Clinical trial · Interventional
Single-port Versus Conventional Laparoscopic Colorectal Surgery
Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal 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)
Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL. In this study, the investigators aim to randomise patients who are deemed suitable for SPA surgery to either SPA approach, or CL; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, the investigators aim to compare the physiological response to trauma through biochemical markers (including C-reactive protein, White Blood Cell count) and cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Colorectal Neoplasm | Benign Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Diverticular Disease | — | UNRESOLVED | — |
| Inflammatory Bowel Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Laparoscopic Access | Procedure | — | UNRESOLVED |
| Single-port access surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPA
- description
- Single-port access surgery
- interventionNames
- Procedure: Single-port access surgery
- type
- ACTIVE_COMPARATOR
- label
- CL
- description
- Conventional Laparoscopic access
- interventionNames
- Procedure: Conventional Laparoscopic Access
Primary outcomes (1)
- measure
- Operative Time
- timeFrame
- assessment of electronic records at 30 days from surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * large bowel disorder requiring surgical resection * body habitus suitable for single-port access surgery Exclusion Criteria: * patients not capable of informed consent and/or quality of life assessment * planned open procedure for surgical reason * multiple previous abdominal operations * body-mass index \> 40
References
Publications (0)
Data not yet available