorusso D, Raspagliesi F Abstract OBJECTIVES: Nerve-sparing radical hysterectomy has been implemented in order to reduce pelvic floor dysfunctions in women undergoing radical surgery for cervical cancer. Here, we aimed to investigate if the adoption of laparoscopic surgery impacts on patients' outcomes. METHODS: Data of consecutive patients affected by cervical cancer who had laparoscopic nerve-sparing radical hysterectomy were matched 1:1 with an historical cohort of patients undergoing open procedure. A propens...
Source: Journal of Gynecologic Oncology - Category: OBGYN Tags: J Gynecol Oncol Source Type: research
Authors: Pennington KP, Urban RR, Gray HJ Abstract Minimally invasive surgery (MIS) was previously considered an acceptable alternative to open radical hysterectomy in the management of early-stage cervical cancer (ESCC), but adequately powered, high-quality prospective trials evaluating survival outcomes were lacking. Recently, a large randomized phase III trial, the Laparoscopic Approach to Cervical Cancer (LACC) trial, showed that MIS for ESCC is associated with a higher risk of recurrence and death compared with open surgery. We review the LACC trial findings in depth, as well as a recent National Cancer Databa...
Source: Journal of the National Comprehensive Cancer Network : JNCCN - Category: Cancer & Oncology Tags: J Natl Compr Canc Netw Source Type: research
Abstract OBJECTIVE: To compare survival outcomes of minimally invasive surgery (MIS) and conventional open surgery for radical hysterectomy (RH) among patients with early-stage cervical cancer (CC). METHODS: We retrospectively identified stage IB1-IIA2 CC patients who underwent either laparoscopic or open Type C RH between 2000 and 2018. Patients' clinicopathologic characteristics and survival outcomes were compared according to the surgical approach. For a more robust statistical analysis, we narrowed the study population down to the patients with stage IB1 who underwent pre-operative MRI. RESULTS: In t...
Source: Gynecologic Oncology - Category: Cancer & Oncology Authors: Tags: Gynecol Oncol Source Type: research
Abstract OBJECTIVE: Report the up-to-date trends in surgical approach for cervical cancer and compare outcomes between open and minimally invasive routes. METHODS: Radical Hysterectomy (RH) cases from the National Inpatient Sample (NIS) dataset between 2012 and 2015 were grouped into abdominal (ARH) and Minimally Invasive Surgery (MIS). The MIS group was subdivided as "Laparoscopic", "Robotic", and "Converted". Univariate and multivariable logistic regression were used to analyze differences in complication rates. The National Surgical Quality Improvement Dataset 2015 was used fo...
Source: Gynecologic Oncology - Category: Cancer & Oncology Authors: Tags: Gynecol Oncol Source Type: research
Opinion statementThe main advancement in the surgical treatment of early cervical cancer has been a de-escalation in the radical surgical approach of early stage disease. Similarly, sentinel lymph node detection with cervical tracer injection can be performed alone in microscopic tumors (stage IA) while additional lymphadenectomy is still performed in macroscopic tumors (IB1 and IIA). Parametrial resection has been progressively reduced in tumors less than 2  cm, and simple procedures, conservative (trachelectomy) or not (simple hysterectomy), are currently being evaluated in several phase III trials. Since the prelim...
Source: Current Treatment Options in Oncology - Category: Cancer & Oncology Source Type: research
More News: Cancer | Cancer & Oncology | Cervical Cancer | Clinical Trials | Hysterectomy | Laparoscopy | Minimally Invasive Surgery | Reproduction Medicine | Study | Women