Prospective Nonrandomized Comparative Study of Laparoscopic Versus Open Surgical Staging for Endometrial Cancer in India

摘要

Laparoscopic procedures to treat endometrial cancer are currently emerging. At present, we have evidence to do laparoscopic oncologic resections for endometrial cancer as proven by many prospective studies from abroad such as LAP2 by GOG. So, we have decided to assess the safety and feasibility of such a study in our population with the following as our primary objectives: (1) to study whether laparoscopy is better compared to open approach in terms of duration of hospital stay, perioperative morbidity and early recovery from surgical trauma and (2) to study whether the laparoscopic approach is noninferior to the open approach in terms of number of lymph nodes harvested in lymphadenectomy and rate of conversion to open surgery. We did a prospective nonrandomized comparative study of open versus laparoscopy approach for surgical staging of endometrial cancer from 16th May 2013 to 15th May 2015. To prove a significant difference in the hospital stay, we needed 29 patients in each arm. Thirty patients in each arm were enrolled for the study. The median duration of stay in the open arm was 7 days and in the laparoscopy arm it was 5 days. The advantage of 2 days in the laparoscopic arm was statistically significant (P value 0.006). Forty percent of patients in the open arm had to stay in the hospital for more than 7 days whereas only 3% of patients in the laparoscopy arm required to stay for more than 7 days (P value 0.001). This difference was statistically significant. There was no significant difference between the early complication rates between the two arms (20% in open vs. 13% in laparoscopy; P value 0.730). There was a conversion rate of 10% in laparoscopy. The median number of nodes harvested in open arm was 16.50 and in the laparoscopy arm, it was 13.50. The difference was not statistically significant (P value 0.086). Laparoscopy approach for endometrial cancer staging is feasible in Indian patients and the short-term advantages are replicable with same oncologic safety as proved by randomized controlled trials.