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

Results

The trial flow diagram is shown in Figure 1. Between January 2000 and October 2003, 60 patients were operated according to the procedure allocated after randomization. In both groups, 4 patients refused to fill in the questionnaires after surgery. However, data such as return to diet, hospital stay, morbidity, and costs could be collected in these patients. Patient characteristics at baseline are presented in Table 1 ; there were no differences between the 2 groups. Results in terms of surgical parameters for the 2 procedures are shown in Table 2 . The operation time was significantly longer in the patients operated by laparoscopy (115 minutes) compared with the open procedure (90 minutes, P < 0.003).

Figure 1.

Trial flow diagram.

There was one conversion to an open procedure and 2 to a hand-assisted laparoscopic procedure (Omniport; Advanced Surgical Concepts Ltd., Wicklow, Ireland) due to a large inflammatory mass in the former, and extended disease in the latter two. There was no mortality. Twelve patients in the laparoscopic group and 11 patients in the open group had fistula to bladder, small bowel, or the colon, which were excised with an additional resection if necessary. Additional procedures were performed in 23% in the laparoscopic group and 17% in the open. One patient received a protecting loop ileostomy after laparoscopic ileocolic resection and sigmoidectomy because of ileosigmoidal fistula.

During the first 30 days after surgery, 3 patients had 4 complications in the laparoscopic group; 1 patient had a major complication viz. a prolonged ileus and a urinary tract infection. There were 2 other minor complications viz. pneumonia and a urinary tract infection.

In the open group, 10 patients had 12 complications in the first 30 days after surgery. Four patients had major complications, with or without a minor complication, 1 patient had a relaparotomy because of an intra-abdominal abscess that was not amenable for percutaneous drainage. The other 3 patients were treated conservatively: 2 patients had an ileus, and the third patient had an intra abdominal abscess. There were 8 minor complications in these 10 patients: 6 wound infections and 2 urinary tract infections. Four of the 6 patients with wound infection used steroids and/or immunosuppressive medication. The number of patients with morbidity within the first 30 days was different between the laparoscopic and open group (10% versus 33%; P = 0.028).

Hospital stay was significantly longer in the open group compared with the laparoscopic group; 7 days (range, 4-12 days) versus 5 days (range, 3-13 days) (P = 0.008).

All patients had adequate analgesia since the mean VAS was lower than 5 in rest. There were no significant differences in pain VAS scores in rest or while moving/coughing (Fig. 2). In the laparoscopic group, patients needed less morphine than in the open group according to registration with the PCA pump; however, this was not a significant difference. The median return to a normal diet did not differ between groups; however, overall laparoscopic patients returned to a normal diet faster (mean 3.8 days after laparoscopy versus 5.0 days after open surgery, P < 0.003) ( Table 3 ).

Figure 2.

Results of postoperative pain measured with VAS scores (mean ± 2 SEM). The x-axis represents the time when the VAS scores were taken after surgery. The gray bars represent the laparoscopic group; the black bars represent the open group.

The results of the SF-36 and the GIQLI questionnaire are shown in Figure 3. Preoperative QoL levels were not significantly different ( Table 4 ). No statistically significant difference was shown in QoL over time between the 2 surgical approaches. There was a decline in QoL over time on all scales of the SF-36 and total GIQLI-score in the first week. QoL returned to baseline levels after 2 weeks. Particularly during the first 2 weeks, slight differences were seen for physical function, bodily pain, and social function in favor of laparoscopy. However, these differences were not significant.

Figure 3.

Results of postoperative quality of life measured with SF-36 questionnaire for subscales physical function and bodily pain and the GIQLI questionnaire. The x-axis represents the time when the questionnaires were done, before and after surgery. The gray bars represent the laparoscopic group; the black bars represent the open group.

There was a significant time effect in both groups. QoL had improved in both groups during the 3-month follow-up compared with preoperative levels (SF-36, P < 0.001; and GIQLI, P < 0.001).

Costs of material used during the procedure were different for laparoscopy (€545), compared with the open procedure (€307). The difference could not be attributed to the use of disposables because they were rarely used. During a laparoscopic procedure 2 sets of instruments were used: an open and a laparoscopic set increasing the cleaning and sterilization costs.

The median costs for a laparoscopic assisted procedure were €1.103 (range, €885-€2.318) and for open surgery this was €744 (range, €453-€1.083; P < 0.001, Mann-Whitney U). Median overall costs, including relaparotomies, hospital stay, and readmission costs, were €6.412 (range, €4.195-€35.569) for the laparoscopic procedure and €8.196 (range, €4.964-€19.018) for the open procedure (P = 0.042, Mann-Whitney U).

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