Randomized clinical trial of perioperative selective decontamination of the digestive tract versus placebo in elective gastrointestinal surgery.

BACKGROUND: This randomized clinical trial analysed the effect of perioperative selective decontamination of the digestive tract (SDD) in elective gastrointestinal surgery on postoperative infectious complications and leakage. METHODS: All patients undergoing elective gastrointestinal surgery during a 5-year period were evaluated for inclusion. Randomized patients received either SDD (polymyxin B sulphate, tobramycin and amphotericin) or placebo in addition to standard antibiotic prophylaxis. The primary endpoint was postoperative infectious complications and anastomotic leakage during the hospital stay or 30 days after surgery. RESULTS: A total of 289 patients were randomized to either SDD (143) or placebo (146). Most patients (190, 65·7 per cent) underwent colonic surgery. There were 28 patients (19·6 per cent) with infectious complications in the SDD group compared with 45 (30·8 per cent) in the placebo group (P = 0·028). The incidence of anastomotic leakage in the SDD group was 6·3 per cent versus 15·1 per cent in the placebo group (P = 0·016). Hospital stay and mortality did not differ between groups. CONCLUSION: Perioperative SDD in elective gastrointestinal surgery combined with standard intravenous antibiotics reduced the rate of postoperative infectious complications and anastomotic leakage compared with standard intravenous antibiotics alone. Perioperative SD.D should be considered for patients undergoing gastrointestinal surgery. REGISTRATION NUMBER: P02.1187L (Dutch Central Committee on Research Involving Human Subjects).

Current application of selective decontamination of the digestive tract, perioperative antibiotics and mechanical bowel preparation in surgical departments in the Netherlands.

OBJECTIVE: To study the current application of selective decontamination of the digestive tract (SDD), the use of preoperative antibiotics and mechanical bowel preparation (MBP) in elective gastrointestinal (GI) surgery in surgical departments in the Netherlands. METHODS: A point prevalence survey was carried out and an online questionnaire was sent to GI surgeons of 86 different hospitals. RESULTS: The response rate was 74%. Only 4/64 (6.3%) of the Dutch surgical wards are currently using perioperative SDD as a prophylactic strategy to prevent postoperative infectious complications. The 4 hospitals using SDD on their surgical wards also use it on their ICUs. All hospitals make use of perioperative intravenous antibiotic prophylaxis in elective GI surgery. In most hospitals, a cephalosporin and metronidazole are applied (81.3 and 76.6%). MBP was used in 58 hospitals (90.6%) mainly in left colonic surgery. CONCLUSIONS: Perioperative SDD is rarely used in elective GI surgery in the Netherlands. Perioperative intravenous antibiotic prophylaxis is given in all Dutch hospitals, conforming to guidelines. Although the recent literature does not recommend MBP before surgery, it is still selectively used in 90.6% of the Dutch surgical departments, mainly in open or laparoscopic left colonic surgery (including sigmoid resections).

[Abdominal pain and rectal blood loss]. / Buikpijn en rectaal bloedverlies.

The medical history of a 46-year-old man recorded osteomas in the maxillary bone 18 years before, haemorrhoids, and kidney stones. He presented with pain in the right lower abdomen and rectal blood loss. His complaints were diagnosed as familial adenomatous polyposis, culminating in sigmoid carcinoma. Due to the extent of the polyps and, consequently, the great cancer relapse risk, a surgical treatment was indicated. A symptom ofa familial adenomatous polyposis variant, Gardner's syndrome, is osteomas in the orofacial region. Dentists and oral surgeons should be aware of this rare syndrome in a patient with orofacial osteomas, especially if the patient has a familial risk of adenomatous polyposis.

Evaluation of morbidity and mortality after resection for hilar cholangiocarcinoma--a single center experience.

BACKGROUND: Hilar resection, especially in combination with liver resection, results in substantial morbidity and mortality, which clearly influences the overall outcome. In the present study, patients who underwent resection of a proximal bile duct tumor were analyzed with the aim of identifying risk factors for morbidity and mortality. METHODS: Between 1983 and 1998, 112 consecutive patients underwent a local resection, which in 32 patients was combined with a hemihepatectomy (11 extended resections). Eighty-four percent of the patients underwent preoperative (endoscopic) drainage. For evaluation of different treatment strategies during the study, the period was divided in three 5-year intervals. RESULTS: Postoperative complications occurred in 65% of the patients. The overall hospital mortality was 15% for local resections and 25% for hemi-hepatectomies. There was a significantly lower morbidity and no mortality after hilar resection during the last 5 years. A higher Bismuth classification showed significant correlation with postoperative morbidity. Extended liver resections and vascular resections and a preoperative albumin level below 35 g/L were found to be significant predictors of increased mortality in univariate analysis. CONCLUSIONS: The overall morbidity and mortality rate in this series is higher than most recently published series. More (extended) liver resections resulted in an increased rate of microscopic tumor-free resections, at the cost of higher hospital morbidity and mortality. Improved preoperative work-ups will result in a selection of patients who might benefit from these extensive resections.

Segmental resection and wedge excision of the portal or superior mesenteric vein during pancreatoduodenectomy.

BACKGROUND: Resection of the portal/superior mesenteric vein (PV/SMV) during pancreatoduodenectomy (PD) is disputed. Although morbidity and mortality are acceptable, survival is limited after PV/SMV resection. In this study, we evaluate the effect of PV/SMV resection. METHODS: Between 1992 and 1998, there were 215 consecutive patients who underwent PD for malignant disease. Thirty-four patients underwent a PV/SMV resection. Resection was only performed when minimal venous ingrowth was found perioperatively. Surgical techniques, perioperative parameters, and survival were analyzed. RESULTS: The percentage of PV/SMV resections was 16%. Extensive (segment) resections were performed in 6 patients. The median blood loss was 1.8 L and resection margins were microscopically tumor free in 41% of the patients. The median hospital stay was 15 days, and mortality was 0%. Median survival after PV/SMV resection for pancreatic adenocarcinoma was 14 months. CONCLUSIONS: Limited PV/SMV resection for perioperatively encountered minimal venous ingrowth during PD can be performed safely without increased morbidity and mortality but also results in a high frequency of tumor-positive resection margins.

Results of pancreaticoduodenectomy for ampullary carcinoma and analysis of prognostic factors for survival.

BACKGROUND: Results of pancreaticoduodenectomy for ampullary carcinoma were evaluated, and prognostic factors for survival were analyzed. METHODS: During the period from 1984 to 1992 67 patients underwent subtotal or total pancreaticoduodenectomy for ampullary carcinoma. All clinicopathologic data and their influence on survival were studied. RESULTS: Subtotal pancreaticoduodenectomy was performed in 62 of 67 patients with a mortality of 6% and a morbidity of 65%; the remaining five patients underwent total pancreaticoduodenectomy. Intraabdominal infection was the most important complication. Resection margins were tumor free in 75% of 67 patients. The overall 5-year survival was 50%. Survival was significantly influenced by the involvement of resection margins. After resection with involved margins 5-year survival was 15% and 60% after resection with free margins (p < 0.001). Tumor size, lymph node involvement, and differentiation grade had limited and not significant influence on survival. CONCLUSIONS: Subtotal pancreaticoduodenectomy is the type of resection of first choice for ampullary carcinoma. Involvement of resection margins was the strongest prognostic factor for survival. Patients with a tumor size larger than 2 cm, with lymph node involvement, or with a poorly differentiated tumor still had a 5-year survival rate greater than 40%. Patients with involved margins might be candidates for studies on adjuvant therapy.

Benign fibrosing disease at the hepatic confluence mimicking Klatskin tumors.

BACKGROUND: Hilar obstructions remain a challenge with regard to diagnosis and treatment. METHODS: In the period from 1984 to 1990, 82 patients underwent resective surgery under the presumptive diagnosis of hilar cholangiocarcinoma (Klatskin tumor). The diagnosis was based on the combined appearances on direct cholangiography and ultrasonography in all cases, with the use of various other imaging modalities in some cases. RESULTS: The perioperative findings from an experienced surgical team were usually thought to be compatible with bile duct carcinoma. However, histologic examination of the resected specimens revealed benign fibrosing or localized sclerosing lesions in 11 patients (13.4%). CONCLUSIONS: The current state of diagnostic imaging fails as yet to discriminate reliably between benign and malignant hilar lesions. Whereas the immediate therapeutic consequences may be equal (resection followed by hepaticojejunostomy), the late consequences differ in a major way because benign disease has a much better prognosis. In the presence of suspicious hilar obstruction, operable lesions should not be treated by "palliative" intubational techniques and radiation therapy without a firm diagnosis of malignancy. However, overtreatment (extended liver resection, vascular reconstruction, and liver transplantation) should be avoided as well when a benign lesion has not been ruled out.

Laparoscopy and laparoscopic ultrasonography in staging of carcinoma of the esophagus and gastric cardia.

BACKGROUND: The objective of this prospective study was to assess the contribution of laparoscopy combined with laparoscopic ultrasonography (LLU) in the preoperative staging of patients with carcinoma of the esophagus and cardia. STUDY DESIGN: Preoperative LLU was performed in 56 patients who were selected for curative resection of carcinoma of the esophagus (n = 38) or gastric cardia with involvement of the distal esophagus (n = 18) after routine preoperative workup. During LLU, the peritoneal cavity was scrutinized for metastatic disease, and ultrasonography of the liver and celiac axis was performed. In all patients without histologically proven metastases, laparotomy was then performed. RESULTS: The morbidity rate of the procedure was 3.5 percent (two superficial wound infections). In three (5 percent) of the 56 patients, laparotomy was excluded by the presence of intra-abdominal metastases. In three other patients, laparotomy was necessary to confirm the suspected hepatic or peritoneal metastases, or both, because histologic proof was not obtained at laparoscopy. In one patient, LLU failed to detect a small hepatic metastasis in segment VII. The preoperative stage was altered by laparoscopy in nine (17 percent) patients (M1 in six, T4 in three). Laparotomy was avoided in two (11 percent) and the preoperative stage changed in seven patients (41 percent), all of whom had carcinoma of the gastric cardia, as occurred in one (3 percent) and two (6 percent) patients with middle and distal carcinoma of the esophagus, respectively. CONCLUSIONS: Preoperative staging by LLU is of little value in patients with carcinoma of the middle and lower esophagus. The probable role of LLU in the staging of patients with carcinomas of the gastric cardia remains to be confirmed in larger series.

Incidence, risk factors, and treatment of pancreatic leakage after pancreaticoduodenectomy: drainage versus resection of the pancreatic remnant.

BACKGROUND: Pancreatic leakage is a major cause of morbidity and mortality after pancreaticoduodenectomy, with incidences varying between 6-24% and a mortality rate up to 40%. Treatment is an issue of controversy. In this study we analyzed risk factors for pancreatic leakage and the results of early resection of the pancreatic remnant versus drainage procedures for leakage of the pancreaticojejunostomy. STUDY DESIGN: From 1983 to 1995, 269 patients underwent pancreaticoduodenectomy, with pancreaticojejunostomy. Patients with manifestations of pancreatic leakage were compared with nonleakage patients to evaluate risk factors. Patients with leakage were divided into two treatment groups. One group comprised patients undergoing percutaneous or surgical drainage procedures; the other had patients undergoing resection of the pancreatic remnant. RESULTS: Twenty-nine patients (11%) had clinical manifestations of pancreatic leakage, and the mortality in these patients was 28% (overall mortality: 3.7%). Leakage occurred after a median of 5 days (range 1-20). Age, preoperative bilirubin level, and albumin counts were not risk factors for pancreatic leakage. Small pancreatic duct size (< 2 mm) (p < 0.01) and ampullary carcinoma as histopathologic diagnosis (p < 0.05) were risk factors. The median number of relaparotomies was two (range 0-4) in the drainage group (n = 21), versus 1.5 (range 1-5) in patients who underwent resection (n = 8). The median hospital stay was 74 days (range 36-219), versus 55 days (range 22-107) for the drainage and resection groups, respectively (p < 0.05). Mortality was lower in patients who underwent resection, 38 versus 0% (p < 0.05). CONCLUSIONS: Leakage of the pancreatic anastomosis is a severe complication after pancreaticoduodenectomy and carries a high mortality rate (28%). Completion pancreatectomy could be performed without additional mortality. In patients with severe and persistent leakage of the anastomosis, early completion pancreatectomy is the treatment of choice.

Improvement in the management of bile duct injuries?

BACKGROUND: Previous studies have suggested that improvements in diagnostic workup and treatment of bile duct injuries (BDI) sustained during laparoscopic cholecystectomy can be expected as experience increases with the laparoscopic procedure. Many published articles reported that early diagnosis, proper classification, and optimal timing of treatment of BDI increase the likelihood of successful treatment. This study determined whether diagnosis and management of BDI have improved over the years. STUDY DESIGN: Between June 1990 and November 1996, 106 patients were diagnosed and treated in the Amsterdam Academic Medical Center for BDI sustained during laparoscopic cholecystectomy. Detailed information was obtained about peroperative findings, time interval from laparoscopic cholecystectomy to symptoms, and interval from symptoms to diagnosis. Bile duct injuries were classified into four types. Two patient groups were compared: BDI patients diagnosed from 1990 until 1994 ("learning phase") and patients diagnosed from 1995 until 1996. RESULTS: Bile duct injuries combined with bile leakage were diagnosed significantly earlier in the second period after the learning phase. The percentages of injuries diagnosed peroperatively, "blind laparotomies," and suboptimal timed hepaticojejunostomies were not different between the groups. CONCLUSIONS: Except for earlier diagnosis of BDI in the later period than in previous years, there appeared to be no significant improvement in diagnostic workup and management during the past 2 years.

Staging laparoscopy and laparoscopic ultrasonography in more than 400 patients with upper gastrointestinal carcinoma.

BACKGROUND: Resection offers the only chance of cure to patients with esophageal, gastroesophageal junction, and hepatopancreatobiliary tumors. Staging is essential to select patients who will benefit from operation because palliation can also be performed nonoperatively. Several studies, including limited numbers of patients, have shown that laparoscopic staging prevents unnecessary laparotomies, but it is doubtful whether general application of this staging method can be advised. The aim of this study was to assess the benefit of diagnostic laparoscopy for staging patients with esophageal, gastroesophageal junction, and hepatopancreatobiliary tumors. STUDY DESIGN: Between June 1992 and December 1996, 420 patients with a resectable tumor after conventional staging underwent diagnostic laparoscopy combined with laparoscopic ultrasonography. Histologic proof of metastases or ingrowth was used to cancel laparotomy. RESULTS: Laparoscopic staging avoided laparotomy in 20% of patients (sensitivity 0.70): 5% with an esophageal tumor, 20% with a gastroesophageal junction tumor, 15% with a periampullary tumor, 40% with a proximal bile duct tumor, 35% with a liver tumor, and 40% with a pancreatic body or tail tumor. Complications and port-site metastases were seen in 4% and 2% of patients, respectively. CONCLUSIONS: Laparoscopic staging is a safe procedure with low morbidity and without mortality in this series. It has shown no benefit in esophageal cancer, but seems beneficial for staging tumors located at the gastroesophageal junction, proximal bile duct tumors, liver tumors, and pancreatic body and tail tumors. The value of laparoscopic staging for patients with periampullary tumors is not as great as stated in previous studies and is still the subject of investigation.

Prevention of implantation metastases after resection of proximal bile duct tumours with pre-operative low dose radiation therapy.

AIMS: Pre-operative endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage is associated with a greater risk of implantation metastases after resection of proximal bile duct tumours. In a previous study among patients who had undergone biliary drainage before resection, eight patients (20%) developed implantation metastases, within 1 year following resection. The aim of this analysis was to evaluate the results of pre-operative irradiation with regard to a possible reduction of implantation metastases. METHODS: Twenty-one patients with proximal bile duct tumours who had undergone resection following pre-operative irradiation were retrospectively analysed. Pre-operative radiation therapy consisted of three fractions of 3.5 Gy external beam irradiation of the hilar area. RESULTS: Pre-operative biliary drainage was performed in 19 patients (90%). All patients received pre-operative radiotherapy during which no complications were noted. None of the patients developed implantation metastases within a follow-up time of 2 to 79 months. CONCLUSION: The results of this study suggest that pre-operative radiotherapy in patients with a resectable proximal bile duct tumour who have undergone pre-operative drainage, decreases the risk of implantation metastases. To be certain about the role of pre-operative radiotherapy, a randomized study is required. Until then, we advocate standard low dose radiotherapy preceding resection in all patients with lesions suggestive of a proximal bile duct tumour who have undergone biliary drainage.

Survival after pancreaticoduodenectomy for periampullary adenocarcinoma: an update.

AIM: Survival after pancreaticoduodenectomy for periampullary tumours is limited. Over the last decade peri-operative management has improved and morbidity and mortality decreased. The aim of the study was to analyse recent survival data after pancreaticoduodenectomy and to determine factors that influence survival. METHODS: From October 1992 to September 1998, 204 patients with a ductal adenocarcinoma in the pancreatic head (108), distal bile duct (32), and ampulla (64) who underwent standard pancreaticoduodenectomy, were analysed with regard to histology and tumour status. Survival was calculated by using the Kaplan-Meier method. Risk factors were identified in a univariate and multivariate analysis. RESULTS: Median survival after resection for carcinoma of the pancreatic head, distal bile duct, and ampulla were 16, 25 and 24 months, respectively (P=0.008). In the univariate analysis vein resection, blood transfusion of more than four packed red cells, the presence of tumour positive resection margins, lymph-node metastases and poor tumour differentiation significantly decreased survival. In the multivariate analysis positive resection margins, lymph-node metastases, and poor tumour differentiation independently influenced survival. CONCLUSIONS: Resection margins, lymph-node status and tumour differentiation are independent prognostic factors. Survival after standard pancreaticoduodenectomy for periampullary tumours has not improved.

Hand-assisted laparoscopic splenectomy.

Laparoscopic splenectomy is performed routinely in patients with small and moderately enlarged spleens at specialized centers. Large spleens are difficult to handle laparoscopically and hand-assisted laparoscopic splenectomy might facilitate the procedure through enhanced vascular control, easier retraction and manipulation, manual guidance of endostaplers, and clip appliers. A technique of hand-assisted laparoscopic splenectomy is described.

Analysis of the quality and efficiency in learning laparoscopic skills.

OBJECTIVES: This study demonstrates the application of time-action analysis to the evaluation of task performance of diagnostic laparoscopy with laparoscopic ultrasonography. METHODS: The first 25 diagnostic laparoscopies with laparoscopic ultrasonography performed by a surgical resident were analyzed and compared with the outcomes of these procedures performed by an experienced surgeon. The time, actions, and correctness of task performance were evaluated. Furthermore, outcome correctness and postoperative complications were assessed. RESULTS: No postoperative complications occurred. The resident made one wrong diagnosis, for which the cause was detected by peroperative analysis. Additionally, 1% of the subtasks were performed only partially, 4% not at all, and 2% using the wrong technique. The efficiency for most diagnostic tasks remained significantly lower than that of the experienced surgeon (p < 0.001). CONCLUSIONS: Time-action analysis can be used to provide detailed insight into the quality and efficiency of learning surgical skills. It enables objective measurement of correctness in task performance as well as time and action efficiency.

Hand-assisted laparoscopic donor nephrectomy. Ascending the learning curve.

BACKGROUND: The hand-assisted approach to laparoscopic donor nephrectomy (LDN) might minimize the learning curve and shorten both the operation and the warm ischemia time. Our initial results from hand-assisted LDN are presented and compared with data from the literature. METHODS: From January to September 2000, ten hand-assisted LDNs of the right kidney were performed. RESULTS: The median operation time was 140 min (range, 120-400 min), and the warm ischemia time was 2.5 min (range, 1-4 min). There were no conversions. Postoperative morbidity included one urinary tract infection. All but one patient returned to a normal diet within 48 h. Opiates were needed a maximum of 48 h. One recipient experienced initial loss of graft function as a result of unknown causes. CONCLUSIONS: Even at the beginning of the learning curve, operation time and warm ischemia time are significantly reduced by the hand-assisted approach, as compared with conventional LDN.

Establishment of pneumoperitoneum with a modified blunt trocar.

Veress needle and trocar-related accidents have caused many surgeons to adopt the Hasson technique for establishment of pneumoperitoneum, but this technique also has drawbacks. A modification of the sharp trocar has been developed that overcomes the disadvantages of the Veress needle and Hasson trocar.

Efficacy of establishment of pneumoperitoneum with the Veress needle, Hasson trocar, and modified blunt trocar (TrocDoc): a randomized study.

PURPOSE: To compare three techniques of establishment of pneumoperitoneum for efficacy: the Veress needle/first trocar, the Hasson trocar, and a newly developed modified blunt trocar, the TrocDoc. PATIENTS AND METHODS: Between June and December 1999, 62 patients eligible for laparoscopic surgery were randomized. The effectiveness of installation of the pneumoperitoneum using the three techniques was assessed by time-motion analysis. Primary efficacy measures were total time and number of actions required to establish the pneumoperitoneum. Secondary efficacy measures were procedure-related complications, wound complications, and occurrence of CO2 leakage. RESULTS: Two patients were withdrawn from inclusion. The three groups were comparable for age and body mass index. Total time was shortest using the TrocDoc rather than the Veress needle/first trocar and the Hasson trocar (respectively, 138 +/- 58 v 237 +/- 56 v 350 +/- 103 seconds), and the number of actions was lowest for the Veress needle/first trocar combination: 22 +/- 7 v 32 +/- 12 (TrocDoc) v 53 +/- 17 (Hasson). There was no morbidity related to the installation of pneumoperitoneum nor trocar wound complications. Gas leakage occurred in five of the Hasson introductions. CONCLUSIONS: Establishment of the pneumoperitoneum is more efficient using the TrocDoc compared with the Veress needle/first trocar and the Hasson trocar. The TrocDoc might replace the two alternatives because of its efficacy and open method of introduction.

Quantitative analysis of the functionality and efficiency of three surgical dissection techniques: a time-motion analysis.

The increasing technological complexity of surgery demands objective evaluation of surgical techniques. In particular, alternatives for laparoscopic ligation, such as monopolar coagulation and the relatively new bipolar scissors combining dissection with coagulation, should be analyzed and compared. This study tests the efficacy of quantitative time-motion analysis in evaluating and comparing the functionality and efficiency of dissection and ligation techniques in a clinical setting. Standard dissection with ligation of vessels, bipolar scissors, and monopolar coagulation were consecutively applied to dissect 4 of the small bowel mesentery of pigs, in random order. All actions performed were recorded and analyzed, using a standard action list. The efficiency of each technique was expressed in mean dissection time and number of actions, and the safety in occurrence of complications and severity of microscopic damage. Time-motion analysis evaluated the efficiency objectively and reproducibly (ICC 0.98). Bipolar scissors were significantly more efficient (time 7 +/- 2 min, actions 129 +/- 33) than the standard technique (28 +/- 6, 771 +/- 185) and monopolar coagulation (14 +/- 5, 368 +/- 32) (p < 0.01). Furthermore, bipolar coagulation needed significantly less recoagulation of an oozing vessel (0.5% of the total dissected vessels) than did monopolar coagulation (10.4%), and the damaged zone was significantly smaller (p < 0.05). Significantly less time was spent waiting or exchanging instruments with bipolar scissors than with the standard technique (p < 0.05). This time-motion analysis objectively compared the efficiency and functionality of three surgical dissection techniques during clinical use. Bipolar scissors were more efficient than were both other techniques, and they coagulated vessels more safely than did monopolar coagulation.

Splenectomy revised: manually assisted splenectomy with the dexterity device--a feasibility study in 22 patients.

Laparoscopic splenectomy claims a number of advantages over open surgery: less trauma, quicker recovery, and faster return to normal activity. On the other hand, laparoscopic splenectomy is complex and time consuming, and so far, many surgeons are reluctant to perform such an operation. A new device was designed to give manual access to the abdomen through a utility laparotomy. By using one hand in the abdomen during laparoscopy, the surgeon regains direct tactile sense and hand-eye coordination. A pilot study to assess the feasibility of this method has been performed in 22 patients. The operation could be completed easily in 21 patients (95%). The average blood loss was 230 mL, and the average postoperative stay was 3.9 days. With this simple, inexpensive method, it is possible to combine the established convenience, safety, efficacy of open surgery with the advantages of minimally invasive surgery.