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

Patients and Methods

Patients eligible for an elective ileocolic resection for Crohn's disease were included in a randomized 3-center trial (Academic Medical Center and VU University Medical Center, Amsterdam; and the Isala Clinics, Zwolle). All procedures were done by or supervised by colorectal and/or laparoscopic surgeons having sufficient experience in open and laparoscopic approach (at least 20 laparoscopic ileocolic and/ or right colectomies).

All patients had small bowel series and colonoscopy to establish the diagnosis Crohn's disease in the terminal ileum plus or minus the cecum and to rule out Crohn's disease in the remaining large bowel. When suspected, either an ultrasound or CT scan was performed to diagnose and treat abscesses.

Inclusion criteria were patients with Crohn's disease scheduled for an elective procedure and age above 16 years. Exclusion criteria were a fixed palpable inflammatory mass prior to surgery, prior median laparotomy, earlier bowel resection, or pregnancy. Patients were asked to participate in this study in the outpatient department. After informed consent was obtained and after completing preoperative QoL questionnaires, patients were randomized. Patients were allocated to one of the 2 groups using sealed envelope randomization. Randomization was performed by an independent research fellow in the Academic Medical Center Amsterdam. The study was approved by the Medical Ethical Committee of all the participating centers.

Operative Procedures

Patients were preoperatively prepared with anterograde intestinal cleansing (Klean Prep). Surgery was performed under general anesthesia. Patients received antibiotics according to hospital protocol for 24 hours.

Laparoscopic-Assisted Ileocolic Resection

Patients were placed in the French position. A 3-trocar approach was used (subumbilical, 10 mm; right fossa, 10 mm; suprapubic, 5 mm). The surgeon stood between the legs of the patient with the camera holder in his left hand and laparoscopic scissors with electrocautery in his right hand. The surgeon's assistant was standing on the left side of the patient, manipulating the cecum with a retractor. After full mobilization of the right colon, the distal ileum and the cecum were exteriorized by a 4- to 5-cm vertical incision through the umbilicus. Vascular ligation, bowel division, and a sutured end-to-side anastomosis were performed extracorporeally.

In case of enterosigmoidal fistula, enterovesical fistula, or a large inflammatory mass, a small Pfannenstiel incision (8 cm) was performed instead of the transumbilical incision to facilitate mobilization and extraction of the mass and treatment of the fistula.

Open Surgical Technique

Through a midline incision from the umbilicus to the pubic bone, the right colon was mobilized. After vascular and bowel division, usually an end-to-side ileocolic anastomosis was performed.

Postoperative Care

Postoperatively, all patients were treated equally with regard to feeding, mobilization, and postoperative care. Postoperative pain management was performed by either patient-controlled analgesia (PCA), continuous morphine infusion, or by epidural anesthesia. The amount of morphine required during the first 3 days after surgery was registered if a patient had a PCA pump (B Braun, Oss, The Netherlands).

At the time of the start of the study, it was still common practice to remove the nasogastric tube the morning after surgery. Nowadays, the nasogastric tube is removed at the end of surgery. Oral intake was started with clear liquids and advanced as soon as tolerated. Patients were discharged when a normal diet was tolerated. Hospital stay was defined as the time from the intervention to hospital discharge.

Primary Endpoints

Postoperative QoL was measured with the SF-36 Health Survey,[17] and the total score of the Gastro-Intestinal Quality of Life Index (GIQLI).[18] Two subscales of the SF-36 (physical function and bodily pain) and the total GIQLI score served as primary endpoints. The SF-36 is a generic QoL measurement, consisting of 36 questions combined to form 8 domains. The SF-36 has 0-100 scales in the 8 domains. The GIQLI is a disease-specific questionnaire, consisting of 36 questions with 5 response categories. The responses to questions are summed to give a total numerical score. The QoL in both groups was measured preoperatively and at 1, 2, 4 weeks, and 3 months after surgery.

Secondary Endpoints

The remaining 6 subscales of the SF-36 were secondary endpoints. Furthermore, operating time, blood loss, conversion rate, early morbidity, morphine requirement, pain VAS scores, mortality, hospital stay, and costs were secondary endpoints.

Wound infections, urinary tract infections, pulmonary infections, and deep venous thrombosis were considered minor complications. Intra-abdominal abscesses, anastomotic leakage, bleeding, perforation, sepsis, burst abdomen, respiratory insufficiency, and prolonged ileus were considered major complications. An ileus was considered to be prolonged if patients did not have bowel sounds and/or flatus 5 days after surgery. Morbidity was scored as early morbidity if the event occurred within 30 days after surgery and late if morbidity occurred more than 30 days after surgery. Readmissions and reinterventions were included up to 3 months after surgery.

The calculation of costs for the 2 procedures was based on the mean costs in the main participating center (Academic Medical Center), consisting of costs for material used during the procedure, costs for use of an operating theater with personnel per minute, costs for relaparotomies, and costs for a day of admission.

The median costs for a surgical procedure were calculated by multiplying the mean costs for the use of an operating theater with personnel with the operating time and adding the mean costs for material used during the procedure. Overall costs were calculated by adding costs for hospital stay, readmissions, and reoperations to the costs of the surgical procedure.

Statistical Analysis and Power Analysis

Patients were analyzed according to the intention-to-treat principle. The hypothesis was that patients who underwent a laparoscopic-assisted ileocolic resection would have a faster postoperative recovery during the first month. The subscales physical function and bodily pain of the SF-36 could show clinically significant differences. Accepting the assumption that 20% was a relevant clinical difference in these subscales (standard deviation of 20%-25%) 2 to 4 weeks after surgery; a sample size of 30 patients per group was sufficient to find a statistically significant differences between the open and the laparoscopic-assisted group (α = 0.05, β = 0.1). The same calculation was performed for a 20-point difference in the total GIQLI score after 4 weeks between the 2 groups; again, a total of 60 patients was sufficient to show significant differences. These assumptions were made based on the QoL measurements by Liem et al comparing open versus laparoscopic hernia repair.[19]

Data are presented as median (range). Groups were compared using parametric tests for QoL results, nonparametric Mann-Whitney U tests for patient characteristics and operative parameters, and the χ2 test when appropriate. For QoL analysis, a repeated-measures analysis of variance was used to test between-group differences over time in scores on the QL measures. Statistical analysis was performed using the statistical program Statistical Package for the Social Sciences 11.5 for Windows (SPSS, Chicago, IL).

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