New Perspectives in Endoscopic Treatment of Gastroesophageal Reflux Disease.

Gastroesophageal reflux disease has a high incidence and prevalence in the general population. Clinical manifestations are heterogenous, and so is the response to medical treatment. Proton pump inhibitors are still the most common agents used to control reflux symptoms and for healing esophagitis, but they are not a one-size-fits-all solution for the disease. Patients with persistent troublesome symptoms despite medical therapy, those experiencing some adverse drug reaction, or those unwilling to take lifelong medications deserve valid alternatives. Anti-reflux Nissen fundoplication is an effective option, but the risk of adverse events has limited its spread. In recent years, advancements in therapeutic endoscopy have been made, and three major endoluminal alternatives are now available, including (1) the delivery of radiofrequency energy to the esophago-gastric junction, (2) transoral incisionless fundoplication (TIF), and (3) anti-reflux mucosal interventions (ARMI) based on mucosal resection (ARMS) and mucosal ablation (ARMA) techniques to remodel the cardia. Endoscopic techniques have shown interesting results, but their diffusion is still limited to expert endoscopists in tertiary centers. This review discusses the state of the art in the endoscopic approach to gastroesophageal reflux disease.

Risk factors for recurrence and complications after laparoscopic repair of incisional hernia using a double-layered ePTFE/PP mesh: results of a retrospective study.

BACKGROUND: The objective was to analyse, risk factors for recurrence (primary outcome) and complications (secondary outome) after the implantation of a double layer ePTFE (expanded PolytTetraFluoroEthylene) / PP (PolyPropylene) mesh to treat incisional hernias (IH) using the Intraperitoneal Onlay Mesh (IPOM) technique. METHODS: We included all elective laparoscopic IH repairs with intraperitoneal placement of a ePTFE / PP mesh (Relimesh® - Herniamesh S.r.l.) from January 1, 2010 to December 31, 2017 at Humanitas Mater Domini Clinical Institute in Castellanza (Italy) and at the Centre for Minimally Invasive Surgery of Nis (Serbia). Performance was defined as long-term recurrence rate. RESULTS: A total of 284 patients were enrolled. According to the European Hernia Society (EHS) hernias were classified as: W1 (<4 cm) 60.29%, W2 (≥4-10 cm) 35.02% and W3 (≥10 cm) 4.69%; medial 90.85%, lateral 6.69%, both medial and lateral 2.11%. Average follow-up was 48 (11-110) months. The 30-days complication rate was 4.23%. Hernia recurrence rate was 3.36%. Long-term complication rate was 6.34%. At multivariable analysis, an increased risk of short-term complications was associated to chronic obstructive pulmonary disease (COPD) (OR 7.59 [2.23-25.83], P=0.001); an increased risk of long-term complications was associated to diabetes (OR 6.21 [1.80-21.42], P=0.004), an increased risk of recurrence was correlated to COPD (OR 13.40 [1.36-131.9], P=0.026) and hernia defects larger than 6 cm (OR 19.2 [1.12-329.9], P=0.042). CONCLUSIONS: Elective laparoscopic IH repair with a double-layered ePTFE/PP mesh is safe and effective. Compliance with indications and preoperative patients evaluation are essential to improve outcomes.

5 year oncological outcomes of the HIGHLOW randomized clinical trial.

INTRODUCTION: The oncological outcomes of low ligation (LL) compared to high ligation (HL) of the inferior mesenteric artery (IMA) during low-anterior rectal resection (LAR) with total mesorectal excision are still debated. The aim of this study is to report the 5 year oncologic outcomes of patients undergoing laparoscopic LAR with either HL vs. LL of the IMA MATERIALS AND METHODS: Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian non-academic hospitals were randomized to HL or LL of IMA after meeting the inclusion criteria (HighLow trial; ClinicalTrials.gov Identifier NCT02153801). We analyzed the rate of local recurrence, distant metastasis, overall survival, disease-specific survival, and disease-free survival at 5 years of patients previously enrolled. RESULTS: Five-year follow up data were available for 196 patients. Recurrence happened in 42 (21.4%) of patients. There was no statistically significant difference in the distant recurrence rate (15.8% HL vs. 18.9% LL; P = 0.970) and pelvic recurrence rate (4,9% HL vs 3,2% LL; P = 0.843). No statistically significant difference was found in 5-year OS (p = 0.545), DSS (p = 0.732) or DFS (p = 0.985) between HL and LL. Low vs medium and upper rectum site of tumor, conversion rate, Clavien-Dindo post-operative grade ≥3 complications and tumor stage were found statistically significantly associated to poor oncological outcomes in univariate analysis; in multivariate analysis, however, only conversion rate and stage 3 cancer were found to be independent risk factors for poor DFS at 5 years. CONCLUSION: We confirmed the results found in the previous 3-year survival analysis, the level of inferior mesenteric artery ligation does not affect OS, DSS and DFS at 5-year follow-up.

Multimodal treatment of colorectal postsurgical leaks: long-term results of the over-the-scope clip (OTSC) application.

BACKGROUND: Postsurgical anastomotic colorectal leaks often require a surgical second look with a definite morbidity and the risk of delaying adjuvant treatment. The aim of this study was to analyse the long-term results of the endoscopic closure of colorectal leak following low anterior resection (LAR) using the over-the-scope (Ovesco™; Ovesco Endoscopy AG, Tübingen, Germany) clip. METHODS: Patients who were submitted to endoscopic closure of a colorectal leak of maximum 2 cm with an Ovesco™ clip following LAR from 2016 to 2018 were enrolled in this retrospective single-center study (Humanitas Mater Domini Clinical Institute, Italy). The follow-up was obtained through radiologic and clinic assessments. RESULTS: In the analyzed study period, 48 patients were submitted to LAR. Six patients were enrolled in the study. The median diameter of the leak was 7 mm. 14/6t or 12/6t OTSC® clip was applied. Three patients were managed exclusively endoscopically, 2 of them had a protective ileostomy; 3 patients underwent urgent laparotomy with ostomy and then underwent endoscopic procedure. Complete healing was reached in all patients in a median of 23 days. Adjuvant chemotherapy was indicated and performed in 4 patients after a median of 64 days from the surgery. Among the 5 carriers of an ostomy, 4 patients underwent recanalization. The median follow-up was 21.5 months. During the follow-up no leak reoccurrence or complications were reported. CONCLUSIONS: In the multimodal management of anastomotic leaks following LAR, Ovesco™ clipping system appears a safe and effective technique in the closure of small leaks (<2 cm), allowing an early recanalization of the bowel and not delaying adjuvant chemotherapy when indicated.

High Versus Low Ligation of the Inferior Mesenteric Artery During Rectal Resection for Cancer: Oncological Outcomes After Three Years of Follow-Up From the HIGHLOW Trial.

Objectives: To determine the disease-free survival (DFS), disease-specific survival (DSS), and recurrence in patients who underwent laparoscopic low anterior rectal resection with total mesorectal excision (TME) with either high or low ligation of the inferior mesenteric artery (IMA). Background: The level of IMA ligation during anterior rectal resection with TME is still a matter of debate, especially in terms of oncological adequacy. Methods: Between June 2014 and December 2016, patients scheduled to undergo elective laparoscopic low anterior resection (LAR) and TME in 6 Italian nonacademic hospitals were randomized into 2 groups in the HIGHLOW Trial (ClinicalTrials.gov Identifier: NCT02153801) according to the level of IMA ligation: high ligation (HL) versus low ligation (LL). DFS, DSS, and recurrence were inquired. Recurrence was determined at 3, 6, 9, and 12 months and every 6 months thereafter. Patients and tumor characteristics as well as surgical outcomes were analyzed to identify risk factors for recurrence. Results: One hundred ninety-six patients from the HIGHLOW trial were analyzed. Median follow-up for DFS was 40.6 (interquartile range [IQR], 6-64.7) and 40 (IQR, 7.6-67.8), while median follow-up for DSS was 41.2 (IQR, 10.7-64.7) and 42.7 (IQR, 6-67.6) in the HL and LL groups, respectively. The 3-year DFS rate of HL and LL patients was 82.2% and 82.1% (P = 0.874), respectively. The 3-year DSS for HL and LL patients was 92.1% and 93.4% (P = 0.897), respectively. There was no statistically significant difference in the local recurrence rate (2% HL vs 2.1% LL), in the regional recurrence rate (3% HL vs 2.1% LL), and in the distant recurrence rate (12.9% HL vs 13.7% LL). Multivariate analysis found conversion to open surgery (hazard ratio [HR], 3.68; P = 0.001) and higher stage of disease (HR, 7.73; P < 0.001) to be significant determinant for DFS. Conclusions: The level of inferior mesenteric artery ligation during LAR and TME for rectal cancer does not affect DFS, DSS, and recurrence.

Low Ligation of Inferior Mesenteric Artery in Laparoscopic Anterior Resection for Rectal Cancer Reduces Genitourinary Dysfunction: Results From a Randomized Controlled Trial (HIGHLOW Trial).

OBJECTIVES: The aim of the present study was to compare the incidence of genitourinary (GU) dysfunction after elective laparoscopic low anterior rectal resection and total mesorectal excision (LAR + TME) with high or low ligation (LL) of the inferior mesenteric artery (IMA). Secondary aims included the incidence of anastomotic leakage and oncological outcomes. BACKGROUND: The criterion standard surgical approach for rectal cancer is LAR + TME. The level of artery ligation remains an issue related to functional outcome, anastomotic leak rate, and oncological adequacy. Retrospective studies failed to provide strong evidence in favor of one particular vascular approach and the specific impact on GU function is poorly understood. METHODS: Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian nonacademic hospitals were randomized to high ligation (HL) or LL of IMA after meeting the inclusion criteria. GU function was evaluated using a standardized survey and uroflowmetric examination. The trial was registered under the ClinicalTrials.gov Identifier NCT02153801. RESULTS: A total of 214 patients were randomized to HL (n = 111) or LL (n = 103). GU function was impaired in both groups after surgery. LL group reported better continence and less obstructive urinary symptoms and improved quality of life at 9 months postoperative. Sexual function was better in the LL group compared to HL group at 9 months. Urinated volume, maximum urinary flow, and flow time were significantly (P < 0.05) in favor of the LL group at 1 and 9 months from surgery. The ultrasound measured post void residual volume and average urinary flow were significantly (P < 0.05) better in the LL group at 9 months postoperatively. Time of flow worsened in both groups at 9 months compared to baseline. There was no difference in anastomotic leak rate (8.1% HL vs 6.7% LL). There were no differences in terms of blood loss, surgical times, postoperative complications, and initial oncological outcomes between groups. CONCLUSIONS: LL of the IMA in LAR + TME results in better GU function preservation without affecting initial oncological outcomes. HL does not seem to increase the anastomotic leak rate.

Management and Outcomes of Pancreatic Resections Performed in High-Volume Referral and Low-Volume Community Hospitals Lead by Surgeons Who Shared the Same Mentor: The Importance of Training.

BACKGROUND: High hospital volume improves outcomes after pancreatic resection. The aim of this study was to assess if practice and outcomes differed between high- and low-volume centers across which chief surgeons shared a similar training and mentoring. METHODS: Data on patients undergoing standard pancreatic resections (2010-2013) at 7 Italian hospitals were collected. Chiefs of pancreatic surgery at each hospital had received the same training, with the same mentor. Two centers were high-volume referral hospitals for pancreatic disease, while 5 were low-volume hospitals. RESULTS: A total of 856 patients were included, with median annual volume of resections 82 at high-volume referral hospitals and 11 at low-volume hospitals. Patients at low-volume hospitals were older, had more comorbidities, and were more often referred from the emergency room. Intraoperative techniques and reconstruction methods were similar. Comparable rates of major postoperative complications (18 vs. 22%; p = 0.236) and pancreatic fistula (29 vs. 32%; p = 0.287) were achieved in both groups, with no significant increases in failure to rescue from grade B-C fistula (6.2 vs. 15.0%; p = 0.108) and mortality (2.4 vs. 4.1%; p = 0.233) in low-volume hospitals. Postoperative length of stay was shorter in high-volume referral hospitals (10 vs. 15 days; p < 0.001). CONCLUSION: Similar postoperative outcomes can be achieved across high- and low-volume centers where chief surgeons shared a similar training and mentoring. However, multidisciplinary postoperative provision more often associated with high-volume centers may also affect outcomes.

Ten-year outcomes following laparoscopic colorectal resection: results of a randomized controlled trial.

PURPOSE: To evaluate the impact of laparoscopy compared to open surgery on long-term outcomes in a large series of patients who participated in a randomized controlled trial comparing short-term results of laparoscopic (LPS) versus open colorectal resection. METHODS: This is a retrospective review of a prospective database including 662 patients with colorectal disease (526, 79 % cancer patients) who were randomly assigned to LPS or open colorectal resection and followed every 6 months by office visits. The primary endpoint of the study was long-term morbidity. Secondary outcomes included 10-year overall, cancer-specific, and disease-free survivals. All patients were analyzed on an intention-to-treat basis. RESULTS: Fifty-eight (8.8 %) patients were lost to follow-up. Median follow-up was 131 (IQR 78-153) months in the LPS group and 126 (IQR 52-152) months in the open group (p = 0.121). Overall, long-term morbidity rate was 11.8 % (36/309) in the LPS versus 12.6 % (37/295) in the open group (p = 0.770). Incisional hernia rate was 5.8 % (18/309) in the LPS group versus 8.1 % (24/295) in the open group (p = 0.264). Adhesion-related small-bowel obstruction occurred in five (1.6 %) patients in the LPS versus four (1.4 %) patients in the open group (p = 1.000). In 497 cancer patients, 10-year overall survival was 45.3 % in the LPS group and 40.9 % in the open group (p = 0.160). No difference was found in cancer-specific and disease-free survivals, also when patients were stratified according to cancer stage. CONCLUSION: In this series, LPS colorectal resection was not associated with a lower long-term morbidity rate when compared to open surgery. Overall, cancer-specific and disease-free survivals were similar in cancer patients who were treated with LPS and open surgeries.

Results of 100 consecutive laparoscopic distal pancreatectomies: postoperative outcome, cost-benefit analysis, and quality of life assessment.

BACKGROUND: Laparoscopic distal pancreatectomy (LDP) has been recently proposed as the procedure of choice for lesions of the pancreatic body and tail in experienced centres. The purpose of this study is to assess the potential advantages of LDP in a consecutive series of 100 patients. METHODS: Propensity score matching was used to identify patients for comparison between LDP and control open group. Match criteria were: age, gender, ASA score, BMI, lesion site and size, and malignancy. All patients were treated according to an early feeding recovery policy. Primary endpoint was postoperative morbidity rate. Secondary endpoints were operative time, blood transfusion, length of hospital stay (LOS), hospital costs, and quality of life. RESULTS: Thirty patients of the LDP group had pancreatic adenocarcinoma. Conversion to open surgery was necessary in 23 patients. Mean operative time was 29 min shorter in the open group (p = 0.002). No significant difference between groups was found in blood transfusion rate and postoperative morbidity rate. LDP was associated with an early postoperative rehabilitation and a shorter LOS in uneventful patients. Economic analysis showed 775 extra cost per patient of the LDP group. General health perception and vitality were better in the LDP group one month after surgery. CONCLUSION: Laparoscopic distal pancreatectomy improved short-term postoperative recovery and quality of life in a consecutive series of both cancer and non-cancer patients. Despite the extra cost, the laparoscopic approach should be considered the first option in patients undergoing distal pancreatectomy.

Long-term outcomes after laparoscopic colectomy.

AIM: To evaluate long-term outcomes in a large series of patients who randomly received laparoscopic or open colorectal resection. METHODS: From February 2000 to December 2004, six hundred sixty-two patients with colorectal disease were randomly assigned to laparoscopic (LPS, n = 330) or open (n = 332) colorectal resection. All patients were analyzed on an intention-to-treat basis. Long-term follow-up was carried out every 6 mo by office visits. In 526 cancer patients five-year overall and disease-free survival were evaluated. Median oncologic follow-up was 96 mo. RESULTS: Eight (4.2%) LPS group patients needed conversion to open surgery. Overall long-term morbidity rate was 7.6% (25/330) in the LPS vs 11.1% (37/332) in the open group (P = 0.17). In cancer patients, five-year overall survival was 68.6% in the LPS group and 64.0% in the Open group (P = 0.27). Excluding stage IV patients, five-year local and distant recurrence rates were 32.5% in the LPS group and 36.8% in the Open group (P = 0.36). Further, no difference in recurrence rate was found when patients were stratified according to cancer stage. CONCLUSION: LPS colorectal resection was associated with a slightly lower incidence of long-term complications than open surgery. No difference between groups was found in overall and disease-free survival rates.

Benefits of laparoscopic colorectal resection are more pronounced in elderly patients.

PURPOSE: The purpose of this study was to evaluate the impact of laparoscopic colorectal resection on short-term postoperative outcome in elderly patients. METHODS: A series of 535 patients with colorectal disease who had been randomly assigned to laparoscopic (n=268) or open (n=267) resection was analyzed. A total of 201 patients (37.6 percent) were elderly (aged 70 years or older) and 334 patients (62.4 percent) were younger than aged 70 years. Follow-up for postoperative morbidity was performed for 30 days after hospital discharge. RESULTS: Elderly patients had a higher American Society of Anesthesiologists score compared with younger patients in both the laparoscopic and open groups (P=0.0001). In the open group, elderly patients had higher morbidity rate (37.5 vs. 23.9 percent; P=0.02) and longer length of hospital stay (13 vs. 10.6; P=0.007) compared with younger patients. In the laparoscopic group, morbidity rate (20.2 vs. 15.1 percent) and length of hospital stay (9.5 vs. 9.1) were similar in elderly and younger patients. In elderly patients, the laparoscopy-reduced morbidity rate (20.2 vs. 37.5 percent; P=0.01) and length of hospital stay (9.5 vs. 13; P=0.001) compared to the open approach. In younger patients, the advantages of the laparoscopic approach on morbidity rate (15.1 vs. 23.9 percent; P=0.06) and length of stay (9.1 vs. 10.6; P=0.004) were less pronounced. CONCLUSIONS: Laparoscopy improved short-term postoperative outcome more in elderly than in younger patients. Advanced age was associated with higher morbidity and longer length of stay only in patients who underwent open colorectal surgery.

Open right colectomy is still effective compared to laparoscopy: results of a randomized trial.

OBJECTIVE: The primary goal of this study was to clarify whether a laparoscopic (LPS) approach could be considered the dominant strategy in patients undergoing right colectomy. SUMMARY BACKGROUND DATA: Because few nonrandomized or small sized studies have been carried out so far, definitive conclusions about the role of LPS right colectomy cannot be drawn. METHODS: Two hundred twenty-six patients, candidates for right colectomy, were randomly assigned to LPS (n = 113) or open (n = 113) resection. The postoperative care protocol was the same for both groups. Trained members of the surgical staff who were not involved in the study registered postoperative morbidity. Follow-up was carried out for 30 days after hospital discharge. The following costs were calculated: surgical instruments, operative room occupation, routine care, postoperative morbidity, and hospitalization. RESULTS: Conversion rate in the LPS group was 2.6% (3 of 113). Operative time (in minutes) was longer in the LPS group (131 vs. 112, P = 0.01). Postoperative morbidity rate was 18.6% in the open group and 13.3% in the LPS group (P = 0.31). Postoperative stay was one day longer in the open group (P = 0.002). No difference was found in postoperative quality of life. The additional operative charge in the LPS group was euro980 per patient randomized (euro821 for surgical instruments and euro159 for longer operative time). The savings in the LPS group was euro390 per patient randomized (euro144 for shorter length of hospital stay and euro246 for the lower cost of postoperative morbidity). The net balance resulted in a euro590 extra charge per patient randomly allocated to the LPS group. CONCLUSION: LPS slightly improved postoperative recovery. This translated into a savings that covered only 40% of the extra operative charge. Therefore, open right colectomy could be still considered an effective procedure.

Laparoscopic resection in rectal cancer patients: outcome and cost-benefit analysis.

PURPOSE: This study was designed to evaluate the impact of laparoscopic rectal resection on short-term postoperative morbidity and costs. METHODS: A total of 168 patients with rectal cancer were randomly assigned to laparoscopic (n = 83) or open (n = 85) resection. Outcome parameters were: postoperative morbidity, length of hospital stay, quality of life, long-term survival, and local recurrences. The mean follow-up period was 53.6 months. Cost-benefit analysis was based on hospital costs. RESULTS: Operative time was 53 minutes longer in the laparoscopic group (P < 0.0001). Postoperative morbidity rate was 28.9 percent in the laparoscopic vs. 40 percent in the open group (P = 0.18). The mean length of hospital stay was 10 (4.9) days in the laparoscopic group and 13.6 (10) days in the open group (P = 0.004). Local recurrence rate and five-year survival were similar in both groups; however, the limited number of patients does not allow firm conclusions. Quality of life was better in the laparoscopic group only in the first year after surgery (P < 0.0001). The additional charge in the laparoscopic group was $1,748 per patient randomized ($1,194 the result of surgical instruments and $554 the result of longer operative time). The saving in the laparoscopic group was $1,396 per patient randomized ($647 the result of shorter length of hospital stay and $749 the result of the lower cost of postoperative complications). The net balance resulted in $351 extra cost per patient randomly allocated to the laparoscopic group. CONCLUSIONS: Short-term postoperative morbidity was similar in the two groups. Laparoscopic resection reduced length of hospital stay, improved first-year quality of life, and slightly increased hospital costs.

Laparoscopic versus open colorectal surgery: cost-benefit analysis in a single-center randomized trial.

SUMMARY BACKGROUND DATA: Studies comparing the costs of colorectal resection by laparoscopic (LPS) and open approaches are small sized or not randomized. The main purpose of this study is to compare the hospital costs of LPS and open colorectal surgery in a large series of randomized patients. METHODS: A total of 517 patients with colorectal disease were randomly assigned to LPS (n = 258) or open (n = 259) resection. The following costs were calculated: surgical instruments, operative room (OR) occupation, routine care, postoperative morbidity, and length of hospital stay (LOS). Follow-up for postoperative morbidity was carried out for 30 days after hospital discharge. RESULTS: Operative time was 37 minutes longer in the LPS group. Overall morbidity rate was 18.2% (47 of 258) in the LPS versus 34.7% (90 of 259) in the open group (P = 0.0005). The mean LOS was 9.9 (2.6) days in the LPS group and 12.4 (3.9) days in the open group (P < 0.0001). The additional OR charge in the LPS group was 1171 per patient randomized (864 due to surgical instruments and 307 due to longer time). The saving in the LPS group was 1046 per patient randomized (401 due to shorter LOS and 645 due to the lower cost of postoperative complications). The net balance resulted in 125 extra cost per patient allocated to the LPS group. CONCLUSIONS: The present cost-benefit analysis showed a slight additional cost in the LPS group. The better postoperative short-term outcome in patients receiving LPS had a key role to nearly balance the operative room charges due to laparoscopy.

Laparoscopic vs. open colectomy in cancer patients: long-term complications, quality of life, and survival.

PURPOSE: This study was designed to evaluate long-term complications, quality of life, and survival rate in a series of colorectal cancer patients randomized to laparoscopic or open surgery. METHODS: A total of 391 patients with colorectal cancer were randomly assigned to laparoscopic (n = 190) or open (n = 201) resection. Long-term follow-up was performed every six months by office visits. Quality of life was assessed at 12, 24, and 48 months after surgery by a modified version of Short Form 36 Health Survey questionnaire. All patients were analyzed on an intention-to-treat basis. RESULTS: Eight (4.2 percent) laparoscopic group patients needed conversion to open surgery. Overall long-term morbidity rate was 6.8 percent (13/190) in the laparoscopic vs. 14.9 percent (30/201) in the open group (P = 0.018). Overall quality of life was significantly better in the laparoscopic group in the first 12 months after surgery, whereas at 24 months, patients of the laparoscopic group reported a significant advantage only in social functioning. No difference was found in both overall and disease-free survival rates by comparing laparoscopic vs. open group. CONCLUSIONS: Laparoscopic colorectal resection was associated with a lower incidence of long-term complications and a better quality of life in the first 12 months after surgery compared with open surgery. No difference between groups was found in overall and disease-free survival rates.

Laparoscopic colorectal surgery modifies risk factors for postoperative morbidity.

PURPOSE: The aim of this study was to evaluate whether laparoscopic colorectal surgery can modify the risk factors for the occurrence of postoperative morbidity. METHODS: A total of 384 consecutive patients with colorectal disease were randomized to laparoscopic resection (n = 190) or open resection (n = 194). On admission, demographics, comorbidity, and nutritional status were recorded. Operative variables, patient outcome, and length of stay were also recorded. Postoperative complications were registered by four members of staff not involved in the study. RESULTS: The overall morbidity rate was 27.1 percent, with the rate in the laparoscopic group (18.7 percent) being less than that in the open group (31.5 percent; P = 0.003). Patients who underwent laparoscopic resection had a faster recovery of bowel function (P = 0.0001) and a shorter length of stay (P = 0.0001). In the whole cohort of patients, multivariate analysis identified open surgery (P = 0.003), duration of surgery (P = 0.01), and homologous blood transfusion (P = 0.01) as risk factors for postoperative morbidity. In the open group, blood loss (P = 0.01), homologous blood transfusion (P = 0.01), duration of surgery (P = 0.009), weight loss (P = 0.06), and age (P = 0.08) were related to postoperative morbidity. In the laparoscopic group the only risk factor identified was duration of surgery (P = 0.005). CONCLUSION: In the laparoscopic group, both postoperative morbidity and length of stay were significantly reduced and most risk factors for postoperative morbidity disappeared.

Laparoscopic versus open colorectal surgery: a randomized trial on short-term outcome.

OBJECTIVE: The primary endpoint was to compare the impact of laparoscopic and open colorectal surgery on 30-day postoperative morbidity. Lymphocyte proliferation to mitogens and gut oxygen tension were surrogate endpoints. SUMMARY BACKGROUND DATA: Evidence-based proof of the effect of laparoscopic colorectal surgery on immunometabolic response and clinically relevant outcome variables is scanty. Further randomized trials are desirable before proposing laparoscopy as a superior technique. METHODS: Two hundred sixty-nine patients with colorectal disease were randomly assigned to laparoscopic (n = 136) or open (n = 133) colorectal resection. Four trained members of the surgical staff who were not involved in the study registered postoperative complications. Lymphocyte proliferation to Candida albicans and phytohemagglutinin was evaluated before and 3 and 15 days after surgery. Operative gut oxygen tension was monitored continuously by a polarographic microprobe. RESULTS: In the laparoscopic group the conversion rate was 5.1%. The overall morbidity rate was 20.6% in the laparoscopic group and 38.3% in the open group. Postoperative infections occurred in 15 of the 136 patients in the laparoscopic group and 31 of the 133 patients in the open group. The mean length of hospital stay was 10.4 +/- 2.9 days in the laparoscopic group and 12.5 +/- 4.1 days in the open group. On postoperative day 3, lymphocyte proliferation was impaired in both groups. Fifteen days after surgery, the proliferation index returned to baseline values only in the laparoscopic group. Intraoperative gut oxygen tension was higher in the laparoscopic than in the open group. CONCLUSIONS: Laparoscopic colorectal surgery resulted in a significant reduction of 30-day postoperative morbidity. Lymphocyte proliferation and gut oxygen tension were better preserved in the laparoscopic group than in the open group.

Metabolic and functional results after laparoscopic colorectal surgery: a randomized, controlled trial.

PURPOSE: This study was designed to compare metabolic and functional results after laparoscopic and open colorectal resection. METHODS: Seventy-nine patients were randomly assigned to laparoscopic (n = 40) or open (n = 39) colorectal resection. Before and after operation, the following parameters were determined: respiratory function (spirography and blood gas); serum level of cortisol, lactate, and C-reactive protein; total lymphocyte count; and CD4 and CD8 lymphocyte subsets. Intraoperative core temperature was measured by a bladder probe. Postoperative pain and analgesic consumption were also monitored. RESULTS: Mild operative hypothermia, a trend to postoperative reduction of total lymphocyte count, and significant impairment of respiratory function early after surgery were found in both groups. Laparoscopy showed a higher CD4/CD8 ratio (P = 0.01) on postoperative Day 1 and a faster return of C-reactive protein to preoperative values (P = 0.01) than in the open colorectal resection group. Morphine consumption in the first 48 hours after surgery was lower in the laparoscopic than in the open group (P = 0.02). CONCLUSIONS: Laparoscopy was associated with a less pronounced immunosuppression and inflammatory response and a lower consumption of analgesic drugs than open surgery. Moreover, our data did not show any additional detrimental effect of laparoscopy on either operative core temperature or early postoperative respiratory function.