Hand-assisted laparoscopic surgery vs standard laparoscopic surgery for colorectal disease: a prospective randomized trial. HALS Study Group. Prospective randomized trial comparing conventional laparoscopic colectomy with hand-assisted laparoscopic colectomy: applicability, immediate clinical outcome, inflammatory response, and cost. Hand-assisted laparoscopic vs. laparoscopic colorectal surgery: a multicenter, prospective, randomized trial.
We compare the use of the HandPort(TM)device in hand-assisted laparoscopic surgery (HALS) to standard laparoscopic surgery (SLS) in the treatment of colorectal disease.
                A prospective, randomized, multicenter study was conducted with the participation of 10 advanced laparoscopic surgeons. Forty patients with indications for elective resection of benign colorectal disease or incurable malignant disease were randomized to one of the two treatment arms (22 HALS, 18 SLS). Main outcome measures included operative time, blood loss, HandPort(TM) performance, postoperative pain, time to oral intake, return of bowel function, length of stay, morbidity, and functional recovery.
                The patients in each group were similar with regard to age, sex, weight, diagnosis, coexisting medical disease, and preoperative functional status. Operative time was comparable for hand-assisted laparoscopy (152 +/- 66 min) and standard laparoscopy (141 +/- 54 min) (p = 0.58). Incision length for specimen extraction/bowel anastomosis was similar (HALS 7.4 cm vs SLS 7.0 cm). Three of 22 HALS cases (14%) were converted, as compared with four of 18 (22%) in the laparoscopy group (p = 0.68). Return of bowel function occurred by the 3rd postoperative day for the majority of patients in both groups (HALS 77%, SLS 78%). There was no difference in length of stay (HALS 7.0 days [range, 2-12] vs SLS 6.0 days [range, 2-10], p = 0.25). Severity of postoperative pain and rate of functional recovery were equivalent. One major complication occurred in each group. There were three wound infections in the laparoscopy group. No patient required reoperation, and there were no deaths.
                Hand-assisted laparoscopic surgery is safe and effective for benign and noncurative colorectal resection. As compared to standard laparoscopic surgery, hand-assisted laparoscopy retains the benefits of minimally invasive surgery and may allow the surgeon to perform complex operations more easily. Hand-assisted laparoscopic surgery (HALS) represents a useful alternative to conventional laparoscopic surgery (LS). Its potential advantages--(a quicker, safer procedure and less need to convert to open surgery) are due to the recovery of tactile feedback. However, HALS requires the performance of a mini-laparotomy when surgery commences, and the wound is stretched and compressed throughout the procedure. In addition, it is associated with a more intense manipulation of the intraabdominal viscera. All of these factors increase the surgical trauma, it is not known whether HALS maintains the minimally invasive characteristics of conventional LS. Therefore, we set out to study the applicability, immediate clinical outcome, inflammatory response, and cost of HALS compared with conventional LS using colectomy as a model.
                We performed a prospective randomized trial comparing laparoscopic-assisted colectomy with HAL colectomy. The aims of the study were to assess (a) perioperative features, including time, advantages, and conversion; (b) the patient's immediate clinical response, including recovery of bowel sounds, refeeding time, postoperative pain, local and general morbidity, and hospital stay; (c) the effect on the inflammatory response, using interleukin-6 (ILG) and C-reactive protein (CRP) measurements; (d) oncological issues, including intraoperative cytology and features of the specimen; and (d) the relative costs of the two procedures.
                A total of 54 patients were enrolled in the study, 27 laparoscopic and 27 HALS. The operative times were similar, but HALS was associated with a far lower conversion rate--7% vs 23%. Immediate clinical outcomes, oncological features, and costs were similar for the two procedures, but HALS was associated with a significantly greater increase in IL6 and CRP than the conventional laparoscopic procedure.
                This comparative study shows that HALS simplifies difficult intraoperative situations, reducing the need for conversion. Although it is a more aggressive procedure, HALS preserves the features of a minimally invasive approach, maintains all of the oncological features of conventional laparoscopic surgery, and does not increase the cost. HALS should therefore be considered as a useful adjunct when difficult situations arise during conventional laparoscopic colectomy. This study was designed to compare short-term outcomes after hand-assisted laparoscopic vs. straight laparoscopic colorectal surgery.
                Eleven surgeons at five centers participated in a prospective, randomized trial of patients undergoing elective laparoscopic sigmoid/left colectomy and total colectomy. The study was powered to detect a 30-minute reduction in operative time between hand-assisted laparoscopic and straight laparoscopic groups.
                There were 47 hand-assisted patients (33 sigmoid/left colectomy, 14 total colectomy) and 48 straight laparoscopic patients (33 sigmoid/left colectomy, 15 total colectomy). There were no differences in the patient age, sex, body mass index, previous surgery, diagnosis, and procedures performed between the hand-assisted and straight laparoscopic groups. Resident participation in the procedures was similar for all groups. The mean operative time (in minutes) was significantly less in the hand-assisted laparoscopic group for both the sigmoid colectomy (175 +/- 58 vs. 208 +/- 55; P = 0.021) and total colectomy groups (time to colectomy completion, 127 +/- 31 vs. 184 +/- 72; P = 0.015). There were no apparent differences in the time to return of bowel function, tolerance of diet, length of stay, postoperative pain scores, or narcotic usage between the hand-assisted laparoscopic and straight laparoscopic groups. There was one (2 percent) conversion in the hand-assisted laparoscopic group and six (12.5 percent) in the straight laparoscopic group (P = 0.11). Complications were similar in both groups (hand-assisted, 21 percent vs. straight laparoscopic, 19 percent; P = 0.68).
                In this prospective, randomized study, hand-assisted laparoscopic colorectal surgery resulted in significantly shorter operative times while maintaining similar clinical outcomes as straight laparoscopic techniques for patients undergoing left-sided colectomy and total abdominal colectomy.
Despite the limited number of trials performed, meta-analysis demonstrated a statistically significant decrease in conversion rates among the hand assisted group. There was no difference in operating time or perioperative complication rates.  Additional adequately powered and methodologically sound trials are needed to determine if there is a clinically important difference in perioperative outcomes.  Due to significant costs associated with the use of hand-assist devices, economic analyses are also warranted.