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
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
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- 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