NCT06397014

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

April 29, 2024

Last Update Submit

April 29, 2024

Conditions

Hernia RepairStoma ReconstructionFunction and Appearance

Outcome Measures

Primary Outcomes (2)

  • postoperative recurrence rate

    postoperative recurrence rate

    2018-2024

  • treatment cost

    treatment cost

    2018-2024

Study Arms (2)

D-type

Procedure: D-type stoma lateral hernia repair

Sugerbaker

Procedure: D-type stoma lateral hernia repair

Interventions

D-type stoma lateral hernia repairPROCEDURE

underwent D-type stoma lateral hernia repair

D-typeSugerbaker

Eligibility Criteria

Age60 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with parastomal hernia

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

February 1, 2018

Primary Completion

February 1, 2022

Study Completion

August 1, 2023

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)