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

JRCT ID: jRCT1040230031

Registered date:07/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: defecation disorders
• Date of first enrollment: 20/04/2023
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Intervention group: The intervention group receive instruction on pelvic floor rehabilitation and start rehabilitation one week before rectal cancer surgery. The intervention group restarts pelvic floor rehabilitation in the early postoperative period of rectal cancer surgery and continues them until 6 months postoperatively.
Pelvic floor rehabilitation: The patients contract the external anal sphincter for 10 seconds and relax the external anal sphincter for a few tens of seconds, which is performed 10 times consecutively for one set. The patients undergo 3 sets of the pelvic floor rehabilitation per day.
Non-intervention group: Pelvic floor rehabilitation are not performed. To avoid any disadvantages associated with participation in the study, pelvic floor rehabilitation will be allowed for patients who have severe defecation disorder after 3 months postoperatively and whose quality of life is significantly impaired based on the defecation status survey and medical examination by the study investigators.

Outcome(s)

• Primary Outcome: the rate of patients with low anterior resection syndrome score of 30 or more points at 3 months postoperatively

Secondary Outcome

Defecation function evaluatated 1 week before surgery and 1, 3, 6, 9, and 12 months after surgery.
(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.)
The rate of performance of pelvic floor rehabilitation.
Association between the rate of performance of pelvic floor rehabilitation at 3 and 6 months preoperatively and improvement in defecation function.
The rate of patients receiving postoperative drug therapy for defecation disorders.
Adverse events due to pelvic floor rehabilitation.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.

Exclude 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

Related Information

• Primary Sponsor: Kurachi Kiyotaka