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1. |
Scientific Data from Clinical Trials: Investigators' Responsibilities and Rights |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 725-726
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ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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2. |
Randomized, Double‐Blind, Placebo‐Controlled Trial of Sildenafil (Viagra®) for Erectile Dysfunction After Rectal Excision for Cancer and Inflammatory Bowel Disease |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 727-732
Ian Lindsey,
Bruce George,
Michael Kettlewell,
Neil Mortensen,
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摘要:
PURPOSE:Controlled trials have demonstrated the efficacy of sildenafil for “mixed etiology” erectile dysfunction, but this may not be the case if there is underlying pelvic parasympathetic nerve damage. We aimed to determine the efficacy of sildenafil after rectal excision for rectal cancer and inflammatory bowel disease.METHODS:Patients with erectile dysfunction after rectal excision were randomly assigned in a double‐blind manner to sildenafil or placebo groups. After unblinding, placebo patients crossed over to open sildenafil. Primary end points were improvement in erectile function on a global efficacy question and erectile function questionnaire scores. Secondary end points were frequency and severity of side effects.RESULTS:Thirty‐two patients were randomly assigned, and two dropped out before randomization. Fourteen received sildenafil, and 18 received placebo. Eleven (79 percent) of 14 responded to sildenafil, on global efficacy assessment, compared with 3 (17 percent) of 18 taking placebo (mean difference, 61.9 percent; 95 percent confidence interval, 34.4 to 89.4 percent;P= 0.0009). Sildenafil improved both erectile function domain scores (mean difference, 13.3; 95 percent confidence interval, 7.9 to 18.7;P= 0.0001) and total International Index of Erectile Function scores (mean difference, 30.6; 95 percent confidence interval, 18.7 to 42.6;P< 0.0001) from pretreatment baseline scores. Placebo did not produce improvement in either erectile function (mean difference, 1.7; 95 percent confidence interval, −0.8 to 4.2;P= 0.16) or total International Index of Erectile Function scores (mean difference, 5; 95 percent confidence interval, −1.1 to 11.1;P= 0.1). Ten (100 percent) of 10 crossover patients not responding to placebo did respond to sildenafil (difference, 100 percent;P< 0.0001). Sildenafil improved both erectile function domain scores (mean difference, 16.8; 95 percent confidence interval, 9.7 to 24;P= 0.002) and total International Index of Erectile Function scores (mean difference, 29.5; 95 percent confidence interval, 15.8 to 43.2;P= 0.003) from precrossover baseline scores. Seven (50 percent) of 14 patients on sildenafil compared with 4 (22 percent) of 18 on placebo experienced side effects (difference, 28 percent; 95 percent confidence interval, −4.4 to 60.4 percent;P= 0.14), 91 percent of which were mild and well tolerated.CONCLUSION:Sildenafil completely reverses or satisfactorily improves postproctectomy erectile dysfunction in 79 percent of patients. Side effects are usually mild and well tolerated. The damage incurred by the pelvic nerves after proctectomy, less profound than after prostatectomy, is likely to result in a partial parasympathetic nerve lesion.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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3. |
Mesorectal Microfoci Adversely Affect the Prognosis of Patients With Rectal Cancer |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 733-742
C. Ratto,
R. Ricci,
C. Rossi,
U. Morelli,
F. Vecchio,
G. Doglietto,
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摘要:
PURPOSE:Mesorectal involvement is a common feature in rectal tumors. Neoplastic foci can be identified at pathologic examination of the mesorectum, but their incidence and prognostic significance remain to be defined.METHODS:A series of 77 patients with extraperitoneal rectal cancer, resected with total mesorectal excision, entered the study. After fixation, the excised specimens were submitted to serial transverse sections and staining. Direct tumor infiltration, lymph node involvement, and neoplastic microfoci in the mesorectum were investigated. Patients with mesorectal foci were compared with those without deposits with regard to clinical and pathologic parameters; different patterns of foci (endovasal, endolymphatic, perineural, isolated) were also considered. Univariate and multivariate analyses were used to evaluate the impact on survival rate.RESULTS:Neoplastic mesorectal involvement was found in 64 patients (83.1 percent). Direct tumor infiltration was detected in 66.2 percent, node involvement in 28.6 percent, microscopic foci in 44.2 percent of cases (endovasal in 11.7 percent, endolymphatic in 15.7 percent, perineural in 26 percent, isolated in 14.3 percent). In 7 cases (10.9 percent) microfoci alone (without any kind of other mesorectal involvement) were detected. Deposits were found in 18.8 percent of TNM Stage I tumors, in 46.9 percent of Stage II and in 59.3 percent of Stage III cancers. Similar incidence was found in patients treated with integrated therapies and surgery alone (43.3vs.44.7 percent,P= not significant). Poorer median (44.5vs.57 months,P= 0.04) five‐year overall survival rate (43.4vs.63.3 percent,P= 0.016) and disease‐free survival rate (43.3vs.57.7 percent,P= 0.048) were observed in patients with microscopic foci compared with those without deposits. Tumor configuration was found to be a independent prognostic factor for both overall and disease‐free survival rates; furthermore, endolymphatic, perineural, and isolated foci significantly affected overall survival rate, while TNM staging affected disease‐free survival rate.CONCLUSIONS:The incidence of neoplastic foci in the mesorectum is high, even in early staged tumors and despite aggressive preoperative treatment. They seem to affect prognosis. Such features should, therefore, be considered when local excision of the tumor is planned. Presence of mesorectal foci should modify conventional staging of the rectal tumor.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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4. |
Discontinuous Rectal Cancer Spread in the Mesorectum and the Optimal Distal Clearance Marginin Situ |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 744-749
Chihiro Ono,
Keigo Yoshinaga,
Masayuki Enomoto,
Kenichi Sugihara,
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摘要:
PURPOSE:We examined the frequency, mode, and extent of discontinuous spread of rectal cancer in the mesorectum to determine the optimal distal clearance marginin situ.METHODS:Forty consecutive patients with rectal cancer undergoing locally curative resection were studied prospectively. Discontinuous cancer spread in the mesorectum and the extent of distal spread was examined microscopically. A tissue shrinkage ratio comparing the distal clearance margin measured before transection to that measured after fixation in each case, was used to convert microscopically measured extent of distal spread to extentin situ.RESULTS:Discontinuous cancer spread in the mesorectum was observed in 17 cases (43 percent); lymph node metastasis in 15 cases (38 percent) and small deposits other than nodal metastases in 8 cases (20 percent). Distal cancer spread (either intramural or mesorectal) was observed in 6 cases (15 percent). The mean distal clearance margin before transection and after fixation was 3.2 cm and 2 cm, respectively. The mean tissue shrinkage ratio was 60 percent. The maximum extent of microscopic distal spread and adjusted distal spreadin situwere 20 and 24 mm, respectively.CONCLUSIONS:Excising the mesorectum with fascia propria circumferentially intact is essential for rectal surgery. The optimal distal clearance margin for the rectal wall as well as the mesorectumin situcan be reduced to 3 cm with a right angle.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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5. |
Incidence and Prognostic Implications of Isolated Tumor Cells in Lymph Nodes from Patients with Dukes B Colorectal Carcinoma |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 750-755
Hong‐Jo Choi,
Yun‐Young Choi,
Sook‐Hee Hong,
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摘要:
PURPOSE:Lymph node metastasis in colorectal carcinoma is an important prognostic factor, yet the prognostic relevance of occult tumor cells in lymph nodes has not elucidated. This study was performed to investigate the correlation between isolated tumor cells in lymph nodes and malignancy potential in patients with Dukes B colorectal carcinoma and, thus, to determine whether presence of isolated tumor cells in lymph nodes has a prognostic significance.METHODS:To evaluate the incidence of isolated tumor cells in lymph nodes in patients with Dukes B colorectal carcinoma, 1,808 lymph nodes taken from 93 patients (19.4 per case) were assessed by immunohistochemical technique using a monoclonal antihuman cytokeratin (MNF 116). Clinicopathologic parameters and prognosis were compared between patients with and without isolated tumor cells.RESULTS:Isolated tumor cells were identified in 54 lymph nodes from 29 patients (31.2 percent) by the immunostaining. No correlations were observed between the incidence of positive isolated tumor cells and various clinicopathologic parameters, including preoperative carcinoembryonic level, tumor site and size, histologic differentiation, pT stage, vascular invasion and lymphatic invasion, and perineural invasion. There was no difference in five‐year survival estimated by Kaplan‐Meier life‐table method between positive and negative groups for isolated tumor cells (82.8 and 85.9 percent, respectively). Multivariate analyses showed that sex (P= 0.0236), serum carcinoembryonic level (≥ 5 ng/ml,P= 0.0002), and lymphatic vessel invasion (P= 0.0002) were significant factors in the survival time.CONCLUSION:Immunohistochemical staining with an anticytokeratin antibody is useful in identifying isolated tumor cells in lymph nodes missed in routine hematoxylin‐eosin staining, but clinically it seems to be of little prognostic value in patients with Dukes B colorectal carcinoma. Thus, this immunostaining technique does not offer a significant benefit of different strategies for additional therapy or follow‐up during conventional pathologic staging using hematoxylin‐eosin staining.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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6. |
Extraction and Analysis of Carcinoembryonic Antigen in Lymph NodesA New Approach to the Diagnosis of Lymph Node Metastasis of Colorectal Cancer |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 757-763
Toshiyuki Kanoh,
Takushi Monden,
Yasuhiro Tamaki,
Tadashi Ohnishi,
Kimimasa Ikeda,
Hikaru Izawa,
Mitsugu Sekimoto,
Naohiro Tomita,
Morito Monden,
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摘要:
PURPOSE:To detect lymph node metastasis of colorectal cancer, we extracted protein from lymph nodes and determined the concentration of carcinoembryonic antigen.METHODS:In Experiment 1, a total of 237 lymph nodes from 23 colorectal cancer patients were examined histologically after immersion in 200 &mgr;l of saline for 2 hours. Concentrations of protein and carcinoembryonic antigen in each saline sample were determined by protein assay and immunoradiometric assay, respectively. Each value of carcinoembryonic antigen in the saline was divided by extracted protein, and the carcinoembryonic antigen levels in lymph nodes were represented as nanograms per milligram of protein. In Experiment 2, 63 lymph nodes from 8 colorectal cancer patients were cut into 2 pieces and immersed in 1 ml of saline for 15 minutes, and they were subjected to reverse transcriptase‐polymerase chain reaction for carcinoembryonic antigen and histologic examination, respectively, after measurement of the carcinoembryonic antigen concentration in the extract.RESULTS:From 236 of 237 lymph nodes in Experiment 1, an average of 3,249.4 &mgr;g/ml protein was successfully extracted. Histologic examination revealed that 33 of 236 lymph nodes had colorectal cancer metastases, with a significantly higher concentration of carcinoembryonic antigen on average (655.5 ng/mg protein) than in the 203 lymph nodes without metastasis (18.2 ng/mg protein;P< 0.0001). In Experiment 2, 19 of 63 lymph nodes examined were positive for metastasis in both reverse transcriptase‐polymerase chain reaction and histology and showed a significantly higher carcinoembryonic antigen concentration on average (1,003.9 ng/mg protein) than the 42 lymph nodes that demonstrated no metastasis by either method (18.0 ng/mg protein;P< 0.0001). The remaining two lymph nodes, which were positive by reverse transcriptase‐polymerase chain reaction but negative by histology, showed high carcinoembryonic antigen concentrations of 514.7 and 61,970.5 ng/mg protein, respectively.CONCLUSION:This simple method of protein extraction and determination of carcinoembryonic antigen concentration in lymph nodes may provide an alternative tool for the diagnosis of colorectal cancer metastasis.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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7. |
Strictureplasty in Diffuse Crohn's JejunoileitisSafe and Durable |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 764-770
David Dietz,
Victor Fazio,
Sylvio Laureti,
Scott Strong,
Tracy Hull,
James Church,
Feza Remzi,
Ian Lavery,
Anthony Senagore,
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摘要:
PURPOSE:As an alternative to resection, strictureplasty may allow for preservation of intestinal length and avoidance of short‐bowel syndrome in patients with diffuse Crohn's jejunoileitis. However, the long‐term durability of the procedure and its safety have not been confirmed. The purpose of this study was to report our experience with strictureplasty for diffuse Crohn's jejunoileitis.METHODS:Between 1984 and 1999, 123 patients underwent a laparotomy that included an index strictureplasty for diffuse jejunoileitis. Patient history, operative details, and postoperative morbidities were obtained by chart review. Nineteen patients (15 percent) were receiving total parenteral nutrition for short‐bowel syndrome, and 81 (66 percent) were taking chronic steroids. Total number of strictureplasties performed was 701 (median, 5/patient). Seventy percent of patients underwent a synchronous bowel resection. Follow‐up information was determined by personal or phone interviews. Recurrence was defined as the need for reoperation, and risk was calculated by the Kaplan‐Meier method. Patients with diffuse jejunoileitis were also compared with 219 patients with limited small‐bowel Crohn's disease undergoing strictureplasty.RESULTS:The overall morbidity rate was 20 percent, with septic complications occurring in 6 percent. The surgical recurrence rate was 29 percent with a median follow‐up period of 6.7 (range, 1‐16) years. The recurrence rate in diffuse jejunoileitis patients did not differ from that seen in patients with limited small‐bowel Crohn's disease (P= 0.38). Short duration of disease and short interval since last surgery were significant predictors of accelerated recurrence (P= 0.008 and 0.04, respectively).CONCLUSIONS:Strictureplasty is a safe and durable alternative to resection in diffuse Crohn's jejunoileitis. Patients with a short duration of disease and short interval since last surgery are at higher risk for accelerated recurrence. Patients with diffuse jejunoileitis do not appear to be at higher risk for recurrence than patients with more limited Crohn's disease.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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8. |
Remicade® Does Not Abolish the Need for Surgery in Fistulizing Crohn's Disease |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 771-775
Lisa Poritz,
William Rowe,
Walter Koltun,
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摘要:
PURPOSE:Tumor necrosis factor antagonist therapy in the form of infliximab has been shown to promote significant healing in fistulizing Crohn's disease and therefore is often considered as a possible alternative to surgery. Our aim was to evaluate the role of infliximab in supplanting surgery for fistulizing Crohn's disease.METHODS:We performed a retrospective chart review of all adult patients who received infliximab for fistulizing Crohn's disease at one institution between September 1998 and October 2000.RESULTS:Twenty‐six patients (14 male; mean age, 38 years; range, 19‐80 years) received a mean of three (range, one to six) doses of infliximab (5 mg/kg) with the intent to cure fistulizing Crohn's disease. Nine patients (35 percent) had perianal, 6 (23 percent) enterocutaneous, 3 (12 percent) rectovaginal, 4 (15 percent) peristomal, and 4 (15 percent) intra‐abdominal fistulas. Nineteen (73 percent) of the patients had had prior surgery for Crohn' s disease. Six patients (23 percent) had a complete response to infliximab with fistula closure, 12 (46 percent) had a partial response, and 8 (31 percent) had no response to infliximab. Fourteen (54 percent) patients still required surgery for their fistulizing Crohn's disease after infliximab therapy (10 bowel resections, 4 perianal procedures), whereas half (6/12) of the patients treated with infliximab who still had open fistulas after treatment declined surgical intervention. Five of six patients with fistula closure on infliximab had perianal or rectovaginal fistulas. None of the patients with either enterocutaneous or peristomal fistulas were healed with infliximab.CONCLUSIONS:Although it was associated with a 61 percent complete or partial response rate, infliximab therapy did not supplant the need for surgical intervention in the majority of our patients with fistulizing Crohn's disease. Seventy‐three percent of the patients either required surgery or still had open fistulas after infliximab therapy. Infliximab was much more effective in treating perianal disease than abdominal enterocutaneous disease.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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9. |
Diagnosing PouchitisComparative Validation of Two Scoring Systems in Routine Follow‐Up |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 776-786
Udo Heuschen,
Erik Allemeyer,
Ulf Hinz,
Frank Autschbach,
Tanja Uehlein,
Christian Herfarth,
Gundi Heuschen,
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摘要:
PURPOSE:Pouchitis represents a serious threat to patients with ulcerative colitis after restorative proctocolectomy with ileal pouch‐anal anastomosis. The frequency of pouchitis is high, and it implies the risk of pouch failure and the risk of malignant mucosal transformation in the pouch. Early detection and precise classification of the inflammatory process are required for adequate therapy, which might be facilitated using a scoring system. The aim of the present study was to validate two existing scoring systems in routine outpatient practice.METHOD:The Heidelberg Pouchitis Activity Score and the Pouchitis Disease Activity Index developed at the Mayo Clinic were simultaneously prospectively applied in a consecutive series of 103 outpatient consultations of 41 patients at our hospital and comparatively validated against the diagnosis of “ pouchitis” or “no pouchitis” concurrently made by a physician and a surgeon.RESULTS:The median score of examinations in which the clinicians' diagnosis was consistent with pouchitis were significantly higher than those of examinations inconsistent with pouchitis in both scoring systems (Heidelberg Pouchitis Activity Score, 17 (interquartile range, 14‐21) and 8 (interquartile range, 5‐10), respectively,P< 0.001; Pouchitis Disease Activity Index, 7 (interquartile range, 5‐8) and 2.5 (interquartile range, 1‐4), respectively,P< 0.001). The sensitivity and specificity in the two total scores were 84 and 79.5 percent, respectively (Heidelberg Pouchitis Activity Score), and 60 and 96.2 percent, respectively (Pouchitis Disease Activity Index); in the field clinical manifestations 44 and 73.1 percent, respectively (Heidelberg Pouchitis Activity Score), and 20 and 87.2 percent, respectively (Pouchitis Disease Activity Index); in the field endoscopic manifestations 88 and 83.3 percent, respectively (Heidelberg Pouchitis Activity Score), and 60 and 89.7 percent, respectively (Pouchitis Disease Activity Index); and in the field histologic manifestations 72 and 76.9 percent, respectively (Heidelberg Pouchitis Activity Score), and 44 and 96.2 percent, respectively (Pouchitis Disease Activity Index). Lowering the cutoff point for diagnosis of pouchitis in the Pouchitis Disease Activity Index by 2 points (pouchitis: score ≥ 5) would result in an 88 percent sensitivity and a 67 percent specificity.CONCLUSIONS:Specificity and sensitivity of the Heidelberg Pouchitis Activity Score were satisfactory. The cutoff point for diagnosing pouchitis in the Pouchitis Disease Activity Index would have to be lowered to reach an acceptable sensitivity and specificity. The very poor validity of the field clinical manifestations in diagnosing pouchitis emphasizes the need for endoscopic and histologic examination for detection of pouchitis. The issue of whether the diagnosis of pouchitis should be based on endoscopic and histologic features alone, instead of additionally taking clinical features into account, should be addressed in future studies.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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10. |
Double‐Blind, Randomized Trial Comparing Harmonic Scalpel™ Hemorrhoidectomy, Bipolar Scissors Hemorrhoidectomy, and Scissors ExcisionLigation Technique |
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Diseases of the Colon & Rectum,
Volume 45,
Issue 6,
2002,
Page 789-794
C. Chung,
J. Ha,
Y. Tai,
W. Tsang,
M. Li,
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摘要:
PURPOSE:The aim of this study was to compare the outcome of patients receiving hemorrhoidectomy using Harmonic Scalpel™, bipolar scissors, and the conventional scissors excision‐ligation technique.METHODS:Eighty‐six patients with irreducible prolapsing piles were randomly assigned to receive 1) Milligan‐Morgan hemorrhoidectomy using scissors excision‐ligation technique or 2) bipolar scissors hemorrhoidectomy and Harmonic Scalpel™ hemorrhoidectomy. Neither the patient nor the independent assessor were aware of the technique used at operation. Patients were followed up at 4 and 12 weeks after operation. The measured outcomes included 1) operation time; 2) blood loss; 3) postoperative hospital stay; 4) pain score; 5) pain expectation score; 6) date of first bowel movement; 7) number of pethidine injections; 8) number of dologesic tablets taken; 9) time off work or normal activity; 10) wound healing; 11) satisfaction score; and 12) postoperative complications, including anal stenosis and fecal or flatus incontinence.RESULTS:There was no difference among the three groups in the operation time, hospital stay, pain expectation score, day of first bowel movement, number of dologesic tablets taken, time off work or normal activity, wound healing, and satisfaction score. The complication rate also did not differ in the three groups. Both Harmonic Scalpel™ hemorrhoidectomy and bipolar scissors hemorrhoidectomy were superior to Milligan‐Morgan hemorrhoidectomy in terms of reduced blood loss. Harmonic Scalpel™ hemorrhoidectomy had the best pain score when compared with bipolar scissors hemorrhoidectomy and Milligan‐Morgan hemorrhoidectomy, and patients required significantly less pethidine injection after Harmonic Scalpel™ hemorrhoidectomy than after Milligan‐Morgan hemorrhoidectomy. Although the time required to return to work or normal activity remained similar, patients after Harmonic Scalpel™ hemorrhoidectomy had the best satisfaction score among the three groups.CONCLUSION:The study shows that Harmonic Scalpel™ hemorrhoidectomy is as good as bipolar scissors hemorrhoidectomy in terms of reduced blood loss but is superior because it is associated with less postoperative pain and hence, better patient satisfaction. However, these observed benefits are small, and the time off work or normal activity remains similar.
ISSN:0012-3706
出版商:OVID
年代:2002
数据来源: OVID
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