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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ES anastomosis | Active Comparator | Stapled end-to-side anastomosis |
|
| SS anastomosis | Active Comparator | Stapled side-to-side anastomosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| at 7 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hospital Stay | Time(days) from operation to discharge | at discharge from hospital, an average of 1 week |
| Postoperative Complications | Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention |
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Inclusion Criteria: Patients who have all of the following:
Exclusion Criteria: Patients who have 1 or more of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Bum Kang, M.D, Ph.D. | Seoul National University College of Medicine Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univercity Bundang Hospital | Seongnam | Gyeonggido | 463-707 | South Korea | ||
| Seoul National University Bundang Hospital |
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During the study period, 201 patients met the inclusion criteria. Excluding patients who required combined operations (n = 18), and patients who could not undergo laparoscopic surgery or an ERAS protocol due to previous medical/surgical history (n = 22), 161 patients were invited to participate in the study. Of these, 130 provided informed consent and were randomized to either the ES or the SS group (n = 65 each)
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| ID | Title | Description |
|---|---|---|
| FG000 | ES Anastomosis | Stapled end-to-side anastomosis 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. |
| FG001 | SS Anastomosis | Stapled side-to-side anastomosis SS anastomosis: The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ES Anastomosis | Stapled end-to-side anastomosis 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. |
| BG001 | SS Anastomosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Number | percentage of participants | at 7 days after operation |
|
up to 3 year for each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ES Anastomosis | Stapled end-to-side anastomosis 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ileus | Gastrointestinal disorders | Systematic Assessment |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sung-Bum Kang, MD, PhD | Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital | +82-031-787-7093 | kangsb@snubh.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2018 | Jan 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2016 | Feb 11, 2025 | ICF_001.pdf |
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| 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. |
|
| at 30 days |
| Failure Rate of the Enhanced Recovery Program | the number of patients who failed to adhere to the ERAS protocol | at discharge from hospital, an average of 1 week |
| Readmission Rate Within 1 Month After Surgery | the number of patients who were re-admitted after discharge within 1 month after surgery | at 30 days |
| Seongnam |
| 463-707 |
| South Korea |
Stapled side-to-side anastomosis SS anastomosis: The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiology | the ASA score means ASA 1: A healthy patient with minimal risk ASA 2: A patient with mild systemic disease ASA 3: A patient with severe systemic disease ASA 4: A patient with severe systemic disease that is a constant threat to life ASA 5: A moribund patient who is not expected to live 24 hours with or without surgery ASA 6: A brain-dead patient with plans for organ donation | Number | participants |
|
| OG001 |
| SS Anastomosis |
Stapled side-to-side anastomosis SS anastomosis: The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers. |
|
|
| Secondary | Postoperative Hospital Stay | Time(days) from operation to discharge | Posted | Median | Inter-Quartile Range | days | 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 | Posted | Number | events | at 30 days |
|
|
|
| Secondary | Failure Rate of the Enhanced Recovery Program | the number of patients who failed to adhere to the ERAS protocol | Posted | Number | participants | at discharge from hospital, an average of 1 week |
|
|
|
| Secondary | Readmission Rate Within 1 Month After Surgery | the number of patients who were re-admitted after discharge within 1 month after surgery | Posted | Number | participants | at 30 days |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 8 |
| 65 |
| EG001 | SS Anastomosis | Stapled side-to-side anastomosis SS anastomosis: The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers. | 0 | 65 | 0 | 65 | 6 | 65 |
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Surgical site infection | Infections and infestations | Systematic Assessment |
|
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