AnastomosisNCT02897531
Comparison Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy
A study testing ES anastomosis and SS anastomosis in people with Anastomosis, run by Seoul National University Hospital at 2 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anastomosis
- What is being tested?
- ES anastomosis and SS anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National Univercity Bundang Hospital
Seongnam, Gyeonggido, 463-707
Seoul National University Bundang Hospital
Seongnam, 463-707
About this study
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
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.
Read the 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%.
- Conditions
- Anastomosis
- Being tested
- ES anastomosis, SS anastomosis
- Keywords
- Ileocolic, stapled, laparoscopy, right hemicolectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES anastomosisProcedure or surgery
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 anastomosisProcedure or surgery
The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers.
| Study group | Role | What they receive |
|---|---|---|
| ES anastomosis | Active comparator | Stapled end-to-side anastomosis Receives: Procedure: ES anastomosis |
| SS anastomosis | Active comparator | Stapled side-to-side anastomosis Receives: Procedure: SS anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 7 days after operation
Secondary outcomes (4)
Postoperative Hospital Stay
Time(days) from operation to discharge
Measured: at discharge from hospital, an average of 1 week
Postoperative Complications
Includes any minor complication (ileus, wound infection) to major complications requiring re-intervention
Measured: at 30 days
Failure Rate of the Enhanced Recovery Program
the number of patients who failed to adhere to the ERAS protocol
Measured: 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
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnastomosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Bum Kang, Seoul National University Hospital
- Investigators
- Sung-Bum Kang, M.D, Ph.D., Principal investigator, Seoul National University College of Medicine Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897531
- Sponsor's protocol ID
- B-1607-354-004
- Status last verified
- Feb 2025
- First submitted
- 2 Sep 2016
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02897531
- Acronym / sponsor ID
- B-1607-354-004
- Conditions
- Anastomosis
- Keywords
- Ileocolic, stapled, laparoscopy, right hemicolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES anastomosis | Active comparator | Procedure: ES anastomosisStapled end-to-side anastomosis |
| SS anastomosis | Active comparator | Procedure: SS anastomosisStapled side-to-side anastomosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES anastomosisThe 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. | Procedure or surgery | ES anastomosis |
| SS anastomosisThe side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers. | Procedure or surgery | SS anastomosis |
Primary outcome
Cumulative Recovery Rate
Time frame: 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).
4 secondary outcomes
Postoperative Hospital Stay
Time frame: at discharge from hospital, an average of 1 week
Postoperative Complications
Time frame: at 30 days
Failure Rate of the Enhanced Recovery Program
Time frame: at discharge from hospital, an average of 1 week
Readmission Rate Within 1 Month After Surgery
Time frame: at 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Anastomosis
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Bum Kang, M.D, Ph.D. principal investigator
Seoul National University College of Medicine Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ES anastomosis and SS anastomosis in people with Anastomosis, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Recovery Rate (time frame: at 7 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.