NCT05627284

Unknown

A Prospective Clinical Trial of Colostomy-replacement Combin...

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Source

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Other study identifiers

Sponsor study identifier

2022-LCYJ-PY-33

Study Type

interventional

Estimated enrollment

58

Locations

1 country

Sites

1

Timeline

Study Start

October 1, 2022

Actual (reported)

Primary Completion

September 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 30, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:

Whether bio-mesh placement is safe for patients with a high risk of SSIH.
Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
Whether stoma reversal combining bio-mesh placement will trigger other complications. Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 58 participants
Study completion date: September 30, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 1, 2022
Actual (reported)
First Submitted
November 16, 2022
Actual (reported)
First Posted
November 25, 2022
Actual (reported)
Primary Completion
September 30, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: November 25, 2022
Status Verified: October 2022
Last Update Submitted: November 16, 2022

Conditions

Stoma Site Incisional Hernia

Keywords

Stoma Site Incisional HerniaColon cancer

Outcome Measures

Primary Outcomes (1)

stoma site incisional hernia
Hernia occurs on the primary stoma site
one-year after surgery

Study Arms (1)

Stoma reversal with bio-mesh placement

EXPERIMENTAL

Procedure: Stoma reversal with bio-mesh placement

Interventions

Stoma reversal with bio-mesh placementProcedure

Patients will receive stoma reversal. During the surgery, a bio-mesh is placed beyond the peritoneum on the surgical site to strengthen the abdominal wall.

Stoma reversal with bio-mesh placement

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18-75 years old;
Patients should have colonic prophylactic stoma and have not received reversal yet;

Sponsors & Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Otherlead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Meilin Jiang, Dr.CONTACT+86 025-68182923 gyethics@163.com

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Yonghuan Mao, Dr

CONTACT

+86 15151877330 maoyonghuan@163.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 25, 2022

Study Start

October 1, 2022

Actual (reported)

Primary Completion

September 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection;

No serious underlying diseases, can tolerate general anesthesia surgery

Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;

Preoperative ASA (American Society of Anesthesiologists) grade I-III;

Without vital organs function failure;

All patients and their families signed informed consent before surgery.

You may not qualify if:

Incapacitated persons;
With a history of other types of hernia;
Those who have had hernia mesh implantation before;
Those who are allergic to bio-mesh or their components before;
Combined with other surgeries;
Severe mental illness;
Severe respiratory disease;
Severe liver and kidney insufficiency;
Those who have absolute contraindications to surgery;
Suffering from severe bleeding disorders or obvious abnormal coagulation function;
History of unstable angina or myocardial infarction within 6 months;
History of cerebral infarction or cerebral hemorrhage within 6 months;
Continuous intravenous application of glucocorticoid within 1 month;
The patient has participated or is participating in other clinical studies (within 6 months).

Contact the study team to confirm eligibility.

Study Completion

September 30, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

November 25, 2022

Record last verified: 2022-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05627284
Data provider: ClinicalTrials.gov
Source updated: 2022-11-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:21 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Stoma reversal with bio-mesh placement

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations