Laparoscopy. Gasless vs. CO2 pneumoperitoneum. Energy sources for laparoscopic colectomy: a prospective randomized comparison of conventional electrosurgery, bipolar computer-controlled electrosurgery and ultrasonic dissection. Operative outcome and costs analysis. A randomised trial comparing single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured tubal pregnancy. Laparoscopic surgery in ectopic pregnancy. A randomized trial versus laparotomy. Randomized, prospective, single-blind trial of a new parallel technique of Veress pneumoperitoneum needle insertion versus the conventional closed method.
To compare gasless laparoscopy with conventional laparoscopy using CO2 pneumoperitoneum.
                Women undergoing bilateral laparoscopic tubal coagulation (LTC) were randomly assigned to one of two laparoscopy procedures: (1) a gasless laparoscopy system consisting of an intraabdominal fan retractor and electrically powered mechanical arm, and (2) standard CO2 pneumoperitoneum laparoscopy. The two laparoscopic procedures were compared on the basis of intraoperative visualization, operation duration, procedural difficulty, ventilatory parameters, hemodynamic stability, and postoperative pain and nausea.
                Significant disadvantages for the surgeon (increased technical difficulty, poorer visualization, longer operative times) and patient (greater postoperative pain and nausea) were seen with the gasless system. Because of these findings, the study was prematurely terminated after only 18 patients had participated. Intraoperative ventilatory and hemodynamic parameters were more stable in the gasless laparoscopy groups; however, the differences were not clinically significant in this population of healthy patients.
                The markedly increased technical difficulty and absence of clear clinical benefits for the healthy patient led to the conclusion that laparoscopy with CO2 pneumoperitoneum is preferable for routine LTC and most laparoscopic procedures in the pelvis. Gasless laparoscopy may be of benefit for the fragile patient with a compromised cardiovascular system who may suffer complications from hypercarbenemia. The development of operative laparoscopic surgery is linked to advances in ancillary surgical instrumentation. Ultrasonic energy devices avoid the use of electricity and provide effective control of small- to medium-sized vessels. Bipolar computer-controlled electrosurgical technology eliminates the disadvantages of electrical energy, and a mechanical blade adds a cutting action. This instrument can provide effective hemostasis of large vessels up to 7 mm. Such devices significantly increase the cost of laparoscopic procedures, however, and the amount of evidence-based information on this topic is surprisingly scarce. This study compared the effectiveness of three different energy sources on the laparoscopic performance of a left colectomy. The trial included 38 nonselected patients with a disease of the colon requiring an elective segmental left-sided colon resection. Patients were preoperatively randomized into three groups. Group I had electrosurgery; vascular dissection was performed entirely with an electrosurgery generator, and vessels were controlled with clips. Group II underwent computer-controlled bipolar electrosurgery; vascular and mesocolon section was completed by using the 10-mm Ligasure device alone. In group III, 5-mm ultrasonic shears (Harmonic Scalpel) were used for bowel dissection, vascular pedicle dissection, and mesocolon transection. The mesenteric vessel pedicle was controlled with an endostapler. Demographics (age, sex, body mass index, comorbidity, previous surgery and diagnoses requiring surgery) were recorded, as were surgical details (operative time, conversion, blood loss), additional disposable instruments (number of trocars, EndoGIA charges, and clip appliers), and clinical outcome. Intraoperative economic costs were also evaluated. End points of the trial were operative time and intraoperative blood loss, and an intention-to-treat principle was followed. The three groups were well matched for demographic and pathologic features. Surgical time was significantly longer in patients operated on with conventional electrosurgery vs the Harmonic Scalpel or computed-based bipolar energy devices. This finding correlated with a significant reduction in intraoperative blood loss. Conversion to other endoscopic techniques was more frequent in Group I; however, conversion to open surgery was similar in all three groups. No intraoperative accident related to the use of the specific device was observed in any group. Immediate outcome was similar in the three groups, without differences in morbidity, mortality, or hospital stay. Analysis of operative costs showed no significant differences between the three groups. High-energy power sources specifically adapted for endoscopic surgery reduce operative time and blood loss and may be considered cost-effective when left colectomy is used as a model. To compare single dose systemic methotrexate (50 mg/m2) with laparoscopic surgery for the treatment of unruptured tubal pregnancy.
                An open, pragmatic, prospective randomised trial.
                Departments of obstetrics and gynaecology at three hospitals in Auckland, New Zealand.
                Clinically stable women with an unruptured tubal pregnancy diagnosed by transvaginal ultrasound and quantitative serum beta-hCG measurement. Inclusion criteria included a serum beta-hCG concentration < 5,000 IU/L, and a tubal pregnancy of < 3.5 cm diameter.
                Treatment success, physical and psychological functioning, side effects, and subsequent ipsilateral tubal patency.
                Two hundred and eighteen women with ectopic pregnancies were seen at the three hospitals. 79 women (36% eligibility rate) were eligible for trial entry and 62 women (78% recruitment rate) were recruited. Twenty-six of the 28 women (93%) randomised to laparoscopic surgery required no further treatment, compared with 22 of the 34 women (65%) randomised to methotrexate (95% CI of difference in success rate 10 - 47%; P < 0.01). Two women (7%) in the laparoscopic surgery group had persistent trophoblast. Nine women (26%) in the methotrexate group required more than one dose of methotrexate and five women (15%) underwent laparoscopy during follow up. In the laparoscopy group three women (11%) had negative laparoscopies and two women (7%) had were found to have a ruptured fallopian tube at the time of surgery. Women treated with methotrexate had significantly better objective physical functioning scores but there were no differences in any other psychological outcomes. Women treated with methotrexate experienced greater and more prolonged vaginal bleeding. The likelihood of methotrexate treatment failure was greater at higher serum beta-hCG concentrations. Ipsilateral tubal patency rates were similar in each group.
                This trial shows that in the treatment of tubal pregnancy single dose systemic methotrexate is a less effective treatment than laparoscopic salpingotomy. It is well tolerated, but should only be offered as an alternative to surgery to women who have mild symptoms and present at low serum beta-hCG concentrations. In our population this likely to be no more than a quarter of women presenting with a tubal pregnancy. A randomized, prospective clinical trial was conducted to compare the efficacy of laparoscopic treatment with conventional conservative abdominal surgery for tubal pregnancy. Entry criteria were: size of the ectopic gestation less than 4 cm, hemodynamic stability, accessibility for laparoscopic treatment and a trained laparoscopist on duty. There was no difference between the groups regarding gestational duration, size and location of the ectopic gestation, or the mean preoperative hCG values. The groups differed with respect to total operation time (73 min for the laparoscopy group vs. 88 min for the laparotomy group), hospital stay (2.2 vs. 5.4 days) and convalescence period (11 vs. 24 days). The rates of elimination of hCG was similar in the groups, and there were no statistical difference in the rate of second intervention. To evaluate the safety and effectiveness of a new closed parallel technique of Veress needle insertion and to compare this method with the conventional closed approach.
                Sequential, randomized, prospective, single-blind clinical trial.
                University hospital.
                Women undergoing elective diagnostic and/or operative laparoscopy. Subjects (n = 200) were assigned randomly to undergo the conventional closed method (group 1; n = 100) or the new parallel technique (group 2; n = 100) of Veress needle insertion.
                Randomization of the patients was performed in the operating room. The investigator performed both diagnostic and operative laparoscopy in both study groups.
                Safety and effectiveness of the needle insertion technique.
                There were no significant differences in demographics between the groups, or in the time required for Veress needle insertion to establish pneumoperitoneum. There were no nonlethal major or minor intraoperative complications associated with either laparoscopic approach.
                There is no significant disadvantage to the parallel technique of Veress pneumoperitoneum needle insertion compared with the conventional closed approach. This new technique avoids the anatomic location of large vessels during insertion and may serve as a safeguard to decrease the potential for lethal laceration of a major vessel.
From these limited data there is no evidence of benefit or disadvantage of tubal surgery versus no treatment or alternative treatments. Likewise there is no evidence of advantage or disadvantage of using microsurgery over standard techniques; laparoscopic approach over laparotomy; the use of CO2 laser; or electrocoagulation over thermocoagulation. Randomised controlled trials should be undertaken to determine the role of tubal surgery versus no treatment or alternative treatments. Randomised controlled trials should be undertaken to determine the role at tubal surgery of magnification, laparoscopic approach, the use of lasers or electrocoagulation.