Manual versus mechanical esophagogastric anastomosis after resection for carcinoma: a controlled trial. French Associations for Surgical Research.

BACKGROUND: Mechanical anastomosis has been claimed to reduce the rate of leakage compared with manual anastomosis. No randomized trials have been performed to date to prove this specifically in esophagogastric anastomosis.
METHODS: One hundred fifty-four patients, 139 men and 15 women ranging in age from 36 to 83 years (mean, 50 +/- 10 years) and undergoing elective resection of esophageal or cardial carcinoma, were included in this multiinstitutional (14 centers) randomized study comparing the rate of anastomotic leakage after esophagogastric anastomosis performed manually or mechanically. Eligible for this study were patients with esophageal or cardial carcinoma located between the esophagogastric junction (included) and the upper border of the aortic arch. The choice between resection with or without thoracotomy was left to the discretion of the operating surgeon. Proximal resection of the fundus was mandatory. Intestinal tract continuity was reestablished in a one-stage procedure by an esophagogastric anastomosis without interposition of either the jejunum or the colon. The site of the anastomosis could be either intrathoracic or cervical. The principal end point was anastomotic leakage as judged by (1) egress of intestinal fluids or orally ingested methylene blue through drains, (2) sodium diatrozate swallow prescribed either routinely for all patients between postoperative days 3 and 8 or because of signs of leakage, or (3) reoperation or autopsy.
RESULTS: After two patients were withdrawn for protocol violation, 152 patients, 74 in the manual group and 78 in the mechanical group, were studied. The number of anastomotic leakages was identical in both groups (n = 12, 16% and 15%, respectively). Overall 30-day mortality was 11%. Fewer deaths occurred in the manual group (7%), which had three anastomotic leakages, than in the mechanical group (15%), which had five anastomotic leakages, and fewer repeat operations were done in the manual group (n = 9) than in the mechanical group (n = 13), but both of these differences were not statistically significant. The duration of anastomosis and of operation was similar in both groups. In the mechanical group 16 anastomoses (20%) gave rise to technical mishaps (either in the fashioning of the purse-string, dilation of the esophagus, or in stapling). Among the factors recognized as potentially preventing leakage, only testing for airtightness was significantly correlated with less postoperative leakage (p < 0.05). Eight postoperative strictures were recorded at 3 months in 62 (13%) patients in the manual group, whereas seven strictures occurred in 53 (13%) patients in the mechanical group.
CONCLUSIONS: When mechanical staples rather than manual sutures are chosen, the disadvantages (technical mishaps and higher costs) are not counterbalanced by a gain of time or a decrease in the rate or severity of anastomotic leakage.

RCT Entities:   Population Interventions Outcomes