Rectal NeoplasmsNCT04141566
Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma
An observational study of Rectal Neoplasms and Colostomy Stoma, run by Moroccan Society of Surgery at 1 site in Morocco.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms, Colostomy Stoma, Quality of Life
- What is being tested?
- Perineal pseudocontinent colostomy and Permanent left iliac colostomy
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jan 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients who underwent an abdominoperineal resection for ultra low rectal cancer with the creation of a definitive iliac colostomy or a pseudo continent perineal colostomy. The following informations will be collected : age, gender, type of stoma,operative aspects, postoperative morbidity according to Clavien score, out of pocket costs and out of pocket hospital bills, quality of life at 6 months after surgery according to EORTC 30 and CR29 QOL
Who may be able to join
- 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)
Who cannot join
- -Patients unable to respond to the Quality Of Life questionnaires
Trial locations and contacts
1 site in 1 country.
Morocco1 site
National Institut of Oncology, Surgical oncology department
Rabat
About this study
Official title: 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
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
Read the detailed description
The surgical treatment of ultra low rectal adenocarcinoma has known great changes, yet the abdominoperineal resection (APR) is still indicated in over 20% of these cases.
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
- Rectal Neoplasms, Colostomy Stoma, Quality of Life
- Being tested
- Perineal pseudocontinent colostomy, Permanent left iliac colostomy
- Keywords
- Pseudocontinent perineal colostomy, Abdominoperineal resection, colostomy, Cost effectiveness, quality of life
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal pseudocontinent colostomyProcedure or surgery
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 colostomyProcedure or surgery
After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed
| Study group | Role | What they receive |
|---|---|---|
| PCPC | pseudocontinent perineal colostomy using shmidt technique for perineal reconstruction after abdominoperineal resection Receives: Procedure: Perineal pseudocontinent colostomy | |
| PLIC | Permanenet left iliac colostomy , the standard technique after abdominoperineal resection and primary closure of the perineal wound Receives: Procedure: Permanent left iliac colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of management of both stoma types
defined by out of pocket costs during the first 6 months following the surgery in euros
Measured: 180 days from surgery
Costs of hospital stay
defined as Out of pocket hospital bills in euros for all of the admission and the readmissions for surgical complication management
Measured: 180 days from surgery
Globcal Quality of life of patients with PCPC and PLIC
using the EORTC C30 Quality Of Life questionnaires
Measured: 180 days from surgery
Specific Quality of life of patients with PCPC and PLIC
using the EORTC CR29 Quality Of Life questionnaires
Measured: 180 days from surgery
Secondary outcomes (1)
90 day morbidity and mortality rate
defined by the Clavien Dindo rated from I to V at 90 post operative day.
Measured: 90 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Jan 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National d'Oncologie Sidi Mohammed Ben Abdellah
- Responsible party
- Principal investigator, Amine Souadka, Moroccan Society of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141566
- Sponsor's protocol ID
- PCPC_PLIC
- Status last verified
- Aug 2020
- First submitted
- 20 Oct 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27472021Souadka 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.
PubMed 25888423Souadka 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.
PubMed 24022531Dumont 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.
PubMed 21953024Dumont 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.
PubMed 23868337
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04141566
- Acronym / sponsor ID
- PCPC_PLIC
- Conditions
- Rectal Neoplasms, Colostomy Stoma, Quality of Life
- Keywords
- Pseudocontinent perineal colostomy, Abdominoperineal resection, colostomy, Cost effectiveness, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Collaborators
- Institut National d'Oncologie Sidi Mohammed Ben Abdellah
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The surgical treatment of ultra low rectal adenocarcinoma has known great changes, yet the abdominoperineal resection (APR) is still indicated in over 20% of these cases.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCPC | – | Procedure: Perineal pseudocontinent colostomypseudocontinent perineal colostomy using shmidt technique for perineal reconstruction after abdominoperineal resection |
| PLIC | – | Procedure: Permanent left iliac colostomyPermanenet left iliac colostomy , the standard technique after abdominoperineal resection and primary closure of the perineal wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent an abdominoperineal resection for ultra low rectal cancer with the creation of a definitive iliac colostomy or a pseudo continent perineal colostomy. The following informations will be collected : age, gender, type of stoma,operative aspects, postoperative morbidity according to Clavien score, out of pocket costs and out of pocket hospital bills, quality of life at 6 months after surgery according to EORTC 30 and CR29 QOL
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- -Patients unable to respond to the Quality Of Life questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal pseudocontinent colostomyThe 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. | Procedure or surgery | PCPC |
| Permanent left iliac colostomyAfter a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed | Procedure or surgery | PLIC |
Primary outcome
Cost of management of both stoma types
Time frame: 180 days from surgery
defined by out of pocket costs during the first 6 months following the surgery in euros
Costs of hospital stay
Time frame: 180 days from surgery
defined as Out of pocket hospital bills in euros for all of the admission and the readmissions for surgical complication management
Globcal Quality of life of patients with PCPC and PLIC
Time frame: 180 days from surgery
using the EORTC C30 Quality Of Life questionnaires
Specific Quality of life of patients with PCPC and PLIC
Time frame: 180 days from surgery
using the EORTC CR29 Quality Of Life questionnaires
1 secondary outcome
90 day morbidity and mortality rate
Time frame: 90 days from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Background: PubMed 27472021Souadka 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.
- Background: PubMed 25888423Souadka 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.
- Background: PubMed 24022531Souadka 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.
- Background: PubMed 21953024Dumont 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.
- Background: PubMed 23868337Dumont 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms and Colostomy Stoma, run by Moroccan Society of Surgery at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of management of both stoma types (time frame: 180 days from surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141566, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.