Perioperative floor rehabilitation for defecation disorders after rectal cancer surgery: a randomized controlled trial

Not Applicable

Recruiting

• Conditions: defecation disorders; rectal cancer, postoperative, low anterior resection syndrome; D003672

• Registration Number: JPRN-jRCT1040230031
• Lead Sponsor: Kurachi Kiyotaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-07
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Inclusion criteria is patients diagnosed with rectal cancer 10 cm or below from the anal verge and undergoing surgery at the department of surgery, Hamamatsu University Schoolo of medecine, between April 2023 and March 2028.

Exclusion Criteria

1. patients who are scheduled to undergo colostomy in addition to resection of the primary tumor
2. patietns who are difficluty preserving anorectal function by resection of the primary tumor
3. patients who have undergone preoperative treatment (chemotherapy, radiation therapy, or radiation chemotherapy) related to the primary tumor
4. patients with neuromuscular diseases
5. patients with respiratory dysfunction requiring preoperative respiratory rehabilitation
6. pregnant or potentially pregnant women
7. women who are breast-feeding
8. patients determined ineligible for the study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the rate of patients with low anterior resection syndrome score of 30 or more points at 3 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Defecation function evaluatated 1 week before surgery and 1, 3, 6, 9, and 12 months after surgery.<br>(Defecation dysfunction is evaluated by intra-anal pressure measurement (functional anal canal length, maximum resting pressure, and maximum squeeze pressure), St. Marks score, LARS score, and mFIQL.)<br>The rate of performance of pelvic floor rehabilitation.<br>Association between the rate of performance of pelvic floor rehabilitation at 3 and 6 months preoperatively and improvement in defecation function.<br>The rate of patients receiving postoperative drug therapy for defecation disorders.<br>Adverse events due to pelvic floor rehabilitation.