Clinical trial · Observational
Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma
Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma: Comparaison of Out of Pocket Costs, Hospital Bills and Quality of Life
NCT04141566CI-TRIAL-00046903completedClinicalTrials.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)
Aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (PCPC) and a permanent left iliac colostomy (PLIC) following an abdominoperineal resection (APR) for ultra low rectal cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colostomy Stoma | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perineal pseudocontinent colostomy | Procedure | — | UNRESOLVED |
| Permanent left iliac colostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PCPC
- description
- pseudocontinent perineal colostomy using shmidt technique for perineal reconstruction after abdominoperineal resection
- interventionNames
- Procedure: Perineal pseudocontinent colostomy
- label
- PLIC
- description
- Permanenet left iliac colostomy , the standard technique after abdominoperineal resection and primary closure of the perineal wound
- interventionNames
- Procedure: Permanent left iliac colostomy
Primary outcomes (4)
- measure
- Cost of management of both stoma types
- timeFrame
- 180 days from surgery
- description
- defined by out of pocket costs during the first 6 months following the surgery in euros
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients of 18 years old or above * Abdominoperineal resection for ultra low rectal cancer * Creation of a definitive iliac colostomy or a pseudo continent perineal colostomy * Patients willing to participate to this study (writting consent) Exclusion Criteria: -Patients unable to respond to the Quality Of Life questionnaires
References
Publications (5)
- BACKGROUNDSouadka A, Majbar MA, Amrani L, Souadka A. Perineal pseudocontinent colostomy for ultra-low rectal adenocarcinoma: the muscular graft as a pseudosphincter. Acta Chir Belg. 2016 Oct;116(5):278-281. doi: 10.1080/00015458.2016.1174020. Epub 2016 Jul 29. PMID 27472021
- BACKGROUNDSouadka A, Majbar MA, El Harroudi T, Benkabbou A, Souadka A. Perineal pseudocontinent colostomy is safe and efficient technique for perineal reconstruction after abdominoperineal resection for rectal adenocarcinoma. BMC Surg. 2015 Apr 10;15:40. doi: 10.1186/s12893-015-0027-z. PMID 25888423
- BACKGROUNDSouadka A, Majbar MA, Bougutab A, El Othmany A, Jalil A, Ahyoud FZ, El Malki HO, Souadka A. Risk factors of poor functional results at 1-year after pseudocontinent perineal colostomy for ultralow rectal adenocarcinoma. Dis Colon Rectum. 2013 Oct;56(10):1143-8. doi: 10.1097/DCR.0b013e31829f8cd5. PMID 24022531
- BACKGROUNDDumont F, Souadka A, Goere D, Lasser P, Elias D. Impact of perineal pseudocontinent colostomy on perineal wound healing after abdominoperineal resection. J Surg Oncol. 2012 Jun 1;105(7):628-31. doi: 10.1002/jso.22105. Epub 2011 Sep 22. PMID 21953024
- BACKGROUNDDumont F, Ayadi M, Goere D, Honore C, Elias D. Comparison of fecal continence and quality of life between intersphincteric resection and abdominoperineal resection plus perineal colostomy for ultra-low rectal cancer. J Surg Oncol. 2013 Sep;108(4):225-9. doi: 10.1002/jso.23379. Epub 2013 Jul 19. PMID 23868337