Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma
NCT ID: NCT04141566
Last Updated: 2020-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
35 participants
OBSERVATIONAL
2018-01-01
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer
NCT05245565
Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery
NCT04776421
Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal
NCT01766661
Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
NCT02665026
Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer
NCT00457327
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A permanent left abdominal stoma is the standard salvage technique.
The pseudo continent perineal colostomy (PCPC) is an alternative technique especially in low income countries where the stoma bag and stoma care is not covered by health insurances.
Furthermore, this technique allows the conservation of body image, which is frequently requested by muslim patients whenever it is possible.
The aim of this study is to compare the cost effectiveness of both techniques as well as the quality of life of patients in the 6 first months following the surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PCPC
pseudocontinent perineal colostomy using shmidt technique for perineal reconstruction after abdominoperineal resection
Perineal pseudocontinent colostomy
The procedure is performed in 2stages: as a usual APR starting by a laparoscopic approach esnsuring a complete mesorectal excision,then a perineal approach ensuring an extended excision of the entire internal and external sphincter complex, allowing the excision of the specimen.
8to10cm of tof the colon is resected and harvested as a free graft, stripped of its meso and epiploics , then from its mucosa and placed in an antibiotic solution for 10min. This graft is wrapped snugly around the end of the colon 2-3 cm from its distal end for 1 and a half round. Absorbable 3.0 Sutures are taken to hold it in place. The end of the colon is brought out as a stoma in the perineum.
Colonic irrigations are started from the third day according to the protocol previously reported. Patients and one of their family members are daily educated and assisted while performing colonic irrigations by specialized nurses.
PLIC
Permanenet left iliac colostomy , the standard technique after abdominoperineal resection and primary closure of the perineal wound
Permanent left iliac colostomy
After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Perineal pseudocontinent colostomy
The procedure is performed in 2stages: as a usual APR starting by a laparoscopic approach esnsuring a complete mesorectal excision,then a perineal approach ensuring an extended excision of the entire internal and external sphincter complex, allowing the excision of the specimen.
8to10cm of tof the colon is resected and harvested as a free graft, stripped of its meso and epiploics , then from its mucosa and placed in an antibiotic solution for 10min. This graft is wrapped snugly around the end of the colon 2-3 cm from its distal end for 1 and a half round. Absorbable 3.0 Sutures are taken to hold it in place. The end of the colon is brought out as a stoma in the perineum.
Colonic irrigations are started from the third day according to the protocol previously reported. Patients and one of their family members are daily educated and assisted while performing colonic irrigations by specialized nurses.
Permanent left iliac colostomy
After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut National d'Oncologie Sidi Mohammed Ben Abdellah
UNKNOWN
Moroccan Society of Surgery
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amine Souadka
professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institut of Oncology, Surgical oncology department
Rabat, , Morocco
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Souadka 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.
Souadka 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.
Souadka 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.
Dumont 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.
Dumont 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCPC_PLIC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.