NCT04141566

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

October 20, 2019

Last Update Submit

August 31, 2020

Conditions

Rectal NeoplasmsColostomy StomaQuality of Life

Keywords

Pseudocontinent perineal colostomyAbdominoperineal resectioncolostomyCost effectivenessquality of life

Outcome Measures

Primary Outcomes (4)

  • Cost of management of both stoma types

    defined by out of pocket costs during the first 6 months following the surgery in euros

    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

    180 days from surgery

  • Globcal Quality of life of patients with PCPC and PLIC

    using the EORTC C30 Quality Of Life questionnaires

    180 days from surgery

  • Specific Quality of life of patients with PCPC and PLIC

    using the EORTC CR29 Quality Of Life questionnaires

    180 days from surgery

Secondary Outcomes (1)

  • 90 day morbidity and mortality rate

    90 days from surgery

Study Arms (2)

PCPC

pseudocontinent perineal colostomy using shmidt technique for perineal reconstruction after abdominoperineal resection

Procedure: Perineal pseudocontinent colostomy

PLIC

Permanenet left iliac colostomy , the standard technique after abdominoperineal resection and primary closure of the perineal wound

Procedure: Permanent left iliac colostomy

Interventions

Perineal pseudocontinent colostomyPROCEDURE

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.

PCPC
Permanent left iliac colostomyPROCEDURE

After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed

PLIC

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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)

You may not qualify if:

  • Patients unable to respond to the Quality Of Life questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institut of Oncology, Surgical oncology department

Rabat, Morocco

Location

Related Publications (5)

  • 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.

    PMID: 27472021BACKGROUND

  • 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.

    PMID: 25888423BACKGROUND

  • 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.

    PMID: 24022531BACKGROUND

  • 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.

    PMID: 21953024BACKGROUND

  • 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.

    PMID: 23868337BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 20, 2019

First Posted

October 28, 2019

Study Start

January 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations

MO(1)