Clinical trial · Interventional
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer
- 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)
Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery. Design: randomized, prospective clinical study Patients: 40 patients
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 |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Incision Laparoscopic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SILS-group
- description
- 20 patients undergoing Single Incision Laparoscopic Surgery
- interventionNames
- Procedure: Single Incision Laparoscopic Surgery
- type
- NO_INTERVENTION
- label
- CLS-group
- description
- 20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer
Primary outcomes (1)
- measure
- morbidity
- timeFrame
- 30 days
- description
- The purpose of this study is to compare 30-days postoperative morbidity between the two groups
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years of age. * ASA I-III. * Tumor-location: maximum 15 cm from the anal verge. * No involvement of neighbouring organs. * No distant metastasis. Exclusion Criteria: * Linguistic, physical or psychological barriers precluding oral and written consent. * History of intestinal surgery (excl. appendectomy).
References
Publications (1)
- DERIVEDBulut O, Aslak KK, Levic K, Nielsen CB, Romer E, Sorensen S, Christensen IJ, Nielsen HJ. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery: effects on postoperative pain and the stress response to surgery. Tech Coloproctol. 2015 Jan;19(1):11-22. doi: 10.1007/s10151-014-1237-6. Epub 2014 Nov 8. PMID 25380743