Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications

Background

The fundoplication of choice for the surgical treatment of gastroesophageal reflux disease (GERD) still is debated. Multichannel intraluminal impedance monitoring (MII) has not been used to compare objective data, and comparative subjective data on laparoscopic Nissen and Toupet fundoplications are scarce.

Methods

This study randomly allocated 125 patients with documented chronic GERD to either laparoscopic floppy Nissen fundoplication (LNF; n = 62) or laparoscopic Toupet fundoplication (LTF; n = 63). The Gastrointestinal Quality of Life Index (GIQLI), symptom grading, esophageal manometry, and MII data were documented preoperatively and 1 year after surgery. The pre- and postprocedure data were compared. Statistical significance was set at a p value lower than 0.01 (NCT01321294).

Results

Both procedures resulted in significantly improved GIQLI and GERD symptoms. Preoperative dysphagia improved in both groups, but the improvement reached significance only in the LTF group. The ability to belch was shown to be significantly more decreased after LNF than after LTF. Gas-bloat and “atypical” extraesophageal symptoms also were decreased after surgery (p < 0.01). However, bowel symptoms were virtually unchanged in both groups. Both procedures resulted in significantly improved lower esophageal sphincter pressures. The improvement was greater in the LNF group than in the LTF group (p < 0.01). The DeMeester score and the numbers of total, acid, proximal, upright, and recumbent reflux episodes decreased in both groups after surgery (p < 0.01). No significant difference between the procedures in terms of MII data was found. Six patients (4.8 %) had to undergo reoperation because of intrathoracic slipping of the wrap. All the patients had undergone LNF.

Conclusions

Both procedures proved to be equally effective in improving quality of life and GERD symptoms. However, the reoperation and dysphagia rates were lower and the ability to belch was higher after LTF than after LNF.     

Loss to follow-up after laparoscopic gastric bypass surgery – a post hoc analysis of a randomized clinical trial

BackgroundFollow-up after bariatric surgery is important if we are to identify long-term complications at an early stage and thereby improve long-term outcome. Despite great efforts, many patients are lost to follow-up. Definition of characteristics of patients failing to attend follow-up could help in defining a specific group for whom extra resources may be applied to improve the situation.ObjectivesTo identify characteristics of patients failing to attend follow-up 2 years after laparoscopic gastric bypass surgery.SettingMulticenter study, Sweden.MethodsPost hoc analysis of a randomized clinical trial in which preoperative patient characteristics and postoperative outcome measures were compared between patients who attended or did not attend a 2-year follow-up visit after laparoscopic gastric bypass surgery.ResultsOf the 2495 patients included, 260 did not attend a 2-year follow-up visit. Factors associated with higher risk for failure to attend were younger age (adjusted odds ratio [OR] .96, 95% confidence interval [CI] .94–.98/yr, P < .001); male sex (adjusted OR 2.34, 95% CI 1.51–3.63, P < .001); depression (adjusted OR 1.61, 95% CI 1.05–2.47, P = .029); history of smoking (adjusted OR 1.78, 95% CI 1.26–2.51, P = .001); being single (adjusted OR 1.47, 95% CI 1.03–2.11, P = .036); and being first-generation immigrant (adjusted OR 1.74, 95% CI 1.05–2.88; P = .032). Elementary occupation (adjusted OR .42, 95% CI .18–.99, P = .047) was associated with lower risk.ConclusionThese findings indicate that there are preoperative characteristics that may help in identifying patients likely to fail to attend follow-up visits after laparoscopic gastric bypass surgery. Special effort should be made to inform these patients of the importance of follow-up and to encourage them to attend.     

Bupivacaine use in the Insuflow® device during laparoscopic cholecystectomy: results of a prospective randomized double-blind controlled trial

Background

Recent evidence [Surg Endosc (2007) 21: 602–606] demonstrates that intraperitoneal bupivacaine administered as an aerosol via a special catheter is safe and significantly decreases postoperative pain in laparoscopic surgery. We currently use the Insuflow^® device (Lexion Medical) routinely to warm and humidify gas in laparoscopic surgery. The purpose of this study is to determine whether using bupivacaine instead of water in existing technology already in use (Insuflow) will result in decreased postoperative pain, without increasing operative time or cost.

Methods

Using a double-blind methodology, 50 patients undergoing elective outpatient laparoscopic cholecystectomy were randomized to a study drug: either 10 ml of 0.5% bupivacaine (50 mg) or 10 ml of sterile water. The study drug was injected into the Insuflow in the standard fashion and the operation commenced routinely. No perioperative nonsteroidal anti-inflammatory drugs were used. Using a standard 0–10 pain-scoring scale, patients were assessed by perioperative nurses at 1 and 2 h postoperatively. Pain was again assessed at 24 h by telephone interview, along with the number of narcotic oral analgesics used in the first 24 h.

Results

Fifty patients were randomized, 25 in each group; the groups were comparable. All patients completed the study and 100% follow-up was obtained. All patients were discharged the same day and there were no significant complications in either group, and specifically no complications attributed to bupivacaine or use of the Insuflow device. There were no differences in pain at 1 and 2 h. There was less pain in the bupivacaine group at 24 h, but this was not statistically significant (P = 0.055).

Conclusions

Bupivacaine use in the Insuflow device is safe. No significant differences in postoperative pain were noted in this study compared to using water.     

Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? results of a prospective randomized trial

Despite substantial improvements in perioperative mortality, complications, and specifically the development of a pancreatic fistula, remain a common occurrence after pancreaticoduodenectomy. It was the objective of this study to evaluate the role of fibrin glue sealant as an adjunct to decrease the rate of pancreatic fistula after pancreaticoduodenectomy. One hundred twenty-five patients were randomized after pancreaticoduodenal resection only if, in the opinion of the surgeon, the pancreaticojejunal anastomosis was at high risk for development of a pancreatic anastomotic leak. After completion of the pancreaticojejunal anastomosis, the patients were randomized to topical application of fibrin glue sealant to the surface of the anastomosis or no such application. The primary postoperative end points in this study were pancreatic fistula, total complications, death, and length of hospital stay. A total of 59 patients were randomized to the fibrin glue arm, whereas 66 patients were randomized to the control arm and did not receive fibrin glue application. The pancreatic fistula rate in the fibrin glue arm of the study was 26% vs. 30% in the control group (p = not significant [NS]). The mean length of postoperative stay for all patients randomized was similar (fibrin glue = 12.2 days, control = 13.6 days) and the mean length of stay for patients in whom pancreatic fistula developed was also not different (fibrin glue = 18.9 days, control = 21.7 days). There were no differences with respect to total complications or specific complications such as postoperative bleeding, infection, or delayed gastric emptying. These data demonstrate that the topical application of fibrin glue sealant to the surface of the pancreatic anastomosis in this patient population undergoing high-risk pancreaticojejunal anastomosis did not reduce the incidence of pancreatic fistula or total complications after pancreaticodudodenectomy. There seems to be no benefit regarding the use of this substance in this setting. Presented at the Forty-Fifth Annual Meeting of the Society for Surgery of the Alimentary Tract, New Orleans, Louisiana, May 15–19, 2004 (oral presentation). This work was supported in part by the Haemacure Company and Baxter Health Care.     

Minicholecystectomy vs conventional cholecystectomy: A prospective randomized trial—Implications in the laparoscopic era

The objective of this study was to compare results of elective open conventional cholecystectomy (CC) to those of minicholecystectomy (MC). A clinical prospective, randomized trial was designed. The setting was an academic general surgical unit. In the CC group were 26 patients; in the MC group were 24 patients. In the CC group a conventional open cholecystectomy was performed through a subcostal incision; in the MC group operation through an initial 5-cm subcostal incision was done. Mean length of wound was 14.4 cm and 5.4 cm in the two groups, respectively (p<0.001). Mean operative time was 60 and 59 minutes, respectively. Mean operative difficulty, estimated on a 1–10 scale, was 3.4 and 5.6, respectively (p<0.05). Mean postoperative analgesia requirements (number of doses of 10 mg morphine sulphate) were 5.8 and 4.0, respectively (p=0.002). Mean duration of hospitalization was 4.7 and 3.0 days, respectively (p<0.001). Mean overall patient satisfaction, estimated on 1–10 scale, was 6 and 8.3, respectively (p=0.002). We conclude that Minicholecystectomy offers less pain, earlier recovery, and better cosmetic results than the conventional open procedure. Published results of MC compare favorably with those of laparoscopic procedures. The implications of these results in the laparoscopic era are discussed.

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ResumenObjetivo comparar los resultados de la colecistectomía convencional abierta (CC) con los de la minicolecistectomía (MC).Diseño ensayo clínico prospectivo randomizado en una unidad académica de cirugía general.Sujeto grupo CC de 26 pacientes, MC de 24. Intervenciones: colecistectomía por incisión subcostal en la CC y por incisión subcostal de 5 cm en la MC.Resultados las longitudes promedio fueron 14.4 cm y 5.4 cm (p<0.001); los tiempos operatorios promedio fueron 60 y 59 minutos respectivamente; la dificultad técnica promedio fue calificada como 3.4 y 5.6 en una escala de 1–10, respectivamente (p<0.05); los requerimientos postoperatorios de analgesia (número de dosis de 10 mg de sulfato de morfina) fueron 5.8 y 4.0 (p<0.002); los días de hospitalización fueron de 4.7 y 3.0 dias, respectivamente (p<0.001); el grado de satisfacción del paciente fue estimado en 6 y 8.3 sobre una escala de 1–10 (p=0.002).Conclusion la MC se asocia con menos dolor, recuperación más temprana y mejor resultado estético que la operación convencional abierta. La literatura presenta resultados comparativamente favorables entre MC y los procedimientos lapascópicos. Se discuten las implicaciones de ello en la era laparoscópica.

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RésuméObjectif comparer les résultats de la cholécystectomie traditionnelle (CT) à la cholécystectomie par minilaparotomie (CM).Type d'étude clinique, prospective, randomiséeLieu Unité de soins universitaireMalades 26 patients ayant eu une CT, 24 ayant eu une CMInterventions La CT a été réalisée par une incision souscostale, la MC, à travers une incision sous-costale de 5 cm.Résultats La longeur moyenne de l'incision de la CT a été de 14.4 cm et celle de la CM de 5.4 cm (p<0.001). La durée moyenne des interventions a été respectivement de 60 et de 59 minutes. La difficulté de l'intervention, évaluée sur une échelle de 1 à 10 a été respectivement de 3.4 et de 5.6 (p<0.05). Les besoins moyens d'analgésie postopératoire (nombre de doses de sulphate de morphine, 10 mg) ont été respectivement de 5.8 et de 4.0 (p=0.002). La durée moyenne de l'hospitalisation a été respectivement de 4.7 et de 3.0 jours (p<0.001). L'évaluation des soins par les patients, notée de 1 à 10, a été respectivement de 6 et de 8.3 (p=0.002).Conclusions La CM est moins douleureuse, permet une récupération plus précoce et donne un meilleur résultat esthétique. Ces résultats sont comparables à ceux de la littérature. Les implications de ces résultats, à l'heure de la cholécystectomie laparoscopique, sont discutées.

     

Transanal endoscopic versus total mesorectal laparoscopic resections of T2–N0 low rectal cancers after neoadjuvant treatment: a prospective randomized trial with a 3-years minimum follow-up period

Background This study aimed to compare the results and the oncologic outcomes of transanal endoscopic microsurgery (TEM) with neoadjuvant radiochemotherapy and laparoscopic resection (LR), also with neoadjuvant radiochemotherapy, in the treatment of T₂–N₀ low rectal cancer.Methods The study enrolled 40 patients with T2–N₀ rectal cancer, randomizing 20 to TEM (arm A) and 20 to LR (arm B).Results After neoadjuvant radiochemotherapy, tumor downstaging was observed for 13 patients (65%) in arm A (7 pT0 and 6 pT1) and in 11 patients (55%) in arm B (7 pT0 and 4 pT1). More than a 50% reduction of the tumor diameter was observed in four arm A cases and in six arm B cases. At a median follow-up period of 56 months (range, 44–67 months) in both arms, one local failure (5%) occurred after 6 months in arm A and one (5%) after 48 months in arm B. Distant metastases occurred in one arm A patient (5%) after 26 months of follow-up evaluation and in one arm B patient (5%) at 31 months. The probability of local or distant failure was 10% for TEM and 12% for laparoscopic resection, whereas the probability of survival was 95% for TEM and 83% for laparoscopic resection.Conclusions The findings show comparative results between the two study arms in terms of probability of failure and survival.     

Long-term results of a randomized trial comparing banded versus standard laparoscopic Roux-en–Y gastric bypass

BackgroundBanded Roux-en-Y gastric bypass was designed to avoid or diminish weight regain in the long term. In 2008, we published the initial results of a pilot study design to comparatively evaluate surgical morbidity, mortality, and maximum weight loss in patients undergoing banded and unbanded laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study analyzes the 5-year results.MethodsA randomized, controlled trial was carried out in 60 morbidly obese patients who underwent LRYGB. Patients were divided in 2 groups. Half of the patients underwent the banded version of the LRYGB, and half underwent the unbanded version. The 5-year excess weight loss (EWL) and loss of body mass index (BMI) were comparatively analyzed.ResultsThere were 58 females and 2 males with a mean preoperative BMI of 47±4.9 kg/m². A total of 21 patients with banded LRYGB and 22 with unbanded LRYGB completed 5-year follow-up. One patient died 3 years after surgery from metastatic melanoma. EWL at 5 years was 61.6%±19.6% versus 59.8%±15.9% (P = ns), and loss of BMI was 32.9%±5.2% versus 32.8%±4.3% (P = ns), respectively, for the banded and unbanded group.ConclusionsIn this small study, there were no statistical differences in the EWL and the BMI lost at 5 years between the group of patients who underwent banded and unbanded LRYGB.     

Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial.

INTRODUCTION: The routine use of a nasogastric tube after elective colorectal surgery is no longer mandatory. More recently, early feeding after laparoscopic colectomy has been shown to be safe and well tolerated. Therefore, the aim of our study was to prospectively assess the safety and tolerability of early oral feeding after elective "open" abdominal colorectal operations. MATERIALS AND METHODS: All patients who underwent elective laparotomy with either colon or small bowel resection between November 1992 and April 1994 were prospectively randomized to one of the following two groups: group 1: early oral feeding--all patients received a clear liquid diet on the first postoperative day followed by a regular diet as tolerated; group 2: regular feeding--all patients were treated in the "traditional" way, with feeding only after the resolution of their postoperative ileus. The nasogastric tube was removed from all patients in both groups immediately after surgery. The patients were monitored for vomiting, bowel movements, nasogastric tube reinsertion, time of regular diet consumption, complications, and length of hospitalization. The nasogastric tube was reinserted if two or more episodes of vomiting of more than 100 mL occurred in the absence of bowel movement. Ileus was considered resolved after a bowel movement in the absence of abdominal distention or vomiting. RESULTS: One hundred sixty-one consecutive patients were studied, 80 patients in group 1 (34 males and 46 females, mean age 51 years [range 16-82 years]), and 81 patients in group 2 (43 males and 38 females, mean age 56 years [range 20-90 years]). Sixty-three patients (79%) in the early feeding group tolerated the early feeding schedule and were advanced to regular diet within the next 24 to 48 hours. There were no significant differences between the early and regular feeding groups in the rate of vomiting (21% vs. 14%), nasogastric tube reinsertion (11% vs. 10%), length of ileus (3.8 +/- 0.1 days vs. 4.1 +/- 0.1 days), length of hospitalization (6.2 +/- 0.2 days vs. 6.8 +/- 0.2 days), or overall complications (7.5% vs. 6.1%), respectively, (p = NS for all). However, the patients in the early feeding group tolerated a regular diet significantly earlier than did the patients in the regular feeding group (2.6 +/- 0.1 days vs. 5 +/- 0.1 days; p < 0.001). CONCLUSION: Early oral feeding after elective colorectal surgery is safe and can be tolerated by the majority of patients. Thus, it may become a routine feature of postoperative management in these patients.     

Transvaginal hybrid NOTES cholecystectomy—results of a randomized clinical trial after 6 months

Introduction

For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2–3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy.

Methods

To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains “satisfaction” and “pain” of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months.

Results

Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P?=?0.004 and P?<?0.001). There were no postoperative pathological gynecological findings.

Conclusions

Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.     

Systemic inflammatory response after laparoscopic and conventional colectomy for cancer: a matched case–control study

Background

Studies dealing with laparoscopic colectomy for cancer have reached conflicting results in regards to various inflammatory cytokines. Most of them have not examined potential differences with the open procedures at later postoperative days, when the immunologic advantage of laparoscopic surgery would be more demanding to demonstrate (for earlier administration of adjuvant treatment). The aim of this work is to detect differences of proinflammatory cytokines between conventional and laparoscopic colectomy for cancer.

Patients and methods

30 patients who underwent laparoscopic colectomy were age, sex, and preoperative stage-matched with 30 patients treated by open surgery. C-reactive protein (CRP), interleukin (IL)-1, -6, and -8, and interferon (IFN)-γ serum levels were measured preoperatively, at 24 h, and at the 7th postoperative day (POD).

Results

CRP and IL-6 postoperative values (24 h and 7th POD) were significantly higher than baseline for both groups (p = 0.001), but the respective values at the 7th POD were less than at 24 h (p = 0.001). IL-1 and -8 levels did not show any differences between assessment timepoints. A higher IFN-γ measurement was demonstrated at 24 h compared with baseline for the laparoscopic group only (p = 0.03). This difference was not maintained at the 7th POD. IFN-γ levels at 24 h and the 7th POD were significantly less for the open compared with the laparoscopic group of patients (p = 0.001). No correlation was revealed between measured serum values and age, sex, tumor location, or stage.

Conclusions

This matched case–control study verifies the already reported lack of differences regarding IL-1. Controversy still exists on likely IL-6 differences. The inadequately studied IL-8 does not seem to play an important role in immunologic differences. The immunologically beneficial IFN-γ, produced by the principal effectors of cell-mediated immunity Th1 cells, seems to have a more active presence following laparoscopic colectomy, potentially contributing to an immunologic “advantage” by counteracting “harmful” cytokines, such as IL-1.

     

Chemonucleolysis and automated percutaneous discectomy – a prospective randomized comparison

In this prospective study 22 patients with painful disc herniations were randomized either to chemonucleolysis (CN) or automated percutaneous discectomy (APD). Preoperatively the Oswestry score was 44 points in the CN group and 41 points in the APD group. Except for a longer duration of preoperative leg pain in the APD group, clinical data were approximately the similar same in the two groups. In the APD group there was one intra-operative complication. Open revision surgery in the same segment was performed once in the CN group and twice in the APD group. Improvement of neurologic deficits and of Owestry score was significant in both groups. At 2 years after surgery the CN treated patients were significantly better with respect to Oswestry score, back pain and leg pain recurrence.

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Résumé  Etude prospective de 22 patients avec hernie discale douloureuse. Randomisation entre un traitement par chimionucléolyse (CN) ou discectomie percutanée (APD). Avant l"intervention, le score d"Oswestry était de 44 points dans le groupe CN et de 41 points dans le groupe APD. A part une plus longue durée d"évolution douloureuse dans le groupe APD, les données cliniques étaient approximativement les mêmes dans les deux groupes. Il y a eu une complication opératoire dans le groupe APD. Une reprise chirurgicale classique fut nécessaire une fois dans le groupe CN, et deux fois dans le groupe APD. L"amélioration du déficit neurologique et du score d"Oswestry fut significative dans les deux groupes. 2 ans après le traitement, les patients traités par chimionucléolyse avaient des résultats significativement meilleurs compte-tenu du score d"Oswestry et de la récidive de douleurs lombaires ou du membre inférieur.

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Accepted: 16 February 2000     

Combined laparoscopic–endoscopic resections of colorectal polyps: 10-year experience and follow-up

Background  Large, colorectal polyps or those that are difficult to access may be unamenable to conventional snare polypectomy and may require surgical resection. This study was designed to evaluate the resection of such lesions by the use of combined laparoscopic–endoscopic resections (CLER). Methods  Patients who had received CLER for colorectal polyps between January 1997 and December 2006 were identified from a prospectively maintained database. Patients with biopsies consistent with invasive cancer were excluded from the combined approach. Baseline characteristics, surgical, pathological, postoperative, and follow-up data of patients and lesions were reviewed. Results  A total of 146 consecutive patients underwent CLER for 154 lesions, and 120 (82%) patients underwent local excision (i.e., laparoscopy-assisted endoscopic resection, endoscopy-assisted wedge resection, and endoscopy-assisted transluminal resection). Twenty-six (18%) patients received endoscopy-assisted segmental colon resection. Conversion rate was 5% and intraoperative complications occurred in two patients (1%). Major postoperative complications occurred in five patients (3%), necessitating surgical reintervention in four of them. Follow-up colonoscopy revealed metachronous adenomas in 33 patients, of which 8 patients showed macroscopic or microscopic characteristics of advanced lesions. One patient, who had been converted to open resection because of incomplete laparoscopic resection of an adenoma, developed relapse of the initial adenoma and was successfully treated with repeat CLER accounting for a local recurrence rate of 0.9%. Conclusions  Combined laparoscopic–endoscopic resection is an efficient, safe, and minimally invasive alternative to open resection for selected patients with difficult polyps, but it should be restricted to benign disease.     

Bowel obstruction after laparoscopic and open colon resection for cancer: Results of 5?years of follow-up in a randomized trial

Background

Postoperative bowel obstruction caused by intra-abdominal adhesions occurs after all types of abdominal surgery. It has been suggested that the laparoscopic technique should reduce the risk for adhesion formation and thus for postoperative bowel obstruction. This study was designed to compare the incidence of bowel obstruction in a randomized trial where laparoscopic and open resection for colon cancer was compared.

Methods

A retrospective analysis was performed, collecting data of episodes of bowel obstruction with or without surgery. Only episodes treated in the hospital where the index surgery took place were included. Data for 786 patients were collected for the 5-year period after cancer surgery.

Results

Baseline characteristics for the evaluated laparoscopic (n?=?383) and open (n?=?403) groups were comparable. The cumulative obstruction percentages at 5?years for the open and laparoscopic groups were 6.5 and 5.1% respectively and did not significantly differ from each other. Tumor stage seemed to influence the risk for bowel obstruction: 2.8% in stage I, 6.6% in stage II, and 7% in stage III, but the differences were not significant.

Conclusions

This analysis does not support the hypothesis that laparoscopy leads to fewer episodes of bowel obstruction compared with open surgery.     

Reduction of wound infections in laparoscopic-assisted colorectal resections by plastic wound ring drapes (REDWIL)?—a randomized controlled trial

Introduction

Surgical site infections (SSIs) are frequent complications in colorectal surgery and may lead to burst abdomen, incisional hernia, and increased perioperative costs. Plastic wound ring drapes (RD) were introduced some decades ago to protect the abdominal wound from bacteria and reduce SSIs. There have been no controlled trials examining the benefit of RD in laparoscopic colorectal surgery. The Reduction of wound infections in laparoscopic assisted colorectal resections by plastic wound ring drapes (REDWIL) trial was thus designed to assess their effectiveness in preventing SSIs after elective laparoscopic colorectal resections.

Materials/methods

REDWIL is a randomized controlled monocenter trial with two parallel groups (experimental group with RD and control group without RD). Patients undergoing elective laparoscopic colorectal resection were included. The primary endpoint was SSIs. Secondary outcomes were colonization of the abdominal wall with bacteria, reoperations/readmissions, early/late postoperative complications, and cost of hospital stay. The duration of follow-up was 6?months.

Results

Between January 2008 and October 2010, 109 patients were randomly assigned to the experimental or control group (with or without RD). Forty-six patients in the RD group and 47 patients in the control group completed follow-up. SSIs developed in ten patients with RD (21.7?%) and six patients without RD (12.8?%) (p?=?0.28). An intraoperative swab taken from the abdominal wall was positive in 66.7?% of patients with RD and 57.5?% without RD (p?=?0.46). The number of species cultured within one swab was significantly higher in those without RD (p?=?0.03). The median total inpatient costs including emergency readmissions were 3,402?±?4,038 € in the RD group and 3,563?±?1,735 € in the control group (p?=?0.869).

Conclusions

RD do not reduce the rate of SSIs in laparoscopic colorectal surgery. The inpatient costs are similar with and without RD.     

Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial

OBJECTIVE: To evaluate the endpoints of complications (specifically pancreatic fistula and total complications) and death in patients undergoing pancreaticoduodenectomy. SUMMARY BACKGROUND DATA: Four randomized, placebo-controlled, multicenter trials from Europe have evaluated prophylactic octreotide (the long-acting synthetic analog of native somatostatin) in patients undergoing pancreatic resection. Each trial reported significant decreases in overall complication rates, and two of the four reported significantly lowered rates of pancreatic fistula in patients receiving prophylactic octreotide. However, none of these four trials studied only pancreaticoduodenal resections, and all trials had high pancreatic fistula rates (>19%) in the placebo group. A fifth randomized trial from the United States evaluated the use of prophylactic octreotide in patients undergoing pancreaticoduodenectomy and found no benefit to the use of octreotide. Prophylactic use of octreotide adds more than $75 to the daily hospital charge in the United States. In calendar year 1996, 288 patients received octreotide on the surgical service at the authors' institution, for total billed charges of $74,652. METHODS: Between February 1998 and February 2000, 383 patients were recruited into this study on the basis of preoperative anticipation of pancreaticoduodenal resection. Patients who gave consent were randomized to saline control versus octreotide 250 microg subcutaneously every 8 hours for 7 days, to start 1 to 2 hours before surgery. The primary postoperative endpoints were pancreatic fistula, total complications, death, and length of hospital stay. RESULTS: Two hundred eleven patients underwent pancreaticoduodenectomy with pancreatic-enteric anastomosis, received appropriate saline/octreotide doses, and were available for endpoint analysis. The two groups were comparable with respect to demographics (54% male, median age 66 years), type of pancreaticoduodenal resection (60% pylorus-preserving), type of pancreatic-enteric anastomosis (87% end-to-side pancreaticojejunostomy), and pathologic diagnosis. The pancreatic fistula rates were 9% in the control group and 11% in the octreotide group. The overall complication rates were 34% in the control group and 40% in the octreotide group; the in-hospital death rates were 0% versus 1%, respectively. The median postoperative length of hospital stay was 9 days in both groups. CONCLUSIONS: These data demonstrate that the prophylactic use of perioperative octreotide does not reduce the incidence of pancreatic fistula or total complications after pancreaticoduodenectomy. Prophylactic octreotide use in this setting should be eliminated, at a considerable cost savings.