Clinical trial · Interventional
Monitoring by Microdialysis of Postoperative Complications After Proctectomy
Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy
NCT01999634CI-TRIAL-00095556MTM-COLON-IIcompletedPhase 3ClinicalTrials.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)
The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cma microdialysis catheter placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cma microdialysis catheter placement
- description
- At the end of the surgery the cma microdialysis catheter is placed near the anastomosis
- interventionNames
- Device: cma microdialysis catheter placement
Primary outcomes (1)
- measure
- anastomotic leaks rate
- timeFrame
- postoperative day 30
- description
- the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan or at the clinical examination
Secondary outcomes (2)
- measure
- superficial surgical site infection rate
- timeFrame
- postoperative day 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * rectal disease requiring proctectomy with anastomosis and stomy * proctectomy by laparoscopy or laparotomy * written consent Exclusion Criteria: * history of colorectal surgery * rectal surgery without anastomosis * breastfeeding or pregnancy * ASA score IV
References
Publications (4)
- BACKGROUNDSolligard E, Juel IS, Spigset O, Romundstad P, Gronbech JE, Aadahl P. Gut luminal lactate measured by microdialysis mirrors permeability of the intestinal mucosa after ischemia. Shock. 2008 Feb;29(2):245-51. doi: 10.1097/SHK.0b013e3180cab3ce. PMID 17693938
- BACKGROUNDCibicek N, Zivna H, Zadak Z, Kulir J, Cermakova E, Palicka V. Colon submucosal microdialysis: a novel in vivo approach in barrier function assessment - a pilot study in rats. Physiol Res. 2007;56(5):611-617. doi: 10.33549/physiolres.931004. Epub 2006 Dec 19. PMID 17184153
- BACKGROUNDKrejci V, Hiltebrand L, Buchi C, Ali SZ, Contaldo C, Takala J, Sigurdsson GH, Jakob SM. Decreasing gut wall glucose as an early marker of impaired intestinal perfusion. Crit Care Med. 2006 Sep;34(9):2406-14. doi: 10.1097/01.CCM.0000233855.34344.29. PMID 16878039
- RESULTBeauchemin M, Gonzalez-Frankenberger B, Tremblay J, Vannasing P, Martinez-Montes E, Belin P, Beland R, Francoeur D, Carceller AM, Wallois F, Lassonde M. Mother and stranger: an electrophysiological study of voice processing in newborns. Cereb Cortex. 2011 Aug;21(8):1705-11. doi: 10.1093/cercor/bhq242. Epub 2010 Dec 13. PMID 21149849