Clinical trial · Interventional
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
NCT01656746CI-TRIAL-00030696completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyp | Adenomatous Polyp | ONTOLOGY_EXACT | 0.98 |
| Crohn Disease | — | UNRESOLVED | — |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
| Hereditary Intestinal Polyposis Syndrome | — | UNRESOLVED | — |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (single incision laparoscopic surgery)
- description
- Patients undergo single incision laparoscopic surgery with GelPort® attachment.
- interventionNames
- Procedure: therapeutic laparoscopic surgery
Primary outcomes (4)
- measure
- Operative time
- timeFrame
- Up to 1 year
- description
- Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
- measure
- Length of skin and fascial incisions
- timeFrame
- Up to 1 year
- description
- Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are willing to give consent and comply with the evaluation and the treatment schedule * Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon * American Society of Anesthesiologists (ASA) =\< 3 Exclusion Criteria: * Inability to obtain informed consent * Previous right colon surgery * Previous extensive abdominal surgery that would limit the laparoscopic approach * Stage IV disease at surgery * Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging * Patient enrolled in other interventional study * ASA score greater than 3 * Any condition which precludes compliance with the study (Investigator discretion) * Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial
References
Publications (0)
Data not yet available
No reference posted for this study.