Randomized Controlled Trials
- Effects of Intraoperative Injection of Tarasyn for Pain Relief on Patients Undergoing Hemorrhoidectomy: Result of a prospective, randomized trial.
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Kim, Min Chan , Choi, Hong Jo
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J Korean Soc Coloproctol. 2000;16(6):371-375.
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Abstract
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- PURPOSE
The aim of this prospective study was to evaluate whether additional intraoperative injection of Tarasyn (ketorolac tromethamine) provided a preemptive analgesic effect that improved postoperative pain.
METHODS
Sixty patients scheduled for hemorrhoidectomy were randomly assigned to the study and control groups. For the control group (n=32), patients were treated with standard intravenous injections of Nubain (Nalbuphine hydrochloride; Jeil Pharmaceuticals Co, Seoul) per 8 hours for three times postoperatively for pain relief. In the study group (Tarasyn group, n=28), 60 mg of Tarasyn (ketorolac tromethamine; Roche Korea, Seoul) was injected into the internal sphincter muscle and around the operative wound at the time of hemorrhoidectomy as well as standard intravenous injections of Nubain . Parameters were measured of pain score from 0 (no pain) to 10 (agonizing pain), painless sound sleep, additional analgesic requirements, time to first bowel movement, and postoperative urinary retention.
RESULTS
Rate of painless sound sleep was 75.0% and 53.1% in the Tarasyn and the control groups, respectively, which was significant statically between two groups (P<0.05). Time to first bowel movement was 2 and 3.2 days in Tarasyn and the control groups, respectively, which was also significant statistically (P<0.05). Voiding difficulty developed in one case (3.5%) in the Tarasyn group and he needed catheterization. In the control group, however, the number (15 cases, 46.9%; P<0.001) was much higher requiring more catherization (13 cases, 40.9%; P<0.001). Mean pain scores was significant statically between two groups (P<0.001).
CONCLUSION
The data suggest that the use of intraoperative injection of Tarasyn is associated with a significant decrease in pain and urinary complications after hemorrhoidectomy.
- The Effects of Pudendal Block in Voiding Complication after Anal Surgery.
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Kim, Jae Hwang , Jang, Seon Mo , Shim, Min Chul , Jee, Dae lim
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J Korean Soc Coloproctol. 2000;16(6):365-370.
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Abstract
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- Urinary retention in common benign anal surgery is a burden to ambulatory surgery.
PURPOSE: To reduce voiding complication pudendal nerve block (PB) was applied in hemorrhoids surgery.
METHODS
We compared PB with spinal anesthesia (SA) for anal surgery. In this prospective study, 163 patients undergoing elective hemorrhoids surgery by single surgeon were randomized to receive either PB with 0.5% bupivacaine (n=81) with 1: 20,000 epinephrine or SA with 0.5% bupivacaine (n=83).
RESULTS
There were no statistically significant differences in patient demographics, total amount of administered fluid, time to onset of block, or intraoperative pain. All patients had a successful block for surgery however, puborectalis muscle relaxation with PB was not complete. The time from injection of the anesthetics to first development of pain was longer in the patients who received PB (9.1 vs 3.1h; P<0.001). Urinary catheterization needed in only 6 patients in PB group compared with 57 cases in SA group (p<0.001).
Degree of pain was significantly low in PB (2.7 vs 5.2 with VAS; p<0.001) Injected analgesics was significantly reduced in PB (16/81 vs 45/82; p<0.001) CONCLUSIONS: Our results suggest that PB with bupivacaine results in fewer postoperative voiding complications and less pain compared with traditional SA in hemorrhoidectomy.
- Topical Glyceryl Trinitrate (GTN) Versus Conservative Treatment (CT) in Chronic Anal Fissure: Prospective and Randomized Study.
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Lee, Kwang Real , Cho, Kyung Ah , Hwang, Do Yeon , Kim, Kuhn Uk , Park, Weon Kap , Yoon, Seo Gu , Kim, Hyun Shig , Lee, Jong Kyun
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J Korean Soc Coloproctol. 2000;16(6):360-364.
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Abstract
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- PURPOSE
This study was designed to compare the effect of treatment using glyceryl trinitrate (GTN) ointment with that of conservative treatment (CT) on chronic anal fissure.
METHODS
As a preliminary study, maximal resting pressures of the anal canal were checked in 13 patients having chronic anal fissure before and 10 minutes after application of 0.2% GTN ointment. As the study groups, 59 patients having chronic anal fissure were randomly allocated to the GTN and the placebo groups. All the patients in both groups were given oral analgesics, sedatives, and bulk-forming agents.
They had applied 0.2% GTN ointment or a placebo ointment three times a day to their perianal skin. Maximal resting pressures of the anal canal were checked at the beginning and at the endpoint of the treatment period which continued for 6 weeks. If there was complete healing of the fissure in the middle of the treatment, the treatment was stopped.
Sixteen patients were lost during the study.
RESULTS
Among the rest, 22 and 21 patients were included in the GTN group and the placebo group, respectively. The maximal resting pressure decreased significantly in all groups (p<0.05). The healing rates, the recurrence rates, and the operation rates were not significantly different between the GTN group and placebo group (p>0.05).
CONCLUSION
The effect of GTN on the symptomatic relief and results of treatment in patients having chronic anal fissure is not superior to that of conservative treatment.
- Preventive Effects for Wound Infection of Intra-incisional Metronidazole Infiltration Preoperatively in Appendectomy.
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Park, Bu Il , Kim, Byung Seok , Moon, Duk Jin , Park, Ju Sub
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J Korean Soc Coloproctol. 2000;16(6):356-359.
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Abstract
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- PURPOSE
The aim of this prospective study was to evaluate the effect of metronidazole for wound infection by using intra-incisional infiltration before appendectomy.
METHODS
From January to May 2000, 176 patients with acute appendicitis received appendectomy. All patients were randomly divided into two groups. Group I (n=50) was the treatment group and group II (n=126) was the control group.
After anesthesizing the patients of group I, 7.5 mg/kg of metronidazole was injected into subcutaneous tissue and muscle. All patients of group I and II were given intravenous injection of cephalosporin and intravenous or intramuscular injection of aminoglycoside.
RESULTS
In the 50 cases of group I, the rate of wound infection was 2% and the rate of wound infection in the 126 cases of group II was 4.8%. The rate of anaerobic bacteria of organisms cultured from wound of patients with infection was 0% in group I and 33% in group II. The statistical analysis using chi-square test was not significant (p=0.676) but the rate of wound infection was reduced, especially in infection caused by anaerobic bacteria.
CONCLUSIONS
The rate of wound infection was not significant statistically but it was reduced after intra-incisional infiltration of metronidazole. Therefore we suggest that this method can be one of methods that reduce the rate of wound infection after appendectomy.
- A Prospective Study on the Relationship between Postoperative Urinary Retention and Amount of Infused Fluid during Surgery of Benign Anal Diseases under Spinal Anesthesia.
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Lee, Chai Young , Kim, Hee Cheol , Lee, Dong Hee
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J Korean Soc Coloproctol. 1999;15(5):357-361.
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Abstract
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- PURPOSE
Urinary retention is a frequent postoperative complication after benign anorectal surgery. Factors, known to affect postoperative urinary retention, are age, sex, anesthetics, operative method, operative time and perioperative fluid injection. This study was performed to know whether the incidence of urinary retention might be controlled by reducing the amount of perioperative fluid.
METHODS
Eighty patients underwent surgery for hemorrhoids and chronic anal fissures were allocated into two groups, fluid restriction group (n=37) and hydration group (n=43).
All patients were consecutively randomized from May 1998 to January 1999 and they were under 50 years old without urologic abnormality. Fluid was infused at 100 ml/h from the midnight then it's rate was changed into 10 ml/h for 4 hours from the beginning of the anesthesia for the restriction group, whereas 1000 ml/h only during operation for the hydration group. Thereafter it was changed into the same rate with 100 ml/h on both groups.
RESULTS
There was no significant differences with regard to age, sex, operation time, degree of pain and use of analgesics between two groups. Although there was a significant difference in the total volume of the infused fluid (Restriction group: 53.4 119.5 ml versus Hydration group: 778.6 319.0 ml, mean SD, p<0.001). Catheterization was done in 29 patients of the restriction group (78.4%) and 37 patients of the hydration group (86.0%), respectively.
The frequency of catheterization was 1.3 0.7 times in the former and 1.6 0.7 times in the latter group.
CONCLUSIONS
A strict restriction of fluid infusion appeared to be unnecessary for the purpose of preventing the urinary retention during surgery of benign anorectal diseases with spinal anesthesia.
- The Efficacy of a Nd:YAG Laser in a Hemorrhoidectomy.
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Lim, Seok Won , Lee, Kwang Real , Hwang, Do Yean
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J Korean Soc Coloproctol. 1999;15(3):203-208.
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Abstract
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- BACKGROUND
Even though lasers have been used in hemorrhoidectomies, there has been much debate about their effect. PURPOSE: A prospective randomized study was performed comparing the efficacy of a Nd:YAG laser with that of scalpel excision when performing a ligation excision, semi-closed hemorrhoidectomy.
METHODS
Sixty patients, who had more than three piles, with 3rd or 4th grade hemorrhoids, were enrolled into this study.
Hemorrhoidectomies were performed under low spinal anesthesia. The ligation excision, semi-closed hemorrhoidectomy technique was used. Data evaluated included age, sex, operative time, postoperative pain scores, postoperative analgesic requirement, wound-healing time, and postoperative complications. Of the sixty patients enrolled into this study, 30 received laser excision and the other 30 scalpel excision.
RESULTS
There were no significant differences between the two groups, except for operative time (laser, 34.6 8.4 min; scalpel, 24.1 4.8 min). Postoperative complications, such as urinary retention, fecal impaction, skin tags, and postoperative fissure, were more common in the laser group.
CONCLUSIONS
A hemorrhoidectomy using a Nd:YAG laser takes longer than a conventional hemorrhoidectomy and neither reduces the postoperative pain nor shortens the wound-healing time. For achieving an effective treatment in hemorrhoids by using lasers, improved laser instruments are required, along with more detailed study of lasers and their effects.
- The Effects of Early Ambulation on Urinary Retention and.
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Kim, Seon Hahn , Lee, Il Ok , Kim, Dong Hee
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J Korean Soc Coloproctol. 1999;15(3):179-185.
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Abstract
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- INTRODUCTION: Urinary retention (UR) is one most common complication of anal surgery and its cause is multifactorial. Postdural puncture headache (PDPH) is caused by cerebrospinal fluid leakage after spinal anesthesia, therefore it may be aggravated by early ambulation. PURPOSE: To determine whether early ambulation (EA) vs. bed rest (BR) reduces the incidence of UR after anal surgery under spinal anesthesia, without causing PDPH.
METHODS
In this prospective, randomized study, 107 patients undergoing anal surgery under spinal anesthesia were randomly assigned in the EA group (n=54) or the BR group (n=53). UR was defined as a voiding difficulty that needs catheterization. In the BR group, the patients were positioned flat in bed on the operation day. Anesthetic techniques (tetracaine injection using 24-gauge needle in sitting position, bupivacaine local infiltration) and postoperative pain therapy (intramuscular demerol injection every 6 hours, oral nonsteriodal antiinflammatory drug plus acetaminophen) were standardized. Perioperative intravenous fluids were restricted.
RESULTS
Urinary retention and PDPH occurred in 32 (29.9%) and 7 (6.5%) patients, respectively. UR was significantly reduced in the EA group (10/54=18.5%) vs. the BR group (22/53=41.5%) (p=0.017, Chi-square). The incidence of PDPH, however, was not different between the two groups (5.6% in the EA vs. 7.5% in the BR group).
CONCLUSIONS
Early ambulation has important implication on reducing the incidence of urinary retention after anal surgery under spinal anesthesia, without causing PDPH.
- Clinical Effects of Venitol(R) on Complications after Hemorrhoidectomy Prospective Randomized and Placebo-controlled Trial.
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Lee, Heung Woo , Lee, Woo Yong , Chun, Ho Kyung
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J Korean Soc Coloproctol. 1998;14(4):761-766.
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Abstract
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- Fifty four patients who received closed hemorrhoidectomy were randomized into two parallel groups and treated with Venitol(R)(a micronized flavonoidic fraction containing diosmin 450 mg and hesperidin 50 mg) (group 1) or placebo (group 2). Venitol(R) was administered at the dosage of three toblets b.i.d. the first four days and two tablets b.i.d following three days. Postoperative analgesia and laxative prescription as well as hospital stay were same in two groups. Though there is no difference of symptoms at D1, improvement of symptoms of complications was greater in group 1 than in group 2 at D18. The clinical severity of postoperative spot-bleeding, pain and anal discharge diminished in both groups but to a greater extent in group 1 (P<0.005). There was no side-effects in using Venitol(R). In summary, Venitol(R) is effective in reducing complications after hemorrhoidectomy.
- Safety of Early Postoperative Feeding after Elective Colorectal Surgery.
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Yoo, Chang Oh , Lee, Kyoung Keun , Lee, Jeong Kyun
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J Korean Soc Coloproctol. 1998;14(3):605-610.
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Abstract
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- Introduction: Several investigators demonstrated that routine nasogastric decompression after abdominal surgery was unnecessary and can be safely eliminated. Some authors suggested that early feeding could be tolerated by the majority of patients after elective colorectal surgery.
PURPOSE: The aim of our study was to prospectively assess the safety and tolerability of early oral feeding after colorectal surgery.
METHODS
This trial included 69 patients who underwent an colon or rectal operation between April 1997 and August 1998. Patients were randomized after the operative procedure into one of two groups. Group 1: early oral feeding-all patents received a clear liquid diet on the first postoperative day followed by a regular diet as tolerated.
Group 2: delayed feeding-all patients were treated in the traditional way with feeding only after the resolution of their postoperative ileus. Both groups had intraoperative nasogastric tubes that were removed at the end of surgery.
The patients were monitored for vomiting, nasogastric tube reinsertion, time of regular diet consumption, complication, and length of hospitalization. The nasogastric tube was reinserted if two or more episodes of vomiting of more than 100 ml occurred in the absence of bowel movement.
RESULTS
Sixty-nine consecutive patients were studied, 34 patients in group 1 (12 males and 22 females, mean age 58.1+/-12.7), and 35 patients in group 2 (16 males and 19 females, mean age 58.5+/-12.7). Significant differences were not noted in age and type of procedures. No significant differences were seen in rates of vomiting and overall complications. However, early feeding group well tolerated a regular diet (postoperative period to take regular diet of group 1: 5.4+/-4.0 days, group 2 : 8.1+/-4.6 days, p=0.013), and were discharged from hospital significantly earlier than the delayed feeding group(group 1: 14.0+/-5.1 days, group 2: 19.1+/-8.6 days, p=0.004).
CONCLUSION
Early feeding after colorectal surgery is successfully tolerated by the majority of patients and led to earlier hospital discharge.
- Comparison of Mepivacaine and Bupivacaine as an Adjuvant of Morphine for Benign Anorectal Surgery under Caudal Anesthesia.
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Yun, Sung Mun , Park, Ki Hong , Lim, Jun Sang , Kim, Sung Chul
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J Korean Soc Coloproctol. 1998;14(3):517-522.
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Abstract
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/AIMS: The caudal anesthsia is most commonly used for benign anorectal surgery, The combination of long-acting anesthetics and opiates has been used for longer duration and successful control of postoperative pain. But the side effects of peridural anesthesics and morphine have commonly occured in caudal anesthesia. This study was performed to assess the difference in clinical effects between peridural mepivacaine and bupivacaine with morphine.
METHODS
We evaluated the clinical effects in 60 patients who had anal operation with Jack-Knife position under caudal anesthesia. We divided randomly these 60 patients into two groups, M and B groups (in each group, 30 patients included). Group M (n=30) was given 2% mepivacaine 20 ml with morphine 2 mg caudally, and Group B (n=30) was given 0.5% bupivacaine 20 ml with morphine 2 mg in the same manner. We measured the onset time, duration, postoperative analgesia, and side effects including urinary retention.
RESULTS
The onset time for analgesia was significantly shorter in group M than in group B. The duration of postoperative pain complaints was significantly longer in group M than in group B. The postoperative analgesic effects and side effects were not significantly different between two groups.
CONCLUSIONS
Caudal mepivacaine and morphine mixture is effective for control of postoperative pain without significant side effects.
Clinical Trial
- Application of a New Colostomy Device in Incontinent Dog Model.
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Lim, Myeung Kook , Kim, Jae Hwang , Shim, Min Chul
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J Korean Soc Coloproctol. 1998;14(3):439-446.
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Abstract
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Recently developed electrically stimulated gracilis neosphicter or artificial sphincter is quite a promising trial in fecal incontinence However, surgical technique is not simple, the devices are expensive and only specialists can perform the procedures successfully. The aim of this study is to evaluate the efficacy of a newly developed simple silicon device in incontinent dog model.
METHODS
A New Colostomy Device (NCD; US Patent No.
5,569,216) for fixing in the stoma or rectum of human body, includes an internal balloon, a ring figured extemal balloon surrounding the internal balloon, a connecting tube disposed under the both infernal and external balloons and supply tube containing a pair of air passages and an enema fluid passage. It is designed to be inserted into the rectum and is held in place by an inflatable external balloon and drains irrigated fecal matter through a thin collapsible connecting tube which exist in the anal canal. Six mongrel dog with 22~26 kg of body weight were prepared. Anal incontinence was made by bilateral severing of the internal and external sphincters and puborectalis muscle under the general anesthesia. Marlex mesh ring was applied to the anal canal as Thiersch wire for the prevention of NCD expulsion in straining. After then, NCD with 2.5 cm of luminal diameter was inserted to the rectum proximal to the Malex mesh ring. Daily irrigation and evacuation was done with 800~1000 cc of tepid water in each dogs. Daily food contained 30 gm of Psyllium dextrose.
RESULTS
Initially 6 dogs were observed for 7 days. Daily irrigation made evacuation of fecal matter well in each dogs. There was no prolapse of device through the anal orifice. Anoscopic examination after 7 days showed no rectal and anal mucosal injury. Two dogs were kept for 40 days as same manner. Sometimes spontaneous bowel movement without water irrigation was noted when the stool were loose. Weelky anoscopic examination revealed no evidence of mucosal injuries for 40 days also. There was no septic or other complication.
CONCLUSION
NCD evacuated fecal matter well enough to empty the rectum in all incontinence dog model. Adequate sized NCD could be used for clinical trials in selected incontinence patients.
Randomized Controlled Trials
- Comparative Analysis of Open Versus Semi-Closed Hemorrhoidectomy for 200.
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Son, Woo Young , Sim, Myung Suk , Kang, Jin Kook
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J Korean Soc Coloproctol. 1997;13(3):451-460.
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Abstract
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- Conventional hemorrhoidectomy is still the main stairway to the treatment of the third or the fourth degree hemorrhoids.
Among the various methods of hemorrhoidectomy, open hemonhoidectomy is claimed to decrease postoperative pain and wound infection, but to have disadvantage of long period of wound healing. Semi-closed hemorrhoidectomy has the advantage of rapid wound healing without increased risk of wound infection, but more painful postoperative course than open hemorrhoidectomy is suggested. To assess this conventional concept, two hundreds of patients were randomly allocated to either an open hemorrhoidectomy(Group 4, Operated by modified Goligher method, n=100) or a semi-closed hemorrhoidectomy(Group B, Operated by modified Nesselrod method, n=100), and postoperative results were analyzed. In group 4, the average time for disappearance of wound edema was 4.9days, average time for disappearance of wound pain was 9.0days, average time for painless defecation was 14.1 days, average time for complete wound healing was 28.4days. The main complications were overgranulation, skin tag, anal discharge and pruritus. The overgranulation requires curettage, the skin tags were resected under local anesthesia. Anal discharge and pruritus were spontaneously disappeared after the healing of the wound. In group B, the average time for disappearance of wound edema was 6.1 days, average time for disappearance of wound pain was 6.3days, average time for painless defecation was 9.2days, average time for complete wound healing was 20.7days. The main complications were skin tags, more prevalent than group 4, requiring resection under local anesthesia. No infectious complications were noted in both groups. Consequently, the old concept that open hemorrhoidectomy has advantage of less painful postoperative course than semiclosed hemorrhoidectomy cannot be accepted. Semi-closed hemorrhoidectomy offers more rapid loss of pain and more rapid healing of the wound than open hemorrhoidectomy, without increased risk of infectious complications. In conclusion, semi-closed hemorrhoidectomy is superior method to open hemorrhoidectomy in third or fourth degree hemorrhoids.
- A Comparison of Oral Sodium Phosphate and Polyethylene Glycol Solution for.
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Cho, Hang Jun , Kang, Yoon Sik , Kim, Tae Soo , Jung, Seung Yong , Kim, Do Sun
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J Korean Soc Coloproctol. 1997;13(2):223-228.
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Abstract
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- BACKGROUND
Polyethylene glycol(PEG) has been the most widely used colonic lavage solution. But large volume and salty taste of PEG solution is a problem which can lead to the noncompliance and the poor bowel cleansing. Recent reports have suggested that sodium phosphate solution of much smaller volume is more effective in colon cleansing ability and more easier to complete. Therefore, this study was designed to compare two solutions for colonoscopy and to determine the differences in either patient compliance or cleansing ability.
METHOD
Eighty-two patients were randomized to take either oral sodium phosphate solution or 2 liter of PEG solution.
Patient's discomfort and tolerance during ingestion was asessed by questionnaire and one colonoscopist who did not know the type of solution, assessed colonic preparation status.
RESULTS
Among 25 patients experiencing two separate colonoscopies with PEG solution and sodium phosphate solution respectively, 19(76%) patients preferred sodium phosphate solution. Sodium phosphate solution was found to be easier to take. Sodium phosphate caused thirst more frequently(p=0.013) than PEG solution. Particulate stool and water retention status were similar in two groups. Gas bubble formation that disturbs luminal observation was more frequently found in sodium phosphate preparation group(P=0.00). Sodium phosphate was more effective in right colon cleansing ability than PEG preparation(P=0.04). The Colonoscopist assessed sodium phosphate as "good" in 47.2% vs 58.6% after PEG preparation as a whole, but there was no statistical difference.
CONSLUSION: Sodium Phosphate solution is better tolerated and more easier to take than PEG solution. Gas bubble formation is a correctable problem, but right colonic cleansing effect is not. Our results showed that sodium phosphate is likely to be more effective in colonic cleansing effect comparing to polyethylene glycol solution.