Abstract
BackgroundColorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet.Methods/DesignA study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer.The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol.DiscussionAim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer.Trial registrationGerman Clinical Trial Register Number: DRKS00000040
Highlights
Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%
Concerning closure of loop ileostomy after low anterior resection we are currently observing a situation of clinical equipoise as there is only one small, mono-center trial postulating that stapled anastomosis is superior compared to hand-sewn anastomosis regarding bowel obstruction
As closure of loop ileostomy is a common procedure performed by community hospitals as well as by referral centers we chose an individual design in terms of a pragmatic trial
Summary
Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. Preliminary data One randomized controlled trial (RCT) including 141 patients over 6 years has compared hand-sutured and stapled anastomosis for closure of loop ileostomy so far [9]. The results of this trial have shown a significantly higher rate of postoperative bowel obstruction (14% versus 3%, p = 0.0168) for patients who received handsutured anastomosis. The trial included a heterogeneous group of patients with many different underlying benign and malignant diseases It was performed in a single-center setting with only a low number of surgeons performing the investigated techniques. Due to the methodological and clinical limitations of this trial a multi-center pragmatic trial is needed to confirm the observed findings
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