Laparoscopic Versus Open Surgery for Rectal Cancer: Long-Term Oncologic Results

Long-Term Oncologic Results

Laurent, Christophe MD, PhD; Leblanc, Fabien MD; Wütrich, Philippe MD; Scheffler, Mathieu MD; Rullier, Eric MD

Disclosures

Annals of Surgery. 2009;250(1):54-61. 

In This Article

Materials and Methods

Patients' Selection

From 1994 to 2006, patients with rectal cancer within 15 cm from anal verge treated by open or laparoscopic curative rectal excision were included in a retrospective study. Evaluation included physical examination, colonoscopy with biopsy, endorectal ultrasonography, and abdominal and pelvic computed tomography scan). Pelvic magnetic resonance imaging was performed routinely since 2003. Rigid rectoscopy was performed to assess the exact level of the tumor from the anal verge. Patients were staged using the clinical tumor node metastasis classification. Those with T3, T4, or N+ disease received long-course preoperative radiochemotherapy (45 Gy in 5 weeks with concomitant 5-fluorouracile) and the schedule was similar during all the period study. After both open and laparoscopic surgery, patients with stage III disease (ie, positive lymph nodes 1-2) received postoperative adjuvant chemotherapy with 5-fluorouracil and folinic acid for 6 months.

Criteria for laparoscopic approach was tumor growing inside the rectum and mesorectum, ie, without invasion of adjacent organ (stages T1, T2, and T3), whatever the level of the lesion (0-15 cm from the anal verge). Criteria for open surgery were preoperative suspicion of fixed tumor into adjacent organ (T4 tumor) needing extended TME, synchronous liver metastasis suitable for simultaneous resection, and associated disease needing extensive colectomy (polyposis, ulcerative colitis, and second cancer). To obtain homogeneous groups in our comparative study, we included only patients who had inclusion criteria for a laparoscopic treatment. Patients treated by a laparoscopic approach between 2000 and 2006 were compared with those treated by open surgery between 1994 and 1999.

Surgical Technique

Surgery was performed 6 weeks after radiotherapy. All patients had a mechanic bowel preparation the day before the operation and antibioprophylaxia was given during the surgical procedure. Patients were operated by 2 colorectal surgeons trained in open and laparoscopic surgery (E.R. and C.L.). The surgical technique of open and laparoscopic TME has been previously described.[14,15] The technique was standardized as follows: (1) for upper third rectal tumors, a 5-cm mesorectal excision (partial TME) with end-to-end colorectal anastomosis was performed, (2) for mid and low rectal tumors, TME with pouch supra-anal or anal anastomosis was indicated, and (3) abdominoperineal excision was performed when the levator muscle was invaded. The same steps were applied in both laparoscopic and open procedures. High ligation of the inferior mesenteric artery and mobilization of the splenic flexure were systematically performed first. Mesorectal excision (total or partial) included complete removal of the mesorectum circumferentially with preservation of the hypogastric and pelvic plexuses. Extra facial anatomic dissection of the mesorectum was performed with scissors and bipolar coagulation. The rectum was transected with a linear stapler (Roticulator Endo-GIA 45, Covidien Healthcare Group, Norwalk, Conn for laparoscopic group or TA 45 for open group) or transanally according to the level of the tumor. For very low tumors, intersphincteric resection was performed to achieve sphincter preservation with clear distal margin.[16] The anastomosis was fashioned using a mechanical circular stapler (Proximate ILS, Ethicon endosurgery, Cincinnati, OH) or a coloanal hand-sewn. A colonic pouch was performed when feasible. A loop ileostomy was performed when the anastomosis was below 5 cm from the anal verge.[17] All patients had a pelvic suction drain. In the laparoscopic group, because of potential technical difficulties to achieve low rectal dissection and low rectal stapling, the distal part of rectal dissection was performed by the perineal approach and a manual coloanal anastomosis was done. In this case, we perform first the pelvic dissection by laparoscopic approach, then we transacted the low rectum through the anus and we removed the specimen transanally before performing the hand-sewn anastomosis. This strategy optimized to obtain both distal and circumferential safe margins, and decreased pitfalls due to a difficult laparoscopic low stapling. Conversion to an open operation was defined as a conventional midline laparotomy, ie, an abdominal incision greater in size than that needed for specimen retrieval.[18]

Postoperative analgesia was ensured by intravenous morphine chloridrate (patient-controlled administration) at a maximum of 4 mg per hour with a single dose of 1 mg and free interval of 10 minutes for 1 to 2 days. Patients in both groups were treated according to the same postoperative protocol: nasogastric tube removal at the end of the surgical procedure, fluids intake on postoperative day 1, oral solid food at postoperative day 2 or 3, and bladder catheter removal on postoperative day 3.

Pathologic Assessment

The rectal specimen was examined in the operative room by the surgeon to assess distal resection margin, then addressed freshly to the pathologic department pinned on a cork board with moderate tension. The surface of the mesorectum was inked before slicing to assess the circumferential resection margin. Microscopic assessment included tumor infiltration through the bowel wall (pT), presence of positive lymph nodes, and distal and circumferential resection margins. The resection margin was considered as negative if >1 mm (R0) and positive if ≤1 mm (R1).

Follow-Up

Morbidity was stratified as recommended by Dindo et al.[19] Grades I was any deviation from the normal postoperative course allowing symptomatic therapeutic as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also included wound infections opened at the bedside. Grade II included pharmacological treatment with drugs other than such allowed for grade I complications (antibiotics, parenteral nutrition, and blood transfusions). Grade III was postoperative complications requiring surgical, endoscopic, or radiologic intervention with or without general anesthesia. Grade IV included life-threatening complication requiring intensive care unit management. Grade V was defined by postoperative death of the patient. Minor surgical morbidity was considered as grades I or II and major morbidity as grades III, IV, or V. After surgery, patients were followed prospectively every 6 months for 5 years. Each consultation included clinical examination, abdominal and pelvic computed tomography scan, and chest x-ray. Colonoscopy was performed 1 year after surgery, then every 5 years. Local recurrence was defined as any recurrence diagnosed or suspected in the pelvis (tumor bed, pelvic nodes, anastomosis, drain site, or perineum) occurring alone or with other distant metastases. Distant metastases were defined as any recurrence occurring outside the pelvis.

Statistical Analysis

Data were collected prospectively using a computerized data base. Quantitative data were given as median (range). Difference between laparoscopic and open groups was assessed by Mann-Whitney and χ2 tests or Fisher exact test when appropriate. Comparisons between the 2 groups were made on the intention-to-treat basis: patients in the laparoscopic group converted to the open procedure were not excluded from the analysis. Time to last follow-up evaluation, treatment failure, or death was measured from the date of rectal excision.

Recurrence and survivals (cancer-free and overall) were evaluated by using the Kaplan-Meier and compared with the log-rank test. Analysis of predictive factors of survival was performed. Variables analyzed were sex, age, body mass index, tumor height, tumor stage, surgical approach (laparoscopic vs. open surgery), quality of resection (R0 vs. R1), surgical morbidity, preoperative radiotherapy, and adjuvant chemotherapy. Only variables associated with survival with P ≤ 0.20 in the univariate analysis were used for multivariable analysis using a stepwise Cox proportional hazards regression model. Statistical significance was defined as P < 0.05.

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