Multicenter prospective randomized study comparing the technique of using a bovine pericardium biological prosthesis reinforcement in parietal herniorrhaphy (Tutomesh TUTOGEN) with simple parietal herniorrhaphy, in a potentially contaminated setting.

The use of parietal synthetic prosthetic reinforcement material in potentially contaminated settings is not recommended, as there is a risk that the prosthesis may become infected. Thus, simple parietal herniorrhaphy, is the conventional treatment, even though there is a significant risk that the hernia may recur. Using new biomaterials of animal origin presently appears to offer a new therapeutic solution, but their effectiveness has yet to be demonstrated. The purpose of this multicenter prospective randomized single-blind study was to compare the surgical treatment of inguinal hernia or abdominal incisional hernia by simple parietal herniorrhaphy without prosthetic reinforcement (Group A), with Tutomesh TUTOGEN biological prosthesis reinforcement parietal herniorrhaphy (Group B), in a potentially contaminated setting. We examined early postoperative complications in the first month after the operation, performed an assessment after one year of survival without recurrence and analyzed the quality of life and pain of the patients (using SF-12 health status questionnaire and Visual Analog Pain Scale) at 1, 6, and 12 months, together with an economic impact study. Hundred and thirty four patients were enrolled between January 2009 and October 2010 in 20 French hospitals. The groups were comparable with respect to their enrollment characteristics, their history, types of operative indications and procedures carried out. At one month post-op, the rate of infectious complications (n(A) = 11(18.33%) vs. n(B) = 12(19.05%), p = 0.919) was not significantly different between the two groups. The assessment after one year of survival without recurrence revealed that survival was significantly greater in Group B (Group A recurrence: 10, Group B: 3; p = 0.0475). No difference in the patients' quality of life was demonstrated at 1, 6, or 12 months. However, at the 1 month follow-up, the "perceived health" rating seemed better in the group with Tutomesh (p = 0.022). No significant difference between the two parietal repair groups was observed during the follow-ups with respect to the criterion of pain (using a visual analog scale). There was a significant difference between the two parietal repair groups with regard to the number of days spent in intensive care unit, in favor of the Tutomesh technique (p = 0.010). The use of a Tutomesh bioprosthesis for hernia repair or postincisional hernia in a potentially contaminated workplace reduces the risk of short-term recurrence without increasing overall comorbidity.

Intraperitoneal tension-free repair of a small midline ventral abdominal wall hernia: randomized study with a mean follow-up of 3 years.

Funding received from Cousin Biotech, Wervicq Sud, France, and CR Bard Inc., Cranston, RI. The aim of this prospective randomized study was to determine the long-term recurrence and complication rates after small abdominal wall hernia repair with two different bilayer prostheses. Hernia repair using prosthetic mesh material has become the preferred method of repair, because the recurrence rates are much lower than with conventional repair techniques. The use of a hernia bilayer patch, composite expanded polytetrafluoroethylene (ePTFE)-polypropylene, with intraperitoneal placement behind the hernia defect, through a small incision, may be efficient, safe, and cost-effective. This study is a randomized, single-institution trial, including 83 selected consecutive patients with primary (umbilical, epigastric) or incisional anterior abdominal wall defects from 2 to 5 cm. Hernia repair was performed by direct local access in ambulatory surgery; the prosthesis used was a circular bilayer with an inner face in ePTFE to avoid bowel adhesion. One group was treated with a Ventralex® Hernia Patch (Bard USA). The second group was treated with a Cabs'Air® Composite (Cousin Biotech France), which was delivered with two to four fixation sutures and a balloon to properly deploy the mesh intraperitoneally. Patients' characteristics and operative and postoperative data were prospectively collected. The primary outcome was late recurrence. Secondary outcomes included, pain, discomfort and quality of life before and after (3 months) surgery using the SF-12 questionnaire, patient-surgeon satisfaction, and early and late complications. Among 98 patients, 83 were included in the study protocol between January 2007 and August 2011. The two groups were comparable according to pre- and intraoperative data. According to surgeon experience, placement of the Cabs'Air® device was significantly faster (P = 0.01) and easier. At 3 months, there was significantly less pain and less discomfort for the Cabs'Air® group and patient satisfaction rate was higher. This was confirmed by all components of the SF-12 questionnaire. Long-term follow-up was available for 77 patients. The mean follow-up was similar for the two groups (42 months; range, 14 to 70 months). At this point, for the Ventralex® group, there were four recurrences (11.7%); one mesh infection; one small bowel obstruction; and six cases (15.7%) of severe pain resulting from a mass syndrome (shrinkage) with a sense of the presence of a foreign body. Six reoperations (15.6%) were required with explant of the prosthesis. There were no recurrences or late complications in the comparative group. The Ventralex® Hernia Patch is associated with inconsistent deployment, spreading, or shrinkage, which account for late complications and decreases the overlap, which contributes to the recurrence rate. The Cabs'Air®-associated balloon facilitates superior deployment of the prosthesis allowing for good fixation with four sutures.

Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial.

OBJECTIVE: Test the hypothesis that fibrin sealant mesh fixation can reduce the incidence of postoperative pain/numbness/groin discomfort by up to 50% compared with sutures for repair of inguinal hernias using the Lichtenstein technique. BACKGROUND: Inguinal hernia repair is the most common procedure in general surgery, thus improvements in surgical techniques, which reduce the burden of undesirable postoperative outcomes, are of clinical importance. METHODS: A randomized, controlled, patient- and evaluator-blinded study (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair [TIMELI]; trial NCT00306839) was conducted among patients eligible for Lichtenstein repair of uncomplicated unilateral primary inguinal small-medium sized hernia. Patients were subject to mesh fixation with either fibrin sealant or sutures. Main outcome measures were visual analogue scale (VAS) assessments for "pain," "numbness," and "groin discomfort" on a scale of 0 = best and 100 = worst outcome. The primary endpoint was a composite that evaluated the prevalence of chronic disabling complications (VAS score >30 for pain/numbness/groin discomfort) at 12 months after surgery. RESULTS: In total, 319 patients were randomized between January 2006 and April 2007 (159 fibrin sealant, 160 sutures). At 12 months, the prevalence of 1 or more disabling complication was significantly lower in the fibrin sealant group than in the sutures group (8.1% vs 14.8%; P = 0.0344). Less pain was reported in the fibrin sealant group than in the sutures group at 1 and 6 months (P = 0.0132; P = 0.0052), as reflected by a lower proportion of patients using analgesics in the fibrin group over the study duration (65.2% vs 79.7%; P = 0.0009). Only 3 of 316 patients (0.9%) experienced recurrence. The incidences of wound-healing complications and other adverse events were comparable between groups. CONCLUSIONS: Fibrin sealant for mesh fixation in Lichtenstein repair of small-medium sized inguinal hernias is well tolerated and reduces the rate of pain/numbness/groin discomfort by 45% relative to sutures without increasing hernia recurrence (NCT00306839).

Influence of mesh type on the quality of early outcomes after inguinal hernia repair in ambulatory setting controlled study: Glucamesh® vs Polypropylene®.

BACKGROUND: Early post-operative pain after inguinal hernia repair delays management in ambulatory setting. The type of mesh used for repair appears to influence their incidence. AIMS: The aim of this randomized, prospective study using the alternation principle was to compare post-operative early pain and the quality of life of patients operated on for inguinal hernia depending on the type of mesh used and their impact on management in ambulatory setting. PATIENTS AND METHODS: Fifty successive patients were included prospectively. Hernia repair was performed using the Lichtenstein procedure with two types of mesh, namely standard polypropylene 100 g/m² (Prolène®) or light polypropylene (55 g/m²) with a natural beta-D-glucan coating (Glucamesh®). The main assessment criterion was post-operative pain evaluated twice daily by the patient for 7 days, using the visual analogue scale (VAS) and their use of analgesics. The secondary assessment criteria were the rate of unscheduled admissions the evening of the intervention and the hospital length of stay and the quality of life evaluated by the SF12 questionnaire at pre-operative stage and on days 7 and 30. RESULTS: The two groups were comparable. The operative durations were identical (38.8±10.2 vs 48±15.4 min). On the evening of the intervention before discharge, the pain was less intense in the Glucamesh® group (mean VAS score 21.6±2.4 vs 31.7±6.2, p=0.02). On day 4, 20% of patients from the Glucamesh® group and none of the patients from the Prolène® group had a VAS score of 0 (p=0.02). There were no unscheduled admissions in either group, but the hospital stay was significantly shorter in the Glucamesh® group compared with the Prolène® group (288±35 vs 360±48 min, p=0.02). The post-operative quality of life evaluated by the SF12 questionnaire from day 7 to day 30 was the same in both groups (38±4.8 vs 37±5.2) and altered as at pre-operative stage compared with a control population (normal=50). CONCLUSIONS: This randomized, prospective study showed that the use of a self-adhesive, light mesh, reducing the fixation sutures and coated with factors favouring tissue integration, such as the Glucamesh® prosthesis, significantly reduced early post-operative pain compared with conventional prostheses and could increase the percentage of patients likely to undergo an ambulatory hernia repair.

Laparoscopic peritoneal lavage or primary anastomosis with defunctioning stoma for Hinchey 3 complicated diverticulitis: results of a comparative study.

PURPOSE: This study was designed to compare postoperative outcomes of laparoscopic peritoneal lavage and open primary anastomosis with defunctioning stoma in the management of Hinchey 3 diverticulitis. METHODS: From 1994 to 2006, 35 patients underwent laparoscopic peritoneal lavage for Hinchey 3 diverticulitis in three institutions. Data prospectively collected were compared with those of a retrospective series of 24 patients matched for Hinchey's classification and who underwent primary anastomosis with defunctioning stoma. RESULTS: There was no postoperative death. Postoperative morbidity was not different between the two groups. One patient in the laparoscopic peritoneal lavage group required a Hartmann's procedure because of a colonic fistula. One patient in the primary anastomosis with defunctioning stoma group underwent a reoperation for incisional dehiscence. The median hospital stay was lower in patients treated by laparoscopic peritoneal lavage (8 vs. 17 days, P < 0.0001). Twenty-five patients in the laparoscopic peritoneal lavage group underwent elective laparoscopic resection. One of them required conversion to laparotomy. All patients in the primary anastomosis with defunctioning stoma group have had their ileostomy closed. Cumulative surgical morbidity (16 vs. 37.5 percent, P = 0.0507) and hospital stay (14 vs. 23 days, P < 0.0001) were lower in the laparoscopic peritoneal lavage group. CONCLUSION: In the management of Hinchey 3 diverticulitis, laparoscopic peritoneal lavage does not result in excess morbidity or mortality, it reduces the length of hospital stay and avoids a stoma in most patients, and it is, therefore, a reasonable alternative to primary anastomosis with defunctioning stoma.

Video-assisted versus conventional tracheal intubation in morbidly obese patients.

BACKGROUND: We compared tracheal intubation characteristics and arterial oxygenation quality during airway management of morbidly obese patients whose trachea was intubated under video assistance with the LMA CTrach (SEBAC, Pantin, France) or the Airtraq laryngoscope (VYGON, Ecouen, France) with that of the conventional Macintosh laryngoscope. METHODS: After standardized induction of anesthesia, 318 morbidly obese patients scheduled for elective morbid obesity surgery received tracheal intubation with the LMA CTrach, the Airtraq laryngoscope, or the conventional Macintosh laryngoscope. Duration of apnea, time to tracheal intubation, and oxygenation quality during airway management were compared between the LMA CTrach and the laryngoscope groups. RESULTS: Patients' characteristics were similar in the three groups. The success rate for tracheal intubation was 100% with the LMA CTrach and the Airtraq laryngoscope. One patient of the Macintosh laryngoscope group received LMA CTrach intubation because of early arterial oxygen desaturation associated with unstable facemask ventilation. The duration of apnea was shorter with the LMA CTrach than that of the Airtraq laryngoscope and the Macintosh laryngoscope. The duration tracheal intubation was shorter with the Airtraq laryngoscope than with the Macintosh laryngoscopes and the LMA CTrach. During airway management, arterial oxygenation was of better quality with the LMA CTrach and the Airtraq laryngoscope than that of the Macintosh laryngoscope. CONCLUSION: Because LMA CTrach promoted short apnea time and the Airtraq laryngoscope allowed early definitive airway, both video-assisted tracheal intubation devices prevented most serious arterial oxygenation desaturation evidenced during tracheal intubation of morbidly obese patients with the conventional Macintosh laryngoscope.

Safety and long-term outcome of a new concept for surgical adhesion-reduction strategies (Prevadh): a prospective, multicenter study.

BACKGROUND/AIMS: No agent has been consistently effective in preventing formation of peritoneal adhesions and postoperative bowel obstruction after abdominal surgery. The aim of this prospective multicenter study was to assess clinical safety and efficiency of a new adhesion-reduction barrier METHODOLOGY: Between September 2000 and April 2001, Prevadh was used in 78 patients. Operative procedures included 25 hepatic resections, 7 cholecystectomies, 32 colonic resections, 7 protectomies, 3 colostomy or recovery of continuity, 1 gynaecologic surgery and 3 others. Eleven patients were operated on by laparoscopy and 67 by laparotomy. RESULTS: The overall incidence of abscesses and wound complications was 2.4% and 9% respectively. After a mean follow-up of 36 months (range: 4-51 months), no patients experienced adverse events related to the adhesion barrier. Surgical reoperative procedures were performed in 10 patients for unrelated causes and no bowel obstruction occurred within the protected area. CONCLUSIONS: This study confirmed the safety of Prevadh adhesion barrier and suggested that this resorbable barrier might provide prevention from adhesion formation on peritoneal injured surfaces. However, a large randomized controlled trial remains necessary to prove the real effectiveness of adhesion barriers on clinical long-term outcome.

Laparoscopic appendectomies: retrospective study of 2074 cases.

PURPOSE: To determine feasibility and safety of laparoscopic appendectomy (LA). PATIENTS: From January 1991 to June 2006, 2209 consecutive patients underwent appendectomy; for 2074 patients, appendectomy was performed laparoscopically. One thousand and fifty (53%) were women; mean age was 30.8 (11 to 96) years. Mean body mass index was 23.6 (18 to 58 kg/m2). Mean American Society of Anesthesiology score was 1.3 (I to III). RESULTS: Mean operating time was 52 minutes (15 to 200). Conversion to open appendectomy occurred for 84 patients (3.6%) mainly for acute or generalized peritonitis, abscess, or adhesion. Mean hospital stay was 3.75 (1 to 27) days. There was no mortality. Morbidity occurred in 4.5% of the patients: parietal (1.15%), peritoneal complications (1.1%), and others (2.25%). Additional interventions were required for 30 patients (1.5%) primarily for residual abscesses. In this study, 10.9% (n=226) of the specimens were considered normal by the pathologist. In 3.9% (77 cases), laparoscopy did not find any cause for nonspecific abdominal pain. In these cases, appendix was not removed. CONCLUSIONS: LA is technically feasible and safe. Diagnostic laparoscopy is recommended in cases suspicious for acute appendicitis. Laparoscopy permits a complete exploration of the abdominal cavity, helps to localize the appendix, allows for the eliminations of other diagnoses when the appendix is normal, and to facilitate a better peritoneal lavage in case of peritonitis. It is recommended to perform LA routinely in young women and obese. Although advantages of LA still need to be evaluated, in view of the excellent results, we have decided to perform it routinely. We also recommend not removing macroscopically normal appendices discovered during diagnostic laparoscopy for abdominal pain of unexplained origin.

Quality of life after laparoscopic gastric banding: Prospective study (152 cases) with a follow-up of 2 years.

To evaluate influence of laparoscopic gastric banding (LGB) on quality of life (QOL) in patients with morbid obesity. Laparoscopic adjustable gastric banding is a popular bariatric operation in Europe. The objectives of surgical therapy in patients with morbid obesity are reduction of body weight, and a positive influence on the obesity-related comorbidity as well the concomitant psychologic and social restrictions of these patients. In a prospective clinical trial, development of the individual patient QOL was analyzed, after LGB in patients with morbid obesity. From October 1999 to January 2001, 152 patients [119 women, 33 men, mean age 38.4 y (range 24 to 62), mean body mass index 44.3 (range 38 to 63)] underwent evaluation for LGB according the following protocol: history of obesity; concise counseling of patients and relative on nonsurgical treatment alternatives, risk of surgery, psychologic testing, questionnaire for eating habits, necessity of lifestyle change after surgery; medical evaluation including endocrinologic and nutritionist work-up, upper GI endoscopy, evaluation of QOL using the Gastro Intestinal Quality of Life Index (GIQLI). Decision for surgery was a multidisciplinary consensus. This group was follow-up at least 2 years, focusing on weight loss and QOL. Mean operative time was 82 minutes; mean hospital stay was 2.3 days and the mean follow-up period was 34 months. The BMI dropped from 44.3 to 29.6 kg/m and all comorbid conditions improved markedly: diabetes melitus resolved in 71% of the patients, hypertension in 33%, and sleep apnea in 90%. However, 26 patients (17%) had late complications requiring reoperation. Preoperative global GIQLI score was 95 (range 56 to 140), significant different of the healthy volunteers score (120) (70 to 140) P < 0.001. Correlated with weight loss (percentage loss of overweight and BMI), the global score of the group increased to 100 at 3 months, 104 at 6, 111 at 1 year to reach 119 at 2 years which is no significant different of healthy patients. Analyzing the subscale, physical condition, emotional status, and social integration increased significantly (P < 0.001) from preoperative to end of follow-up. Digestive symptoms were not modified. In case of failure of the procedure (10.5%) global Giqli score is not modified. Patients who have required successful revisional surgery for late complications (6.5%) have an excellent QOL outcome that are not different from the whole group. Together with a satisfactory reduction of the excess overweight, laparoscopic gastric banding may lead in a carefully selected population of patients with morbid obesity to a significant improvement of patient QOL, in at least 2 years follow-up.

Laparoscopic resection of low rectal cancer with a mean follow-up of seven years.

The role of laparoscopic surgery in the management of cancer of the rectum remains controversial. The main concern is the risk of port-site metastasis and neoplastic dissemination. The aim of this study was to evaluate prospectively 29 patients who underwent laparoscopic resection with total mesorectum excision for lower rectal carcinoma with a mean follow-up of 7 years. From January 1993 to December 1998, 29 patients with proven low (<10 cm from the anal verge) rectal cancer were operated by a laparoscopic approach. They were followed up at 1-, 3-, and then every 6-month intervals, postoperatively for an average of 7 years. Mean operative time was 157 +/- 46 minutes. The conversion rate was 13.7% (4 cases): 1 for tumor invasion of adjacent structures, 2 for inadequate margins of resection, and 1 for locally advanced cancer. First flatus occurred after 37.3 +/- 11.5 hours, and oral feeding started at 48.3 +/- 23 hours postoperatively. The length of the suprapubic incision for extraction of the specimen was 5.6 +/- 1.7 cm. Hospital stay was 7.2 +/- 3.0 days. There were no deaths. The morbidity rate was 14.8%. Length of the specimen, lateral and distal margins, and the number of lymph nodes resected were comparable to those of an open surgical approach. The average postoperative follow-up was 7 years (5-10 years). The late complication rate was 3.7%. There were no port-site metastases. Five-year recurrence rates were 0%, 22%, and 37% for Duke's A, B, and C cancers, respectively. The 5-year survival rate was 100% for Duke's A, 89% for B, and 50% for C. Laparoscopic resection for low rectal cancer with total mesorectum excision can be performed with the same oncologic principles, low morbidity, and long-term complications. Five-year survival and recurrence rates are comparable to those of open surgery.

[Laparoscopic resection of benign submucosal stomach tumors. A report of 65 cases]. / Exérèse laparoscopique des tumeurs sous-muqueuses bénignes de l'estomac. A propos de 65 cas.

AIM OF THE STUDY: The aim of this retrospective multicenter study was to evaluate the feasibility and the results of laparoscopic resection of benign submucosal gastric tumors. PATIENTS AND METHODS: We reviewed the cases of 65 patients (20 centers) who have been operated on laparoscopically for benign submucosal gastric tumors. The tumor was symptomatic in 56 cases, located on the posterior wall in 23 cases. The mean size of the tumor was 3.8 cm (1.5-10). RESULTS: A laparoscopic wedge resection was performed in 53 cases. In 1 case a laparoscopic-assisted gastrectomy was done. A conversion to laparotomy was mandatory in 11 cases because of difficulties in localization of the tumor (n=5), in excision (n=5) or for safety reasons (n=1). There was no mortality. Two patients required reoperation because of bleeding. During follow-up, one patient developed recurrence requiring a second laparoscopic excision. CONCLUSION: Most submucosal benign gastric tumors can be removed by laparoscopy. The location of the tumor (posterior wall or closed to the lesser curvature) or the size of the tumor (large or very small) can make the laparoscopic approach difficult.

Laparoscopic splenectomy for idiopathic thrombocytopenic purpura.

We conducted a retrospective multicenter study by questionnaire to evaluate the results of laparoscopic splenectomy for idiopathic thrombocytopenic purpura (ITP). Between 1991 and 1998, 209 patients with a mean age of 41.2 years (range, 10-83) had a laparoscopic splenectomy for idiopathic thrombocytopenic purpura. Preoperatively, 178 patients (85%) underwent medical treatment aimed at achieving a satisfactory platelet count. Twenty-nine patients were obese, with a body mass index greater than 30%, and 14% were HIV-seropositive. The so-called hanging spleen technique in the right lateral decubitus position was used most often. The average duration of surgery was 144 minutes (45-360). This was significantly longer in cases of conversion (170 minutes; P < 0.01). The factors influencing the duration of laparoscopy were operator experience and patient obesity (P < 0.01). A conversion was necessary in 36 cases (17.2%) because of hemorrhage. The conversion rate varied from 5.3% to 46.7%, depending on the surgical team. A multivariate analysis of factors disposing to conversion identified two causes: obesity and operator experience. One or more accessory spleens were found in 34 patients (16.2%). The average weight of the spleens was 194.2 g. There were no deaths. There were no complications in 187 patients (89.5%), with a mean hospital stay of 6.1 days. Patients who did not require a conversion had a significantly earlier return of intestinal transit, used less analgesic, and had a shorter length of hospitalization. Overall morbidity was 10.5% (22 cases), due to subphrenic collections (7 cases), abdominal wall complications (6 cases), re-intervention for actual or suspected hemorrhage or pancreatitis (3 cases), pneumopathology (2 cases) and others (4 cases). A multivariate analysis about morbidity shows a statistically significant difference in conversions (P < 0.05) but not in obesity or in surgeon's experience. Normal activity was achieved on average by the twentieth postoperative day--earlier if conversion was not required (18.4 versus 33.9 days). The average preoperative platelet count was 92.7 x 10(9)/L (range, 3 to 444). Twenty patients had a count of less than 30 x 10(9)/L and in this group the conversion rate was 30% (6 cases). Ninety-six patients were seen in the outpatient clinic, with an average follow-up time of 16.2 months (3 to 72 months), and the average platelet count was 242 x 10(9)/L (6 to 780). Eight patients (8.3%) were failures with a platelet count of <30 x 10(9)/L. In the 20 patients with a preoperative platelet count <30 x 10(9)/L, there were 3 early failures and 5 late relapses. There were 2 late deaths: chest infection at 3 months in an HIV seropositive patient and one case of pulmonary embolus at 6 months. Laparoscopic splenectomy constitutes a real alternative to conventional splenectomy for the treatment of idiopathic thrombocytopenic purpura. It is associated with fewer postoperative complications, a shorter duration of hospitalization and an earlier return to normal activity. The limiting factors are the experience of the operator and patient obesity. The long-term results are identical to those of conventional splenectomy, with a better than average success rate in patients that have failed preoperative medical treatment.

Laparoscopic versus open surgery for colorectal carcinoma: a prospective clinical trial involving 157 cases with a mean follow-up of 5 years.

The role of laparoscopic resection in the management of colorectal cancer is still unclear. It has been shown that laparoscopic colectomies can be accomplished with acceptable morbidity. Major concerns are port-site recurrences and neoplastic dissemination. The aims of this study were to compare perioperative results and long-term outcomes in a prospective, nonrandomized study of patients treated by laparoscopic versus open colorectal resection for cancer. In particular, the effects of an initial laparoscopic approach on survival and recurrence were examined. One hundred fifty-seven patients with colorectal carcinoma were included in the prospective trial: 74 underwent laparoscopic resection and 83 underwent conventional open surgery. The two groups were comparable in terms of characteristics, demographic data, stage of disease, and use of adjuvant or palliative chemoradiotherapy. All patients were observed at 1.3- and 6-month intervals. The median duration of follow-up was 60 months (range, 10-125 months). The mean operating time was significantly longer in the laparoscopic group. Six conversions (8.1%) were necessary. The passage of flatus and the restarting of oral intake (P = 0.0001) occurred earlier in the laparoscopic surgery group than in the open conventional surgery group. The mean postoperative stay was significantly shorter in the former group (P = 0.005), as was the length of the scar (P = 0.001). There were no deaths in either group. The overall morbidity was significantly lower (13% versus 33.7%; P = 0.001) in patients treated laparoscopically. No significant differences were observed between the groups in the length of specimens, the size of the tumor, or the number of nodes removed. Late complications were more frequent after open resection (12% versus 5.4%; P = 0.01). Two port-site metastases (2.6%) were seen in stage III and IV locally advanced carcinoma. There was no significant difference in recurrent disease between the groups (24.3% versus 25%) during the 60-month follow-up. Stage-for-stage comparisons showed that disease recurrence rates and crude death rates were comparable.