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Biomedical subjects

James W Fleshman

Publications and source records attributed to James W Fleshman.

At least 19 recordsLinked to original sources

FDG-PET/CT in the evaluation of anal carcinoma.

PURPOSE: Surgical staging and treatment of anal carcinoma has been replaced by noninvasive staging studies and combined modality therapy. In this study, we compare computed tomography (CT) and physical examination to [(18)F]-fluoro-2-deoxy-D-glucose-positron emission tomography/computed tomography (FDG-PET/CT) in the staging of carcinoma of the anal canal, with special emphasis on determination of spread to inguinal lymph nodes. METHODS AND MATERIALS: Between July 2003 and July 2005, 41 consecutive patients with biopsy-proved anal carcinoma underwent a complete staging evaluation including physical examination, CT, and 2-FDG-PET/CT. Patients ranged in age from 30 to 89 years. Nine men were HIV-positive. Treatment was with standard Nigro regimen. RESULTS: [(18)F]-fluoro-2-deoxy-D-glucose-positron emission tomography/computed tomography (FDG-PET/CT) detected 91% of nonexcised primary tumors, whereas CT visualized 59%. FDG-PET/CT detected abnormal uptake in pelvic nodes of 5 patients with normal pelvic CT scans. FDG-PET/CT detected abnormal nodes in 20% of groins that were normal by CT, and in 23% without abnormality on physical examination. Furthermore, 17% of groins negative by both CT and physical examination showed abnormal uptake on FDG-PET/CT. HIV-positive patients had an increased frequency of PET-positive lymph nodes. CONCLUSION: [(18)F]-fluoro-2-deoxy-D-glucose-positron emission tomography/computed tomography detects the primary tumor more often than CT. FDG-PET/CT detects substantially more abnormal inguinal lymph nodes than are identified by standard clinical staging with CT and physical examination.

Adult↗

Is there any difference in recurrence rates in laparoscopic ileocolic resection for Crohn's disease compared with conventional surgery? A long-term, follow-up study.

PURPOSE: The long-term outcome of laparoscopic ileocolic resection in patients with Crohn's disease is not well defined. This study was designed to define the surgical recurrence rate after laparoscopic ileocolic resection for Crohn's disease and to compare it with that seen after open ileocolic resection. METHODS: A retrospective review of 113 records of patients who underwent index ileocolic resection for terminal ileal Crohn's disease was performed (1987-2003). Recurrence was defined as development of new preanastomotic Crohn's disease requiring surgical intervention. Details of recurrence and use of chemoprophylaxis was determined by phone interview and chart review. RESULTS: Sixty-three patients (26 males; mean age, 35.2 years) underwent laparoscopic ileocolic resection and 50 had open ileocolic resection (17 males; mean age, 37.1 years). Surgical recurrence developed in 6 of 63 patients (9.5 percent) in the laparoscopic ileocolic resection group (mean follow-up, 62.9 months) and in 12 of 50 patients (24 percent) in the open ileocolic resection group (mean follow-up, 81.8 months). Rates of chemoprophylaxis were similar between groups (laparoscopic ileocolic resection, 39 percent; open ileocolic resection, 54 percent; P = not significant). Median times to recurrence after laparoscopic ileocolic resection and open ileocolic resection were 60 (range, 36-72) months and 62 (range, 12-180) months, respectively. Fifty percent of the recurrences in the laparoscopic ileocolic resection group and 4 of 12 in the open ileocolic resection group were able to be retreated laparoscopically. Re-recurrence occurred in 4 of 12 open ileocolic resection patients (33 percent) at a mean of 63.6 months, and one patient had a third recurrence at 28 months. CONCLUSIONS: In this study, the long-term outcome after laparoscopic ileocolic resection was not shown to be statistically different from that of open ileocolic resection. The relatively low recurrence rates in both groups may be explained by our aggressive use of chemoprophylaxis.

Adolescent↗

Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.

INTRODUCTION: Although Seprafilm has been demonstrated to reduce adhesion formation, it is not known whether its usage would translate into a reduction in adhesive small-bowel obstruction. METHODS: This was a prospective, randomized, multicenter, multinational, single-blind, controlled study. This report focuses on those patients who underwent intestinal resection (n = 1,701). Before closure of the abdomen, patients were randomized to receive Seprafilm or no treatment. Seprafilm was applied to adhesiogenic tissues throughout the abdomen. The incidence and type of bowel obstruction was compared between the two groups. Time to first adhesive small-bowel obstruction was compared during the course of the study by using survival analysis methods. The mean follow-up time for the occurrence of adhesive small-bowel obstruction was 3.5 years. RESULTS: There was no difference between the treatment and control group in overall rate of bowel obstruction. The incidence of adhesive small-bowel obstruction requiring reoperation was significantly lower for Seprafilm patients compared with no-treatment patients: 1.8 vs. 3.4 percent (P < 0.05). This finding represents an absolute reduction in adhesive small-bowel obstruction requiring reoperation of 1.6 percent and a relative reduction of 47 percent. In addition, a stepwise multivariate analysis indicated that the use of Seprafilm was the only predictive factor for reducing adhesive small-bowel obstruction requiring reoperation. In both groups, 50 percent of first adhesive small-bowel obstruction episodes occurred within 6 months after the initial surgery with nearly 30 percent occurring within the first 30 days. Additionally no first adhesive small-bowel obstruction events were reported in Years 4 and 5 of follow-up. CONCLUSIONS: The overall bowel obstruction rate was unchanged; however, adhesive small-bowel obstruction requiring reoperation was significantly reduced by the use of Seprafilm, which was the only factor that predicted this outcome.

Adolescent↗

Preoperative anal manometry predicts continence after perineal proctectomy for rectal prolapse.

PURPOSE: This study examines whether preoperative anal manometry and pudendal nerve terminal motor latency predict functional outcome after perineal proctectomy for rectal prolapse. METHODS: All adult patients treated by perineal proctectomy for rectal prolapse from 1995 to 2004 were identified (N = 106). Forty-five patients underwent anal manometry and pudendal nerve terminal motor latency testing before proctectomy and they form the basis for this study. RESULTS: Perineal proctectomy with levatoroplasty (anterior 88.9 percent; posterior 75.6 percent) was performed in all patients, with a mean resection length of 10.4 cm. Four patients (8.9 percent) developed recurrent prolapse during a 44-month mean follow-up. Preoperative resting and maximal squeeze pressures were 34.2 +/- 18.3 and 60.4 +/- 30.5 mmHg, respectively. Pudendal nerve terminal motor latency testing was prolonged or undetectable in 55.6 percent of patients. Grade 2 or 3 fecal incontinence was reported by 77.8 percent of patients before surgery, and one-third had obstructed defecation. The overall prevalence of incontinence (77.8 vs. 35.6 percent, P < 0.0001) and constipation (33.3 vs. 6.7 percent, P = 0.003) decreased significantly after proctectomy. Patients with preoperative squeeze pressures >60 mmHg (n = 19) had improved postoperative fecal continence relative to those with lower pressures (incontinence rate, 10 vs. 54 percent; P = 0.004), despite having similar degrees of preoperative incontinence. Abnormalities of pudendal nerve function and mean resting pressures were not predictive of postoperative incontinence. CONCLUSIONS: Perineal proctectomy provides relief from rectal prolapse, with good intermediate term results. Preoperative anal manometry can predict fecal continence rates after proctectomy, because patients with maximal squeeze pressures >60 mmHg have significantly improved outcomes.

Adult↗

Sentinel lymph node mapping for adenocarcinoma of the colon does not improve staging accuracy.

PURPOSE: This study was designed to: determine the efficacy of sentinel lymph node mapping in patients with intraperitoneal colon cancer; and create an algorithm to predict potential survival benefit by using best-case estimates in favor of sentinel node mapping and lymph node ultraprocessing techniques. METHODS: Forty-one patients with intraperitoneal colon cancer undergoing colectomy with curative intent were studied prospectively. After mobilization of the colon and mesentery, 1 to 2 ml of isosulfan blue dye was injected subserosally around the tumor. The first several nodes highlighted with blue dye were identified as sentinel nodes. Additional nodes were identified by the pathologist in routine fashion by manual dissection of the mesentery. All nodes were processed in routine fashion by bivalving and hematoxylin and eosin staining. To create an algorithm to predict potential survival benefit of sentinel node mapping and lymph node ultraprocessing techniques, assumptions were made using data from the literature. All bias was directed toward success of the techniques. RESULTS: Three of 41 patients (7 percent) did not undergo injection of dye and were excluded from further analysis. Stage of disease in the remaining 38 patients was: I, n = 10 (26 percent); II, n = 15 (39 percent); III, n = 11 (29 percent); IV, n = 2 (5 percent). At least one sentinel node was identified in 30 of 38 patients (79 percent). The median number of sentinel nodes identified was two (range, 1-3). Median total nodal retrieval was 14 (range, 7-45). All nodes were negative in 26 of 38 patients (68 percent). Sentinel nodes and nonsentinel nodes were positive in 2 of 38 patients (5 percent). Sentinel nodes were the only positive nodes in 1 of 38 patients (3 percent). Sentinel nodes were negative and nonsentinel nodes were positive in 9 of 38 patients (24 percent). Thus, sentinel node mapping would have potentially benefited only 3 percent, and failed to accurately identify nodal metastases in 24 percent of the patients in our study. To create a survival benefit algorithm, we assumed the following: combined fraction of Stage I and II disease (0.5); fraction understaged by bivalving and hematoxylin and eosin staining that would have occult positive nodes by more sophisticated analysis (0.15); fraction of occult positive nodes detected by sentinel node mapping (0.9); and survival benefit from chemotherapy (0.33). Thus, the fraction of patients benefiting from sentinel lymph node mapping and lymph node ultraprocessing techniques would be 0.02 (2 percent). CONCLUSIONS: Sentinel node mapping with isosulfan blue dye and routine processing of retrieved nodes does not improve staging accuracy in patients with intraperitoneal colon cancer. Even using best-case assumptions, the percentage of patients who would potentially benefit from sentinel lymph node mapping is small.

Adenocarcinoma↗

Retrorectal tumors: a diagnostic and therapeutic challenge.

PURPOSE: Tumors occurring in the retrorectal space are heterogeneous and uncommon. The utility of newer imaging techniques has not been extensively described, and operative approach is variable. This study examined the diagnosis, treatment, and outcome of retrorectal tumors at a tertiary referral center. METHODS: Patients with primary, extramucosal neoplasms occurring in the retrorectal space were identified using a prospectively maintained, procedural database of all adult colorectal surgical patients (1981-2003). Patients also were incorporated from the gynecologic oncology service. Exclusion criteria included inflammatory processes, locally advanced colorectal cancer, and metastatic malignancy. Medical records, radiology, and pathology reports were reviewed retrospectively. RESULTS: Thirty-four patients with retrorectal tumors were treated. Malignant tumors comprised 21 percent. Older age, male gender, and pain were predictive of malignancy (P < 0.05). Sensitivity of proctoscopy was 53 percent; this increased to 100 percent with the use of transrectal ultrasound. Accuracy of magnetic resonance vs. computed tomographic imaging for specific histologic tumor type was 28 vs. 18 percent, respectively. Surgical approach was anterior (n = 14), posterior (n = 11), and combined abdominoperineal (n = 9). Eleven patients required en bloc proctectomy. Patients undergoing posterior resection had lower blood loss and required fewer transfusions (P < 0.05). All benign tumors were resected with normal histologic margins and none recurred (median follow-up, 22 months). All patients with malignancy had recurrence/recrudescence of their disease. For these patients, median disease-free and overall survivals were 38 and 61 months, respectively. CONCLUSIONS: Retrorectal tumors remain a diagnostic and therapeutic challenge. Pain, male gender, and advanced age increase the likelihood of malignancy. Various imaging modalities are useful for planning resection but cannot establish a definitive diagnosis. Whereas benign retrorectal tumors can be completely resected, curative resection of malignant retrorectal tumors remains difficult.

Abdomen↗

Delayed treatment for rectal cancer.

PURPOSE: Reports of the relationship between length of delay before diagnosis of rectal cancer and stage of the disease have been mixed. The present study documented the magnitude and medical ramifications of delay in diagnosing rectal cancer. METHODS: One hundred twenty patients who had been recently diagnosed with rectal cancer provided information regarding history of symptoms and initial perceptions of those symptoms. Patients also estimated the time elapsed from onset of symptoms until their first consultation with a physician, as well as time elapsed from consultation until the diagnosis of rectal cancer was made. Stage information was gathered from patient charts. RESULTS: For 106 of the patients, the first sign of rectal cancer was in the form of symptoms, and the most common first symptom was rectal bleeding. For the remaining 14 patients, their cancer was first discovered through routine examination. Over 75 percent of patients with symptoms did not initially believe that they were caused by cancer or any other serious problem, and over 50 percent attributed their symptoms to hemorrhoids. There was a clear trend, albeit statistically nonsignificant, toward worsening disease with longer delays. Median delay times in weeks were Stage I (10.0 weeks), Stage II (14.0 weeks), Stage III (18.5 weeks), and Stage IV (26.0 weeks). CONCLUSIONS: Delayed diagnosis for rectal cancer remains a significant problem, with instances of delay attributable to both patient and physician. Delayed diagnosis can result in more serious disease and, when attributable to the physician, can result in damaged trust and sometimes legal action.

Adult↗

Neoadjuvant therapy for rectal cancer: histologic response of the primary tumor predicts nodal status.

PURPOSE: This study was designed to compare histologic T and N stages in patients with rectal adenocarcinoma undergoing various neoadjuvant radiotherapy regimens and proctectomy, in an attempt to determine if final histologic stage of the mural tumor predicts nodal status. METHODS: Data were collected from computerized databases at two institutions on 649 consecutive patients who underwent neoadjuvant radiotherapy or chemoradiotherapy and proctectomy for primary adenocarcinoma of the rectum from 1990 to 2002. RESULTS: Five patients were excluded because of incomplete pathology data sets, leaving a study population of 644. Patients underwent neoadjuvant radiotherapy alone (2000 cGy in 5 fractions, n = 191; or 4500 cGy in 25 fractions, n = 259) or chemoradiation (4500 cGy in 25 fractions with concurrent 5-fluorouracil, n = 194). Histologic stage of the remaining mural tumor (ypT) correlated with nodal status (ypN). Lymph nodes harboring metastatic tumor were found in 1 of 42 (2 percent) ypT0 patients, 2 of 45 (4 percent) ypT1 patients, 43 of 186 (23 percent) ypT2 patients, 158 of 338 (47 percent) ypT3 patients, and 16 of 33 (48 percent) ypT4 patients ( P < 0.001, chi-squared test). The probability of finding ypN+ disease was 3 of 87 (3 percent) in patients with ypT0-1 residual primary tumors vs. 220 of 557 (39 percent) in patients with ypT2-4 residual primary tumors ( P < 0.0001; Fisher's exact test). CONCLUSIONS: Nodal metastases are rare in patients whose mural tumor burden shrinks to ypT0-1 after neoadjuvant radiotherapy. If transanal excision is offered to select patients with distal rectal cancer, it is reasonable to select those who have an excellent clinical response to neoadjuvant therapy for transanal excision, and then reserve proctectomy for patients proven to have residual ypT2-4 disease.

Adenocarcinoma↗

Fibrin glue treatment of complex anal fistulas has low success rate.

PURPOSE: Fibrin glue has been used to treat anal fistulas in an attempt to avoid more radical surgical intervention. Reported success rates vary widely. The purpose of this study was to review the use of fibrin glue in the management of complex anal fistulas at a tertiary referral center. METHODS: This study was designed as a retrospective review of all patients treated with fibrin glue injection for complex anal fistulas in the Section of Colon and Rectal Surgery, Washington University School of Medicine/Barnes-Jewish Hospital. Demographics, previous treatment, operative information, and early follow-up were obtained from the patients' medical records. Phone interviews were conducted to determine successful healing or recurrence of fistulas requiring further treatment. Statistical analysis was by Fisher's exact test. The institutional review board approved the study. RESULTS: A total of 42 patients (19 males; median age, 44 (range, 20-76) years) were treated between 1999 and 2002. Three patients were lost to follow-up and were excluded from the study. Etiology of fistulas were cryptoglandular (n = 22), Crohn's disease (n = 13), or coloanal and ileal pouch-anal anastomotic (n = 4). Fistulas were classified as deep transsphincteric (n = 33), superficial transsphincteric (n = 1), supralevator (n = 2), or rectovaginal (n = 3). Initially, most patients had "closure" of the fistula but recrudescence was common. Durable healing was only achieved in 31 percent (12/39). Healing rates by etiology were cryptoglandular 23 percent (5/22), Crohn's disease 31 percent (4/13), and ileal pouch-anal anastomotic 75 percent (3/4; P = 0.14). Success rates by classification were deep transsphincteric 33 percent (11/33), superficial transsphincteric 0 percent (0/1), supralevator 0 percent (0/2), and rectovaginal 33 percent (1/3; P = 1). The success rate for patients with no previous treatment was 38 percent (8/21) vs. 22 percent (4/18) in those whose fistulas had been previously treated ( P = 0.32). Eight patients underwent a second fibrin glue treatment and only one of them healed (12.5 percent). Median follow-up for successfully healed fistula was 26 months. CONCLUSIONS: Fibrin glue treatment for complex anal fistulas has a low success rate and most recrudescences occurred within three months. However, given the low morbidity and relative simplicity of the procedure, fibrin glue should still be considered as a first-line treatment for patients with complex anal fistulas.

Adult↗

Outcomes, risk of other malignancies, and need for formal mapping procedures in patients with perianal Bowen's disease.

PURPOSE: Local excision is standard treatment for Bowen's disease, but controversy exists over the incidence of synchronous and metachronous cancers as well as the role of a preexcision mapping procedure. METHODS: The medical records of 25 patients treated for perianal Bowen's disease between 1978 and 2001 were retrospectively reviewed. RESULTS: There were 11 men and 14 women with a mean age at diagnosis of 47.9 +/- 14.9 years. The majority of patients (72 percent) had symptom-driven biopsies. Presentation included pruritus (56 percent), mass (28 percent), bleeding (24 percent), and anal pain (4 percent). The average duration of symptoms before diagnosis was 1.3 +/- 0.5 years. Two patients had microscopic disease discovered incidentally after hemorrhoidectomy and underwent no further treatment. Twenty-three patients underwent wide local excision, of which 19 (83 percent) had a formal mapping procedure. On final pathology, 23 patients (92 percent) had clear margins. There were three recurrences (mean time to recur 2.0 +/- 1.0 years), including the two patients who had positive margins after wide excision (1 after mapping) and one patient who had clear margins after mapping. Five patients (20 percent) had other carcinomas (1 sigmoid, 4 vulvar). At follow-up, 24 patients were alive with no evidence of Bowen's disease and 1 patient was dead secondary to sigmoid cancer with no evidence of Bowen's disease. CONCLUSIONS: Wide excision of perianal Bowen's disease results in excellent local control, although this is highly dependent on clear pathologic margins. A formal mapping procedure does not preclude recurrence. Initial screening and follow-up regimens are not uniform because of the wide range of treatment options available.

Adult↗

Outcome of salvage abdominoperineal resection after failed endocavitary radiation in patients with rectal cancer.

PURPOSE: Endocavitary radiation is a treatment option for selected patients with rectal cancer, but concern exists for the effectiveness of salvage abdominoperineal resection. This study was designed to examine outcomes after salvage abdominoperineal resection for recurrence after endocavitary radiation. METHODS: A prospective database was used to identify patients undergoing abdominoperineal resection after endocavitary radiation from 1985 to 2001. Office records and a tumor registry were used for disease status and survival data. Survival was calculated using the Kaplan-Meier method and groups compared using the Mantel-Haenszel test. RESULTS: Thirty-eight patients underwent salvage abdominoperineal resection. The mean time to recurrence after completion of endocavitary radiation was 21 +/- 27 months, with 29 percent having persistent disease, 63 percent recurrent disease, and 8 percent a second primary. At abdominoperineal resection, 47 percent had tumor transection, specimen perforation, or injury to the genitourinary or gynecologic tract. Nine patients (24 percent) had positive radial margins. The mean time to perineal wound healing was 56 +/- 74.1 days postoperatively, with 36.8 percent taking more than 60 days. Seventeen patients (45 percent) re-recurred at a mean of 21 +/- 25 months after salvage, with a local control rate of 26 percent at 45 +/- 37 months of follow-up. Median disease-specific survival from completion of endocavitary radiation was 115.5 months, with a five-year, disease-specific survival rate of 66 percent. Patients with recurrent disease after endocavitary radiation had significantly (P = 0.025) better disease-specific survival than those with persistent disease (median survival 115 vs. 25 months). CONCLUSIONS: Although technically difficult and associated with a high morbidity, abdominoperineal resection can salvage a significant fraction (55 percent) of patients failing endocavitary radiation. A high index of suspicion for recurrence and a tenacious approach to its diagnosis are essential for optimal outcomes.

Adult↗

Obesity decreases perioperative tissue oxygenation.

BACKGROUND: Obesity is an important risk factor for surgical site infections. The incidence of surgical wound infections is directly related to tissue perfusion and oxygenation. Fat tissue mass expands without a concomitant increase in blood flow per cell, which might result in a relative hypoperfusion with decreased tissue oxygenation. Consequently, the authors tested the hypotheses that perioperative tissue oxygen tension is reduced in obese surgical patients. Furthermore, they compared the effect of supplemental oxygen administration on tissue oxygenation in obese and nonobese patients. METHODS: Forty-six patients undergoing major abdominal surgery were assigned to one of two groups according to their body mass index: body mass index less than 30 kg/m2 (nonobese) or 30 kg/m2 or greater (obese). Intraoperative oxygen administration was adjusted to arterial oxygen tensions of approximately 150 mmHg and approximately 300 mmHg in random order. Anesthesia technique and perioperative fluid management were standardized. Subcutaneous tissue oxygen tension was measured with a polarographic electrode positioned within a subcutaneous tonometer in the lateral upper arm during surgery, in the recovery room, and on the first postoperative day. Postoperative tissue oxygen was also measured adjacent to the wound. Data were compared with unpaired two-tailed t tests and Wilcoxon rank sum test; P < 0.05 was considered statistically significant. RESULTS: Intraoperative subcutaneous tissue oxygen tension was significantly less in the obese patients at baseline (36 vs. 57 mmHg; P = 0.002) and with supplemental oxygen administration (47 vs. 76 mmHg; P = 0.014). Immediate postoperative tissue oxygen tension was also significantly less in subcutaneous tissue of the upper arm (43 vs. 54 mmHg; P = 0.011) as well as near the incision (42 vs. 62 mmHg; P = 0.012) in obese patients. In contrast, tissue oxygen tension was comparable in each group on the first postoperative morning. CONCLUSION: Wound and tissue hypoxia were common in obese patients in the perioperative period and most pronounced during surgery. Even with supplemental oxygen tissue, oxygen tension in obese patients was reduced to levels that are associated with a substantial increase in infection risk.

Abdomen↗

The addition of continuous infusion 5-FU to preoperative radiation therapy increases tumor response, leading to increased sphincter preservation in locally advanced rectal cancer.

PURPOSE: To compare the outcome from preoperative chemoradiation (CXRT) and from radiation therapy (RT) in the treatment of rectal cancer in two large, single-institutional experiences. PATIENTS AND METHODS: Between 1978 and 1995, 403 patients with localized, nonmetastatic, clinically staged T3 or T4 rectal cancer patients were treated with preoperative RT alone at two institutions. Patients at institution 1 (n = 207) were treated with pelvic CXRT exclusively, and patients at institution 2 were treated (except for 8 given CXRT) with pelvic RT alone (n = 196). In addition, a third group (n = 61) was treated with CXRT at institution 2 between 1998 and 2000 after a policy change. Both institutions delivered 45 Gy in five fractions as a standard dose, but institution 2 used 20 Gy in five fractions in selected cases (n = 26). At both institutions, concurrent chemotherapy consisted of a continuous infusion of 5-fluorouracil (5-FU) at a dosage of 1500 mg/m(2)/week. The end points were response, sphincter preservation (SP), relapse-free survival (RFS), pelvic disease control (PC), and overall survival (OS). RESULTS: Median follow-up was 63 months for all living patients at institution 1 and in the primary group of institution 2. Multivariate analysis of the patients in these groups showed that the use of concurrent chemotherapy improved tumor response (T-stage downstaging, 62% vs. 42%, p = 0.001, and pathologic complete response, 23% vs. 5% p < 0.0001), but did not significantly improve LC, RFS, or OS. Follow-up for the secondary group at institution 2 was insufficient to allow the analysis of these endpoints. In the subset of patients receiving 45 Gy who had rectal tumors < or /=6 cm from the anal verge (institution 1: n = 132; institution 2 primary: n = 79; institution 2 secondary: n = 33), there was a significant improvement in SP with the use of concurrent chemotherapy (39% at institution 1 compared with 13% in the primary group at institution 2, p < 0.0001). A logistic regression analysis of clinical prognostic factors indicated that the use of concurrent chemotherapy independently influenced SP in these low tumors (p = 0.002). This finding was supported by a 36% SP rate in the secondary group at institution 2. Thus SP increased after the addition of chemotherapy at institution 2. CONCLUSIONS: The use of concurrent 5-FU with preoperative radiation therapy for T3 and T4 rectal cancer independently increases tumor response and may contribute to increased SP in patients with low rectal cancer.

Academic Medical Centers↗

A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine.

INTRODUCTION: Seprafilm adhesion barrier (Seprafilm) has been proven to prevent adhesion formation after abdominal and pelvic surgery. This article reports safety results, including the postoperative incidence of abdominal and pelvic abscess and pulmonary embolism, from a large, multicenter trial designed to evaluate the safety and effectiveness of Seprafilm for reduction of adhesion-related postoperative bowel obstruction after abdominopelvic surgery. METHODS: A total of 1791 patients participated in this prospective, randomized, multicenter, multinational, single-blind, controlled study in patients undergoing abdominopelvic surgery, the majority of whom had inflammatory bowel disease. Just before closure of the abdomen, patients were randomized to a Seprafilm or no-treatment control group. Patients received an average of 4.4 and as many as 10 Seprafilm adhesion barriers applied to organs and tissue surfaces that sustained direct surgical trauma and to suspected adhesiogenic surfaces. Complications that occurred within the first month after surgery were evaluated. RESULTS: During the safety evaluation period, the difference between the Seprafilm and control groups for the incidence of abscess (4 vs. 3 percent, respectively) or pulmonary embolism (<1 percent in both groups) was not statistically significant (P > 0.05). Foreign body reaction was not reported in either group. Fistula (2 vs. <1 percent) and peritonitis (2 vs. <1 percent) occurred more frequently (P <or= 0.05) in the Seprafilm group. In a subpopulation of patients in whom Seprafilm was wrapped around a fresh bowel anastomosis, leak-related events, which included anastomotic leak, fistula, peritonitis, abscess, and sepsis, occurred more frequently (P <or= 0.05). There were no other differences in the incidence, severity, or causative relationship of complications between study groups. CONCLUSIONS: This study confirmed the safety of Seprafilm adhesion barrier with respect to abdominal abscess, pelvic abscess, and pulmonary embolism when administered to patients undergoing abdominopelvic surgery. Foreign body reaction was not reported for any patient. However, wrapping the suture or staple line of a fresh bowel anastomosis with Seprafilm should be avoided, because the data suggest that this practice may increase the risk of sequelae associated with anastomotic leak.

Abdomen↗

Supplemental perioperative fluid administration increases tissue oxygen pressure.

BACKGROUND: Wound infections are common and serious surgical complications. Wound perfusion delivers oxygen, inflammatory cells, growth factors, and cytokines to injured tissues. Hypoperfused regions experience low oxygen tensions that do not support adequate oxidative killing or wound healing. Clinicians may fail to recognize clinically important hypovolemia because hemodynamic stability and urine output are maintained after peripheral perfusion is compromised. We tested the hypothesis that supplemental fluid administration during and after elective colon resection increases tissue perfusion and tissue oxygen pressure. METHODS: Fifty-six patients undergoing colon resection were randomly assigned to conservative (8 mL x kg(-1) x h(-1), n = 26) or aggressive (16 to 18 mL x kg(-1) x h(-1), n = 30) fluid management. Anesthetic technique was standardized. We used 60% nitrous oxide in 40% oxygen. During surgery and postanesthetic recovery, subcutaneous oxygen tension (P(sq)O(2)) was measured by using a polarographic sensor implanted subcutaneously into 1 upper arm. Capillary blood flow was evaluated postoperatively with a thermal diffusion system. Data were analyzed with 2-tailed t tests; P value less than.05 was considered statistically significant. RESULTS: Hemodynamic and renal responses were similar in the groups. Intraoperative tissue oxygen tension was significantly greater in patients given supplemental fluid: 81 +/- 26 vs 67 +/- 18 mm Hg, P =.03. Postoperative P(sq)O(2) (77 +/- 26 vs 59 +/- 15 mm Hg, P =.009) and capillary blood flow (69 +/- 12 vs 53 +/- 12, P <.001) were also greater in the supplemental fluid patients. CONCLUSIONS: Supplemental perioperative fluid administration significantly increases tissue perfusion and tissue oxygen partial pressure. Optimizing tissue perfusion will require providing more fluid than indicated by normal clinical criteria or use of invasive monitoring to guide treatment. The actual effect of supplemental fluid administration on incidence of wound infection requires further investigation.

Adult↗