Treatment interval in curative treatment of colon cancer, does it impact (cancer free) survival? A non-inferiority analysis.

BACKGROUND: In treatment of colon cancer, strict waiting-time targets are enforced, leaving professionals no room to lengthen treatment intervals when advisable, for instance to optimise a patient's health status by means of prehabilitation. Good quality studies supporting these targets are lacking. With this study we aim to establish whether a prolonged treatment interval is associated with a clinically relevant deterioration in overall and cancer free survival. METHODS: This retrospective multicenter non-inferiority study includes all consecutive patients who underwent elective oncological resection of a biopsy-proven primary non-metastatic colon carcinoma between 2010 and 2016 in six hospitals in the Southern Netherlands. Treatment interval was defined as time between diagnosis and surgical treatment. Cut-off points for treatment interval were ≤35 days and ≤49 days. FINDINGS: 3376 patients were included. Cancer recurred in 505 patients (15.0%) For cancer free survival, a treatment interval >35 days and >49 days was non-inferior to a treatment interval ≤35 days. Results for overall survival were inconclusive, but no association was found. CONCLUSION: For cancer free survival, a prolonged treatment interval, even over 49 days, is non-inferior to the currently set waiting-time target of ≤35 days. Therefore, the waiting-time targets set as fundamental objective in current treatment guidelines should become directional instead of strict targets.

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study).

BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.

Mesh OR Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS-Trial): The Complete Two-year Follow-up.

OBJECTIVE: The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complications. Complications such as an extended operation duration, additional use of painkillers, reoperation, infection, seroma, extended wound care, extended hospitalization, and early recurrence were reported according to the Clavien-Dindo grading system. SUMMARY BACKGROUND DATA: Over the years mesh repair is proven the gold standard for umbilical and epigastric hernias. The question remains, which mesh should be used? METHODS: In this randomized controlled, multicenter trial, all patients ≥ 18 years with a single, symptomatic, and primary small umbilical or epigastric hernia qualified for inclusion. Flat preperitoneal polypropylene mesh repair was compared with patch repair (PROCEED Ventral Patch) (PVP). RESULTS: A total of 352 patients were randomized; 348 patients received the intervention (n = 177 PVP vs n = 171 mesh). One out of 4 suffered from any kind of complication within 2 years postoperative (27.6%). A significant difference in complications was seen, in favor of polypropylene mesh repair (P = 0.044, 22.1% mesh vs 32.5% PVP). Reoperation was performed in 19 PVP operated patients (10.7%) versus 7 patients with polypropylene mesh repair (4.0%, P = 0.021).No significant differences were seen in recurrences (n = 13, 8.4% PVP vs n = 6, 4.1% mesh, P = 0.127). CONCLUSIONS: In small epigastric and small umbilical hernia repair a flat polypropylene mesh repair was associated with a lower complication rate than PVP repair. No differences in recurrence rates were seen. Combining all complications, the preperitoneal positioned flat polypropylene mesh performed better.

Transanal Endoscopic Microsurgery with or without Completion Total Mesorectal Excision for T2 and T3 Rectal Carcinoma.

AIM: Transanal endoscopic microsurgery (TEM) is used for the resection of large rectal adenomas and well or moderately differentiated T1 carcinomas. Due to difficulty in preoperative staging, final pathology may reveal a carcinoma not suitable for TEM. Although completion total mesorectal excision is considered standard of care in T2 or more invasive carcinomas, this completion surgery is not always performed. The purpose of this article is to evaluate the outcome of patients after TEM-only, when completion surgery would be indicated. METHODS: In this retrospective multicenter, observational cohort study, outcome after TEM-only (n = 41) and completion surgery (n = 40) following TEM for a pT2-3 rectal adenocarcinoma was compared. RESULTS: Median follow-up was 29 months for the TEM-only group and 31 months for the completion surgery group. Local recurrence rate was 35 and 11% for the TEM-only and completion surgery groups respectively. Distant metastasis occurred in 16% of the patients in both groups. The 3-year overall survival was 63% in the TEM-only group and 91% in the completion surgery group respectively. Three-year disease-specific survival was 91 versus 93% respectively. CONCLUSIONS: Although local recurrence after TEM-only for pT2-3 rectal cancer is worse compared to the recurrence that occurs after completion surgery, disease-specific survival is comparable between both groups. The lower unadjusted overall survival in the TEM-only group indicates that TEM-only may be a valid alternative in older and frail patients, especially when high morbidity of completion surgery is taken into consideration. Nevertheless, completion surgery should always be advised when curation is intended.

The end of robot-assisted laparoscopy? A critical appraisal of scientific evidence on the use of robot-assisted laparoscopic surgery.

BACKGROUND: Robot-assisted laparoscopy has been used in a wide variety of surgical fields; however, the financial costs involved are high and convincing proof of superiority in terms of quality of life, cost effectiveness and survival is often lacking. Possibly, there might be small benefits for the patient or for the surgeon's health that might warrant the use of robotics in limited fields of surgery. METHODS: We performed a critical appraisal of the literature, searching for scientific evidence supporting the use of robotics in daily laparoscopic surgery. RESULTS: Convincing evidence supporting the use of robotics is lacking. CONCLUSION: In an era of worldwide economic crisis, it is about time to start a critical discussion as to whether we should drastically limit, or even abandon, the use of robot-assisted laparoscopic surgery and focus on more cost-effective strategies of healthcare improvement. We suggest the use of robotics should be limited to well-powered, randomized clinical trials in a limited field of research.

Relax, it's just laparoscopy! A prospective randomized trial on heart rate variability of the surgeon in robot-assisted versus conventional laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic surgery might be beneficial for the patient, but it imposes increased physical and mental strain on the surgeon. Robot-assisted laparoscopic surgery addresses some of the laparoscopic drawbacks and may potentially reduce mental strain. This could reduce the risk of surgeon's fatigue, mishaps and strain-induced illnesses, which may eventually improve the safety of laparoscopic surgical procedures. METHODS: To test this hypothesis, a randomized study was performed, comparing both heart rate and heart rate variability (HRV) of the surgeon as a measure of total and mental strain, respectively, during conventional and robot-assisted laparoscopic cholecystectomy. RESULTS: Both heart rate and HRV (the low-frequency band/high-frequency band ratio) were significantly decreased when using robotic assistance. CONCLUSIONS: These data suggest the use of the daVinci® Surgical System leads to less physical and mental strain of the surgeon during surgery. However, assessing mental strain by means of HRV is cumbersome since there is no clear cutoff point or scale for maximum tolerated strain levels and its related effects on surgeon's health.

Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial.

BACKGROUND: Evidence is accumulating that, similar to other ventral hernias, umbilical and epigastric hernias must be mesh repaired. The difficulties involved in mesh placement and in mesh-related complications could be the reason many small abdominal hernias are still primary closed. In laparoscopic repair, a mesh is placed intraperitoneally, while the most common procedure is open surgery is pre-peritoneal mesh placement. A recently developed alternative method is the so-called patch repair, in this approach a mesh can be placed intraperitoneally through open surgery. In theory, such patches are particularly suitable for small hernias due to a reduction in the required dissection. This simple procedure is described in several studies. It is still unclear whether this new approach is associated with an equal risk of recurrence and complications compared with pre-peritoneal meshes. The material of the patch is in direct contact with intra-abdominal organs, it is unknown if this leads to more complications. On the other hand, the smaller dissection in the pre-peritoneal plane may lead to a reduction in wound complications. METHODS/DESIGN: 346 patients suffering from an umbilical or epigastric hernia will be included in a multi-centre patient-blinded trial, comparing mesh repair with patch repair. Randomisation will take place for the two operation techniques. The two devices investigated are a flat pre-peritoneal mesh and a Proceed Ventral Patch®. Stratification will occur per centre. Post-operative evaluation will take place after 1, 3, 12 and 24 months. The number of complications requiring treatment is the primary endpoint. Secondary endpoints are Verbal Descriptor Scale (VDS) pain score and VDS cosmetic score, operation duration, recurrence and costs. An intention to treat analysis will be performed. DISCUSSION: This trial is one of the first in its kind, to compare different mesh devices in a randomized controlled setting. The results will help to evaluate mesh repair for epigastric an umbilical hernia, and find a surgical method that minimizes the complication rate. TRIAL REGISTRATION: Netherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10.

Primary Lumbar Hernia, Review and Proposals for a Standardized Treatment.

A lumbar abdominal wall hernia is a protrusion of intraperitoneal or extraperitoneal contents through a weakness in the posterior abdominal wall, usually through the superior or inferior lumbar triangle. Due to its rare occurrence, adequate knowledge of anatomy and methods for optimal diagnosis and treatment might be lacking with many surgeons. We believe a clear understanding of anatomy, a narrative review of the literature and a pragmatic proposal for a step-by-step approach for treatment will be helpful for physicians and surgeons confronted with this condition. We describe the anatomy of this condition and discuss the scarce literature on this topic concerning optimal diagnosis and treatment. Thereafter, we propose a step-by-step approach for a surgical technique supported by intraoperative images to treat this condition safely and prevent potential pitfalls. We believe this approach offers a technically easy way to perform effective reinforcement of the lumbar abdominal wall, offering a low recurrence rate and preventing important complications. After meticulously reading this manuscript and carefully following the suggested approach, any surgeon that is reasonably proficient in minimally invasive abdominal wall surgery (though likely not in lumbar hernia surgery), should be able to treat this condition safely and effectively. This manuscript cannot replace adequate training by an expert surgeon. However, we believe this condition occurs so infrequently that there is likely to be a lack of real experts. This manuscript could help guide the surgeon in understanding anatomy and performing better and safer surgery.

Ultrasound-guided abdominal wall infiltration versus freehand technique in anterior cutaneous nerve entrapment syndrome (ACNES): randomized clinical trial.

BACKGROUND: The optimal technique of abdominal wall infiltration for chronic abdominal wall pain due to anterior cutaneous nerve entrapment syndrome (ACNES) is unknown. The aim of this study was to compare pain reduction after an abdominal wall anaesthetic injection by use of an ultrasound-guided technique (US) or given freehand (FH). METHODS: In this multicentre non-blinded randomized trial, adult patients with ACNES were randomized (1:1) to an US or a FH injection technique. Primary outcome was the proportion of injections achieving a minimum of 50 per cent pain reduction on the Numeric Rating Scale (range 0-10) 15-20 min after abdominal wall infiltration ('successful response'). Secondary outcomes were treatment efficacy after 6 weeks and 3 months, and the influence of the subcutaneous tissue thickness on treatment outcome. RESULTS: Between January 2018 and April 2020, 391 injections (US = 192, FH = 199) were administered in 117 randomized patients (US = 55, FH = 62; 76.0 per cent female, mean age 45 years). The proportion of successful responses did not significantly differ immediately after the injection regimen (US 27.1 per cent versus FH 33.2 per cent; P = 0.19) or after 3 months (US 29.4 per cent versus FH 30.5 per cent; P = 0.90). Success was not determined by subcutaneous tissue thickness. CONCLUSION: Pain relief following abdominal wall infiltration by a US or FH technique in ACNES is similar and not influenced by subcutaneous tissue thickness. REGISTRATION NUMBER: Dutch Clinical Trial Register NL8465.

Recurrence and functional results after open versus conventional laparoscopic versus robot-assisted laparoscopic rectopexy for rectal prolapse: a case-control study.

PURPOSE: This study was designed to evaluate recurrence and functional outcome of three surgical techniques for rectopexy: open (OR), laparoscopic (LR), and robot-assisted (RR). A case-control study was performed to study recurrence after the three operative techniques used for rectal procidentia. The secondary aim of this study was to examine the differences in functional results between the three techniques. MATERIALS AND METHODS: All consecutive patients who underwent a rectopexy between January 2000 and September 2006 enrolled in this study. Peri-operative data were collected from patient records and functional outcome was assessed by telephonic questionnaire. RESULTS: Eighty-two patients (71 females, mean age 56.4 years) underwent a rectopexy for rectal procidentia. Nine patients (11%) had a recurrence; one (2%) after OR, four (27%) after LR, and four (20%) after RR. RR showed significantly higher recurrence rates when controlled for age and follow-up time compared to OR, (p = 0.027), while LR showed near-significant higher rates (p = 0.059). Functional results improved in all three operation types, without a difference between them. CONCLUSIONS: LR and RR are adequate procedures but have a higher risk of recurrence. A RCT is needed assessing the definitive role of (robotic assistance in) laparoscopic surgery in rectopexy.

Camera navigation and tissue manipulation; are these laparoscopic skills related?

BACKGROUND: It is a tacit assumption that clinically based expertise in laparoscopic tissue manipulation entails skilfulness in angled laparoscope navigation. The main objective of this study was to investigate the relation between these skills. To this end, face and construct validity had to be established for the place arrow (PA) and camera navigation (CN) tasks on the SimSurgery SEP. METHODS: Thirty-three novices (no laparoscopy experience) and 33 experienced participants (>50 laparoscopic procedures and familiar with angled laparoscopy) performed both tasks twice, on one of two hardware platforms (SimSurgery SimPack or Xitact/Mentice IHP), and rated the realism and didactic value of SimSurgery SEP on five-point scales. RESULTS: Both tasks were rated by the experienced participants as realistic (CN: 3.7; PA: 4.1) and SimSurgery SEP as a user-friendly environment to train basic skills (4.1). Both tasks were performed in less time by the experienced group, with shorter tip trajectories. For both groups jointly, the time to accomplish each task correlated with the tip trajectory and also with the time and tip trajectories of the opposite task (Spearman's correlation, p

Expert and construct validity of the Simbionix GI Mentor II endoscopy simulator for colonoscopy.

OBJECTIVES: The main objectives of this study were to establish expert validity (a convincing realistic representation of colonoscopy according to experts) and construct validity (the ability to discriminate between different levels of expertise) of the Simbionix GI Mentor II virtual reality (VR) simulator for colonoscopy tasks, and to assess the didactic value of the simulator, as judged by experts. METHODS: Four groups were selected to perform one hand-eye coordination task (EndoBubble level 1) and two virtual colonoscopy simulations on the simulator; the levels were: novices (no endoscopy experience), intermediate experienced (<200 colonoscopies performed before), experienced (200-1,000 colonoscopies performed before), and experts (>1,000 colonoscopies performed before). All participants filled out a questionnaire about previous experience in flexible endoscopy and appreciation of the realism of the colonoscopy simulations. The average time to reach the cecum was defined as one of the main test parameters as well as the number of times view of the lumen was lost. RESULTS: Novices (N = 35) reached the cecum in an average time of 29:57 (min:sec), intermediate experienced (N = 15) in 5:45, experienced (N = 20) in 4:19 and experts (N = 35) in 4:56. Novices lost view of the lumen significantly more often compared to the other groups, and the EndoBubble task was also completed significantly faster with increasing experience (Kruskal Wallis Test, p < 0.001). The group of expert endoscopists rated the colonoscopy simulation as 2.95 on a four-point scale for overall realism. Expert opinion was that the GI Mentor II simulator should be included in the training of novice endoscopists (3.51). CONCLUSION: In this study we have demonstrated that the GI Mentor II simulator offers a convincing realistic representation of colonoscopy according to experts (expert validity) and that the simulator can discriminate between different levels of expertise (construct validity) in colonoscopy. According to experts the simulator should be implemented in the training programme of novice endoscopists.

Learning curves of robot-assisted laparoscopic surgery compared with conventional laparoscopic surgery: an experimental study evaluating skill acquisition of robot-assisted laparoscopic tasks compared with conventional laparoscopic tasks in inexperienced users.

BACKGROUND: Laparoscopic surgery can be demanding, resulting in longer operating time and a longer time before reaching proficiency compared with open surgery. Robotic assistance allows stereoscopic vision and improves dexterity, potentially leading to faster and safer laparoscopic surgery and a shortening of the learning curve. METHODS: Duration and accuracy were measured in inexperienced participants, performing basic and advanced laparoscopic tasks using both conventional laparoscopy and the daVinci Surgical System. RESULTS: Eight participants performed 176 laparoscopic tasks. Robotic assistance resulted in faster and more accurate performance of laparoscopic tasks. However, conventional laparoscopy showed faster skill acquisition. CONCLUSIONS: Robotic assistance resulted in faster and more accurate performance of laparoscopic tasks. However, learning curves favored conventional laparoscopy. These data suggest robotic assistance might be most beneficial in inexperienced subjects. The relatively flat learning curve in robot-assisted laparoscopy suggests robotic assistance might be less (or marginally) beneficial in experienced surgeons. This could explain why robotic assistance has failed to show clear benefit in several clinical studies. Extensive conventional laparoscopic training might lead to faster, safer, and less expensive surgery, further marginalizing the role for robotic assistance in laparoscopic surgery.

Robot-assisted versus conventional laparoscopic Nissen fundoplication: a comparative retrospective study on costs and time consumption.

BACKGROUND: Laparoscopic Nissen fundoplication offers clear benefits for our patients, but requires advanced laparoscopic skills. Robotic assistance in laparoscopic antireflux surgery improves dexterity skills and shortens learning curve, possibly leading to faster, more precise, and safer laparoscopic surgery. METHODS: We review our first 11 cases of robot-assisted laparoscopic Nissen fundoplication using the 4-armed daVinci surgical system, comparing them with patients who underwent conventional laparoscopic Nissen fundoplication for gastroesophageal reflux disease in the same period. RESULTS: Robot-assisted laparoscopic Nissen fundoplication did not result in more complications. However, the use of robotic assistance took an extra-47 minutes to complete the operation and costs were raised with an accessory euro 987.47. CONCLUSIONS: The use of robotic assistance in laparoscopic antireflux surgery is safe and feasible, but results in longer operating time and higher costs compared with conventional laparoscopic surgery without proven benefit at this moment.

[Acute appendicitis with goblet cell carcinoid]. / Acute appendicitis bij een slijmbekercelcarcinoïd.

A 43-year-old man presented at the emergency room with continuous right lower quadrant abdominal pain. The pain started the previous day. Physical and laboratory examination indicated acute appendicitis. The patient underwent an appendicectomy of the inflamed appendix with periappendicular infiltrate. However, histological examination revealed a small goblet cell carcinoid, histological group C, with acute inflammation. The patient then underwent laparoscopic right hemicolectomy. Several tumour cells were present in a lymph duct at the appendix base. Without histological examination such a rare diagnosis can easily be missed. The treatment should be based also on the histological classification.

Robot-assisted vs. conventional laparoscopic rectopexy for rectal prolapse: a comparative study on costs and time.

PURPOSE: Laparoscopic rectopexy has become one of the most advocated treatments for full-thickness rectal prolapse, offering good functional results compared with open surgery and resulting in less postoperative pain and faster convalescence. However, laparoscopic rectopexy can be technically demanding. Once having mastered dexterity, with robotic assistance, laparoscopic rectopexy can be performed faster. Moreover, it shortens the learning curve in simple laparoscopic tasks. This may lead to faster and safer laparoscopic surgery. Robot-assisted rectopexy has been proven safe and feasible; however, until now, no study has been performed comparing costs and time consumption in conventional laparoscopic rectopexy vs. robot-assisted rectopexy. METHODS: Our first 14 cases of robot-assisted laparoscopic rectopexy were reviewed and compared with 19 patients who underwent conventional laparoscopic rectopexy in the same period. RESULTS: Robot-assisted laparoscopic rectopexy did not show more complications. However, the average operating time was 39 minutes longer, and costs were euro 557.29 (or: dollars 745.09) higher. CONCLUSION: Robot-assisted laparoscopic rectopexy is a safe and feasible procedure but results in increased time and higher costs than conventional laparoscopy.

First results after introduction of the four-armed da Vinci Surgical System in fully robotic laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy offers less post-operative pain, less complications, and faster recovery compared with open cholecystectomy. However, laparoscopic surgery can be demanding because of several technical drawbacks. Robotic surgery allows dexterity skills to be performed faster and shortens the learning curve, possibly leading to faster and safer laparoscopic surgery. METHODS: In this paper, we report the results of our first 12 cases of fully robotic laparoscopic cholecystectomy using the da Vinci Surgical System, comparing them with 12 cases of conventional laparoscopic cholecystectomy. Using a fourth arm in robotic laparoscopy enables the surgeon to perform surgery without the use of a tableside assistant, leading to non-tiring, tremble-free assistance and reducing salary costs. Primary end points are operating time and costs. Secondary end points are operative complications and duration of admission. RESULTS: Fully robotic cholecystectomy was completed in all 12 cases without increased complication rate and without conversions. However, robotic assistance results in an increased overall operating room stay of 31 min and increased costs of EUR 1,180.62. CONCLUSION: Fully robotic laparoscopic cholecystectomy is safe and feasible but seems more expensive and time consuming at this moment.