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Clinical Trials/NCT05580484
NCT05580484
Completed
Not Applicable

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

Taipei Medical University Shuang Ho Hospital1 site in 1 country83 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adhesions Abdominal
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
83
Locations
1
Primary Endpoint
Adhesion severity
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tungcheng Chang

Chief of department of colorectal surgery

Taipei Medical University Shuang Ho Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Adhesion severity

Time Frame: three to six months

Adhesion severity was scored as grade 0 (no adhesion), grade I (filmy adhesion and blunt dissection), grade II (strong adhesion and sharp dissection), and grade III (very strong vascularized adhesion, sharp dissection, and damage barely preventable).

Adhesion area

Time Frame: three to six months

Adhesion area was scored as grade 0 (no adhesion), grade I (adhesion of less than one-third of the area between the abdominal wall and the visceral organ in the lower abdominal cavity), grade II (adhesion of one-third and two-thirds of the area between the abdominal wall and the visceral organ in the lower abdominal cavity), and grade III (adhesion of more than two-thirds of the area between the abdominal wall and the visceral organ in the lower abdominal cavity).

Study Sites (1)

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