Prospective Randomized Comparison Research Articles

FIRST STEPS - a randomized controlled trial on the evaluation of the implementation and effectiveness of two early prevention programs for promoting the social integration and a healthy development of children with an immigrant background from 0-3.

BackgroundThe social integration of children with an immigrant background has become one of the most urgent social responsibilities in Germany. They are more likely to live in high-risk environments and are disadvantaged with respect to health related variables as well as educationally. Quite a number of projects supporting their integration into the German society exist although many are hardly scientifically evaluated. Most of them focus on the acquisition of German language and therefore address older children (and adults). However, international experts agree that social integration is not only a matter of language but also of earlier developmental processes of children in their first months of life connected to adequate early parenting.Methods/DesignThe model project FIRST STEPS focuses on earliest prevention for children with an immigrant background, supporting their parents in the critical phase of migration and early parenthood. In a prospective randomized comparison group design the effectiveness of a psychoanalytically oriented early prevention program (intervention A) is compared to the outcomes of groups offered by paraprofessionals with an immigrant background (intervention B). Intervention A is a professional offer supporting immigrant families based on developmental psychological and on knowledge on early parenting. 180 families are randomly assigned to intervention A or B. They are supported during the first 3 years of the children’s lives. Social and family stressors, the quality of the parent–child-interaction, child attachment security, the affective, cognitive and social-emotional development of the children and the social integration of the families are assessed during and after the intervention.DiscussionThe project aims at evaluating the implementation as well as the short- and long-term effectiveness of psychoanalytically oriented intervention A compared to the outcomes of intervention B. It is expected that professionally supported early parenting (intervention A) improves the social-emotional, cognitive and language development of immigrant children as well as the social integration of their families to a greater extent than in the comparison groups. In case the model project proves to be effective, a rollout across Germany is possible. Due to the “difficult-to-reach” immigrant families challenges in recruitment, uptake and retention of participants are anticipated.Trial registrationDRKS-ID: DRKS00004632, trial registration date: 05.02.2013

Prospective Comparison Study Between the Fluoroscopy-guided and Navigation Coupled With O-arm–guided Pedicle Screw Placement in the Thoracic and Lumbosacral Spines

This is a prospective randomized comparison study between the fluoroscopy-guided and navigation coupled with O-arm-guided pedicle screw placement in the thoracic and lumbosacral spines. The objective of the study was to evaluate the accuracy and clinical benefits of a navigation coupled with O-arm-guided method in the thoracic and lumbar spines by comparing with a C-arm fluoroscopy-guided method. Under fluoroscopy guidance, 138 pedicle screws were inserted from T9 to S1 in 20 patients, and 124 pedicle screws were inserted from T9 to S1 in 20 patients using the navigation. The position of the screws within the pedicle was assessed from grade 0 (no violation cortex) to grade 3 (>4 mm violation), and the location of the violated cortex was determined. Preparation time of each equipment setting, time for screwing, and the number of x-ray shots were evaluated. The number of screws observed as grade 0 was 121 (87.7%) in the fluoroscopy-guided group and 114 (91.9%) in the navigation-guided group. The lateral cortex was most commonly involved in the fluoroscopy-guided group (6 cases, 35.3%), and the medial cortex was most common in the navigation-guided group (4 cases, 40%). The mean time required for preparation for screw placement was 3.7 minutes in the fluoroscopy-guided group and 14.2 minutes in the navigation-guided group. Average screwing time was 3.6 minutes in the fluoroscopy-guided group and 4.3 minutes in the navigation-guided group. The mean number of x-ray shots for each screw placement in the fluoroscopy-guided group was 6.5. Postoperatively, 2 patients with misplacement of a screw under fluoroscopy guidance presented ipsilateral leg paresthesia, possibly related to the screw position. The present prospective study reveals that the pedicle screw placement guided by the navigation coupled with O-arm system was more accurate and safer than that under fluoroscopy guidance.

SWOG S0518: Phase III prospective randomized comparison of depot octreotide plus interferon alpha-2b versus depot octreotide plus bevacizumab (NSC #704865) in advanced, poor prognosis carcinoid patients (NCT00569127).

4004 Background: Treatment options for advanced carcinoid tumors (NETs) are limited. Somatostatin analogues (SSA) prolong progression-free survival (PFS) among patients (pts) who are treatment naiv...

QOL Comparison of Acute Side Effects From a High Dose Rate Vs. Low Dose Rate Prostate Brachytherapy Boost Combined With External Beam Radiotherapy

To compare acute side-effects of patients undergoing a prostate brachytherapy boost combined with pelvic radiotherapy. From February 2012 to May 2014 all patients undergoing a combination of external beam pelvic radiotherapy (EBRT) and a prostate brachytherapy boost were approached for a prospective evaluation of acute toxicity and quality of life. All patients received 46 Gy in 23 fractions of EBRT using either a 3D conformal or IMRT technique. HDR brachytherapy preceded EBRT (either 15 Gy in one fraction or 20 Gy in 2 fractions) while LDR permanent seed implant using iodine-125 followed EBRT within 1-3 weeks. Patients may have been prescribed androgen deprivation therapy (ADT). Side effects were reported using the prostate cancer-specific HRQOL domains (urinary incontinence, urinary irritation/obstruction, sexual, bowel, and hormonal) of the EPIC questionnaire at baseline, 1 month and 3 or 4 months after completion of treatment, as well as physical and mental status using the SF-12 questionnaire. Additionally as per department standards all patients completed the International Prostate Symptom Score (IPSS). Patients had to be able to complete the health surveys in English. Two sample T-test was used to compare mean differences of month 0 and month 1 domain scores, mean differences of month 1 and month 4 domain scores and recovery of pre-treatment HRQOL scores after four months. 60 patients completed the required surveys (29 HDR and 31 LDR). Comparisons of the sexual and hormonal domains were not valid because of an imbalance in the use of ADT between the 2 groups (26/31 LDR and only 8/29 HDR). With p-values of 0.019, LDR patients were found to experience a significantly higher drop in urinary health after treatment. On average, bowel domain scores decreased by 20.1 points for the LDR group and 10.4 points for the HDR group. Four months after treatment, LDR patients continued to experience a significantly lower urinary health compared to HDR patients (p = 0.012). Urinary domain scores for the LDR group were on average 12.6 points lower compared to the pre-treatment assessment. In contrast, HDR patients almost regained pre-treatment urinary health standards with a mean difference of only 1.4. For the remaining domains, no significant difference in recovery between the two treatment groups could be found. This prospective non randomized comparison of acute toxicity and QOL after combined BT and EBRT suggests better tolerance of an HDR boost, whether a single 15 Gy or 2 × 10 Gy. A prospective randomized comparison is underway.

57 A prospective randomized comparison between the transperitoneal and retroperitoneoscopic approaches for the robotic assisted pyeloplasty

57 A prospective randomized comparison between the transperitoneal and retroperitoneoscopic approaches for the robotic assisted pyeloplasty

Transperitoneal versus retroperitoneal laparoscopic pyeloplasty in children: Randomized clinical trial

Laparoscopic pyeloplasty achieves good cosmetic and functional outcomes. Both transperitoneal and retroperitoneal approaches are used. No single study to date has compared the two approaches in a prospective randomized design. We present a prospective randomized comparison between both approaches in children in a trial to define which technique is better with regard to multiple factors including operative time, hospital stay, recovery of bowel movement, analgesic requirement and complication rate. In the period from June 2010 to September 2012, 38 children (25 boys and 13 girls) were operated laparoscopically. Children were randomized into Group I (19 children) operated by the transperitoneal approach, and Group II (19 children) operated by the retroperitoneal approach. Both groups were compared as regards to the operative time, anesthetic changes, and postoperative recovery. A minimum sample size required was calculated to be 19 for each arm based on previous studies of laparoscopic pyeloplasty, using a mean difference in operative time = 40 min, effect size = 0.95, an alpha of 0.05 and power 80% and an online sample size calculator. Statistical analysis was performed using SPSS software using the Fischer exact test, chi square test and Mann-Whitney U test. The operative time was the primary endpoint for comparison between both approaches. Our series is the first in the literature that compares in a prospective randomized design the transperitoneal and retroperitoneal laparoscopic pyeloplasty in children. Shouma et al. is the only prospective randomized study to compare both techniques in adult pyeloplasty. They had a significantly shorter operative time in the transperitoneal group however, the author in the discussion mentioned that he was at the start of the learning curve for retroperitonoscopic pyeloplasty when he conducted his study, which affected the result of the operative time. Hence, as mentioned above, we stressed the importance of a single surgeon with adequate equal experience in both techniques. The recovery of the intestinal motility and start of oral feeding were significantly faster in the retroperitoneal group compared to the transperitoneal group. In our opinion this can be explained by the absence of intraperitoneal manipulations and urine leakage in the peritoneal space. In their series of retroperitoneal pyeloplasty, El Ghoneimi et al. reported feeding after a mean of 1.4 days, however, in our series there was even earlier oral feeding. Shouma et al. reported no significant difference in the start of oral feeding in their adult series. The limitations of our study are: the choice of the 40 min difference created a statistically significant difference in operative time between the groups which might not be considered a truly clinically important difference. In addition, the single author operating for both approaches, which might create a bias, however the author has sufficient experience in both approaches. Moreover, although there were significant differences in hospital stay and intestinal movement between the two groups, it is not clear if these were of clinical significance. Both transperitoneal and retroperitoneal approaches have high success rate. The shorter operative time, shorter hospital stay, rapid recovery of intestinal movement and early resumption of oral feeding are in favor with the retroperitoneal approach.

Usefulness of a novel nasal anesthesia technique — sliding-stick method— : prospective randomized comparison with a conventional technique

Usefulness of a novel nasal anesthesia technique — sliding-stick method— : prospective randomized comparison with a conventional technique

A Prospective Randomized Comparison Between Shockwave Lithotripsy and Semirigid Ureteroscopy for Upper Ureteral Stones <2 cm: A Single Center Experience

The best management of upper ureteral calculi is undefined. We performed a prospective randomized comparison between semirigid ureteroscopy (URS) and shockwave lithotripsy (SWL) for upper ureteral stones <2 cm to evaluate safety and efficacy of both procedures. Patients with a single radiopaque upper ureteral stone <2 cm undergoing treatment between January 2010 and May 2011 in our department were included. Randomization was performed into two groups-group A: SWL performed as an outpatient procedure using an electromagnetic lithotripter (Dornier Compact Delta); group B: URS performed using an 6/7.5F semirigid ureteroscope with holmium laser intracorporeal lithotripsy. Statistical analysis was performed regarding demographic profile, success rates, retreatment rates, auxiliary procedures, and complications. There were 90 patients enrolled in each group. Mean stone size: 12.3 mm in group A vs 12.5 mm in group B (P=0.52). The overall 3-month stone-free rate was (74/90) 82.2% for group A vs (78/90) 86.6% for group B (P=0.34). For stone size <10 mm, 3-month stone-free rates were (45/53) 84.9% for group A vs (43/49) 87.7% for group B (P=0.32). For 10 to 20 mm stones, 3-month stone-free rates were (29/37) 78.4% for group A vs (35/41) 85.4% for group B (P=0.12).The re-treatment rate was significantly greater in group A than group B (61.1% vs 1.1%, respectively; P<0.001). The auxiliary procedure rate was comparable in both groups (21.1% vs 17.7%; P=0.45). The complication rate was 6.6% in group A vs 11.1% in group B (P=0.21). Both SWL and semirigid URS are safe and highly efficacious for treating patients with proximal ureteral stones <20 mm. For stones <10 mm, SWL was safer, less invasive, and of comparable efficacy with URS. For stones between 10 and 20 mm, however, URS was more effective, with a lesser re-treatment rate.

Early Motherhood in Migration: A First Report from FIRST STEPS - An Integration Project for Infants with an Immigrant Background

Background: Children with an immigrant background tend to underachieve in German education with respect to their German peers. Furthermore they are more likely to live in high-risk environments. Quite a number of projects for the integration of these children exist. However most of them are hardly scientifically evaluated. The project FIRST STEPS focuses on the earliest integration of children with an immigrant background by supporting parenting capacities in the critical phase of migration and early parenthood. Furthermore it serves as a scientifically evaluated model project. Methods: By using a prospective randomized comparison group design the effectiveness of a psychoanalytically oriented early prevention program (intervention A) is compared to the outcomes of groups offered by paraprofessionals with an immigrant background (intervention B). Both interventions begin during pregnancy and last until the commencement of kindergarten when the children are about three years old. Over 270 families have already been recruited in Frankfurt am Main and Berlin. A variety of different instruments is applied during as well as after the intervention in order to assess social and family stressors, the quality of the parent-child-interaction, child attachment security, the affective, cognitive and social-emotional development as well as language development of the children, the children’s stress level and the social integration of the families. Results and Conclusion: The project is still on-going and aims at evaluating the implementation as well as the short- and long-term effectiveness of the psychoanalytically oriented intervention. A compared to the outcomes of intervention B (comparison group). First preliminary results show that FIRST STEPS is accepted by these “difficult to reach” immigrant families and indeed can support the early motherhood in migration.

A Prospective Randomized Comparison Between Shock Wave Lithotripsy and Flexible Ureterorenoscopy for Lower Caliceal Stones ≤2 cm: A Single-Center Experience

The optimal management method of lower caliceal calculi is still undefined. We performed a prospective randomized comparison to evaluate safety and efficacy of shock wave lithotripsy (SWL) and flexible ureteroscopy (RIRS) for lower caliceal calculus ≤2 cm. Between December 2011 and January 2012, 195 patients with single radio-opaque lower caliceal calculi ≤2 cm were included in the study. Randomization was done into two groups-group A: SWL performed as an outpatient procedure using the electromagnetic lithotripter (Dornier compact delta) and group B: RIRS was performed using the 6F/7.5F flexible ureteroscope (Richard Wolf) with holmium laser intracorporeal lithotripsy. Demographic characteristics, success, retreatment, and auxiliary procedure rates and complications were analyzed statistically. Of 195 patients, 97 and 98 patients were enrolled in group A and B, respectively. Mean stone size was 12.1 mm in group A vs 12.3 mm in group B (p=0.52). The overall 3 month stone-free rate was (74/90) 82.2% for group A vs (78/90) 86.6% for group B (p=0.34); for stones <10 mm, it was (45/55) 84.9% for group A vs (43/51) 87.7% for group B (p=0.32) and for 10-20 mm stones, it was (29/35) 78.4% for group A vs (35/39) 85.4% for group B (p=0.12). Retreatment rate was significantly greater in group A compared with group B (61.1% vs 11.1%; p<0.001). Auxiliary procedure rate was comparable (21.1% vs 17.7%; p=0.45). The complication rate was 6.6% in group A vs 11.1% in group B (p=0.21). Both SWL and RIRS are safe and efficacious for lower caliceal calculi ≤20 mm. For stones <10 mm, SWL was less invasive and safer than RIRS with efficacy comparable to it. However, for 10-20 mm stones, RIRS was more effective, with lesser retreatment rate.

The placement of peritoneal dialysis catheters: a prospective randomized comparison of open surgery versus “Mini-Perc” technique

Currently, most ESRD patients are treated with open surgical technique or with laparoscopic technique. In this study, we examined the role of the ureteroscope-assisted "Mini-Perc" technique versus the modified open surgery in the treatment of ESRD in a prospective randomized manner. A total of 72 patients with chronic renal failure were prospectively randomized for the ureteroscope-assisted "Mini-Perc" technique or modified open surgery. Intraoperative and postoperative morbidity, incision size, dose of local anesthesia, operative time, hospital stay, and initial catheter survival and follow-up were compared for both methods. "Mini-Perc" group was associated with shorter incision size, operative time, and hospital stay, with lower dose of local anesthesia and incidence of bloody ascites. Two of five patients with the history of abdominal surgery in "Mini-Perc" group required adhesiolysis under direct vision of telescope. All adhesions were easily dissected. All complications of leakage (8.1 %) and incisional hernia (2.7 %) occurred in the open surgery group, but a difference of no significant value with "Mini-Perc" group (p = 0.2400, p = 1.0000). There was no any other significant difference in common complications between two groups. After 2 years of follow-up, 54 patients (75 %) survived with their initial PD catheter. The overall death was 5 (6.9 %). Compared to modified open surgical technique, the ureteroscope-assisted "Mini-Perc" technique can be used to achieve the same clinical efficacy for placement of peritoneal dialysis catheters in ESRD patients, and it carries minimal morbidity.

Treatment of varicose veins of lower limb: A prospective randomized comparison of radiofrequency ablation and conventional surgery

Objectives To compare the effectiveness of conventional surgery and radiofrequency ablation in the treatment of varicose veins as regards 1) duration of procedure, 2) postoperative pain, 3) complications, 4) duration of stay in hospital and 5) return to normal routine work.

Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery?

Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown. Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n=99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n=100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n=101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P=.437). Mean age was 75 ± 8 years and 164 were men (68%). Between dismissal and 1 year there were 9 deaths (3.7%) (Epic: 3.7%, Magna: 5.0%, and Mitroflow: 2.3%; P=.654), 6 episodes of heart failure (2.5%) (Epic:1.3%, Magna: 1.3%, and Mitroflow: 5.8%; P=.265), 27 instances of atrial fibrillation/flutter (11.2%) (Epic: 8.1%, Magna: 11.0%, and Mitroflow: 7.9%; P=.577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P<.001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm(2)/m(2), respectively; P=.015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m(2), and was similar among groups (P=.262). There were no aortic valve reoperations. Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.

Robotic Intracorporeal Orthotopic Neobladder during Radical Cystectomy in 132 Patients

We present a 2-institution experience with completely intracorporeal robotic orthotopic ileal neobladder after radical cystectomy in 132 patients. Established open surgical techniques were duplicated robotically with all neobladders suture constructed intracorporeally in a globular configuration. Nerve sparing was performed in 56% of males. Lymphadenectomy was extended (up to aortic bifurcation in 51, 44%) and superextended (up to the inferior mesenteric artery in 20, 17%). Ureteroileal anastomoses were Wallace-type (86, 65%) or Bricker-type (46, 35%). The learning curve at each institution was assessed using chronological subgroups and by trends across the entire cohort. Data were prospectively collected and retrospectively queried. Mean operating time was 7.6 hours (range 4.4 to 13), blood loss was 430 cc (range 50 to 2,200) and hospital stay was 11 days (median 8, range 3 to 78). Clavien grade I, II, III, IV and V complications within 30 days were 7%, 25%, 13%, 2% and 0%, respectively, and between 30 and 90 days were 5%, 9%, 11%, 1% and 2%, respectively. Mean nodal yield was 29 (range 7 to 164) and the node positivity rate was 17%. Operative time, blood loss, hospital stay and prevalence of late complications improved with experience. During a mean followup of 2.1 years (range 0.1 to 9.8) cancer recurred in 20 patients (15%). Five-year overall, cancer specific and recurrence-free survival was 72%, 72% and 71%, respectively. We developed a refined technique of robotic intracorporeal orthotopic neobladder diversion, duplicating open principles. Operative efficiency and outcomes improved with experience. Going forward, we propose a prospective randomized comparison between open and robotic intracorporeal neobladder surgery.

抗凝固薬服用患者における小ポリープ摘除― cold polypectomyとconventional polypectomyとのランダム化比較試験

抗凝固薬服用患者における小ポリープ摘除― cold polypectomyとconventional polypectomyとのランダム化比較試験

Anterior Cervical Discectomy and Fusion with Polyether ether Ketone Cage

IntroductionThe use of polyether ether ketone (PEEK) cage prosthetic devices in anterior cervical discectomy with fusion (ACDF) has increased rapidly. The authors present preliminary outcomes data ...

A prospective randomised comparison of two insertion methods for i-gel™placement in anaesthetised paralysed patients: standard vs rotational technique

In this prospective randomised study, we compared two techniques for i-gel(™) insertion. One hundred and eighty-one anaesthetised, paralysed adult patients were randomly allocated into one of two groups. In the standard group (n = 91), the i-gel was inserted using the standard technique. In the rotation group (n = 90), the i-gel was rotated 90° anticlockwise in the mouth and re-rotated in the hypopharynx to the original alignment. The success rate, insertion time, air leak pressure and complications were assessed. The success rate for insertion at the first attempt was lower for the standard technique, 78 (86%) vs. 87 (97%; p = 0.016). The mean (SD) insertion time was longer (26.9 (14.5) s vs. 22.4 (10.2) s; p = 0.016) and air leak pressure was lower (22.5 (10.4) cm H2O vs. 27.1 (9.4) cm H2O; p = 0.002) in the standard group. The incidence of bloodstaining was higher with the standard technique (8 (9%) vs. 1 (1%); p = 0.034). This study suggests that the rotational technique is superior to the standard technique for i-gel insertion.

277 A 2 weeks DJ stent indwelling time is safe and sufficient for patients undergoing dismembered pyeloplasty – long term data from a prospective randomized comparison

INTRODUCTION AND OBJECTIVES: DJ stents are widely used in patients who undergo dismembered pyeloplasty for ureteropelvic junction obstruction. However there exist no consensus in terms of optimal stent indwelling time. We therefore evaluated the impact of a short (group A: 2 weeks) compared to a long (group B: 6 weeks) indwelling time on stent related complications and functional outcome. METHODS: Prospective randomized single surgeon series including 82 patients (group A: 41, group B: 41) who underwent minimally invasive dismembered pyeloplasty from 2007 to 2013 at our institution. Preoperatively, baseline split kidney function (scintigraphy) was assessed in all patients. Routinely, retrograde examination with consecutive DJ (4.8 Charr/French, Percuflex Plus Ureteral Stent with HydroPlus Coating, Boston Scientific) placement was performed immediately prior to pyeloplasty. The evaluation of functional outcome was based on objective (renal scintigraphy at 6, 24, 36, 60 months, diuretic renography at 3 months) and subjective findings (flank pain). Statistical analysis was performed with Fisher-test. RESULTS: Median follow up was 24 months (range 3-60) in group A and 24 months (range 3-60) in group B. None of the patients encountered a stent related complication (infection, obstruction, dislocation). Postoperatively, diuretic renography at 3 months showed unobstructed drainage in all 82 patients. Renal scintigraphy detected improved drainage in 91% (32/35) of patients at 6 months and 95% (18/19) of patients at 24 months in group A compared to 95% (36/38) of patients and 96% (23/24) of patients in group B, respectively (p1⁄40.666, p1⁄41). Subjectively, 100% (41/41) of patients in group A compared to 98% (40/ 41) of patients in group B were free of symptoms at last follow up (p1⁄4 1). CONCLUSIONS: Our data demonstrate that 2 weeks stenting provides similarly good periinterventional and functional results compared to 6 weeks stenting. Hence, we suggest that all patients following dismembered pyeloplasty should be uniformly treated with a two weeks DJ stent indwelling interval.

136 A prospective-randomized comparison of a 1.9 μm and 2 μm thulium:yttrium-aluminium-garnet laser device for Thulium VapoEnucleation of the prostate: Early results

136 A prospective-randomized comparison of a 1.9 μm and 2 μm thulium:yttrium-aluminium-garnet laser device for Thulium VapoEnucleation of the prostate: Early results

A prospective randomized comparison between pylorus‐ and subtotal stomach‐preserving pancreatoduodenectomy on postoperative delayed gastric emptying occurrence and long‐term nutritional status

Pylorus-preserving pancreatoduodenectomy (PPPD) has been associated with a high incidence of delayed gastric emptying (DGE). There are few studies comparing DGE associated with PPPD and subtotal stomach-preserving pancreatoduodenectomy (SSPPD). Moreover, differences between the procedures with respect to long-term results have not been reported. A prospective randomized study was conducted to compare perioperative complications and long-term nutritional status with PPPD and SSPPD. One hundred patients with periampullary lesions were randomized to receive either PPPD (n = 50) or SSPPD (n = 50). All patients were followed up for 3 years after surgery or to the time of recurrence to evaluate nutritional status for the study. The effects of the procedure, age, and malignancy on changes in nutritional indicators were estimated with linear mixed models. This study was registered at UMIN Clinical Trials Registry (UMIN 000012337). The incidence of DGE assessed by the International Study Group of Pancreatic Surgery was 20% with PPPD and 12% with SSPPD (P = 0.414). There were no significant differences between the two procedures on postoperative serum albumin levels, serum total cholesterol levels, and body mass index during the 3-year follow-up period. SSPPD is equally effective in DGE occurrence rate and long-term nutritional status comparing to PPPD.