Trial Outcomes & Findings for Comparison Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy (NCT NCT02897531)
NCT ID: NCT02897531
Last Updated: 2025-03-05
Results Overview
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).
COMPLETED
NA
130 participants
at 7 days after operation
2025-03-05
Participant Flow
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)
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ES Anastomosis
n=65 Participants
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.
|
SS Anastomosis
n=65 Participants
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.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 10.6 • n=65 Participants
|
59.7 years
STANDARD_DEVIATION 11.5 • n=65 Participants
|
62.2 years
STANDARD_DEVIATION 11.1 • n=130 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=65 Participants
|
32 Participants
n=65 Participants
|
74 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=65 Participants
|
33 Participants
n=65 Participants
|
56 Participants
n=130 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
65 participants
n=65 Participants
|
65 participants
n=65 Participants
|
130 participants
n=130 Participants
|
|
American Society of Anesthesiology
ASA 1
|
18 participants
n=65 Participants
|
22 participants
n=65 Participants
|
40 participants
n=130 Participants
|
|
American Society of Anesthesiology
ASA 2
|
39 participants
n=65 Participants
|
33 participants
n=65 Participants
|
72 participants
n=130 Participants
|
|
American Society of Anesthesiology
ASA 3
|
8 participants
n=65 Participants
|
10 participants
n=65 Participants
|
18 participants
n=130 Participants
|
PRIMARY outcome
Timeframe: at 7 days after operationThe 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).
Outcome measures
| Measure |
ES Anastomosis
n=65 Participants
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.
|
SS Anastomosis
n=65 Participants
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.
|
|---|---|---|
|
Cumulative Recovery Rate
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: at discharge from hospital, an average of 1 weekTime(days) from operation to discharge
Outcome measures
| Measure |
ES Anastomosis
n=65 Participants
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.
|
SS Anastomosis
n=65 Participants
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.
|
|---|---|---|
|
Postoperative Hospital Stay
|
5 days
Interval 5.0 to 7.0
|
6 days
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: at 30 daysIncludes any minor complication (ileus, wound infection) to major complications requiring re-intervention
Outcome measures
| Measure |
ES Anastomosis
n=65 Participants
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.
|
SS Anastomosis
n=65 Participants
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.
|
|---|---|---|
|
Postoperative Complications
|
11 events
|
8 events
|
SECONDARY outcome
Timeframe: at discharge from hospital, an average of 1 weekthe number of patients who failed to adhere to the ERAS protocol
Outcome measures
| Measure |
ES Anastomosis
n=65 Participants
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.
|
SS Anastomosis
n=65 Participants
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.
|
|---|---|---|
|
Failure Rate of the Enhanced Recovery Program
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: at 30 daysthe number of patients who were re-admitted after discharge within 1 month after surgery
Outcome measures
| Measure |
ES Anastomosis
n=65 Participants
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.
|
SS Anastomosis
n=65 Participants
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.
|
|---|---|---|
|
Readmission Rate Within 1 Month After Surgery
|
3 participants
|
2 participants
|
Adverse Events
ES Anastomosis
SS Anastomosis
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ES Anastomosis
n=65 participants at risk
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.
|
SS Anastomosis
n=65 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
ileus
|
3.1%
2/65 • Number of events 2 • up to 3 year for each participant
|
3.1%
2/65 • Number of events 2 • up to 3 year for each participant
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.00%
0/65 • up to 3 year for each participant
|
1.5%
1/65 • Number of events 1 • up to 3 year for each participant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.5%
1/65 • Number of events 1 • up to 3 year for each participant
|
0.00%
0/65 • up to 3 year for each participant
|
|
Infections and infestations
Surgical site infection
|
7.7%
5/65 • Number of events 5 • up to 3 year for each participant
|
4.6%
3/65 • Number of events 3 • up to 3 year for each participant
|
Additional Information
Sung-Bum Kang, MD, PhD
Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place