Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial. Cholecystectomy with and without drainage. A randomized, prospective study of 300 patients. The effect of drains in laparoscopic cholecystectomy. A prospective, controlled study of prophylactic drainage after colonic anastomoses. Cholecystectomy with and without drainage: a prospective randomised study. Effect of drainage on postoperative nausea, vomiting, and pain after laparoscopic cholecystectomy. Randomized clinical trial of laparoscopic versus open abdominal rectopexy for rectal prolapse. Drainage after thyroidectomy: a randomized clinical trial. Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation.
To determine whether primary peritoneal drainage improves survival and outcome of extremely low birth weight (ELBW) infants with intestinal perforation.
                Optimal surgical management of ELBW infants with intestinal perforation is unknown.
                An international multicenter randomized controlled trial was performed between 2002 and 2006. Inclusion criteria were birthweight >or=1000 g and pneumoperitoneum on x-ray (necrotizing enterocolitis or isolated perforation). Patients were randomized to peritoneal drain or laparotomy, minimizing differences in weight, gestation, ventilation, inotropes, platelets, country, and on-site surgical facilities. Patients randomized to drain were allowed to have a delayed laparotomy after at least 12 hours of no clinical improvement.
                Sixty-nine patients were randomized (35 drain, 34 laparotomy); 1 subsequently withdrew consent. Six-month survival was 18/35 (51.4%) with a drain and 21/33 (63.6%) with laparotomy (P = 0.3; difference 12% 95% CI, -11, 34%). Cox regression analysis showed no significant difference between groups (hazard ratio for primary drain 1.6; P = 0.3; 95% CI, 0.7-3.4). Delayed laparotomy was performed in 26/35 (74%) patients after a median of 2.5 days (range, 0.4-21) and did not improve 6-month survival compared with primary laparotomy (relative risk of mortality 1.4; P = 0.4; 95% CI, 0.6-3.4). Drain was effective as a definitive treatment in only 4/35 (11%) surviving neonates, the rest either had a delayed laparotomy or died.
                Seventy-four percent of neonates treated with primary peritoneal drainage required delayed laparotomy. There were no significant differences in outcomes between the 2 randomization groups. Primary peritoneal drainage is ineffective as either a temporising measure or definitive treatment. If a drain is inserted, a timely "rescue" laparotomy should be considered. Trial registration number ISRCTN18282954; http://isrctn.org/ A randomized, prospective study of 300 cholecystectomies was undertaken to evaluate the merits of drainage through a standard Penrose or Chaffin-Pratt sump tube matched against no drainage at all. There was no difference in mortality or length of hospital stay. There was, however, a significantly higher incidence of postoperative pyrexia due to atelectasis and wound infection in the drainage groups. Neither drain fulfilled its objective of providing outflow for a subhepatic collection, thus avoiding bile peritonitis. This study suggests that surgical drainage after every uncomplicated cholecystectomy is unnecessary and unwise. A prospective controlled randomized study was performed on 100 patients undergoing elective laparoscopic cholecystectomy to evaluate the benefit of routine drainage in simple uncomplicated procedures. The 100 patients were randomized into two groups. Group 1 patients (n = 50) had a drain placed through the epigastric trocar site. The drain was removed before their discharge unless bile or blood was present. Group 2 patients (n = 50) did not have a drain placed. Eleven patients in group 2 (no drain) (22%) were discharged on the same day of surgery (within 8 h), and the remaining 89 patients in both groups were discharged the day after surgery (within 23 h). There were no wound infections or postoperative fever in either group. There were minor but not statistically significant differences between the two groups in postoperative severity and duration of abdominal pain, shoulder pain, and nausea. Furthermore, the two groups were similar in respect to postoperative recovery time and return to work. A prospective, randomized, controlled trial was designed to study the influence of a corrugated latex drain on anastomotic integrity, wound infection, and respiratory complications after elective colonic resections above the pelvic peritoneum. Sixty patients entered the trial; 28 were drained and 32 undrained. Three patients in the undrained group died soon after surgery of causes unrelated to their colon anastomoses. There were no other differences in the incidence of postoperative complications in the two groups. When an anastomosis leaked, neither feces nor pus emerged via the drain. It is concluded that while the drains did not increase the incidence of postoperative complications, neither did they accomplish the purpose for which they were inserted. If, in addition, the economic cost of drainage is considered, it would seem that there is no advantage in inserting prophylactic drains after colonic anastomoses and their routine use needs to be reconsidered. The use of subhepatic intraperitoneal drains was prospectively studied in 100 patients who underwent elective cholecystectomy for symptomatic gallstones. These patients were randomised to have subhepatic drains (group A, n = 50 patients) or to have no drains (group B, n = 50 patients). There was no difference in the age or sex composition of the two groups. The patients were followed in the post-operative period (0-7 days) for evidence of fever, wound infection, septicaemia and any evidence of intra-peritoneal bile leakage. Also post operative hospital stay of patients was noted. In group A, 14 patients (28%) developed spikes of temperature of 38 degrees C or more while only 5 patients (10%) in group B developed such episodes. The difference was statistically significant between the two groups (P < 0.05). Wound infection occurred significantly more (P < 0.05) in group A (in 15 patients) as compared to group B (in 5 patients). Septicaemia occurred in 2 patients in group A and in none in group B. There was no evidence of intraperitoneal bile leakage in either group. Patients in group A tended to have longer post operative hospital stay (mean of 10.2 days) than patients in group B (mean 8.7 days); but the difference between the two groups in this respect was not significant. We conclude that subhepatic intra-peritoneal drains offered no additional advantage in elective cholecystectomy. The evidence we had pointed to their harmful effects. Laparoscopic cholecystectomy is associated with a high incidence of postoperative pain, nausea, and vomiting. Pneumoperitoneum created during the operation and residual gas after the operation are two of the factors in postoperative pain and nausea. We studied the effects of a subdiaphragmatic gas drain, which is intended to decrease the residual gas, on postoperative pain, nausea, and vomiting after laparoscopic cholecystectomy.
                Seventy patients were randomized into two demographically and clinically comparable groups: drainage and control. Postoperative pain, nausea, and vomiting were measured by verbal grading and visual analog scale 2-72 h postoperatively. Analgesic and antiemetic use and incidence of retching, vomiting and other complaints were also recorded.
                Subdiaphragmatic drain effectively reduced the incidence and amount of subdiaphragmatic gas bubble. The incidence and severity of nausea was lower in the drainage group at 72 h. Although severity of pain was lower at 8 and 12 h in the drainage group, the difference was not significant. There was also no difference between the groups in regard to analgesic and antiemetic use.
                Subdiaphragmatic drain offers only minor, if any, benefit on postoperative pain, nausea, and vomiting after laparoscopic cholecystectomy, and this effect is probably clinically irrelevant. The objectives of this study were to compare both subjective clinical outcomes and the objective stress response of laparoscopic and open abdominal rectopexy in patients with full-thickness rectal prolapse. Abdominal rectopexy for patients with rectal prolapse is well suited for a laparoscopic approach as no resection or anastomosis is necessary.
                Forty patients with a full-thickness rectal prolapse were randomized before operation to a laparoscopic group and an open group. They agreed to conform to a clinical pathway (CP) of liquid diet (CP1) and full mobility (CP2) on day 1, solid diet (CP3) on day 2 and discharge (CP4) before day 5. Their compliance was monitored by an assessor blinded to the operative group, who also rated pain and mobility. Patient-controlled morphine use was documented. Neuroendocrine and immune stress response and respiratory function were measured.
                Some 75 per cent of all clinical pathway objectives of early recovery were achieved in the laparoscopic group compared with 37 per cent in the open group (P < 0.01). Significant differences in favour of laparoscopy were noted with regard to narcotic requirements, and pain and mobility scores. Differences in objective measures of stress response favouring laparoscopy were found for urinary catecholamines, interleukin 6, serum cortisol and C-reactive protein. No differences were noted in respiratory function but significant respiratory morbidity was greater in the open group (P < 0.05). None of the measured outcomes, subjective or objective, favoured the open group apart from operating time, which was significantly shorter (153 versus 102 min; P < 0.01).
                This study has demonstrated significant subjective and objective differences in favour of a laparoscopic technique for abdominal rectopexy. The advantages were all short term but no evidence of any adverse effect on longer-term outcomes was observed. A randomized clinical trial of surgical drainage in thyroid surgery was performed on 97 patients. Morbidity was not significantly different between both groups. The length of hospital stay was shorter in the undrained group. However, this RCT is not an indication of the value of drainage after thyroid surgery because the series is too small. Using a meta-analysis of the RCTs reported it is possible to show that to drain is not useful. Perforated necrotizing enterocolitis is a major cause of morbidity and mortality in premature infants, and the optimal treatment is uncertain. We designed this multicenter randomized trial to compare outcomes of primary peritoneal drainage with laparotomy and bowel resection in preterm infants with perforated necrotizing enterocolitis.
                We randomly assigned 117 preterm infants (delivered before 34 weeks of gestation) with birth weights less than 1500 g and perforated necrotizing enterocolitis at 15 pediatric centers to undergo primary peritoneal drainage or laparotomy with bowel resection. Postoperative care was standardized. The primary outcome was survival at 90 days postoperatively. Secondary outcomes included dependence on parenteral nutrition 90 days postoperatively and length of hospital stay.
                At 90 days postoperatively, 19 of 55 infants assigned to primary peritoneal drainage had died (34.5 percent), as compared with 22 of 62 infants assigned to laparotomy (35.5 percent, P=0.92). The percentages of infants who depended on total parenteral nutrition were 17 of 36 (47.2 percent) in the peritoneal-drainage group and 16 of 40 (40.0 percent) in the laparotomy group (P=0.53). The mean (+/-SD) length of hospitalization for the 76 infants who were alive 90 days after operation was similar in the primary peritoneal-drainage and laparotomy groups (126+/-58 days and 116+/-56 days, respectively; P=0.43). Subgroup analyses stratified according to the presence or absence of radiographic evidence of extensive necrotizing enterocolitis (pneumatosis intestinalis), gestational age of less than 25 weeks, and serum pH less than 7.30 at presentation showed no significant advantage of either treatment in any group.
                The type of operation performed for perforated necrotizing enterocolitis does not influence survival or other clinically important early outcomes in preterm infants. (ClinicalTrials.gov number, NCT00252681.).
                Copyright 2006 Massachusetts Medical Society.
Evidence from two RCTs suggests no significant benefits or harms of peritoneal drainage over laparotomy. However, due to the very small sample size, clinically significant differences may have easily been missed. No firm recommendations can be made for clinicians. Large multicentre randomised controlled trials are needed to address this question definitively.