A new bowel preparation for elective colon and rectal surgery. A prospective, randomized clinical trial

A two-day cathartic/enema preparation with oral administration of erythromycin and neomycin was compared with an orthograde lavage preparation with oral administration of metronidazole and neomycin in a prospective randomized trial in 300 and 293 eligible patients, respectively, who were undergoing elective colon and rectal surgery. Patients were assessed for infections at six weeks after discharge from the hospital. The major infection rate was less than 1% and the minor infection rate was less than 4%. The overall infection rate was 4.2%. The type of bowel preparation used, the type of operation, and the addition of systemic antibiotic therapy did not affect infection rates significantly. We conclude that this one-day lavage technique, as described, is a safe, effective, economical, and preferred method of colonic preparation for elective colon and rectal surgery.     

Complications after colorectal surgery without mechanical bowel preparation

BACKGROUND: The current practice of mechanical bowel preparation (MBP) before colorectal surgery is questionable. Mechanical bowel preparation is unpleasant for the patient, often distressful, and potentially harmful. The results are often less than desired, increasing the risk of contamination. Cleansing the colon and rectum before surgery has never been shown in clinical trials to benefit patients. In animal experiments MBP has a detrimental effect on colonic healing. STUDY DESIGN: To investigate the outcomes of colorectal surgery without MBP, we prospectively evaluated a consecutive series of patients who underwent resection and primary anastomosis of the colon and upper rectum, including emergency operations. One surgeon performed all operations. Endpoints were wound infection, anastomotic failure, and death. Late signs and symptoms that might be secondary to leakage of the anastomosis were considered as an anastomotic failure as well, during a followup of 1 year. RESULTS: Two hundred fifty operations were performed, of which 199 (79.6%) were elective. Colectomies were left-sided in 65.6%. Anastomoses were ileocolic in 32%, colocolic in 20.8%, colorectal intraperitoneal in 34.4%, and extraperitoneal in 12.8%. No patient suffered from fecal impaction. Followup was complete in 97.2%. Eight patients (3.3%; 95% confidence interval [CI]: 1.4-6.4) developed superficial wound infections. In three patients there was leakage from an extraperitoneal colorectal anastomosis, in two of them after hospital discharge. The overall anastomotic failure rate was 1.2% (95% CI: 0.3-3.6). The in-hospital mortality rate was 0.8% (95% CI: 0.1-2.9) and was not related to abdominal or septic complications. CONCLUSION: Mechanical bowel preparation is not a sine qua non for safe colorectal surgery.     

Elective colon and rectal surgery without nasogastric decompression. A prospective, randomized trial.

Nasogastric (NG) decompression after colorectal surgery is practiced commonly. Our aim was to determine whether routine NG decompression benefitted patients undergoing this type of surgery. Five hundred thirty-five patients were randomized prospectively to either NG decompression or no decompression. Stratification was by type of operation and patient age. Excluded were patients who had emergency surgery with peritonitis, extensive fibrous adhesions, enterotomies, previous pelvic irradiation, intra-abdominal infection, pancreatitis, chronic obstruction. prolonged operating times, or difficult endotracheal intubation. Two hundred seventy-four patients received NG decompression (Salem sump, Argyle Co., Division of Sherwood Medical, St. Louis, MO) and two hundred sixty-one did not. There were 33 protocol violations included in the 535 patients. Patients who were not decompressed experienced significantly more abdominal distention, nausea, and vomiting than did those patients who were. Moreover, 13% required subsequent NG decompression as opposed to a reinsertion rate of 5% for patients routinely decompressed. The mean length of hospitalization for both groups was 11 days. There were no significant differences in nasopharyngeal or gastric bleeding, inability to cough effectively, respiratory infections, wound disruptions, reoperation, and wound infection rates (5%) between the two groups. We conclude that even though there is an increase in the rate of minor symptoms of nausea, vomiting, and abdominal distention, routine nasgastric decompression is not warranted after elective colon and rectal surgery.     

Meta-analysis of randomized clinical trials of colorectal surgery with or without mechanical bowel preparation

BACKGROUND: Mechanical bowel preparation is used routinely before colorectal surgery, but some randomized clinical trials have suggested that it is of no benefit. This study assesses whether such bowel preparation may safely be omitted before elective colorectal surgery. METHODS: A search of the literature was performed; the inclusion criteria were randomized clinical trials comparing bowel preparation with no preparation in colorectal surgery. The methodological quality of included trials was assessed. The primary outcome was anastomotic leakage; secondary outcomes were other septic complications. The meta-analysis was conducted using the Peto one-step method. RESULTS: Eleven trials were retrieved, of which seven, containing 1454 patients, were included in the meta-analysis. There was no heterogeneity between the trials. Significantly more anastomotic leakage was found after mechanical bowel preparation (5.6 versus 3.2 per cent; odds ratio 1.75 (95 per cent confidence interval 1.05 to 2.90); P = 0.032). All other endpoints (wound infection, other septic complications and non-septic complications) also favoured the no-preparation regimen, but the differences were not statistically significant. Sensitivity analysis showed that these results were similar when trials of poor quality were excluded. Subgroup analysis showed that anastomotic leakage was significantly greater after bowel preparation with polyethylene glycol (PEG) compared with no preparation, but not after other types of preparation. CONCLUSION: There is good evidence to suggest that mechanical bowel preparation using PEG should be omitted before elective colorectal surgery. Other bowel preparations should be evaluated by further large randomized trials.     

Gastric cancer surgery without drains: A prospective randomized trial

Prophylactic drain placement during major abdominal surgery has been widely practiced without clear scientific evidence to support it. We hypothesized that prophylactic drain placement is not necessary in gastric cancer surgery. A randomized prospective trial was conducted between February 1, 2001, and July 30, 2001. Patients were randomly assigned to either the drain group or the no-drain group. One hundred seventy patients completed the study by undergoing either subtotal or total gastrectomy with D2 lymph node dissection. Surgical outcome between the two groups was compared within the subtotal and total gastrectomy subgroups. Postoperative complication within 30 days was the primary end point of the study. No significant difference was noted in the incidence of postoperative complication between the drain group and the no-drain group. The results of this study suggest that prophylactic drain placement does not offer additional benefit for patients undergoing gastric cancer surgery with extended lymph node dissection.     

结直肠手术前磷酸钠盐一日肠道准备法临床观察

目的探讨结直肠术前1d肠道准备的安全性和可行性。方法将40例结直肠手术患者随机分为实验组和对照组,每组各20例,两组分别采用磷酸钠术前1d和硫酸镁术前3d肠道准备法;所有患者分别于肠道准备前后抽取外周静脉血检测血红蛋白、血细胞比容和血清部分离子水平,取粪做厌氧菌培养计数,并观察手术前后患者一般情况、手术并发症和肠道黏膜形态。结果两种肠道准备方法对患者的吻合口愈合及感染并发症均无明显影响,实验组患者对肠道准备耐受性明显优于对照组,手术前后的腹泻次数明显低于对照组;两组患者各项血液检验指标、肠道黏膜形态等没有明显差异;全部病例肠道准备后大便厌氧菌计数显著增加。结论磷酸钠术前1d准备法安全可靠,可替代传统的3d准备法;适当缩短肠道准备时间可降低患者的不适程度和术后菌群紊乱的发生,减轻肠屏障的损害。     

The efficacy of polyethylene glycol-electrolyte lavage solution versus traditional mechanical bowel preparation for elective colonic surgery: a randomized, prospective, blinded clinical trial

This study documents the efficacy, safety and patient tolerance of GoLYTELY (Braintree Laboratories, Inc., Braintree, Mass.) an orally administered, nonexplosive, polyethylene glycol-electrolyte lavage solution, in elective colonic surgery. Fifty-three patients admitted for colonic surgery were randomized to either GoLYTELY or a traditional 3-day bowel preparation. Both groups received oral and perioperative antibiotics. Pre- and postpreparation weights, blood chemistries, and hematologic values were obtained. Postpreparation patient tolerance was assessed. During surgery the surgeon scored the bowel for the presence of retained air, fluid, or feces. Standardized semiquantitative aerobic and anaerobic bacterial counts were obtained from sigmoid aspirates. Postoperative infectious complications were recorded. Mechanical preparation with GoLYTELY resulted in a greater feeling of fullness, while the traditional preparation produced more hunger and abdominal cramping. The use of GoLYTELY resulted in better scores of overall quality and bowel appearance, reflecting a greater efficiency with which it removed air, fluid, and feces from the bowel. GoLYTELY also resulted in significantly fewer total aerobic and anaerobic organisms in sigmoid aspirates. This study suggests that GoLYTELY is a safe, well-tolerated, and effective orthograde lavage solution that has significant advantages over other mechanical preparations and should be considered the preparation of choice for elective colonic surgery.     

Multicentre randomized clinical trial of mechanical bowel preparation in elective colonic resection

BACKGROUND: Recent studies have suggested that MBP does not lower the risk of postoperative septic complications after elective colorectal surgery. This randomized clinical trial assessed whether preoperative MBP is beneficial in elective colonic surgery. METHODS: A total of 1505 patients, aged 18-85 years with American Society of Anesthesiologists grades I-III, were randomized to MBP or no MBP before open elective surgery for cancer, adenoma or diverticular disease of the colon. Primary endpoints were cardiovascular, general infectious and surgical-site complications within 30 days, and secondary endpoints were death and reoperations within 30 days. RESULTS: A total of 1343 patients were evaluated, 686 randomized to MBP and 657 to no MBP. There were no significant differences in overall complications between the two groups: cardiovascular complications occurred in 5.1 and 4.6 per cent respectively, general infectious complications in 7.9 and 6.8 per cent, and surgical-site complications in 15.1 and 16.1 per cent. At least one complication was recorded in 24.5 per cent of patients who had MBP and 23.7 per cent who did not. CONCLUSION: MBP does not lower the complication rate and can be omitted before elective colonic resection. Registration number: ISRCTN28535118 (http://www.controlled-trials.com).     

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial

Purpose

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study.

Methods

Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery.

Results

A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7 % in group 1 and 13.6 % in group 2 (difference [95 % confidence interval]: ?0.2 % [?0.9 to 0.7 %]).

Conclusion

The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.     

Early rehabilitation versus conventional care after laparoscopic rectal surgery: a prospective, randomized, controlled trial

Background

Although early rehabilitation programs have been reported to be effective after laparoscopic colectomy, there is no report of the efficacy of rehabilitation programs after rectal cancer surgery. This study was designed to evaluate the efficacy of an early rehabilitation program after laparoscopic low anterior resection for mid or low rectal cancer in a randomized, controlled trial.

Methods

Ninety-eight patients who had undergone a laparoscopic low anterior resection with defunctioning ileostomy were randomized on a 1:1 basis to an early rehabilitation program (n = 52) or conventional care (n = 46). The primary endpoint was recovery rate at 4 days postoperatively. The secondary endpoints were recovery time, postoperative hospital stay, complications, readmission rates, pain on a visual analogue scale, and quality of life (QOL) according to Short Form 36.

Results

The recovery rates were not different in both groups (rehabilitation, 25 % vs. conventional, 13 %, p = 0.135). Recovery time and postoperative hospital stay was similar between the groups (rehabilitation, 137 h [107–188] vs. conventional, 146.5 h [115–183], p = 0.47; 7.5 days [7–11] vs. 8.0 days [7–10], p = 0.882). The complication rates did not differ between the two groups, but more complications were noted in the rehabilitation program group (42.3 vs. 24.0 %, p = 0.054), which was related to postoperative ileus (28.8 vs. 13.0 %, p = 0.057) and acute voiding difficulty (19.6 vs. 4.7 %, p = 0.032). There was no readmission within 1 month of surgery. Pain and QOL were similar in both groups.

Conclusions

This randomized trial did not show that an early rehabilitation program is beneficial after laparoscopic low anterior resection. Our results confirm that postoperative ileus and acute voiding difficulty are major obstacles to fast-track surgery for mid or low rectal cancer. This study was registered (registration number NCT00606944).     

Clinical outcomes of manual bowel decompression (milking) in the mechanical small bowel obstruction: a prospective randomized clinical trial

BackgroundThe aim of this prospective randomized study was to investigate the effects of manual bowel decompression in patients who were operated on for mechanical small bowel obstruction.MethodsBetween March 2008 and February 2010, 40 consecutive patients with mechanical small bowel obstruction were randomized into 2 clinically comparable groups. The intestinal content of the dilated small bowel was caressed to the stomach (by milking) and aspirated via a nasogastric tube in the milking group (group M, n = 20) and left uncaressed in the control Group (group C, n = 20). Patients' characteristics and general operative outcomes were compared and analyzed.ResultsThe resumption of a regular diet and postoperative hospital stay (P = .68) were not significantly different in groups M and group C. Similarly, there were no differences between the 2 groups regarding respiratory complications (P = .34), bacterial translocation (P = 1), or wound infection (P = 1).ConclusionsThe findings suggest that routine milking is unnecessary in mechanical small bowel obstruction.     

Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery

BACKGROUND: Mechanical bowel preparation (MBP) is performed routinely before colorectal surgery to reduce the risk of postoperative infectious complications. The aim of this randomized clinical trial was to compare the outcome of patients who underwent elective left-sided colorectal surgery with or without MBP. METHODS: Patients scheduled for elective left-sided colorectal resection with primary anastomosis were randomized to preoperative MBP (3 litres of polyethylene glycol) (group 1) or surgery without MBP (group 2). Postoperative abdominal infectious complications and extra-abdominal morbidity were recorded prospectively. RESULTS: One hundred and fifty-three patients were included in the study, 78 in group 1 and 75 in group 2. Demographic, clinical and treatment characteristics did not differ significantly between the two groups. The overall rate of abdominal infectious complications (anastomotic leak, intra-abdominal abscess, peritonitis and wound infection) was 22 per cent in group 1 and 8 per cent in group 2 (P = 0.028). Anastomotic leak occurred in five patients (6 per cent) in group 1 and one (1 per cent) in group 2 (P = 0.210) [corrected] Extra-abdominal morbidity rates were 24 and 11 per cent respectively (P = 0.034). Hospital stay was longer for patients who had MBP (mean(s.d.) 14.9(13.1) versus 9.9(3.8) days; P = 0.024). CONCLUSION: Elective left-sided colorectal surgery without MBP is safe and is associated with reduced postoperative morbidity.     

Trillium-coated oxygenators in adult open-heart surgery: a prospective randomized trial

This randomized, prospective clinical trial examines the impact of the use of Trillium biopassive surface coating on clinical outcomes after cardiopulmonary bypass (CPB) that may be induced by contact of blood elements with foreign surfaces. The study consisted of 98 consecutive patients randomly assigned to either a CPB circuit that consisted of a Trillium-coated Affinity open reservoir oxygenator or a CPB circuit with an uncoated Affinity open reservoir oxygenator. The operative procedure performed on all 98 patients consisted of either coronary artery bypass graft (CABG), valve, or a combination of the two. Exclusion criteria consisted of patients who presented to the operating room in circulatory arrest. Trillium biopassive surface coating resulted in improved clinical outcomes and fewer adverse events when compared to the control group. Significantly, fewer patients required no blood products (18.3% in the control group vs. 32.7% in the treatment group), even though the control group had a significantly higher pre-bypass hematocrit. Postoperative atrial fibrillation (24.5% vs. 16.3%) and reoperation for bleeding (10.2% vs. 4.1%) showed a much lower incidence in the Trillium group. Significance was not reached because of the small sample size resulting in low power. Trillium circuits result in improved patient outcomes in the treatment group when compared to the control circuit group.