ES anastomosis
ProcedureThe side wall of the transverse colon will be anastomosed to the end of the distal ileum with one circular stapler, and the blind end of the transverse colon will be closed with one linear stapler.
NCT Number: NCT02897531
The purpose of this study is to evaluate the efficacy of end-to-side anastomosis after laparoscopic right hemicolectomy compared with that of side-to-side anastomosis. The investigators hypothesize that the end-to-side anastomosis may be associated with superior recovery compared with side-to-side anastomosis after laparoscopic right hemicolectomy under enhanced recovery program. The primary endpoint is the cumulative recovery rate, consisting of the recovery time of diet, pain, ambulation, and afebrile status.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Seoul National Univercity Bundang Hospital, Seongnam, Gyeonggido, South Korea
All patients will be received a laparoscopic right hemicolectomy by three experienced colorectal surgeons and randomly divided into two groups according to the method of anastomosis: - the end-to-side anastomosis group and the side-to-side anastomosis group. After the surgery, enhanced recovery program will be implemented. The primary endpoint is the cumulative recovery rate according to the method of anastomosis. The cumulative recovery rate is defined as the percentage of patients who are satisfied with all aspects of recovery time, including i) tolerance of diet for 24 hours, 2) analgesic-free (oral or intravenous (IV) analgesic drugs not necessary after cessation of patient-controlled analgesia (PCA)), 3) safe ambulation (ambulation of 600m without assistance), 4) afebrile status without major complications (fever was defined as body temperature greater than 37.2°C at axilla). Secondary endpoints are postoperative hospital stay, complications, the failure rate of the enhanced recovery program, and the readmission rate within 1 month after surgery. The expected cumulative recovery rate in postoperative day 7 is 90% in the end-to-side anastomosis group and 70% in the side-to-side anastomosis group. The sample size of 130 patients was calculated as follow: Based on the assumption that cumulative recovery rate will increase to 20% using the end-to-side anastomosis, it was calculated that 65 patients should be in each group. The sample size was calculated by the formula for a power 80%, alpha error of 0.05 and dropout rate of 10%.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients who have all of the following:
Exclusion criteria
Patients who have 1 or more of the following:
The side wall of the transverse colon will be anastomosed to the end of the distal ileum with one circular stapler, and the blind end of the transverse colon will be closed with one linear stapler.
The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers.
Time frame: at 7 days after operation
The cumulative recovery rate is defined as the percentage of patients who are satisfied with all aspects of recovery time. Recovery time includes the following:
Time frame: at discharge from hospital, an average of 1 week
Time(days) from operation to discharge
Time frame: at 30 days
Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention
Time frame: at discharge from hospital, an average of 1 week
the number of patients who failed to adhere to the ERAS protocol
Time frame: at 30 days
the number of patients who were re-admitted after discharge within 1 month after surgery
Seoul National University Hospital
Other
A Comparison of Surgical Outcomes Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy: A Prospective Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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