NCT05831956

Brief Summary

In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. The goal of study was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

April 16, 2023

Last Update Submit

April 16, 2023

Conditions

Anastomosis, Functional

Outcome Measures

Primary Outcomes (1)

  • Bowel function recovery

    The primary outcome measurements were the number of days until first flatus and defecation after surgery, which were recorded as the number of days from surgery to the first occurrence of each event.

    0-30 days after colectomy

Study Arms (1)

Collagen group /Control group

Patients who received collagen patches on the anastomotic site during colectomy were allocated to the collagen group. Patients without collagen patches on the anastomotic site during colectomy were allocated to the control group.

Procedure: Laparoscopic colectomy

Interventions

Laparoscopic colectomyPROCEDURE

Patients who under went laparoscopic colectomy

Collagen group /Control group

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent laparoscopic colectomy.

You may qualify if:

  • Patients who underwent laparoscopic colectomy.

You may not qualify if:

  • Patients who underwent open surgery, emergent surgery, or had prior chemotherapy or concurrent chemoradiotherapy were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

New Taipei City, 235, Taiwan

Location

Related Publications (1)

  • Huang PY, Tsai MC, Kiu KT, Yen MH, Chang TC. Collagen patch cover facilitates recovery of bowel function after laparoscopic colectomy. BMC Surg. 2024 Feb 20;24(1):66. doi: 10.1186/s12893-024-02339-w.

    PMID: 38378522DERIVED

Study Officials

  • Tung-Cheng Chang, MD,PhD

    Taipei Medical University Shuang Ho Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Colorectal Surgery

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 26, 2023

Study Start

September 28, 2022

Primary Completion

February 24, 2023

Study Completion

March 15, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

TW(1)