Clinical trial · Interventional
Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery
A Randomized Trial Comparing Outcomes for the LigaSure and Disposable Stapling Instruments for Laparoscopic Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research is to compare two different standard of care surgical methods for the following large bowel (colon) procedures: laparoscopic right colectomy, total colectomy, and left colectomy. The study will compare electrocautery, used with surgical clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be looking at which procedure is faster and more cost efficient and the investigators will calculate hospital expenses for the two groups to make comparisons.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Diseases | — | UNRESOLVED | — |
| Rectal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bipolar electrosurgical generator and instruments | Procedure | — | UNRESOLVED |
| Disposable stapling instruments | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group A
- description
- Standard of Care
- interventionNames
- Procedure: Disposable stapling instruments
- type
- OTHER
- label
- Group B
- description
- Standard of Care
- interventionNames
- Procedure: Bipolar electrosurgical generator and instruments
Primary outcomes (1)
- measure
- this study will evaluate the surgical approach using the Ligasure device at six weeks post operative.
- timeFrame
- 6 weeks post-op
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who have benign or malignant colonic or rectal disease that mandate resection and are approached laparoscopically. Potential indications or conditions include ulcerative colitis, Crohn's disease, colorectal polyps, colorectal malignancy, endometriosis, diverticulitis, and colonic inertia * Subjects who are 18 years of age and older * Subjects of either sex * Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent Exclusion Criteria: * Subjects who undergo conversion to the open approach before mobilization of the colon or pedicle ligation will be excluded from the analysis * Subjects who are pregnant * Subjects who have undergone a previous colectomy * Subjects with a medical condition that may interfere with the evaluation of safety or effectiveness of the study device * Subjects who have another condition that in the opinion of the investigator precludes further participation in the study
References
Publications (1)
- DERIVEDAdamina M, Champagne BJ, Hoffman L, Ermlich MB, Delaney CP. Randomized clinical trial comparing the cost and effectiveness of bipolar vessel sealers versus clips and vascular staplers for laparoscopic colorectal resection. Br J Surg. 2011 Dec;98(12):1703-12. doi: 10.1002/bjs.7679. Epub 2011 Oct 13. PMID 21997317