Hernia RepairNCT06397014
The Clinical Applications of D-type Parastomal Hernia Repair Surgery
An observational study of Hernia Repair and Stoma Reconstruction, run by Daorong Wang at 1 site in China.
Trial summary
During the period from February 2018 to February 2022, a study was conducted on patients with parastomal hernia.There were 23 patients who underwent repair surgery for D-type colostomy hernia, while 68 patients underwent traditional laparoscopic repair surgery for hernia.The inclusion criteria were: (1) preoperative… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hernia Repair, Stoma Reconstruction, Function and Appearance
- What is being tested?
- D-type stoma lateral hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Aug 2023
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with parastomal hernia
Who may be able to join
- preoperative diagnosis of parastomal hernia by CT scan; (2) underwent laparoscopic repair surgery or combined laparoscopic repair with abdominal wall and stoma reconstruction surgery.
Who cannot join
- occurrence of tumor recurrence and/or new tumors during the follow-up period; (2) death or loss to follow-up during the follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
During the period from February 2018 to February 2022, a study was conducted on patients with parastomal hernia.There were 23 patients who underwent repair surgery for D-type colostomy hernia, while 68 patients underwent traditional laparoscopic repair surgery for hernia.The inclusion criteria were: (1) preoperative diagnosis of parastomal hernia by CT scan; (2) underwent laparoscopic repair surgery or combined laparoscopic repair with abdominal wall and stoma reconstruction surgery.The exclusion criteria were: (1) occurrence of tumor recurrence and/or new tumors during the follow-up period; (2) death or loss to follow-up during the follow-up period.
- Conditions
- Hernia Repair, Stoma Reconstruction, Function and Appearance
- Being tested
- D-type stoma lateral hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-type stoma lateral hernia repairProcedure or surgery
underwent D-type stoma lateral hernia repair
| Study group | Role | What they receive |
|---|---|---|
| D-type | Not described Receives: Procedure: D-type stoma lateral hernia repair | |
| Sugerbaker | Not described Receives: Procedure: D-type stoma lateral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative recurrence rate
postoperative recurrence rate
Measured: 2018-2024
treatment cost
treatment cost
Measured: 2018-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Feb 2018
- Primary completion1 Feb 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia RepairStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daorong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daorong Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397014
- Sponsor's protocol ID
- PSH001
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Applications of D-type Parastomal Hernia Repair Surgery
- ClinicalTrials.gov ID
- NCT06397014
- Acronym / sponsor ID
- PSH001
- Conditions
- Hernia Repair, Stoma Reconstruction, Function and Appearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Daorong WangUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 2 May 2024 (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.
During the period from February 2018 to February 2022, a study was conducted on patients with parastomal hernia.There were 23 patients who underwent repair surgery for D-type colostomy hernia, while 68 patients underwent traditional laparoscopic repair surgery for hernia.The inclusion criteria were: (1) preoperative diagnosis of parastomal hernia by CT scan; (2) underwent laparoscopic repair surgery or combined laparoscopic repair with abdominal wall and stoma reconstruction surgery.The exclusion criteria were: (1) occurrence of tumor recurrence and/or new tumors during the follow-up period; (2) death or loss to follow-up during the follow-up period.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-type | – | Procedure: D-type stoma lateral hernia repair |
| Sugerbaker | – | Procedure: D-type stoma lateral hernia repair |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with parastomal hernia
Key inclusion criteria (1 listed)
- preoperative diagnosis of parastomal hernia by CT scan; (2) underwent laparoscopic repair surgery or combined laparoscopic repair with abdominal wall and stoma reconstruction surgery.
Key exclusion criteria (1 listed)
- occurrence of tumor recurrence and/or new tumors during the follow-up period; (2) death or loss to follow-up during the follow-up period.
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 |
|---|---|---|
| D-type stoma lateral hernia repairunderwent D-type stoma lateral hernia repair | Procedure or surgery | D-type, Sugerbaker |
Primary outcome
postoperative recurrence rate
Time frame: 2018-2024
postoperative recurrence rate
treatment cost
Time frame: 2018-2024
treatment cost
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 2 May 2024.
- Individual participant dataSharing planned: No
Related trials for Hernia Repair
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
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 Repair and Stoma Reconstruction, run by Daorong Wang at 1 site in China.
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 2 May 2024. 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 China. 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?
postoperative recurrence rate (time frame: 2018-2024). The study lists 2 primary outcomes in all. 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 2 May 2024.