A pilot randomized controlled trial comparing THUNDERBEAT to the Maryland LigaSure energy device in laparoscopic left colon surgery.

BACKGROUND: The THUNDERBEAT is a multi-functional energy device which delivers both ultrasonic and bipolar energy, but there are no randomized trials which can provide more rigorous evaluation of the clinical performance of THUNDERBEAT compared to other energy-based devices in colorectal surgery. The aim of this study was to compare the clinical performance of THUNDERBEAT energy device to Maryland LigaSure in patients undergoing left laparoscopic colectomy. METHODS: Prospective randomized trial with two groups: Group 1 THUNDERBEAT and Group 2 LigaSure in a single university hospital. 60 Subjects, male and female, of age 18 years and above undergoing left colectomy for cancer or diverticulitis were included. The primary outcome was dissection time to specimen removal (DTSR) measured in minutes from the start of colon mobilization to specimen removal from the abdominal cavity. Versatility (composite of five variables) was measured by a score system from 1 to 5 (1 being worst and 5 the best), and adjusted/weighted by coefficient of importance with distribution of the importance as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue manipulation 0.1. Other variables were: dryness of surgical field, intraoperative and postoperative complications, and mortality. Follow-up time was 30 days. RESULTS: 60 Patients completed surgery, 31 in Group 1 and 29 in Group 2. There was no difference in the DTSR between the groups, 91 min vs. 77 min (p = 0.214). THUNDERBEAT showed significantly higher score in dissecting and tissue manipulation in segment 3 (omental dissection), and in overall versatility score (p = 0.007) as well as versatility score in Segment 2 (retroperitoneal dissection p = 0.040) and Segment 3 (p = 0.040). No other differences were noted between the groups. CONCLUSIONS: Both energy devices can be employed effectively and safely in dividing soft tissue and sealing mesenteric blood vessels during laparoscopic left colon surgery, with THUNDERBEAT demonstrating some advantages over LigaSure during omental dissection and tissue manipulation. CLINICALTRIAL: gov # NCT02628093.

Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients.

OBJECTIVE: The purpose of this study was to identify patient, clinical, and surgical factors that may predispose patients to anastomotic leak (AL) after large bowel surgery. BACKGROUND: Anastomotic leak is still one of the most devastating complications following colorectal surgery. Knowledge about factors predisposing patients to AL is vital to its early detection, decision making for surgical time, managing preoperative risk factors, and postoperative complications. METHODS: This was a prospective observational, quality improvement study in a cohort of 616 patients undergoing colorectal resection in a single institution with the main outcome being AL within 30 days postoperatively. Some of the predictor variables were age, sex, Charlson Comorbidity Index (CCI), radiation and chemotherapy, immunomodulator medications, albumin, preoperative diagnoses, surgical procedure(s), surgical technique (laparoscopic vs open), anastomotic technique (staple vs handsewn), number of major arteries ligated at surgery, surgeon's experience, presence of infectious condition at surgery, intraoperative adverse events, and functional status using 36-Item Short Form General Health Survey. RESULTS: Of the 616 patients, 53.4% were female. The median age of the patients was 63 years and the mean body mass index was 25.9 kg/m. Of them, 80.3% patients had laparoscopic surgery and 19.5% had open surgery. AL occurred in 5.7% (35) patients. In multivariate analysis, significant independent predictors for leak were anastomoses less than 10 cm from the anal verge, CCI of 3 or more, high inferior mesenteric artery ligation (above left colic artery), intraoperative complications, and being of the male sex. CONCLUSIONS: Multiple risk factors exist that predispose patients to ALs. These risk factors should be considered before and during the surgical care of colorectal patients.

Rectal Prolapse Repair with Abdominal Fixation Under Sedation and Local or Epidural Anesthesia: Prospective Pilot Study in 10 Elderly Subjects.

Background: Rectal prolapse (RP) is primarily a disease of the elderly, where treatment may be associated with significant postoperative morbidity including that related to anesthesia. Objective: The aim of this study was to evaluate the safety and feasibility of a novel abdominal approach to RP repair under sedation and local anesthesia and to assess short- and long-term clinical outcomes in elderly patients (>70 years). Design Settings: This is a prospective pilot study with 10 patients using a novel RP repair. The anesthesia type was local or epidural with sedation. Follow-up was done at 30 days, 12, and 24 months. Patients: Patients were men and women >70 years of age with RP. Main Outcome Measures: (1) Feasibility: successful completion of RP repair using the novel abdominal approach with laparoscopic assistance. (2) Safety: safety was measured by the incidence of the intraoperative complications (bowel perforation, organ injury, and bleeding requiring blood transfusion). (3) Sedation and local anesthesia feasibility: surgery was safely completed without patient intubation. Results: Ten female patients >70 years of age underwent RP repair using the novel abdominal approach. General anesthesia was not required in any of the 10 patients. Two patients recurred within 6 months. One of the patients with recurrence of RP subsequently underwent laparoscopic rectopexy, and the other was minimal and required no further treatment. One mortality occurred at 3 months unrelated to the procedure. No other anesthetic or surgical intraoperative and postoperative complications were observed. Limitations: This is a single-institution pilot study. Conclusions: Abdominal RP repair under sedation and regional anesthesia appears feasible and safe in elderly patients and may, in the future, provide an effective alternative to current treatment options for RP, avoiding general anesthesia. ClinicalTrial.gov registration number: NCT01980043.