Comparison Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy

Overview

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.

Full Title of Study: “A Comparison of Surgical Outcomes Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy: A Prospective Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2019

Detailed Description

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%.

Interventions

  • Procedure: ES anastomosis
    • 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.
  • Procedure: SS anastomosis
    • The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers.

Arms, Groups and Cohorts

  • Active Comparator: ES anastomosis
    • Stapled end-to-side anastomosis
  • Active Comparator: SS anastomosis
    • Stapled side-to-side anastomosis

Clinical Trial Outcome Measures

Primary Measures

  • Cumulative recovery rate
    • 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: Tolerance of diet for 24hours Analgesic-free status (oral or intravenous (IV) analgesic drugs not necessary after cessation of patient-controlled analgesia (PCA)), Safe ambulation (ambulation of 600m without assistance), Afebrile status without major complications (fever was defined as body temperature greater than 37.2°C at axilla).

Secondary Measures

  • Postoperative hospital stay
    • Time Frame: at discharge from hospital, an average of 1 week
    • Time(days) from operation to discharge
  • Postoperative complications
    • Time Frame: at 30 days
    • Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention
  • Failure rate of the enhanced recovery program
    • Time Frame: at discharge from hospital, an average of 1 week
    • The rate of adherence to the ERAS protocol
  • Readmission rate within 1 month after surgery
    • Time Frame: at 30 days
    • Readmissions after discharge

Participating in This Clinical Trial

Inclusion Criteria

Patients who have all of the following:

  • Age: 18 – 80 – Right-sided colon cancer (adenocarcinoma, located in cecum to hepatic flexure) – Appropriate laboratory (Bone marrow) findings (Hemoglobin ≥ 10g/dl, White blood cell count ≥ 4,000/mm3, Platelet ≥ 100,000/mm3) – Appropriate renal function (Creatinine ≤ 1.5 mg/dl) – Appropriate cardio-pulmonary functions – Appropriate understanding of the study and provide the informed consent Exclusion Criteria:
  • Patients who have 1 or more of the following:

  • Distant metastasis or locally advanced tumor which required combined resection of other organs, such as the ureter, duodenum, or small bowel. – Not suitable for laparoscopic surgery – Currently taking medication for dyschezia, such as constipation or diarrhea. – Not suitable for adapting enhanced recovery program due to underlying diseases, such as cardio-pulmonary disease, mental disorder, and etc. – Not suitable for participation in this clinical trial based on the judgment of the investigators
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 80 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Seoul National University Hospital
    • Provider of Information About this Clinical Study
      • Principal Investigator: Sung-Bum Kang, Professor – Seoul National University Hospital
    • Overall Official(s)
      • Sung-Bum Kang, M.D, Ph.D., Principal Investigator, Department of Surgery Seoul National University College of Medicine Seoul National University Bundang Hospital 300 Gumi-dong Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, Korea

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