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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05286411
Other study ID # RMM_INO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 31, 2020

Study information

Verified date March 2022
Source Moroccan Society of Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Morbidity and mortality reviews represent an opportunity to discuss adverse events and healthcare issues. Aim is to report the first experience of implementing a standardized procedure of morbidity and mortality reviews, and assess its impact on quality improvement.


Description:

From July 2019 to December 2019, members of the surgical and intensive care unit departments designed and implemented a regular procedure of morbidity and mortality reviews. Cases of severe postoperative complications after curative resection for digestive cancer were selected to be presented by a surgical resident and discussed in an interdisciplinary conference following a standardized presentation based on an analysis tool adapted from the ALARM framework. Process was assessed by the number of morbidity and mortality reviews held, number and type of recommendations issued and implemented. Among 13 serious complications during the study period, 10 were discussed. The "Tasks" category was activated in 90% of the cases where lack or misuse of protocols was identified in 90% of the events discussed. Test results availability or accuracy were incarnated in 30% of cases. Poor communication was a contributing factor in 60% of the cases. Written medical records were defective in 40% of the cases. From 16 recommendations for improvement emitted, 87.5% (14/16) were translated into projects and successfully implemented. Thus, a standardized and regular procedure of morbidity and mortality reviews in a tertiary care facility in a developing country allowed a significant improvement in patient care through quality initiatives implementation. Morbidity and mortality reviews might be a strong tool for the improvement of surgical care particularly for low-mid income countries


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - severe adverse events defined as postoperative morbidity > 3a according to the Clavien Dindo grading system - within the first 90 postoperative days of surgery - Cases discussed in a morbidity and mortality review Exclusion Criteria: - Cases not discussed in a morbidity mortality review

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Morocco National Institute of Oncology Rabat

Sponsors (1)

Lead Sponsor Collaborator
Moroccan Society of Surgery

Country where clinical trial is conducted

Morocco, 

References & Publications (4)

Houssaini K, Lahnaoui O, Souadka A, Majbar MA, Ghanam A, El Ahmadi B, Belkhadir Z, Amrani L, Mohsine R, Benkabbou A. Contributing factors to severe complications after liver resection: an aggregate root cause analysis in 105 consecutive patients. Patient Saf Surg. 2020 Sep 29;14:36. doi: 10.1186/s13037-020-00261-7. eCollection 2020. Erratum in: Patient Saf Surg. 2020 Nov 12;14(1):41. — View Citation

Majbar MA, Courtot L, Dahbi-Skali L, Rafik A, Jouppe PO, Moussata D, Benkabbou A, Mohsine R, Ouaissi M, Souadka A. Two-step pull-through colo-anal anastomosis aiming to avoid stoma in rectal cancer surgery: A "real life" study in a developing country. J Visc Surg. 2021 Jun 3. pii: S1878-7886(21)00061-8. doi: 10.1016/j.jviscsurg.2021.04.004. [Epub ahead of print] — View Citation

Souadka A, Benkabbou A, Al Ahmadi B, Boutayeb S, Majbar MA. Preparing African anticancer centres in the COVID-19 outbreak. Lancet Oncol. 2020 May;21(5):e237. doi: 10.1016/S1470-2045(20)30216-3. Epub 2020 Apr 3. — View Citation

Souadka A, Majbar MA, Essangri H, Amrani L, Benkabbou A, Mohsine R, Souadka A. Functional outcomes over time following perineal pseudocontinent colostomy reconstruction after abdominoperineal resection for ultralow rectal adenocarcinoma. J Surg Oncol. 2020 Jun 20. doi: 10.1002/jso.26074. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Process assessment evaluation of the number of MMRs, numbers and categories of identified contributing factors, number and types of recommendations and number and types of implemented recommendations. one year
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