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

Completed

• Conditions: Adhesions Abdominal
• Interventions: Procedure: Second surgery

• Registration Number: NCT05580484
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Purified starch/Control group	Second surgery	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.

Primary Outcome Measures

Name	Time	Method
Adhesion severity	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	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).

Trial Locations

Locations (1)

Taipei Medical University Shuang-Ho Hospital; 🇨🇳 New Taipei City, Taiwan