Anastomosis
Conditions
Keywords
Ileocolic, stapled, laparoscopy, right hemicolectomy
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.
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
PROCEDUREES 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.
PROCEDURESS anastomosis
The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Recovery Rate | 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: 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hospital Stay | at discharge from hospital, an average of 1 week | Time(days) from operation to discharge |
| Postoperative Complications | at 30 days | Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention |
| Failure Rate of the Enhanced Recovery Program | at discharge from hospital, an average of 1 week | the number of patients who failed to adhere to the ERAS protocol |
| Readmission Rate Within 1 Month After Surgery | at 30 days | the number of patients who were re-admitted after discharge within 1 month after surgery |
Countries
South Korea
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| 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. | 65 |
| Total | 130 |
Baseline characteristics
| Characteristic | ES Anastomosis | SS Anastomosis | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 10.6 | 59.7 years STANDARD_DEVIATION 11.5 | 62.2 years STANDARD_DEVIATION 11.1 |
| American Society of Anesthesiology ASA 1 | 18 participants | 22 participants | 40 participants |
| American Society of Anesthesiology ASA 2 | 39 participants | 33 participants | 72 participants |
| American Society of Anesthesiology ASA 3 | 8 participants | 10 participants | 18 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 65 participants | 65 participants | 130 participants |
| Sex: Female, Male Female | 42 Participants | 32 Participants | 74 Participants |
| Sex: Female, Male Male | 23 Participants | 33 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 8 / 65 | 6 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
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: 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).
Time frame: at 7 days after operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ES Anastomosis | Cumulative Recovery Rate | 100 percentage of participants |
| SS Anastomosis | Cumulative Recovery Rate | 100 percentage of participants |
Secondary
Failure Rate of the Enhanced Recovery Program
the number of patients who failed to adhere to the ERAS protocol
Time frame: at discharge from hospital, an average of 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ES Anastomosis | Failure Rate of the Enhanced Recovery Program | 7 participants |
| SS Anastomosis | Failure Rate of the Enhanced Recovery Program | 5 participants |
Secondary
Postoperative Complications
Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention
Time frame: at 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ES Anastomosis | Postoperative Complications | 11 events |
| SS Anastomosis | Postoperative Complications | 8 events |
Secondary
Postoperative Hospital Stay
Time(days) from operation to discharge
Time frame: at discharge from hospital, an average of 1 week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ES Anastomosis | Postoperative Hospital Stay | 5 days |
| SS Anastomosis | Postoperative Hospital Stay | 6 days |
Secondary
Readmission Rate Within 1 Month After Surgery
the number of patients who were re-admitted after discharge within 1 month after surgery
Time frame: at 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ES Anastomosis | Readmission Rate Within 1 Month After Surgery | 3 participants |
| SS Anastomosis | Readmission Rate Within 1 Month After Surgery | 2 participants |