Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia
1 other identifier
observational
100
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedStudy Start
First participant enrolled
October 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedOctober 11, 2023
October 1, 2023
Same day
September 19, 2023
October 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence rate
recurrence was determined by CT scan
one year follow-up time
Secondary Outcomes (4)
surgical site infection
30 days after surgery
reoperation and readmission
30 days after surgery
chronic pain
one year follow-up time
major complication
one year follow-up time
Study Arms (2)
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.
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.
Interventions
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.
The modified Sugarbaker technique uses a mesh to place a patch on the lateralized intestine, effectively preventing herniation of abdominal contents through the stoma.
Eligibility Criteria
Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to August 2022 were included.
You may qualify if:
- Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were included.
You may not qualify if:
- Patients with less than one year follow-up periods were excluded from the cohort.
- Patients received other repair approaches.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Related Publications (1)
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.
PMID: 39033484DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 19, 2023
First Posted
October 11, 2023
Study Start
October 20, 2023
Primary Completion
October 20, 2023
Study Completion
December 20, 2023
Last Updated
October 11, 2023
Record last verified: 2023-10