Clinical trial · Interventional
Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery
Randomized Controlled Trial to Evaluate the Effect of a Retractor Sponge in Postoperative Hospital Stay in Laparoscopic Colorectal Surgery in Patients With Malignancy
- 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)
Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract the small intestine. This method is associated with haemostatic changes caused by the cranial shift of abdominal organs and blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor, with the aim to keep the small intestines aside while the patient remains in a horizontal position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a clear surgical field and potentially prevents haemostatic instability by avoiding Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that use of the sponge might be associated with shorter hospital stay.
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 |
|---|---|---|---|
| Colon Carcinoma | Colon Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectum Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sponge | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sponge group
- description
- Patients offered surgery with the retractor sponge
- interventionNames
- Device: Sponge
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients receiving standard care: surgery in Trendelenburg position
Primary outcomes (1)
- measure
- Postoperative hospital stay (days)
- timeFrame
- Up to 4 weeks
- description
- Based on a discharge checklist
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion criteria: * Participant in the PICNIC project (METC 12-510) * Informed consent obtained for being offered experimental interventions within the PICNIC project * Informed consent obtained for questionnaires on patient reported outcomes within the PICNIC project * Planned for laparoscopic surgery of distal colorectal cancer in St. Antonius Hospital Exclusion Criteria: * Planned for open colorectal surgery * Surgery for benign colorectal diseases * Emergency colorectal surgery * Inadequate understanding of the Dutch language in speech and/or writing
References
Publications (0)
Data not yet available