HerniaNCT05458310
The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries
An observational study of Hernia, run by Prince Sultan Military College of Health Sciences at 1 site in Saudi Arabia.
Trial summary
This is a retrospec/ve cohort study of colon cancer patients who underwent laparoscopic colorectal surgeries at Prince Sultan Military Medical City (PSMMC) in Riyadh, Saudi Arabia. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hernia
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2018to 1 Dec 2021
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.
Who may be able to join
- The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.
Who cannot join
- Duplicated data, subjects younger than 16, patients with previous abdominal surgery, and surgically complicated cases which were converted to open surgery were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries: A Retrospective Single Centered Cohort Study
This is a retrospec/ve cohort study of colon cancer patients who underwent laparoscopic colorectal surgeries at Prince Sultan Military Medical City (PSMMC) in Riyadh, Saudi Arabia. The aim of this study is to determine the best site for specimen extrac/on with lowest risk of developing incisional hernia a0er laparoscopic colorectal surgeries.
- Conditions
- Hernia
- Medical subject headings
- Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of incision
The rate of incisional hernia development in relation to the incision site
Measured: Over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sultan Military College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Alboqami, Prince Sultan Military College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458310
- Sponsor's protocol ID
- HP-01-R-079
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries: A Retrospective Single Centered Cohort Study
- ClinicalTrials.gov ID
- NCT05458310
- Acronym / sponsor ID
- HP-01-R-079
- Conditions
- Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Prince Sultan Military College of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Jul 2022 (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.
This is a retrospec/ve cohort study of colon cancer patients who underwent laparoscopic colorectal surgeries at Prince Sultan Military Medical City (PSMMC) in Riyadh, Saudi Arabia. The aim of this study is to determine the best site for specimen extrac/on with lowest risk of developing incisional hernia a0er laparoscopic colorectal surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.
Key inclusion criteria (1 listed)
- The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.
Key exclusion criteria (1 listed)
- Duplicated data, subjects younger than 16, patients with previous abdominal surgery, and surgically complicated cases which were converted to open surgery were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of incision
Time frame: Over 2 years
The rate of incisional hernia development in relation to the incision site
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 14 Jul 2022.
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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 Hernia, run by Prince Sultan Military College of Health Sciences at 1 site in Saudi Arabia.
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 1 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 14 Jul 2022. 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 Saudi Arabia. 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?
Type of incision (time frame: Over 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2022.