Hand-assisted laparoscopic surgery vs standard laparoscopic surgery for colorectal disease: a prospective randomized trial. HALS Study Group.

摘要

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.