Laparoscopic-Assisted Versus Open Ileocolic Resection for Crohn's Disease: A Randomized Trial

Stefan Maartense, MD, PhD; Mich S. Dunker, MD, PhD; J Frederik M. Slors, MD, PhD; Miguel A. Cuesta, MD, PhD; Erik G. J. M. Pierik, MD, PhD; Dirk J. Gouma, MD, PhD; Daan W. Hommes, MD, PhD; Miriam A. Sprangers, MD, PhD; Willem A. Bemelman, MD, PhD

Disclosures

Annals of Surgery. 2006;243(2):143-149. 

In This Article

Discussion

This study presents the results obtained by the first multicenter prospective randomized controlled trial comparing laparoscopic-assisted versus open ileocolic resection in 60 patients with Crohn's disease. Potential advantages of laparoscopy, such as less morbidity, shorter hospital stay, and faster return to normal diet are discriminating parameters in this study in favor of laparoscopy. Since outcome parameters such as return to diet and hospital stay are very likely to be biased, QoL was chosen as the primary efficacy parameter. Restoration of QoL postoperatively was not different for the laparoscopic procedure compared with the open procedure as measured by the SF-36 and the GIQLI questionnaires. QoL decreased immediately after surgery, but levels were back at baseline levels after 2 weeks and had increased after 3 months.

The differences in QoL between the 2 groups were limited, while assuming that a 20% difference would be of clinical relevance.[19] The lack of significant differences between the 2 surgical approaches can be explained as follows: the SF-36 measures generic QoL; this questionnaire might not be specific for these patients. However, the GIQLI is disease specific, and this questionnaire did not show significant differences between the 2 approaches either. A second explanation might be that the assumption that a 20% difference in certain subscales as discriminating factor was wrong. At the start of the trial, this was thought to be acceptable for the power analysis. Nowadays, it is generally accepted that 10% difference is clinically significant. However, this depends on baseline levels, expected differences, the domain of interest, score distribution, etc. When looking at the results at 2 weeks after surgery, a difference of about 10% was found on the domains physical function, bodily pain, and social function. A larger sample size is probably required to make these figures significant. At 4 weeks and beyond, all possible differences had disappeared.

Thaler et al[20] obtained similar results in a nonrandomized study. No different results in QoL were found comparing laparoscopic and open colectomy for benign diseases, particularly not for long-term results.

Since open ileocolic resection was, at the start of this study, still considered the standard procedure, laparoscopy was only offered in context of this trial. This partly explains the high percentage of patient accrual in this trial. Other hospitals with sufficient institutional laparoscopic experience were asked to participate in this study, but some refused since they considered the laparoscopic approach as the preferred procedure. Therefore, only 3 centers included patients in this multicenter study.

The present study showed that laparoscopic ileocolic resection is feasible, with a low conversion rate, and acceptable operating times. Postoperative morphine requirement was less in the laparoscopic group, although not significantly, which can be explained by the limited sample size. Furthermore, the laparoscopic approach is safe in terms of postoperative morbidity, which was significantly lower compared with open surgery. This difference was mainly due to a higher rate of wound complications in the open group. These data are in accordance with those from the institutional randomized trial of Milsom et al.[13] The difference in postoperative stay was 2 days in favor of the laparoscopic approach. These figures must be interpreted carefully, since neither the patient nor the medical staff were blinded. Blinding the patient and medical staff for the type of procedure has been tried in a previous study, but was abandoned, since blinding turned out to be very difficult despite all measures to blind personnel and patients for the type of procedure. Although there were no restrictions with respect to advancement of diet and mobilization in both groups, nonblinding still might be a cause of bias in favor of the laparoscopic group.

Hospital stay as outcome parameter in studies comparing laparoscopy with open techniques has further been criticized since the implementation of fast track colon surgery protocols. The fast track multimodal perioperative care demonstrated that even after open segmental colonic resection patients can be discharged within 3 to 4 days after surgery.[21] However, fast track multimodal approach is demanding both for the patient and the medical staff, and has not been that successful in every hospital. Nevertheless, it is likely that fast track protocols will further reduce the difference in hospital stay between the open and laparoscopic approaches.[22]

One of the most obvious advantages of the laparoscopic approach is the improved cosmesis.[23] The preferred extraction site of the specimen was a transumbilical vertical incision. Since the incision was made right through the umbilicus, most of the scar disappeared in the shallow of the umbilicus. Sometimes it was not possible to extract the specimen through a small 4- to 5-cm incision due to the size of the inflammatory mass. In these cases, a Pfannenstiel incision was used to maintain the cosmetic advantages of the operation despite a relatively large extraction incision.

In this study, costs for the surgical procedure were significantly higher in the laparoscopic group (P < 0.001). However, overall costs (costs of surgical procedure, use of an operating theater, personnel, hospital stay, readmissions, and reoperations, etc.) were significantly lower for laparoscopy in comparison to open surgery (P = 0.042). The overall healthcare costs were calculated for the situation in the Academic Medical Hospital and might not be representative for other hospitals. In the literature, results of studies reporting costs for laparoscopic and open surgery are conflicting. Chapman et al[24] and Janson et al[25] concluded that laparoscopy was more expensive. However, in a review, Ballantyne[26] reported comparable costs, while Delaney et al[27] showed that costs for laparoscopic colorectal surgery were lower than for open surgery. Furthermore, Duepree et al[15] and Shore et al[16] have shown that the laparoscopic ileocolic resection was cheaper than the open resection in patients with Crohn's disease.

At present, there is no clear evidence yet with respect to other potential advantages of the laparoscopic approach such as an easier approach for a reresection, a lower rate of small bowel obstruction, or a lower rate of incisional hernias. The present study demonstrated that laparoscopic-assisted ileocolic resection is safe and cost-effective compared with open ileocolic resection for patients with primary Crohn's disease. Therefore, laparoscopy is the preferred approach treating distal ileitis in Crohn's disease provided the surgery is done by expert laparoscopists ensuring low conversion rates, acceptable operating times, and low morbidity.

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