Parastomal HerniaNCT06077318
Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia
An observational study of Parastomal Hernia, run by Fudan University.
Trial summary
Parastomal hernia (PSH) is difficult to manage, with high rates of post-operative recurrence and complication. Keyhole and Sugarbaker are the most commonly used techniques in the surgical repair of the PSH. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Keyhole repair and Sugarbaker repair
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 20 Dec 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to August 2022 were included.
Who may be able to join
- Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were included.
Who cannot join
- Patients with less than one year follow-up periods were excluded from the cohort.
- Patients received other repair approaches.
About this study
Official title: Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia: 10 Years of Experience From a Single Center in China
Parastomal hernia (PSH) is difficult to manage, with high rates of post-operative recurrence and complication. Keyhole and Sugarbaker are the most commonly used techniques in the surgical repair of the PSH. However, the efficacy and safety of the two surgical methods have not been adequately compared in the East Asian population.
Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to August 2022 will be included. Patient demographic data and postoperative outcomes will be retrospectively analyzed. The primary outcome measure is the recurrence rate at one year follow-up time.
Read the detailed description
Consecutive patients undergoing surgical PSH repair in the Hernia Center of Huadong Hospital Affiliated to Fudan University from August 2012 to August 2022 were included in this study. Huadong Hospital undertakes surgical treatment of complex hernia and abdominal wall diseases in Shanghai, China. The surgical records and clinical data of patients will be retrospectively analyzed. Due to the retrospective design of the study, the patient's informed consent was waived. The study was conducted following the ethical standards set out in the 1964 Declaration of Helsinki and its later amendments.
The patient's surgical strategy was made by the center's experienced colorectal surgeons or specialists in the department of hernia and abdominal wall surgery. In surgical practice, preference is given to the laparoscopic approach, while open surgery is chosen in cases of severe abdominal adhesions. The following three aspects of clinical data were recorded: (1) patients' demographic data, such as age, sex, the primary disease for the stoma, body mass index and comorbidities; (2) Surgical details: repair technique, size of abdominal wall defect, duration of the surgical procedure; (3) Short-term and long-term postoperative outcomes: the primary outcome is the recurrence rate at one year follow-up time, while the secondary outcomes were length and cost of the hospitalization, and rates of the intensive care unit admission, chronic pain, surgical site infection (SSI), re-admission and re-operation rates within 30 days after surgery, major complications after surgery, and surgery-related death.
Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were included. These patients were scheduled for follow-up appointments at the outpatient clinics, specifically at 1 month, 3 months, and 1 year after surgery. If recurrence is suspected by the surgeon after a physical examination, the patient would be requested for an abdominal CT scan. During the CT scan, patients were asked to perform the Valsava maneuver to facilitate the identification of any potential recurrences through imaging. Postoperative major complications were defined as complications requiring hospitalization after surgery to the one-year follow-up time. Patients with follow-up periods of less than one year were excluded from the cohort. Recorded death, recurrence, or loss to follow-up were considered to be the endpoint.
- Conditions
- Parastomal Hernia
- Being tested
- Keyhole repair, Sugarbaker repair
- Keywords
- Parastomal hernia, Keyhole, Sugarbaker, mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keyhole repairOther
The keyhole technique involves placing a mesh with a slit in the central hole around the intestinal ring, allowing facilitating the passage of the intestine through the central slit.
Sugarbaker repairOther
The modified Sugarbaker technique uses a mesh to place a patch on the lateralized intestine, effectively preventing herniation of abdominal contents through the stoma.
| Study group | Role | What they receive |
|---|---|---|
| Keyhole repair | The keyhole technique involves placing a mesh with a slit in the central hole around the intestinal ring, allowing facilitating the passage of the intestine through the central slit. Receives: Other: Keyhole repair | |
| Sugarbaker repair | The modified Sugarbaker technique uses a mesh to place a patch on the lateralized intestine, effectively preventing herniation of abdominal contents through the stoma. Receives: Other: Sugarbaker repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
recurrence was determined by CT scan
Measured: one year follow-up time
Secondary outcomes (4)
surgical site infection
wound infection in the surgical site
Measured: 30 days after surgery
reoperation and readmission
rates of the patients suffered from reoperation and readmission
Measured: 30 days after surgery
chronic pain
rate of patients suffered from chronic pain in the surgical site
Measured: one year follow-up time
major complication
rate of patients suffered from severe complications (need hospitalization)
Measured: one year follow-up time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077318
- Sponsor's protocol ID
- Huadong hernia
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi H, Li S, Lin Y, Yang D, Dong W, Song Z, Song H, Gu Y. Comparison of the 3-D mesh and Sugarbaker repair for parastomal hernia: a single center experience in China. Updates Surg. 2024 Sep;76(5):1991-1996. doi: 10.1007/s13304-024-01946-9. Epub 2024 Jul 21.
PubMed 39033484
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia: 10 Years of Experience From a Single Center in China
- ClinicalTrials.gov ID
- NCT06077318
- Acronym / sponsor ID
- Huadong hernia
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal hernia, Keyhole, Sugarbaker, mesh
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 11 Oct 2023 (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.
Parastomal hernia (PSH) is difficult to manage, with high rates of post-operative recurrence and complication. Keyhole and Sugarbaker are the most commonly used techniques in the surgical repair of the PSH. However, the efficacy and safety of the two surgical methods have not been adequately compared in the East Asian population.
Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to August 2022 will be included. Patient demographic data and postoperative outcomes will be retrospectively analyzed. The primary outcome measure is the recurrence rate at one year follow-up time.
Detailed description
Consecutive patients undergoing surgical PSH repair in the Hernia Center of Huadong Hospital Affiliated to Fudan University from August 2012 to August 2022 were included in this study. Huadong Hospital undertakes surgical treatment of complex hernia and abdominal wall diseases in Shanghai, China. The surgical records and clinical data of patients will be retrospectively analyzed. Due to the retrospective design of the study, the patient's informed consent was waived. The study was conducted following the ethical standards set out in the 1964 Declaration of Helsinki and its later amendments.
The patient's surgical strategy was made by the center's experienced colorectal surgeons or specialists in the department of hernia and abdominal wall surgery. In surgical practice, preference is given to the laparoscopic approach, while open surgery is chosen in cases of severe abdominal adhesions. The following three aspects of clinical data were recorded: (1) patients' demographic data, such as age, sex, the primary disease for the stoma, body mass index and comorbidities; (2) Surgical details: repair technique, size of abdominal wall defect, duration of the surgical procedure; (3) Short-term and long-term postoperative outcomes: the primary outcome is the recurrence rate at one year follow-up time, while the secondary outcomes were length and cost of the hospitalization, and rates of the intensive care unit admission, chronic pain, surgical site infection (SSI), re-admission and re-operation rates within 30 days after surgery, major complications after surgery, and surgery-related death.
Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were included. These patients were scheduled for follow-up appointments at the outpatient clinics, specifically at 1 month, 3 months, and 1 year after surgery. If recurrence is suspected by the surgeon after a physical examination, the patient would be requested for an abdominal CT scan. During the CT scan, patients were asked to perform the Valsava maneuver to facilitate the identification of any potential recurrences through imaging. Postoperative major complications were defined as complications requiring hospitalization after surgery to the one-year follow-up time. Patients with follow-up periods of less than one year were excluded from the cohort. Recorded death, recurrence, or loss to follow-up were considered to be the endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keyhole repair | – | Other: Keyhole repairThe keyhole technique involves placing a mesh with a slit in the central hole around the intestinal ring, allowing facilitating the passage of the intestine through the central slit. |
| Sugarbaker repair | – | Other: Sugarbaker repairThe modified Sugarbaker technique uses a mesh to place a patch on the lateralized intestine, effectively preventing herniation of abdominal contents through the stoma. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to August 2022 were included.
Key inclusion criteria (1 listed)
- Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were included.
Key exclusion criteria (2 listed)
- Patients with less than one year follow-up periods were excluded from the cohort.
- Patients received other repair approaches.
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 |
|---|---|---|
| Keyhole repairThe keyhole technique involves placing a mesh with a slit in the central hole around the intestinal ring, allowing facilitating the passage of the intestine through the central slit. | Other | Keyhole repair |
| Sugarbaker repairThe modified Sugarbaker technique uses a mesh to place a patch on the lateralized intestine, effectively preventing herniation of abdominal contents through the stoma. | Other | Sugarbaker repair |
Primary outcome
recurrence rate
Time frame: one year follow-up time
recurrence was determined by CT scan
4 secondary outcomes
surgical site infection
Time frame: 30 days after surgery
reoperation and readmission
Time frame: 30 days after surgery
chronic pain
Time frame: one year follow-up time
major complication
Time frame: one year follow-up time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 39033484Shi H, Li S, Lin Y, Yang D, Dong W, Song Z, Song H, Gu Y. Comparison of the 3-D mesh and Sugarbaker repair for parastomal hernia: a single center experience in China. Updates Surg. 2024 Sep;76(5):1991-1996. doi: 10.1007/s13304-024-01946-9. Epub 2024 Jul 21.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Parastomal Hernia, run by Fudan University.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
recurrence rate (time frame: one year follow-up time). 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 NCT06077318, which also lists 1 linked publication.
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 11 Oct 2023.