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Completed

NCT Number: NCT02897531

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

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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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Univercity Bundang Hospital, Seongnam, Gyeonggido, South Korea

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About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ES anastomosis

Procedure

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.

SS anastomosis

Procedure

The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers.

Primary outcomes

  1. 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 outcomes

  1. Postoperative Hospital Stay

    Time frame: at discharge from hospital, an average of 1 week

    Time(days) from operation to discharge

  2. Postoperative Complications

    Time frame: at 30 days

    Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention

  3. Failure Rate of the Enhanced Recovery Program

    Time frame: at discharge from hospital, an average of 1 week

    the number of patients who failed to adhere to the ERAS protocol

  4. Readmission Rate Within 1 Month After Surgery

    Time frame: at 30 days

    the number of patients who were re-admitted after discharge within 1 month after surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2016
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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