November 2023

The goal of this randomized controlled trial (RCT) was to assess disease-free survival after neoadjuvant chemotherapy alone as compared to neoadjuvant chemoradiotherapy for locally advanced rectal cancer. They found that neoadjuvant chemotherapy (with selective use of radiotherapy for poor responders) was non-inferior to neoadjuvant chemoradiotherapy.

Summary: Treatment with neoadjuvant chemoradiotherapy for locally advanced rectal cancer (LARC) is reported to reduce the risk of local recurrence to less than 10%. However, this must be balanced against the risk of pelvic fibrosis that can result from radiotherapy, and the concomitant potential poor quality of life and functional outcomes that may ensue. The PROSPECT trial was designed to test whether neoadjuvant FOLFOX alone, with selective use of chemoradiotherapy reserved for poor responders, would be noninferior to neoadjuvant chemoradiotherapy in patients with LARC that was amenable to sphincter-sparing surgery.

The trial included adults with LARC who were eligible for chemoradiotherapy followed by sphincter sparing surgery. Patients were randomized to either receive six cycles FOLFOX followed by surgery with omission of chemoradiotherapy, or to receive a standard chemoradiotherapy regimen followed by surgery. Patients in the FOLFOX group whose primary tumor did not respond to treatment (primary tumor had decreased in size by less than 20% on restaging) received chemoradiotherapy. The primary objective was to determine whether neoadjuvant FOLFOX with selective use of chemoradiotherapy would be noninferior to standard neoadjuvant chemoradiotherapy with the primary outcome being disease-free survival. Patients with T4 or N2 disease were excluded. 

A total of 1128 patients (585 in the FOLFOX group and 543 in the chemoradiotherapy group) began treatment and were included in the primary per-protocol analysis from June 2012 to December 2018. Median follow-up time was 58 months. FOLFOX with selective use of chemoradiotherapy was found to be noninferior to chemoradiotherapy with respect to disease-free survival (HR 0.92; 95% CI: 0.74 to 1.14; p=0.005 for noninferiority). Five-year disease-free survival was 80.8% in the FOLFOX group and 78.6% in the chemoradiotherapy group. The incidence of local recurrence at 5 years was 1.8% in the FOLFOX group and 1.6% in the chemoradiotherapy group. Among the patients assigned to receive neo¬adjuvant FOLFOX, 89.6% were ultimately able to avoid receiving chemoradiotherapy. Overall sur¬vival was also similar between the two treatment strategies.

While this study demonstrates that for the majority of patients with LARC, neoadjuvant radiotherapy can be omitted without compromising long-term oncologic outcomes, there are some important points to note. The current use of neoadjuvant radiotherapy for the treatment of rectal cancer historically comes from the treatment era prior to the total mesorectal excision (TME). Before universal adoption of TME, local recurrence rates for LARC were >20%, which are markedly higher than those seen today with the implementation of TME, even without neoadjuvant radiotherapy. In this context, modern use of radiotherapy may provide little benefit. Additionally, treatment regimens for LARC in North America differ from those in Europe. Specifically, many of the patients included in the PROSPECT trial (those with T3N0 disease) would have undergone upfront TME without any neoadjuvant therapy in Europe, and thus these T3N0 patients are viewed as being overtreated. That being said, this trial is an excellent example of how a one size fits all approach is not necessary for the treatment of rectal cancer, and how radiotherapy may be safely omitted for patients with favorable clinical staging on diagnosis. As we move into a new era of rectal cancer management, which is heavily based on tumor biology and treatment response, the PROSPECT trial brings us closer to tailoring the treatment plan to the patient.

Bottom line: In patient with locally advanced rectal cancer who are candidates for sphincter-sparing surgery, patients who receive neoadjuvant FOLFOX and selective use of pelvic chemoradiotherapy have similar disease-free survival compared to patients who receive neoadjuvant pelvic chemoradiotherapy, suggesting that we can potentially spare patients from the potential adverse effects of radiation in this disease. 

This study is a 13-year follow-up of a single-center, double-blind randomized controlled trial (RCT) of patients with sliding hiatal hernias who underwent hiatal hernia repair with Nissen fundoplication. The authors found that there was no difference in hiatal hernia recurrence rates between those patients who received mesh-based crural repair versus primary crural repair. 

Summary: The incidence of recurrent hiatal hernia after surgical repair occurs in as high as 66% of cases. The current study is a follow-up of a RCT of 159 patients with symptomatic GERD and sliding hiatal hernias >2cm who underwent hiatal hernia repair with Nissen fundoplication from 2006 to 2010. In the original study, patients were randomized to either a primary crural repair (77 patients) or PTFE mesh crural closure (82 patients) with their fundoplication. The primary study outcome was hiatal hernia recurrence, evaluated by barium swallow. Secondary outcomes included use of antireflux medication and dysphagia. At 1 year and 3 years of follow-up, there were no differences in recurrence rates between the two procedures, although more patients reported dysphagia to solid food after a mesh repair. 

In the current study, the authors interviewed 103 (65%) out of the original 159 patients (50 primary repair, 53 PTFE). Hernia recurrence was evaluated by CT scan in 64 patients (40%; 35 primary repair, 29 PTFE). There remained no difference in recurrent hernia rates between the two groups (31% primary repair, 38% PTFE), and patients who underwent a mesh repair continued to report higher rates of dysphagia to solid foods. 

The results of this study reinforce that routine use of mesh for crural closure does not decrease the rates of recurrent hiatal hernias. It is, however, worth noting that only patients with sliding hiatal hernias were included, and most patients had small hernias. As such, the results cannot be extrapolated to patients with larger para-esophageal hernias. Additionally, at 13 years of follow-up, recurrence rates were evaluated by CT scan, while in the original study, a barium swallow was utilized to assess recurrent hernia rates. However, the overall message remains that routine use of mesh for these patients can safely be avoided. 

Bottom line: Mesh-based crural repair during Nissen fundoplication for hiatal hernias offers no advantage in preventing hernia recurrence after surgery compared to primary crural repair.

This study aimed to assess the safety and efficacy of a standardized competency-based training program for groin hernia mesh repair in Sierra Leone. They found that, with appropriate training, hernia recurrence rates and mortality remain low and don’t differ between those who were training and those who completed training. 

Summary: Untreated, symptomatic hernias have a prevalence rate of about 2.5% in Sub-Saharan Africa. However, in these countries, inguinal hernias are typically repaired using tissue-only techniques as mesh is not readily available or affordable; additionally, many providers are not trained in the proper technique for mesh placement. Thus, the goal of this study was to test the effectiveness and safety of a standardized short-course competency-based training program for groin hernia mesh repair and look at the impact on post-operative clinical outcomes.

Both trainees and patients were study participants. Trainees included medical doctor (MDs), who are physicians that have completed at least one year of internship, including six months of general surgery training but are not in residency as well as associate clinicians (ACs), who have graduated from a two-year surgical training program followed by one-year internships. In order to be included, the MDs and ACs had to be able to independently perform an inguinal hernia repair. The patients included were men who were 18 years or older with a reducible inguinal hernia. The MDs and ACs were trained by 5 senior consultant general surgeons with training modules that covered theoretical and practical aspects of mesh-based hernia repair and a performance assessment using a structured rating system. The primary outcomes of this study were hernia recurrence and mortality within one year after repair. 

This research, conducted in three surgical camps from October 2017 to February 2018, involved 13 Sierra Leonean MDs (7) and ACs (6) as trainees. The trainees, with an average of 2.8 years of clinical experience post-graduation, had limited experience with mesh repair for inguinal hernias. Ultimately, 359 patients were recruited for the study, where 129 underwent surgery for training purposes of the trainees and 230 underwent surgery for trial purposes of the trainees. Patients who underwent surgery in the training group had twice as many wound infections requiring antibiotics versus the trial group (8.5% versus 3.1%, p = 0.041). However, there was no difference in recurrence after one year between the training and trial patients (5.4% versus 3.5%, p = 0.423). The mortality at one year also did not differ significantly (2.2% in trial group versus 3.9%, in training group, p=0.509), all cases of which were unrelated to the surgery and occurred more than 6 months after surgery. 

Limitations of this study are mainly related to limited resources. The small samples sizes were likely due to difficulty in recruitment, as MDs are often the only surgical-skilled doctor at their hospital and are too busy to participate. Additionally, many providers already had some skills as it relates to hernia surgery and therefore, there was learner bias in the standardized training programs. However, in the context of these limitations, this is a proof of concept that standardized training skill sessions may be feasible and safe in teaching non-specialty surgical providers a procedure that is much needed in low-income, low-resourced countries. 

Bottom line: Short course, hands-on standardized skill training programs provide a practical option for low-income, low-resourced countries in need of more advanced surgical procedures within certain areas of surgery.