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

Anastomosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02897531
• Other study ID #: B-1607-354-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2022

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: August 2022
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univercity Bundang Hospital	Seongnam	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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).	at 7 days after operation
Secondary	Postoperative hospital stay	Time(days) from operation to discharge	at discharge from hospital, an average of 1 week
Secondary	Postoperative complications	Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention	at 30 days
Secondary	Failure rate of the enhanced recovery program	The rate of adherence to the ERAS protocol	at discharge from hospital, an average of 1 week
Secondary	Readmission rate within 1 month after surgery	Readmissions after discharge	at 30 days