Randomized clinical trial of diathermy versus scalpel incision in elective midline laparotomy

BACKGROUND: Electrocautery is used increasingly for tissue dissection, although fears of excessive scarring and poor wound healing have curtailed its widespread use for skin incision. This study compared electrosurgical incision with traditional scalpel incision. METHODS: One hundred patients requiring elective midline laparotomy were randomized prospectively to either scalpel or diathermy incision. Parameters measured included incision time, wound size, wound blood loss, total intraoperative blood loss and postoperative wound pain. All wound complications were recorded. RESULTS: The two groups did not differ significantly in relation to patient or wound characteristics. Laparotomy incisions using diathermy were significantly quicker than scalpel incisions (mean(s. e.m.) 6.1(0.4) versus 7.5(0.5) s/cm2; P < 0.04). There was significantly less blood loss in the diathermy group compared with the scalpel group (0.8(0.1) versus 1.7(0.3) ml/cm2; P = 0.002). Postoperative pain scores were significantly lower in the diathermy group for the first 48 h after operation (P < 0.05). Morphine requirements were also significantly lower over the first 5 postoperative days in the diathermy incision group (P < 0.04). There was no difference between groups in wound complications before discharge and at the 1-month follow-up. CONCLUSION: Electrosurgical midline incision in elective surgery has significant advantages over scalpel use on the basis of incision time, blood loss, early postoperative pain and analgesia requirements.     

Transabdominal versus retroperitoneal incision for abdominal aortic surgery: Report of a prospective randomized trial

Purpose: The purpose of this study was to perform a randomized, prospective trial that compares the transabdominal with the retroperitoneal approach to the aorta for routine infrarenal aortic reconstruction.Methods: From August 1990 through November 1993, patients undergoing surgery for abdominal aortic aneurysm (AAA) disease or aortoiliac occlusive disease (AIOD) were asked to participate in a randomized trial comparing the transabdominal incision (TAI) to the retroperitoneal incision (RPI) for aortic surgery. One hundred forty-five patients were randomized, with 75 (41 with AAA and 34 with AIOD) in the TAI group and 70 (40 with AAA and 30 with AIOD) in the RPI group. There were no significant differences between the groups in terms of age, sex, postoperative pain control (epidural vs patient-controlled analgesia), or comorbid conditions, except for a higher incidence of chronic obstructive pulmonary disease in the TAI group (21 vs 8 patients).Results: The incidence of intraoperative complications was similar for both groups. After surgery, the incidence of prolonged ileus (p = 0.013) and small bowel obstruction (p = 0.05) was higher in the TAI group. Overall, the RPI group had significantly fewer complications (p < 0.0001). The overall postoperative mortality rate (two deaths) was 1.4%, with both occurring in the TAI group (p = 0.507). The RPI group also had significantly shorter stays in the intensive care unit (p = 0.006), a trend toward shorter hospitalization (p = 0.10), lower total hospital charges (p = 0.019), and lower total hospital costs (p = 0.017). There was no difference in pulmonary complications (p = 0.71). In long-term follow-up (mean 23 months), the RPI group reported more incisional pain (p = 0.056), but no difference was found in incisional hernias or bulges (p = 0.297).Conclusions: We conclude that the RPI approach for abdominal aortic surgery is associated with fewer postoperative complications, shorter stays in the hospital and intensive care unit, and lower cost. There is, however, an increase in long-term incisional pain. Current methods of postoperative pain control seem to decrease the incidence of pulmonary complications. (J VASC SURG 1995;21:174-83.)     

Fascia closure after midline laparotomy: results of a randomized trial

Four techniques to close the fascia after midline laparotomy were compared in a prospective randomized multicentre trial. The four techniques were: interrupted closure with polyglactin; continuous closure with polyglactin; continuous closure with polydioxanone-s, and continuous closure with nylon. The early postoperative results in 1491 patients revealed an incidence of wound infection of 8.6 per cent and of wound dehiscence of 2.3 per cent with no statistically significant differences between the four techniques. We reviewed 1156 patients after 1 year. Wound pain was present in 9.7 per cent of the patients, statistically significantly more in the group closed with nylon (16.7 per cent). Suture sinuses developed in 3.5 per cent of the patients, statistically significantly more frequently in the nylon group (7.7 per cent). The total number of incisional hernias detected 1 year postoperatively was high (15.2 per cent) (interrupted polyglactin 16.9 per cent, continuous polyglactin 20.6 per cent, continuous polydioxanone 13.2 per cent and continuous nylon 10.3 per cent). The difference between nylon and continuous polyglactin is statistically significant. The results of this trial indicate that although nylon has the lowest incidence of incisional hernia it also is associated with more wound pain and suture sinuses.     

Incisional hernia after upper abdominal surgery: a randomised controlled trial of midline versus transverse incision

Objectives  To determine whether a transverse incision is an alternative to a midline incision in terms of incisional hernia incidence, surgical site infection, postoperative pain, hospital stay and cosmetics in cholecystectomy. Summary background data  Incisional hernias after midline incision are commonly underestimated but probably complicate between 2 and 20% of all abdominal wall closures. The midline incision is the preferred incision for surgery of the upper abdomen despite evidence that alternatives, such as the lateral paramedian and transverse incision, exist and might reduce the rate of incisional hernia. A RCT was preformed in the pre-laparoscopic cholecystectomy era the data of which were never published. Methods  One hundred and fifty female patients were randomly allocated to cholecystectomy through midline or transverse incision. Early complications, the duration to discharge and the in-hospital use of analgesics was noted. Patients returned to the surgical outpatient clinic for evaluation of the cosmetic results of the scar and to evaluate possible complications such as fistula, wound dehiscence and incisional hernia after a minimum of 12 months follow-up. Results  Two percent (1/60) of patients that had undergone the procedure through a transverse incision presented with an incisional hernia as opposed to 14% (9/63) of patients from the midline incision group (P = 0.017). Transverse incisions were found to be significantly shorter than midline incisions and associated with more pleasing appearance. More patients having undergone a midline incision, reported pain on day one, two and three postoperatively than patients from the transverse group. The use of analgesics did not differ between the two groups. Conclusions  In light of our results a transverse incision should, if possible, be considered as the preferred incision in acute and elective surgery of the upper abdomen when laparoscopic surgery is not an option.     

Preoperative versus postoperative endoscopic retrograde cholangiopancreatography in mild to moderate gallstone pancreatitis: a prospective randomized trial

OBJECTIVE: To determine whether endoscopic retrograde cholangiopancreatography (ERCP) and common bile duct (CBD) stone extraction should be performed routinely before surgery or'selectively after surgery in patients with mild to moderate gallstone pancreatitis. SUMMARY BACKGROUND DATA: The role and timing of ERCP in mild to moderate gallstone pancreatitis remains controversial. Routine preoperative ERCP identifies persisting CBD stones but carries risks of complications and may delay definitive care. Selective postoperative ERCP, performed only if a CBD stone is seen on intraoperative cholangiography (IOC), avoids unnecessary ERCP but risks unsuccessful stone extraction. METHODS: A prospective, randomized study of consecutive patients with gallstone pancreatitis was conducted. Using previously determined criteria, patients with acute cholangitis or necrotizing pancreatitis were excluded. Patients considered at high risk for persisting CBD stones (CBD size > or =8 mm on admission ultrasound, serum total bilirubin > or = 1.7 mg/dL, or serum amylase > or = 150 U/L on hospital day 4) were randomly assigned to routine preoperative ERCP followed by laparoscopic cholecystectomy, or laparoscopic cholecystectomy with selective postoperative ERCP and endoscopic sphincterotomy only if a CBD stone was present on IOC. Primary end points were costs, length of hospital stay, and the combined treatment failure rates (failure of diagnostic ERCP and IOC, complications of ERCP and endoscopic sphincterotomy, and complications of surgery). RESULTS: One hundred fifty-four consecutive patients with gallstone pancreatitis were evaluated prospectively for study eligibility. Sixty patients met the randomization criteria. Thirty patients were randomized to routine preoperative ERCP and 29 patients to selective postoperative ERCP (1 patient refused). Age, admission laboratory values, and APACHE II and Imrie scores were similar in both groups. By protocol, ERCP was performed in all patients in the preoperative ERCP group. In the postoperative ERCP group, ERCP was necessary in only 7 of 29 patients (24%). Mean hospital stay was significantly longer in the routine preoperative ERCP group (11.7 days) than in the selective postoperative ERCP group (9.0 days). Mean total cost was higher in the preoperative ERCP group ($9,426) than in the postoperative ERCP group ($7,798). The combined treatment failure rate was 10% in both groups. CONCLUSIONS: In patients with mild to moderate gallstone pancreatitis without cholangitis, selective postoperative ERCP and CBD stone extraction is associated with a shorter hospital stay, less cost, no increase in combined treatment failure rate, and significant reduction in ERCP use compared with routine preoperative ERCP.     

Electrosurgical skin incision versus conventional scalpel: a prospective trial

A controlled clinical study comparing skin incision by conventional scalpel with electrosurgical needle incision has shown the latter technique to be highly effective, consistently quicker, and to give better cosmetic results with minimal complications. It is a convenient technique and well tolerated by the patients with no added discomfort. Skin diathermy burns and wound haematomas were only seen after conventional scalpel incision. Fears of delayed wound healing, keloid formation and high infection rates are unfounded.     

Ultrasonic versus standard electric dissection in laparoscopic colorectal surgery: a prospective randomized clinical trial

OBJECTIVE: To assess the safety and efficacy of the ultrasonic dissection (UC) compared with standard electrosurgery (ES) in laparoscopic colorectal surgery. BACKGROUND DATA: High-frequency ultrasound energy was introduced in laparoscopic surgery to improve dissection and coagulation. Very limited data have been published on its use in laparoscopic colorectal surgery. METHODS: Patients eligible for elective laparoscopic right or left hemicolectomy (RH and LH), sigmoidectomy (SG), or low anterior resection (LAR) were randomized to either UC or ES. The following data were collected and analyzed: preoperative data (individual patient data, indication for surgery), intraoperative data (conversion to open surgery, conversion ES to UC, operative time, blood loss, complication rate), and postoperative data (morbidity and mortality, volume of drainage, hospital stay). RESULTS: Between January 2002 and December 2003, 171 patients underwent elective laparoscopic colorectal resection. Twenty-5 patients did not satisfy the inclusion criteria and were excluded. The diagnosis of the remaining 146 patients was diverticulitis (44), colonic adenoma (31), adenocarcinoma (70), or epidermoid carcinoma (1). These patients underwent laparoscopic RH (28), LH (31), SG (47), or LAR (40). There were no differences in preoperative data. The overall conversion rate to open surgery was 11.6%, with no differences between the two groups; 20.8% undergoing ES were converted to UC, more frequently during right hemicolectomy or low anterior resection. Operative time, the primary endpoint of this study, did not differ between the two groups: UC 93 minutes versus ES 102.6 minutes (P = 0.46). Intraoperative blood loss was significantly less in UC 140.8 mL versus ES 182.6 mL (P = 0.032). No differences were observed in postoperative morbidity or other preoperative or postoperative parameters. CONCLUSIONS: UC is a useful device in laparoscopic colorectal surgery that facilitates completion of difficult cases and reduces intraoperative blood loss. Nevertheless, the majority of laparoscopic procedures can be completed with ES. Therefore, selective use of UC appears to be the most cost-effective policy.     

Subcuticular closure versus Dermabond: a prospective randomized trial

2-Octylcyanoacrylate tissue adhesive (Dermabond, Ethicon, Inc, Somerville, NJ) is being used successfully for closure of minor lacerations. To date, however, there have been no studies evaluating its use in the operating room for surgical incisions. We conducted a prospective randomized trial to compare the closure of inguinal herniorrhaphy incisions using 2-octylcyanoacrylate tissue adhesive (Dermabond) with closures using 4-0 Monocryl (Ethicon, Inc) in a running subcuticular closure. A total of 46 incisions were randomized at the time of closure. Of these incisions 24 were randomized to Dermabond closure (TA) and 22 were randomized to subcuticular closure (SC). Performance measures included: time for closure, wound complications, and cosmesis. Cosmesis was evaluated by blinded evaluation of photographs of the incisions taken 4 weeks after surgery. Closure times for the TA group were faster than in the SC group (mean of 155 vs 286 seconds; P < 0.001). Wound complications were higher in the TA group (P = 0.045). Cosmesis was also felt to be better in the SC group with a score of 4.2 versus 3.88, but this did not reach statistical significance. Although the use of Dermabond did result in faster wound cultures it also resulted in an increase in wound complications. The difference in mean cosmetic score for each group was not statistically significant but trended toward better scores in the SC group. Based on these findings we do not feel Dermabond is an acceptable alternative to subcuticular suture closure in inguinal herniorrhaphy incisions.     

Early ductal decompression versus conservative management for gallstone pancreatitis with ampullary obstruction: a prospective randomized clinical trial

OBJECTIVE: To compare the efficacy of endoscopic retrograde cholangiopancreatography +/- endoscopic sphincterotomy (ERCP +/- ES) versus traditional conservative management in early gallstone pancreatitis with persistent ampullary obstruction (GSP + AO). SUMMARY BACKGROUND DATA: The effectiveness of early ERCP +/- ES in this setting is controversial. METHODS: Sixty-one consecutive patients with GSP + AO within 48 hours from the onset of symptoms were randomized to receive either conservative treatment and selective ERCP +/- ES after 48 hours (control group, 31 patients) or initial conservative treatment and systematic ERCP +/- ES within 48 hours if obstruction persisted 24 hours or longer (study group, 30 patients). Patient outcome was compared in relation to treatment groups and to duration of obstruction. RESULTS: In the control group, 22 patients disobstructed spontaneously within 48 hours; 3 of the remaining 9 patients underwent ERCP +/- ES and none had impacted stones. In the study group, 16 patients disobstructed spontaneously and 14 underwent ERCP within 48 hours from the onset of symptoms; impacted stones were found and extracted by ES in 79% (11 of 14) of these. PATIENTS: There were no deaths in either group. Patients in the study group showed a shorter period of obstruction (P = 0.016) and a lower rate of immediate complications (P = 0.026) than controls. Patients with obstruction lasting < or =48 hours regardless of the treatment group had fewer immediate complications than those whose obstruction persisted longer (P < 0.001). CONCLUSIONS: This study shows that in patients with GSP + AO limiting the duration of obstruction to not longer than 48 hours by ERCP + ES decreased morbidity.     

One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery: a prospective randomized trial

Introduction and hypothesis  

For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization.     

Laparoscopic versus open appendectomy in men: a prospective randomized trial

Background  

The role of laparoscopic treatment in acute appendicitis still is unclear. Although some evidence in the literature suggests diagnostic benefits from laparoscopy for young women with suspected acute appendicitis, there is scepticism about the utility of this approach for men. This study aimed to compare open and laparoscopic appendectomy performed for men with suspected acute appendicitis.     

颈动脉内膜剥脱术和颈动脉支架的前瞻性随机对照研究

目的 评价颈动脉内膜剥脱术和颈动脉支架治疗颈动脉狭窄的近期和中期临床效果.方法 前瞻性单中心随机对照研究,自2004年5月至2006年12月,将同意入组的40例有症状(狭窄程度>50%)和无症状(狭窄程度>70%)颈动脉狭窄患者随机分为两组,即颈动脉内膜剥脱术组(CEA)和颈动脉支架组(CAS).一期观察终点是术后30 d内出现严重脑梗死或死亡;二期观察终点是各种手术并发症、急性脑缺血发作、偏瘫、急性心肌梗死和术后18个月内的脑卒中、死亡和再狭窄等,同时回顾性分析两组总的住院费用.结果 CEA和CAS两组患者术前一般资料、临床症状、伴随疾病等因素均无差异.CEA组20例23支颈动脉手术(3例分别行双侧CEA),术中应用转流管9条(39.1%),颈动脉补片12条(52.2%);CAS组20例23支颈动脉支架(3例行双侧CAS),应用脑保护装置21个(91.3%).CEA和CAS两组术后30 d内神经系统并发症(4.3%对8.7%,P=0.46)、急性心肌梗死(4.3%对0,P=0.31)和伤口血肿(8.7%对0,P=0.14)等差异均无统计学意义,至术后18个月无短暂性脑缺血发作和再狭窄病例.CEA和CAS两组平均住院费用分别为(16 450.95±6188.76)和(70 130.15±11 999.02)元人民币,差异有统计学意义(P<0.01).结论 CEA和CAS术后30 d和术后18个月的并发症、病死率和临床疗效无明显差异,但CAS的住院花费明显高于CEA.     

Laparoscopic common bile duct exploration versus open surgery: comparative prospective randomized trial

The aim of the study was to analyse safety and benefits of laparoscopic common bile duct (CBD) exploration compared to open. Prospective randomized trial included a total of 256 patients with CBD stones operated from 2005 to 2009 years in a single center. There were two groups of patients: group I-laparoscopic CBD exploration (138 patients), group II-open CBD exploration (118 patients). Patient comorbidity was assessed by means of the American Society of Anesthesiology (ASA) score; i.e. ASA II-109 patients, ASA III-59 patients. Bile duct stones were visualized preoperatively by means of US examination in 129 patients, by means of ERCP in 26 patients, by magnetic resonance cholangiopancreatography in 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography. There was no statistical significant difference between 2 groups of patients. No mortality occurred. The mean duration of laparoscopic operations was 82 min (range, 40-160 min). The mean duration of open operations were 90 min (range, 60-150 min). Mean blood loss was much less in laparoscopic group than in open group (20 ± 2 vs. 285 ± 27 ml; p < 0.01). Postoperative complications were observed is nine patients of laparoscopic group and in 15 patients in open group (p < 0.01). There were 102 attempts to perform transcystic exploration of CBD. External drainage was used in 25 (32.8%) patients with transcystic approach. Conversion to laparotomy was performed in two patients. Open operations were performed in 118 patients with choledocholithiasis. External drainage was used in 85% of patients. Morbidity in open group was higher (12.7%) than in laparoscopic group (6.5%). Laparoscopic CBD exploration can be performed with high efficiency, minimal morbidity and mortality. Laparoscopic procedures have advances over open operations in terms of postoperative morbidity and length of hospital stay.     

A prospective randomized study in 20 patients undergoing bilateral TKA comparing midline incision to anterolateral incision

Background

Lateral flap numbness is a known side-effect of midline skin incision in total knee arthroplasty (TKA) and a cause of patient dissatisfaction. Anterolateral incision is an alternative approach which preserves the infrapatellar branches of the saphenous nerve and avoids numbness. Studies have compared both incisions, but in different patients. However, different patients may assess the same sensory deficit dissimilarly, because of individual variations in anatomy and healing responses. We compared the two incisions in the same patient at the same time, using an anterolateral incision on one knee and a midline incision on the other knee in simultaneous bilateral TKA. Other surgical steps including medial arthrotomy were idential. We also correlated subjective and objective findings.

Materials and methods

Twenty patients were prospectively randomized. Sensory loss and skin healing were assessed at 6, 12 and 52 weeks. Subjective preference for the knee with less numbness was charted on Wald’s Sequential Probability Ratio Test. Sensation scores for touch, vibration, static and moving two-point discrimination were measured. Scar healing was evaluated using the Patient and Observer Scar Assessment Scale (POSAS). Functional scores were measured.

Results

A statistically significant difference favoring knees with anterolateral incision was observed in patient preference at all assessment points and this correlated with sensation scores. A statistically significant difference was observed in POSAS score favoring knees with anterolateral incision at 6 and 12 weeks which became statistically insignificant at 1 year. Functional scores remained comparable.

Conclusion

We recommend anterolateral incision as a safe and effective method to circumvent the problem of lateral flap numbness with midline incision.

Level of evidence

I.

     

Paramedian versus midline incision for the insertion of permanent peritoneal dialysis catheters. A randomized clinical trial

A randomized trial was conducted to examine the influence of the site of catheter insertion on the mechanical complications associated with the use of peritoneal dialysis catheters (pericatheter leakage/herniation and tip migration). 37 patients requiring a dialysis catheter for future CAPD were randomized to insertion by either a midline (prior standard approach) or a lateral incision (new approach). Thirteen catheters (6 midline, 7 lateral) failed for mechanical reasons--mainly irreversible tip migration. The one year estimated catheter survival without mechanical failure was found to be similar in the two groups: midline (59%) and lateral (51%), (0.4 less than p less than 0.5).     

Laparoscopic versus open appendectomy: prospective randomized trial

Although classic open surgery is simple, expeditious, and effective, it has some drawbacks, including wound sepsis, delayed recovery, operative difficulties, and possibility of unnecessary appendectomies for false appendicitis. The aim of this study was to assess the applicability and safety of laparoscopic appendectomy (LA) in a prospectively randomized trial. Seventy nonselective patients with suspected appendicitis were randomized to laparoscopic (n = 35, 17 male) or open appendectomy (n = 35, 15 male) and operated on an emergency basis. Operative findings, operating time, postoperative complications, and length of hospital stay were compared. We found that LA is associated with a shorter hospital stay, fewer postoperative complications, and better diagnostic accuracy, and it is recommended as the procedure of choice for the diagnosis and management of acute appendicitis.