Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial
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Colorectal cancer (CRC) is the third most frequent cancer diagnosed in men and the second in women. Laparoscopic surgery has been a technical revolution in colorectal surgery, facilitating a better recovery of patients with lower morbidity and better esthetic results, compared to traditional surgery via laparotomy, without compromising safety and long-term oncological results.
The trial is a randomized controlled trial indented to evaluate the two interventions with thorough measurements of the postoperative variables and complications to improve the evaluation of the surgical technique. The primary endpoint is to compare the hospital stay, which will be measured in days between both groups. The purpose of the study at secondary endpoints is to compare intraoperative and postoperative events between both groups in terms of operating time, anastomotic performance time, intraoperative complications, number of harvested lymph nodes, need for blood transfusion, length of the surgical wound, start and tolerance of oral intake, beginning of digestive functionality, postoperative pain, need for analgesic administration, surgical wound infection, paralytic ileus, anastomosis leakage or dehiscence, need for surgical reintervention, and hospital readmission within the first 30 days after surgery.
This trial is a prospective, randomized, single-blind, and single-center clinical trial comparing intracorporeal anastomosis versus extracorporeal anastomosis for right laparoscopic hemicolectomy.
Nowadays, there are several retrospective trials comparing the benefits for extracorporeal anastomosis versus intracorporeal anastomosis in right colon cancer patients. Considering the impact for laparoscopic surgery, we think it is necessary to do a randomized trial comparing extracorporeal versus intracorporeal anastomosis modalities.
www.clinicaltrials.gov No. NCT02667860 and Hospital de la Santa Creu i Sant Pau Research Institute No. IIBSP-AIE-2015-01
KeywordsIntracorporeal Anastomosis Right hemicolectomy Laparoscopy
Compliance with ethical standards
The study will rigorously follow the international ethical recommendations for research and clinical trials in humans. Likewise, the standards contained in the Declaration of Helsinki will be guaranteed and will be developed in accordance with the protocol and standardized work procedures.
The ethical approval of this study has been obtained from the ethics committee at Hospital de la Santa Creu i Sant Pau and the research institute.
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