Biomedical subjects

J Fleshman

Publications and source records attributed to J Fleshman.

12 recordsLinked to original sources

PubMed2004

A prospective, randomized, controlled multicenter trial comparing stapled hemorrhoidopexy and Ferguson hemorrhoidectomy: perioperative and one-year results.

PURPOSE: There is a growing body of evidence supporting the lesser degrees of pain with stapled hemorrhoidopexy, also called the procedure for prolapse and hemorrhoids. However, there have been few randomized comparisons assessing both perioperative and long-term outcomes of the procedure for prolapse and hemorrhoids and Ferguson hemorrhoidectomy. Results are presented here from the first prospective, randomized, multicenter trial comparing these hemorrhoid procedures in the United States. METHODS: Patients with prolapsing hemorrhoids (Grade III) were randomized to undergo the procedure for prolapse and hemorrhoids or Ferguson hemorrhoidectomy by colorectal surgeons who had training in using the stapling technique. Primary end points were acute postoperative pain, and hemorrhoid symptom recurrence requiring additional treatment at one-year follow-up from surgery. RESULTS: A total of 156 patients (procedure for prolapse and hemorrhoids, 77; Ferguson, 79) completed randomization and the surgical procedure, 18 (procedure for prolapse and hemorrhoids, 12; Ferguson, 6) had significant protocol violations. One hundred seventeen patients (procedure for prolapse and hemorrhoids, 59; Ferguson, 58) returned for one-year follow-up. Demographic parameters, hemorrhoid symptoms, preoperative pain scores, and bowel habits were similar between groups. There were a similar number of patients with adverse events in each group (procedure for prolapse and hemorrhoids, 28 (36.4 percent) vs. Ferguson, 38 (48.1 percent); P = 0.138). Reoperation for an adverse effect was required in six (7.6 percent) Ferguson patients and in 0 patients having the procedure for prolapse and hemorrhoids (P = 0.028). Postoperative pain during the first 14 days, pain at first bowel movement, and need for postoperative analgesics were significantly less in the procedure for prolapse and hemorrhoids group. Control of hemorrhoid symptoms was similar between groups; however, significantly fewer patients having the procedure for prolapse and hemorrhoids required additional anorectal procedures during one-year follow-up (procedure for prolapse and hemorrhoids, 2 (2.6 percent), vs. Ferguson, 11 (13.9 percent); P = 0.01). Only four of the Ferguson patients (5 interventions) required additional procedures more than 30 days after surgery. CONCLUSIONS: These data demonstrate that stapled hemorrhoidopexy offers the benefits of less postoperative pain, less requirement for analgesics, and less pain at first bowel movement, while providing similar control of symptoms and need for additional hemorrhoid treatment at one-year follow-up from surgery.

Analysis of Variance↗

PubMed2003

Age and type of procedure influence the choice of patients for laparoscopic colectomy.

BACKGROUND: The aim of this retrospective, case-matched controlled study was to determine the benefit of laparoscopic-assisted colectomy (LC) for the elderly (>75 years of age) and the young (<75 years of age) compared to an open colectomy (OC) control group. METHODS: A retrospective review of 39 patients older than 75 years of age and 38 patients younger than 75 years of age who underwent LC for colorectal cancer between 1991 and 1999 was performed. LC patients were matched with an open control group for procedure, age, gender, year of procedure, and surgeon. Procedures included right and left colectomy, anterior resection of the rectosigmoid, and abdominoperineal resection. Measured intraoperative variables included anesthesia time, operative time, and estimated blood loss. Postoperative parameters consisted of duration of intravenous or epidural narcotic usage, return of bowel function (RBF), length of stay, and independence at discharge. These variables were compared in the entire group of 154 patients. RESULTS: Mean ages were 81.4 and 81.8 years for LC and OC age >75 and 62.9 and 62.7 for LC and OC age <75. Mean anesthesia time and operative time were significantly longer (p < 0.05) for LC compared to OC (46.8 vs 39.3 and 159.3 vs 111.7 min, respectively) for age >75 and for age <75 (47.1 vs 40.3 and 182.8 vs 135.5 min, respectively). LC achieved faster recovery in both age groups: RBF (3.9 vs 4.9 days for age >75; 6.7 vs 7.7 days for age <75) (p < 0.05). Narcotic usage was shorter for the LC group age <75 (3.3 vs 4.4 days; p < 0.05). There was no significant difference in independence at discharge between LC and OC in either age group. Faster recovery was seen with left LC in age >75 and right LC in age <75 compared to OC. CONCLUSION: The advantages of LC over OC are the same for the elderly and the young. There may be a selective benefit of laparoscopic left colectomy in the elderly and laparoscopic right colectomy in the young.

Age Factors↗

PubMed2001

Dual-organ ablative surgery using a hand-assisted laparoscopic technique. A report of four cases.

In clinical situations where more than one procedure is required, a properly positioned hand-assist device can be used to obviate the need for two large incisions. We present four cases of hand-assisted laparoscopic nephrectomy combined with a simultaneous second organ extraction. Each of the four primary procedures, as well as one of the four secondary procedures, was performed using a hand-assisted laparoscopic technique. In two cases, the secondary procedure was performed with an open surgical technique through the hand-assist incision. For the remaining secondary procedure, we used a laparoscopically assisted technique.

Aged↗

PubMed2001

Guidelines 2000 for colon and rectal cancer surgery.

BACKGROUND: Oncologic resection techniques affect outcome for colon cancer and rectal cancer, but standardized guidelines have not been adopted. The National Cancer Institute sponsored a panel of experts to systematically review current literature and to draft guidelines that provide uniform definitions, principles, and practices. METHODS: Methods were similar to those described by the American Society of Clinical Oncology in developing practice guidelines. Experts representing oncology and surgery met to review current literature on oncologic resection techniques for level of evidence (I-V, where I is the best evidence and V is the least compelling) and grade of recommendation (A-D, where A is based on the best evidence and D is based on the weakest evidence). Initial guidelines were drafted, reviewed, and accepted by consensus. RESULTS: For the following seven factors, the level of evidence was II, III, or IV, and the findings were generally consistent (grade B): anatomic definition of colon versus rectum, tumor-node-metastasis staging, radial margins, adjuvant R0 stage, inadvertent rectal perforation, distal and proximal rectal margins, and en bloc resection of adherent tumors. For another seven factors, the level of evidence was II, III, or IV, but findings were inconsistent (grade C): laparoscopic colectomy; colon lymphadenectomy; level of proximal vessel ligation, mesorectal excision, and extended lateral pelvic lymph node dissection (all three for rectal cancer); no-touch technique; and bowel washout. For the other four factors, there was little or no systematic empirical evidence (grade D): abdominal exploration, oophorectomy, extent of colon resection, and total length of rectum resected. CONCLUSIONS: The panel reports surgical guidelines and definitions based on the best available evidence. The availability of more standardized information in the future should allow for more grade A recommendations.

Colonic Neoplasms↗

PubMed1999

Five fractions of preoperative radiotherapy for selected cases of rectal carcinoma: long-term tumor control and tolerance to treatment.

BACKGROUND: Randomized Swedish studies demonstrate the efficacy of a 5-fraction course of preoperative radiotherapy for rectal carcinoma. The present study evaluates the results in a single U.S. institution over a 20-year period with a similar regimen. METHODS AND MATERIALS: During the period of 1975-1995, 83 patients received pelvic radiotherapy of 20 Gy/5 fractions, followed by immediate surgery for rectal cancer. These patients represented 21% of cases receiving preoperative treatment; the remainder received 45-50 Gy preoperatively. The 5-fraction course was used for lesions deemed readily resectable but too bulky for conservative endocavitary treatment. Since 1990, it has been our policy to administer postoperative chemotherapy to medically fit patients who prove to have pathologic Stage II or III disease. Patient characteristics including age (mean 65 years, range 23-90), gender (45% male), and location within the rectum were comparable to our previously reported cases that received 45 Gy/25 fractions preoperatively. However, the group selected for 5 fractions preoperatively had relatively fewer lesions that were tethered (20% vs. 61%), circumferential (11% vs. 20%), or near obstructing (1% vs. 16%). RESULTS: With a post treatment follow-up of 1-15 years (mean 4.7), there have been 3 local failures and 12 distant failures, with an actuarial local control of 95%, and disease-specific survival of 77% at 5 and 10 years. Grade > or = 3 perioperative or late toxicity occurred in 11 cases (13%), including 3 (3.5%) late bowel obstructions. Stage II or III disease was found in 56% of the cases, 74% of which were free of disease at last follow-up. However, patients with Stage II or III lesions that were significantly tethered or fixed had a 40% greater likelihood of recurring than similar stage lesions that were, at most, slightly tethered. Sphincter-preserving surgery was possible in 60% of the patients. In recent years, postoperative chemotherapy has been administered to 16 patients with Stage II or III disease; this has been well tolerated, with only 1 late toxicity (cystitis managed medically). When compared with a matched group of cases receiving conventionally fractionated preoperative radiation, there were no significant differences in perioperative morbidity and nonradiotherapeutic cost generating factors (length of hospital stay, duration of postoperative antibiotics, blood loss at surgery). CONCLUSION: Patients with resectable rectal cancer who received 20 Gy/5 fractions preoperative radiotherapy to the pelvis had excellent local and distant control of disease. These patients were able to undergo sphincter-preserving surgery and postoperative chemotherapy. It would be of interest to conduct a randomized trial comparing short course with longer course (45 or 50 Gy) preoperative radiotherapy for resectable T3 lesions. The results of this study suggest that, in general, differences in toxicity, local control, and disease-free survival would probably be < 10%. However, since the results of this study suggest that patients with significantly tethered lesions may be better served with the higher dose and longer duration course of radiation, clinical degree of fixation should be included as a stratification parameter, and stopping criteria should be included for tethered lesions.

Adult↗

PubMed1996

Carcinoma of the rectum. Possible cellular predictors of metastatic potential and response to radiation therapy.

BACKGROUND: Preoperative radiation therapy can markedly improve local control of rectal carcinoma. However, some tumors do not respond well to moderate doses of preoperative radiation and would be better served by more aggressive preoperative treatment (e.g., chemoradiotherapy). Cellular predictors of responsiveness to radiation can help to select lesions for more aggressive treatment. In addition, there is a need for cellular predictors of metastatic potential. This is particularly important in the setting of preoperative radiation-downstaging by preoperative treatment can obscure the true pathologic stage of a tumor and confound the usual selection criteria for postoperative chemotherapy. PURPOSE: This study was undertaken to determine if proliferating cell nuclear antigen (PCNA), p53, DNA ploidy, and S-phase fraction are associated with response to radiation and/or risk for distant metastatic disease and to determine if these cellular markers are best evaluated from preradiation biopsy specimen or the larger (but possibly altered) final surgical specimen. MATERIALS AND METHODS: Archival specimens from 23 cases of ultrasound T3 or T4 rectal carcinoma treated preoperatively with radiation therapy were reviewed. Eligible lesions had preradiation biopsy specimens of sufficient size for flow cytometric review of archival tissue. Factors considered included PCNA positivity, presence of mutant nuclear p53, more than 30 percent tumor cells in S-phase, and presence of aneuploidy. RESULTS: With a median follow-up of three years, overall freedom from relapse was 83 percent, with all but one failure being extrapelvic. PCNA positivity in the preradiation specimen was significantly (P = 0.025) associated with a greater risk of tumor recurrence. In addition, there was a trend to greater likelihood of "probable downstaging" (defined as surgical T stage less than preradiation ultrasound T stage) for lesions that were PCNA-negative or lesions with normal p53. Biomarkers measured in the postradiation surgical specimen were not associated with either freedom from relapse or response to radiation. Radiation treatment appeared to produce false-negatives in the final specimen. Thus, there were significantly more specimens converting from PCNA-positive to PCNA-negative after preoperative radiation than would be expected solely on the basis of sampling errors (P = 0.004). Similar results were found for abnormal p53 findings (P = 0.02). CONCLUSIONS: Prospective studies of biomarkers should be based on pretreatment specimens if preoperative radiation is given. For carcinoma of the rectum, PCNA and p53 may be useful predictors of both metastatic potential and responsiveness to radiation.

Adenocarcinoma↗

PubMed1995

Adjuvant radiation therapy for rectal carcinoma: predictors of outcome.

PURPOSE: To review predictors of outcome, including sequencing of modalities and pretreatment findings for adjuvantly treated rectal cancer. METHODS AND MATERIALS: From 1975 through 1990, 307 patients with adenocarcinoma of the rectum underwent adjuvant radiation therapy. In 251 cases the radiation therapy was administered preoperatively, either 40-50 Gy (median dose 45 Gy) followed in 6-7 weeks by surgery (210 cases), or 20 Gy in five fractions immediately prior to surgery (41 cases). In 56 cases, patients were referred postoperatively for radiation (median dose 50 Gy). Adjuvant chemotherapy was never given concurrently with the preoperative radiation (RT), although 43 of the cases (including 14 of the preoperative RT cases) received postoperative chemotherapy. RESULTS: Multivariate analysis (Cox model) indicated that significant predictors of better overall freedom from disease were preoperative rather than postoperative RT (p < 0.001), low surgical stage (p < 0.0001), specialist surgeon (p = 0.007), low or moderate histologic grade (p = 0.026), and proximal lesion (p = 0.033). The significant predictors for better local control included use of preoperative RT (p < 0.001), low or moderate grade (p = 0.001), and low surgical stage (p = 0.015). The 5-year local control and freedom from disease for the preoperative RT patients were 90% +/- 2% and 73% +/- 3%, respectively. The selected cases that received the short course of 20 Gy preoperatively did well. Although 24 out of 41 patients proved to have Astler Coller B2 or C disease, local control at last follow-up was 39 out of 41 (95%). A second multivariate analysis of pretreatment factors was performed on the preoperative RT cases. The significant factors for both local control and overall freedom from disease were noncircumferential vs. circumferential tumor, proximal vs. distal lesion, and background of the surgeon. Additional negative factors on univariate analysis (although not achieving independent significance on multivariate analysis) included the finding of near-obstructing lesions and elevated carcinoembryonic antigen (CEA). Grade > or = 3 sequelae occurred in 8% of cases (including 3% bowel obstruction). The only significant factor for complications was background of the surgeon (4% for colorectal specialists vs. 12% for nonspecialists, p = 0.015). CONCLUSIONS: Significant factors for better tumor control included preoperative as opposed to postoperative RT and the experience of the surgeon. In selected cases, excellent results can be obtained with a short course of preoperative radiation. Concurrent chemotherapy need not be given routinely with preoperative radiation. Subgroups of preoperative RT cases at risk for distant metastases (who might benefit from postoperative chemotherapy), and at high risk for local failure (for whom concurrent preoperative chemotherapy and radiation might be considered), are identified.

Adenocarcinoma↗

PubMed1995

Practice parameters for sigmoid diverticulitis. The Standards Task Force American Society of Colon and Rectal Surgeons.

It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient.

Acute Disease↗

PubMed1995

Laparoscopic-assisted colectomy learning curve.

PURPOSE: The purpose of this paper is to establish the number of cases necessary to master laparoscopic removal of the left or right colon. METHODS: Data were obtained by chart review and by individually completed questionnaires. RESULTS: A total of 144 laparoscopic-assisted or intracorporeal right or left hemicolectomies were completed by four surgeons at separate institutions. Questionnaires were completed by each surgeon for each sequential hemicolectomy, and data concerning the type of surgery and total operating time were recorded. Times were plotted to diagram individual learning curves for each surgeon, and data grouping methods were used to determine the curve for each surgeon as well as for the combined data base. Learning was said to have been completed when the surgeon's operative time reached a low point and subsequently did not vary by more than 30 minutes. A total of 78 right colectomies and 66 left colectomies were completed by the group. Respectively, each surgeon appeared to learn the procedure after 16, 21, 11, and 6 cases. When the entire database was analyzed as a whole, it was shown that between 11 and 15 completed colectomies were needed for learning, after which operative times remained relatively stable. CONCLUSIONS: This analysis, using total operative time as an indication of learning, shows that approximately 11 to 15 completed laparoscopic colectomies are needed to comfortably learn this procedure.

Colectomy↗

PubMed1995

Carcinoma of the anal canal.

From 1975 to 1990 65 patients with carcinoma of the anal canal received radiation therapy alone or in conjunction with other modalities. Follow-up ranged from 12 to 171 months (mean: 59 months; median: 44 months). Actuarial disease-free survival (including salvage surgery) for T1-3 N0 lesions was 88% +/- 7% at 10 years. This was independent of T stage (91% for T1, 88% for T2, and 100% for T3). Disease-free survival was significantly worse for T1-3 N+ lesions (52% +/- 23% disease-free at 10 years, P = .025) and T4 lesions (0/8 disease free by 21 months, P < .001). Of the 57 patients with T1-3 lesions, 46 received low to moderate doses of radiation (< or = 5,000 cGy) in conjunction with infusional 5FU based chemotherapy. These were reviewed for treatment related factors. Among patients treated with low to moderate dose chemoradiotherapy the local control (including salvage surgery) was excellent: 100% for T1 lesions and 88% +/- 6% for T2, 3 lesions. There was a suggestion that increasing the dose of radiation to the tumor may reduce the need for surgery for T2, 3 lesions. For T2, 3 lesions the local control excluding surgery was 63% +/- 12% with 3,000 cGy plus chemotherapy, as opposed to 77% +/- 11% with 4,000-5,000 Gy (mean 4,600 cGy) plus chemotherapy. The most important factor for posttreatment toxicity was the addition of pelvic surgery to chemotherapy and radiotherapy. Eighteen patients who received chemoradiotherapy either had a history of prior pelvic surgery (five cases) or underwent APR following chemotherapy (13 cases). There were a total of nine grade 3 or 4 complications (including all five cases of small bowel obstruction) in this group. There was a significantly lower (P = .04) incidence of complications in the remaining patients: 2/47 (4%). It should be noted that no patient required a colostomy for management of treatment sequelae, the interventions taken were all successful in managing complications, and no complication was fatal. Nonetheless these results suggest that, for some T3 and T2 lesions, measures which reduce the need for salvage surgery might improve overall quality of life by reducing complications, although it may prove difficult to demonstrate an improvement in the excellent disease-free survival. In addition, measures should be taken to reduce the volume of irradiated bowel if a patient has a history of prior pelvic surgery.

Adult↗

PubMed1993

Laparoscopic small bowel resection and anastomosis.

Our aim was to assess the feasibility and safety of performing totally intracorporeal laparoscopic small bowel resection and anastomosis using a linear stapling device. Laparoscopic small bowel resection and anastomosis were performed in five young domestic pigs. Five trocars were used (2-5 mm, 2-11 mm, and 1-12 mm) for video laparoscopic access to the peritoneal cavity. Segments of jejunum 5 to 10 cm long were excised using two firings of a 30-mm linear stapler (Endo-GIA). The bowel was anastomosed with the stapler in a functional end-to-end fashion, and the enterotomy was stapled closed. The excised bowel segment was then placed in a nylon entrapment sack, morcellated, and aspirated with an automatic electrical tissue morcellator. The pigs recovered uneventfully, were allowed oral feedings on the day after the operation, and gained weight normally in the postoperative period. Sacrifice after 4 to 10 weeks revealed few adhesions, no evidence of anastomotic leaks, and the anastomoses to be widely patent. Clinical application will be facilitated by the use of longer laparoscopic staplers, but surgeons must also develop suturing skills to assure safe performance of advanced laparoscopic surgery.

Anastomosis, Surgical↗

PubMed1992

Adjunctive radiation therapy for rectal carcinoma.

From 1977 through 1985, 113 patients received radiation therapy in conjunction with definitive surgery for adenocarcinoma of the rectum. Posttreatment consisted of a minimum follow-up of 4 years. Radiation was given as postoperative (eight patients), short-course preoperative (2,000 cGy/5 fx, 21 patients), or as full-course preoperative treatment (4,500-5,000 cGy, 84 patients). Three patients received chemotherapy as part of the adjuvant treatment. The local control for the total group was 90% (local failures, 11 of 113), and the rate of recurrence at any site (distant or local) was 30% (34 of 113). Local failure was not significantly influenced by pretreatment clinical findings, tumor grade, or surgical stage. Because of distant failures, overall recurrence was significantly associated with surgical stage--0% (0 of 15) for Astler-Coller A, 23% (7 of 30) for B1, 25% (7 of 28) for B2, and 50% (20 of 40) for B3 or C lesions (p less than 0.01). Locally advanced pretreatment clinical findings were not independent of surgical stage as predictors of outcome. In particular, 14 of the tumors that received full course preoperative radiation were initially either nearly obstructing, circumferential, or deeply fixed. However, by the time of surgery, they were A or B1 lesions (probably down-staged lesions). Only one of 14 (7%) ultimately failed with a local and distant recurrence. There were four cases (3.5%) of small bowel obstruction requiring surgical management. Overall, there were 12 complications (11%) requiring either surgical or major medical management. The complication rate was not associated with radiotherapeutic factors. A strong association was noted between complications and the surgeon. Of 66 patients who had surgery with two colorectal specialists, four (6%) had serious complications. Of the remaining 47 patients who had general surgeons, eight (17%) experienced serious complications.

Actuarial Analysis↗