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

NCT02897531 | Completed Results DMC

• 1 other identifier: B-1607-354-004
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anastomosis

Keywords

Ileocolic, stapled, laparoscopy, right hemicolectomy

Outcome Measures

Primary Outcomes (1)

• Cumulative Recovery Rate

  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: 1. Tolerance of diet for 24hours 2. Analgesic-free status (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).

  at 7 days after operation

Secondary Outcomes (4)

• Postoperative Hospital Stay

  at discharge from hospital, an average of 1 week

• Postoperative Complications

  at 30 days

• Failure Rate of the Enhanced Recovery Program

  at discharge from hospital, an average of 1 week

• Readmission Rate Within 1 Month After Surgery

  at 30 days

Study Arms (2)

ES anastomosis

ACTIVE COMPARATOR

Stapled end-to-side anastomosis

Procedure: ES anastomosis

SS anastomosis

ACTIVE COMPARATOR

Stapled side-to-side anastomosis

Procedure: SS anastomosis

Interventions

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.

ES anastomosis

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.

SS anastomosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National Univercity Bundang Hospital

Seongnam, Gyeonggido, 463-707, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Limitations and Caveats

Second, our ERAS protocol did not include recent developments such as preoperative carbohydrate loading, multimodal analgesia, and routine administration of drugs for prevention of postoperative nausea and vomiting

Results Point of Contact

• Title: Sung-Bum Kang, MD, PhD
• Organization: Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital

kangsb@snubh.org

+82-031-787-7093

Study Officials

• Sung-Bum Kang, M.D, Ph.D.

  Seoul National University College of Medicine Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 13, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: July 1, 2020
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)