A randomized study comparing retroperitoneal drainage with no drainage after lymphadenectomy in gynecologic malignancies. A prospective randomized study comparing retroperitoneal drainage with no drainage and no peritonization following radical hysterectomy and pelvic lymphadenectomy for invasive cervical cancer. Randomised trial of drains versus no drains following radical hysterectomy and pelvic lymph node dissection: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) study in 234 patients. Gastric cancer surgery without drains: a prospective randomized trial. A prospective, controlled study of prophylactic drainage after colonic anastomoses. [Routine drainage following uncomplicated, elective cholecystectomy? A prospective, randomized study]. A prospective randomised study of drains in infra-peritoneal rectal anastomoses. Cholecystectomy with and without drainage: a prospective randomised study. Is prophylactic pelvic drainage useful after elective rectal or anal anastomosis? A multicenter controlled randomized trial. French Association for Surgical Research.
To evaluate the clinical effectiveness of retroperitoneal drainage following lymphadenectomy in gynecologic surgery.
                One hundred thirty-seven consecutive patients undergoing systematic lymphadenectomy for gynecologic malignancies were randomized to receive (Group A, 68) or not (Group B, 69) retroperitoneal drainage. The pelvic peritoneum and the paracolic gutters were not sutured after node dissection. Perioperative data and complications were recorded.
                Clinical and surgical parameters were comparable in the two groups. Postoperative hospital stay was significantly shorter in Group B (P < 0.001), whereas the complication rate was significantly higher in Group A (P = 0.01). This was mainly due to a significant increase in lymphocyst and lymphocyst-related morbidity. Sonographic monitoring for lymphocyst showed free abdominal fluid in 18% of drained and 36% of not-drained patients (P = 0.03). Symptomatic ascites developed in 2 drained (3%) and 3 not-drained (4%) patients (NS), respectively.
                Prophylactic drainage of the retroperitoneum seems to increase lymphadenectomy-related morbidity and postoperative stay. Therefore, routine drainage following lymphadenectomy seems to be no longer indicated when the retroperitoneum is left open. To evaluate the postoperative morbidity and lymphocyst formation in invasive cervical cancer patients undergoing radical hysterectomy and pelvic lymphadenectomy (RHPL) with no drainage and no peritonization compared with retroperitoneal drainage and peritonization.
                Between July 1999 and May 2000, 100 patients with stage IA-IIA cervical cancer undergoing RHPL in Chiang Mai University Hospital were prospectively randomized to receive either no peritonization and no drainage (Group A = 48 cases) or retroperitoneal drainage and peritonization (Group B = 52 cases). Perioperative data and morbidity were recorded. Transabdominal and transvaginal sonography were performed at 4, 8 and 12 weeks postoperatively to detect lymphocyst formation.
                Both groups were similar regarding age, size and gross appearance of tumor, tumor histology and stage. There was no difference between groups in respect of operative time, need for blood transfusion, intraoperative complications, hospital stay, number of nodes removed, nodal metastases, and need for adjuvant radiation and chemotherapy. Asymptomatic lymphocysts were sonographically detected at 4, 8 and 12 weeks postoperatively in 3 (6.8%), 2 (4.6%), and 3 (7.7%) of 44, 43, and 39 patients, respectively in Group A, whereas none was found in Group B (P = 0.2). No significant difference was found in term of postoperative morbidity in the two groups.
                Routine retroperitoneal drainage and peritonization after RHPL for invasive cervical cancer can be safely omitted. Drainage, following radical hysterectomy and pelvic lymph node dissection to prevent postoperative lymphocyst formation and surgical morbidity, is controversial. To study the clinical significance of drainage, 253 patients were registered and 234 patients were randomised into two arms. In one arm (n=117) postoperative drainage was performed, in the other arm (n=117) no drains were inserted. In both arms closure of the peritoneum of the operating field was omitted. The main exclusion criteria were blood loss of more than 3000 ml during surgery or persistent oozing at the end of the operation. Clinical and ultrasound or CT-scan evaluation was done at one and 12 months postoperatively. The median follow-up amounted to 13.3 months. No difference in the incidence of postoperative lymphocyst formation or postoperative complications was found between the two study arms. The late (12 months) incidence of symptomatic lymphocysts was 3.4% (drains: 5.9%; no drains: 0.9%). The difference showed a p-value of 0.06 in Fisher's Exact test. The operating time was related to the occurrence of postoperative lymphocyst formation. It was concluded that drains can be safely omitted following radical hysterectomy and pelvic node dissection without pelvic reperitonisation in patients without excessive bleeding during or oozing at the end of surgery. 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. 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. A prospective randomized and controlled study of prophylactic drainage after simple, elective cholecystectomy was carried out. From March 1988 to June 1991 80 patients received an Easy-Flow drain and 80 did not. Operation and perioperative management were standardized. The endpoint of the study was postoperative morbidity, especially postoperative pyrexia and subhepatic fluid collection. The latter was identified by ultrasonography performed daily on postoperative day 1-4. No patient died. The morbidity including postoperative pyrexia revealed no difference between drained and undrained patients. In 19 of the patients with (23.8%) and in 25 of the patients without drainage (31.3%) a subhepatic fluid collection could be demonstrated by ultrasonography. This difference was not statistically significant either. We conclude that prophylactic drainage after elective, simple cholecystectomy is of no use for the patient. As subhepatic fluid collections can be seen in drained as well as in undrained patients it has to be accepted that drainage does not guarantee the removal of subhepatic fluid. Therefore its indicatory function (bleeding) and the ability to prevent the patient having biliary peritonitis or local abscess has to be put in doubt. Although increasing evidence suggests that prophylactic drainage after intra-peritoneal colorectal anastomoses is unnecessary, drains for infra-peritoneal rectal anastomoses, where the leak rate is higher, are widely employed still. The aim of this study was to assess the effect of prophylactic drainage after anastomosis below the peritoneal reflection. All patients attending one specialist unit over an 8-month period for elective rectal cancer resection with an infra-peritoneal anastomosis were randomised to drainage or no drainage. The incidence of anastomotic leak and complications specific to the drain as well as other complications were compared. Fifty-nine patients were analysed (31 with drain). Twenty-five of the drained and 16 of the no-drain patients had a defunctioning stoma (p=ns). The groups were comparable for demographic data, operation and anastomotic height from the anal verge. There were three leaks (10%) in the drain group and five leaks (18%) in the no-drain group (p=ns). There were 2 (7%) patients in each group with a clinical leak. There were no specific drain complications and the incidence of other complications was similar in both groups. In conclusion, this study supports the contention that there is no difference in morbidity with or without the use of a drain for infra-peritoneal anastomoses. 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. We investigated the role of drainage in the prevention of complications after elective rectal or anal anastomosis in the pelvis. Anastomotic leakage after colorectal resection is more prevalent when the anastomosis is in the distal or infraperitoneal pelvis than in the abdomen. The benefit of pelvic drains versus their potential harm has been questioned. Drain-related complications include (1) those possibly benefiting from drainage (leakage, intra-abdominal infection, bleeding) and (2) those possibly caused by drainage (wound infection or hernia, intestinal obstruction, fistula).
                Between September 1990 and June 1995, 494 patients (249 men and 245 women), mean age 66 +/- 15 (range 15 to 101) years, with either carcinoma, benign tumor, colonic Crohn's disease, diverticular disease of the sigmoid colon, or another disorder located anywhere from the right colon to the midrectum undergoing resection followed by rectal or anal anastomosis were randomized to undergo either drainage (n = 248) with 2 multiperforated 14F suction drains or no drainage (n = 246). The primary end point was the number of patients with one or more postoperative drain-related complications. Secondary end points included severity of these complications as assessed by the rate of related repeat operations and associated deaths as well as extra-abdominally related morbidity and mortality.
                After withdrawal of 2 patients (1 in each group) both groups were comparable with regard to preoperative characteristics and intraoperative findings. The overall leakage rate was 6.3% with no significant difference between those with or without drainage. There were 18 deaths (3.6%), 8 (3.2%) in those with drainage and 10 (4%) in those without drainage. Five patients with anastomotic leakage died (1%), 3 of whom had drainage. There were 32 repeat operations (6.5%) for anastomotic leakage 11 in the group with drainage and 4 in the group with no drainage. The rate of these and the other intra-abdominal and extra-abdominal complications did not differ significantly between the 2 groups.
                Prophylactic drainage of the pelvic space does not improve outcome or influence the severity of complications.
Placement of retroperitoneal tube drains has no benefit in prevention of lymphocyst formation after pelvic lymphadenectomy in patients with gynaecological malignancies. When the pelvic peritoneum is left open, the tube drain placement is associated with a higher risk of short and long-term symptomatic lymphocyst formation.