Efficacy and Safety of Purified Starch for Adhesion Prevention in Colorectal Surgery

NCT ID: NCT05580484

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-06-30

Brief Summary

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Intra-abdominal adhesion occurs in up to 90% of patients after abdominal surgery. Many patient will undergo a second surgery for temporary stoma closure, therefore these ostomy closure operations can give an opportunity to evaluate adhesion caused by previous operations. This study was conducted to use second surgery to investigate the anti-adhesion effect of purified starch among patients who underwent colorectal surgery.

Detailed Description

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Data was analyzed from the medical records of patients who underwent a second surgery after colectomy between January 2020 and April 2022. Patient were allocated to either the purified starch group and control group. Since January 2020, adhesion scores have been registered in operation note when patients undergo a second colorectal surgery. The primary outcomes in this study were adhesion severity and adhesion area. The secondary outcomes were operation time, blood loss, and postopera-tive complications.

Conditions

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Adhesions Abdominal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Purified starch/Control group

Patients who were willing to receive purified starch at their own expense during this first surgery were included in the purified starch group, and patients who did not re-ceive purified starch or other anti-adhesion products were included in the control group.

Second surgery

Intervention Type PROCEDURE

The primary outcomes were adhesion severity and adhesion area in the lower ab-dominal cavity, as determined through direct visual observation of a laparotomy wound or laparoscopic observation from stoma closure wound.

Interventions

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Second surgery

The primary outcomes were adhesion severity and adhesion area in the lower ab-dominal cavity, as determined through direct visual observation of a laparotomy wound or laparoscopic observation from stoma closure wound.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent a second surgery after colorectal resection between January 2020 and April 2022 were enrolled into this study.

Exclusion Criteria

* Patients who underwent a second surgery less than 1 month after the first colorectal resection or who developed peritoneum carcinomatosis in the second surgery and patients younger than 20 years were excluded.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tungcheng Chang

Chief of department of colorectal surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tung-Cheng Chang

Role: STUDY_CHAIR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University Shuang-Ho Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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N202109018

Identifier Type: -

Identifier Source: org_study_id

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