An interventional study of ES anastomosis and SS anastomosis in Anastomosis, sponsored by Seoul National University Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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%.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients who have all of the following:
Exclusion Criteria: Patients who have 1 or more of the following:
Stapled end-to-side anastomosis
Procedure: ES anastomosis
Stapled side-to-side anastomosis
Procedure: SS 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.
The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers.
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
Postoperative Hospital Stay
Time(days) from operation to discharge
Time frame: at discharge from hospital, an average of 1 week
Postoperative Complications
Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention
Time frame: at 30 days
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
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
| Milestone | ES Anastomosis | SS Anastomosis |
|---|---|---|
| Started | 65 | 65 |
| Completed | 65 | 65 |
| Not completed | 0 | 0 |
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).
| percentage of participants | ES Anastomosis | SS Anastomosis |
|---|---|---|
| Cumulative Recovery Rate | 100 | 100 |
Time(days) from operation to discharge
| days | ES Anastomosis | SS Anastomosis |
|---|---|---|
| Postoperative Hospital Stay | 5 (5 to 7) | 6 (5 to 7) |
Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention
| events | ES Anastomosis | SS Anastomosis |
|---|---|---|
| Postoperative Complications | 11 | 8 |
the number of patients who failed to adhere to the ERAS protocol
| participants | ES Anastomosis | SS Anastomosis |
|---|---|---|
| Failure Rate of the Enhanced Recovery Program | 7 | 5 |
the number of patients who were re-admitted after discharge within 1 month after surgery
| participants | ES Anastomosis | SS Anastomosis |
|---|---|---|
| Readmission Rate Within 1 Month After Surgery | 3 | 2 |
Collected over up to 3 year for each participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ES Anastomosis | 0/65 (0%) | 0/65 (0%) | 8/65 (12.3%) |
| SS Anastomosis | 0/65 (0%) | 0/65 (0%) | 6/65 (9.2%) |
| Event | ES Anastomosis | SS Anastomosis |
|---|---|---|
| Surgical site infectionInfections and infestations | 5/65 | 3/65 |
| ileusGastrointestinal disorders | 2/65 | 2/65 |
| Gastrointestinal bleedingGastrointestinal disorders | 0/65 | 1/65 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/65 | 0/65 |
| Age, Continuous(years) | ES Anastomosis | SS Anastomosis | Total |
|---|---|---|---|
| Mean | 64.8 ± 10.6 | 59.7 ± 11.5 | 62.2 ± 11.1 |
| Sex: Female, Male(Participants) | ES Anastomosis | SS Anastomosis | Total |
|---|---|---|---|
| Female | 42 | 32 | 74 |
| Male | 23 | 33 | 56 |
| Race and Ethnicity Not Collected(Participants) | ES Anastomosis | SS Anastomosis | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | ES Anastomosis | SS Anastomosis | Total |
|---|---|---|---|
| South Korea | 65 | 65 | 130 |
| American Society of Anesthesiology(participants) | ES Anastomosis | SS Anastomosis | Total |
|---|---|---|---|
| ASA 1 | 18 | 22 | 40 |
| ASA 2 | 39 | 33 | 72 |
| ASA 3 | 8 | 10 | 18 |
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Seoul National University Hospital