Pelvic Floor rehabilitation to improve functional Outcome and quality of life after surgery for Rectal CancEr: a randomized trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27444

Enrollment

112

Registered

2015-07-03

Start date

2016-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Pelvic floor rehabilitation after low anterior resection for rectal cancer, including pelvic floor muscle training, biofeedback, electrostimulation and rectal balloon training.

Eligibility

Inclusion criteria

Inclusion criteria: - Patients undergoing a low anterior resection for rectal cancer. - Age over 18 years.

Exclusion criteria

Exclusion criteria: - No informed consent. - Certain comorbidities: proctitis, colitis ulcerosa, Crohn's disease - Necessity for resection beyond TME, ie T4 tumor. - Previous course of pelvis radiotherapie, for other reasons then the current rectal carcinoma. - Pelvic floor rehabilitation therapy in the last six months prior to rectal resection. - Life expectancy less than 1 year. - Mental or physical condition, that compromises the feasibility of the intervention. - Not mastering the Dutch language.

Design outcomes

Primary

Measure	Time frame
- Wexner-score - Fecal Incontinence Quality of Life score (FIQL)	—

Secondary

Measure	Time frame
- EORTC Colorectal Quality of Life Questionnaire QLQ-CR38 - defecation diary - LARS-score - preoperative radiotherapy or radiochemotherapy - perioperative parameters - level of anastomosis - morbidity and mortality related to surgery	—

Contacts

Public ContactB.R. Klarenbeek

br.klarenbeek@vumc.nl+31 (0)6 41254152

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)