There is ongoing debate whether laparoscopic right colectomy is superior to open surgery. The purpose of this study was to address this issue and arrive at a consensus using data from a national ...database.
Patients who underwent elective open or laparoscopic right colectomy for colorectal cancer during the period 2009-2013 were identified from the Dutch Surgical Colorectal Audit. Complications that occurred within 30 days after surgery and 30-day mortality rates were calculated and compared between open and laparoscopic resection.
In total, 12,006 patients underwent elective open or laparoscopic surgery for right-sided colorectal cancer. Of these, 6,683 (55.7%) underwent open resection and 5,323 (44.3%) underwent laparoscopic resection. Complications occurred within 30 days after surgery in the laparoscopic group in 26.1% of patients and in 32.1% of patients in the open group (p < 0.001). Thirty-day mortality was also significantly lower in the laparoscopic group (2.2 vs. 3.6% p < 0.001).
In this non-randomized, descriptive study conducted in the Netherlands, open right colectomy seems to have a higher risk for complications and mortality as compared to laparoscopic right colectomy, even after correction for confounding factors.
Data from observational studies suggest that minimally invasive pancreatoduodenectomy (MIPD) is superior to open pancreatoduodenectomy regarding intraoperative blood loss, postoperative morbidity, ...and length of hospital stay, without increasing total costs. However, several case-matched studies failed to demonstrate superiority of MIPD, and large registry studies from the USA even suggested increased mortality for MIPDs performed in low-volume (<10 MIPDs annually) centers. Randomized controlled multicenter trials are lacking but clearly required. We hypothesize that time to functional recovery is shorter after MIPD compared with open pancreatoduodenectomy, even in an enhanced recovery setting.
LEOPARD-2 is a randomized controlled, parallel-group, patient-blinded, multicenter, phase 2/3, superiority trial in centers that completed the Dutch Pancreatic Cancer Group LAELAPS-2 training program for laparoscopic pancreatoduodenectomy or LAELAPS-3 training program for robot-assisted pancreatoduodenectomy and have performed ≥ 20 MIPDs. A total of 136 patients with symptomatic benign, premalignant, or malignant disease will be randomly assigned to undergo minimally invasive or open pancreatoduodenectomy in an enhanced recovery setting. After the first 40 patients (phase 2), the data safety monitoring board will assess safety outcomes (not blinded for treatment allocation) and decide on continuation to phase 3. Patients from phase 2 will then be included in phase 3. The primary outcome measure is time (days) to functional recovery. All patients will be blinded for the surgical approach, at least until postoperative day 5, but preferably until functional recovery has been attained. Secondary outcome measures are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life, and costs.
The LEOPARD-2 trial is designed to assess whether MIPD reduces time to functional recovery, as compared with open pancreatoduodenectomy in an enhanced recovery setting.
Netherlands Trial Register, NTR5689 . Registered on 2 March 2016.
Full text
Available for:
IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Venous resection of the superior mesenteric or portal vein is increasingly performed in pancreatic cancer surgery, whereas results of studies on short- and long-term outcomes are contradictory. The ...aim of this study was to evaluate the impact of the type of venous resection in pancreatoduodenectomy for pancreatic cancer on postoperative morbidity and overall survival.
This nationwide retrospective cohort study included all patients who underwent pancreatoduodenectomy for pancreatic cancer in 18 centres (2013-2017).
A total of 1311 patients were included, of whom 17 per cent underwent wedge resection and 10 per cent segmental resection. Patients with segmental resection had higher rates of major morbidity (39 versus 20 versus 23 per cent, respectively; P < 0.001) and portal or superior mesenteric vein thrombosis (18 versus 5 versus 1 per cent, respectively; P < 0.001) and worse overall survival (median 12 versus 16 versus 20 months, respectively; P < 0.001), compared to patients with wedge resection and those without venous resection. Multivariable analysis showed patients with segmental resection, but not those who had wedge resection, had higher rates of major morbidity (odds ratio = 1.93, 95 per cent c.i. 1.20 to 3.11) and worse overall survival (hazard ratio = 1.40, 95 per cent c.i. 1.10 to 1.78), compared to patients without venous resection. Among patients who received neoadjuvant therapy, there was no difference in overall survival among patients with segmental and wedge resection and those without venous resection (median 32 versus 25 versus 33 months, respectively; P = 0.470), although there was a difference in major morbidity rates (52 versus 19 versus 21 per cent, respectively; P = 0.012).
In pancreatic surgery, the short- and long-term outcomes are worse in patients with venous segmental resection, compared to patients with wedge resection and those without venous resection.
Full text
Available for:
BFBNIB, FZAB, GIS, IJS, KILJ, NUK, OILJ, SBCE, SBMB, UL, UPUK
Practice variation exists in venous resection during pancreatoduodenectomy, but little is known about the potential causes and consequences as large studies are lacking. This study explores the ...potential causes and consequences of practice variation in venous resection during pancreatoduodenectomy for pancreatic cancer in the Netherlands.
This nationwide retrospective cohort study included patients undergoing pancreatoduodenectomy for pancreatic cancer in 18 centers from 2013 through 2017.
Among 1,311 patients undergoing pancreatoduodenectomy, 351 (27%) had a venous resection, and the overall median annual center volume of venous resection was 4. No association was found between the center volume of pancreatoduodenectomy and the rate of venous resections, nor between patient and tumor characteristics and the rate of venous resections per center. Female sex, lower body mass index, neoadjuvant therapy, venous involvement, and stenosis on imaging were predictive for venous resection. Adjusted for these factors, 3 centers performed significantly more, and 3 centers performed significantly fewer venous resections than expected. In patients with venous resection, significantly less major morbidity (22% vs 38%) and longer overall survival (median 16 vs 12 months) were observed in centers with an above-median annual volume of venous resections (>4).
Patient and tumor characteristics did not explain significant practice variation between centers in the Netherlands in venous resection during pancreatoduodenectomy for pancreatic cancer. The clinical outcomes of venous resection might be related to the volume of the procedure.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The systemic inflammatory response seen after surgery seems to be related to postoperative complications. A reduction of the inflammatory response through minimally invasive surgery might therefore ...be the mechanism via which postoperative outcome could be improved. The aim of this study was to investigate if postoperative inflammatory markers differed between laparoscopic (LPD) and open pancreatoduodenectomy (OPD) and if there was a relationship between inflammatory markers and the occurrence of postoperative complications.
A side study of the multicenter randomized controlled LEOPARD-2 trial comparing LPD to OPD was performed. Area under the curve (AUC) for plasma inflammatory markers, including interleukin (IL-) 6, IL-8 and C reactive protein (CRP) levels, were determined during the first 96 postoperative hours and compared between LPD and OPD, Clavien-Dindo ≥ III complications, and postoperative pancreatic fistula (POPF) grade B/C.
Overall, 38 patients were included (18 LPD and 20 OPD). The median AUC of IL-6 was 627 (195–1378) after LPD vs. 338 (175–694)pg/mL after OPD, (p = 0.114). The AUC of IL-8 and CRP were comparable. IL-6 levels were higher in patients with a Clavien-Dindo ≥ III complication (634309–1489 vs. 297 171–680, p = 0.034) and POPF grade B/C (994 534–3265 vs. 334 173–704, p = 0.003). In patients with a POPF grade B/C, IL-6 levels tended to be higher after LPD, as compared to OPD (3533IQR 1133–3533 vs. 715IQR 39–1658, p = 0.053).
LPD, as compared to OPD, did not reduce the postoperative inflammatory response. IL-6 levels were associated with postoperative complications and pancreatic fistula.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background
Centralization of pancreatic surgery in high-volume hospitals is under debate in many countries. In the western part of the Netherlands, the professional network of surgical oncologists ...agreed to centralize all pancreatic surgery from 2006 in two high-volume hospitals. Our aim is to evaluate whether centralization of pancreatic surgery has improved clinical outcomes and has changed referral patterns.
Materials and Methods
Data of the Comprehensive Cancer Centre West (CCCW) of all 249 patients who had a resection for suspected pancreatic cancer between 1996 and 2008 in the western part of the Netherlands were analyzed. Multivariable modeling was used to evaluate survival for 3 time periods; 1996–2000, 2001–2005 (introduction of quality standards), and 2006–2008 (after centralization). In addition, the differences in referral pattern were analyzed.
Results
From 2006, all pancreatic surgery was centralized in 2 hospitals. The 2-year survival rate increased after centralization from 39% to 55% (
P
= .09) for all patients who had a pancreatic resection for pancreatic cancer. After adjustment for age, tumor location, stage, histology, and adjuvant treatment, the latter period was significantly associated with improved survival (hazard ratio HR 0.50; 95% confidence interval 95% CI 0.34–0.73).
Conclusions
Centralization of pancreatic surgery was successful and has resulted in improved clinical outcomes in the western part of the Netherlands, demonstrating the effectiveness of centralization.
Full text
Available for:
EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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.
Laparoscopic pancreatoduodenectomy with open reconstruction (LPD-OR) has been suggested to lower the rate of postoperative pancreatic fistula reported after laparoscopic pancreatoduodenectomy with ...laparoscopic reconstruction (LPD). Propensity score matched studies are, lacking.
This is a multicenter prospective cohort study including patients from 7 Dutch centers between 2014–2018. Patients undergoing LPD-OR were matched LPD patients in a 1:1 ratio based on propensity scores. Main outcomes were postoperative pancreatic fistulas (POPF) grade B/C and Clavien-Dindo grade ≥3 complications.
A total of 172 patients were included, involving the first procedure for all centers. All 56 patients after LPD-OR could be matched to a patient undergoing LPD. With LPD-OR, the unplanned conversion rate was 21% vs. 9% with LPD (P < 0.001). Median blood loss (300 vs. 400 mL, P = 0.85), operative time (401 vs. 378 min, P = 0.62) and hospital stay (10 vs. 12 days, P = 0.31) were comparable for LPD-OR vs. LPD, as were Clavien-Dindo grade ≥3 complications (38% vs. 52%, P = 0.13), POPF grade B/C (23% vs. 21%, P = 0.82), and 90-day mortality (4% vs. 4%, P > 0.99).
In this propensity matched cohort performed early in the learning curve, no benefit was found for LPD-OR, as compared to LPD.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Epidural analgesia is the international standard for pain treatment in abdominal surgery. Although some studies have advocated continuous wound infiltration with local anaesthetics, robust evidence ...is lacking, especially on patient-reported outcome measures. We aimed to determine the effectiveness of continuous wound infiltration in hepato-pancreato-biliary surgery.
In this randomised controlled, open label, non-inferiority trial (POP-UP), we enrolled adult patients undergoing hepato-pancreato-biliary surgery by subcostal or midline laparotomy in two Dutch hospitals. Patients were centrally randomised (1:1) to receive either pain treatment with continuous wound infiltration using bupivacaine plus patient-controlled analgesia with morphine or to receive (patient-controlled) epidural analgesia with bupivacaine and sufentanil. All patients were treated within an enhanced recovery setting. Randomisation was stratified by centre and type of incision. The primary outcome was the mean Overall Benefit of Analgesic Score (OBAS) from day 1-5, a validated composite endpoint of pain scores, opioid side-effects, and patient satisfaction (range 0 best to 28 worst). Analysis was per-protocol. The non-inferiority limit of the mean difference was + 3·0. This trial is registered with the Netherlands Trial Registry, number NTR4948.
Between Jan 20, 2015, and Sept 16, 2015, we randomly assigned 105 eligible patients: 53 to receive continuous wound infiltration and 52 to receive epidural analgesia. One patient in the continuous wound infiltration group discontinued treatment, as did five in the epidural analgesia group; of these five patients, preoperative placement failed in three (these patients were treated with continuous wound infiltration instead), one patient refused an epidural, and data for the primary endpoint was lost for one. Thus, 55 patients were included in the continuous wound infiltration group and 47 in the epidural analgesia group for the per-protocol analyses. Mean OBAS was 3·8 (SD 2·4) in the continuous wound infiltration group versus 4·4 (2·2) in the epidural group (mean difference -0·62, 95% CI -1·54 to 0·30). Because the upper bound of the one-sided 95% CI did not exceed +3·0, non-inferiority was shown. Four (7%) patients in the continuous wound infiltration group and five (11%) of those in the epidural group had an adverse event. One patient in the continuous wound infiltration group had a serious adverse event (temporary hypotension and arrhythmia after bolus injection); no serious adverse events were noted in the epidural group.
These data suggest that continuous wound infiltration is non-inferior to epidural analgesia in hepato-pancreato-biliary surgery within an enhanced recovery setting. Further large-scale trials are required to make a definitive assessment of non-inferiority.
Academic Medical Centre, Amsterdam, Netherlands.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract
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.
PDF
