Prospective Randomized Controlled Trial Comparing Side to Side Stapled and Hand Sewn Esophagogastric Anastomosis in the Neck

Hypothesis:

Side-to-side stapled anastomosis will decrease anastomotic leak rate by 15% compared to hand sewn technique in cervical esophagogastric anastomosis

Background:

Following esophagectomy or esophageal bypass, restoration of continuity by gastric interposition with cervical esophagogastric anastomosis (CEGA) can be done either by a hand-sewn or stapled anastomosis. Regardless of the surgical approach, decreasing anastomotic complications is essential for minimizing early morbidity and improving long-term functional results and quality of life. Cervical esophagogastric anastomosis almost eliminates the risk of postoperative mediastinitis associated with anastomotic leaks. Further, 98% of CEGA leaks can be managed successfully with local wound care (1), and less than 2% are associated with serious complications such as gastric tip necrosis, cervical vertebral osteomyelitis, epidural abscess and tracheogastroesophageal fistula, etc (2). Though early complications of CEGA are less, the long-term sequelae such as anastomotic stricture occur in nearly half the patients with an anastomotic leak. The need for life long esophageal dilatation negates the benefit of an operation intended to relieve dysphagia. The cause of anastomotic dehiscence in CEGA is possibly multifactorial (3,4) with both local tissue and systemic factors are being implicated. As the esophagus has no serosa, its longitudinal muscles hold sutures poorly and the awkward surgical exposure, possibly contribute to the higher anastomotic leak rates. Surgical technique is thus likely to play an important role. The incidence of CEGA leakage with hand sewn has been reported from 15% to 25% (5). While the stapled anastomosis is considered to be more expedient, less traumatic to tissues, with lower leak rates and associated with less mortality and morbidity, they are criticized for increased cost and high stricture rates. Most reports prior to 2000 showed identical leak rates in patients having a hand-sewn or stapled anastomosis with higher stricture rate in the stapled group (6-8). With recent technical refinements the CEGA has been performed in side-to-side manner using the Auto-Suture Endo-GIA 30-3.5 stapler. Following side to side anastomosis the leak rates have been reported to be less than 5%, with lower incidence of anastomotic stricture after leak and improved satisfaction in swallowing compared to hand sewn technique (9). These studies were retrospective and demanded a randomized trial to confirm the results. We therefore planned a randomized trial comparing the anastomotic sequelae after hand-sewn anastomosis with mechanical stapled side-to-side anastomosis

Objective: