Clinical trial NCT00238381: Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
Official title: Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the rectum
stage 0 rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent rectal cancer
Lead sponsor: Swiss Group for Clinical Cancer Research
Sponsor class: OTHER
First posted: 2005-10-13
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery.

PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.

Detailed description: This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (\> 5 cm vs ≤ 5 cm), age (\< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.

Eligibility criteria: * Histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy
* Total mesorectal excision needed
* Age ≥ 18 years
* Clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools)
* Any T, any N, any M or adenoma
* An R0-resection is expected (liver metastases planned to be simultaneously
* Written informed consent, signed and dated by the patient and the investigator
* Completed baseline quality of life questionnaire

Exclusion criteria:

* Rectal tumor other than adenocarcinoma or adenoma
* Previous rectal cancer surgery, other than local excision within the last 2 months
* Histologically proven chronic inflammatory bowel disease
* Contraindications to any of the 3 surgical techniques
* BMI \> 35
* Patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the QL questionnaires and/or following the structured interview
* Inability to read and understand any of the languages available on the QL questionnaires,and spoken during the interview (German, French, Italian)

Primary outcomes:
measure: Composite evacuation score after total mesorectal excision
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Composite evacuation score at 6, 18, and 24 months after total mesorectal excision
timeFrame: 6, 18 and 24 months after surgery
measure: Composite incontinence score after total mesorectal excision
timeFrame: 6, 12, 18 and 24 months
measure: Quality of life after total mesorectal excision
timeFrame: 6, 12m 18 and 24 months
measure: Overall survival
timeFrame: 2 years follow-up
measure: Morbidity
timeFrame: 2 years follow-up
Other outcomes:
Locations:
city: Lörrach
country: Germany
facility: Kreiskrankenhaus Lörrach
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Baar
country: Switzerland
facility: Zuger Kantonsspital AG
city: Basel
country: Switzerland
facility: Universitaetsspital-Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Bruderholz
country: Switzerland
facility: Kantonsspital Bruderholz
city: Dornach
country: Switzerland
facility: Bezirksspital Dornach
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: La Chaux-de-Fonds
country: Switzerland
facility: Hopital de La Chaux-de-Fonds
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Luzerne
country: Switzerland
facility: Kantonsspital Luzern
city: Mendrisio
country: Switzerland
facility: Ospedale Beata Vergine
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: Wetzikon
country: Switzerland
facility: GZO Spital Wetzikon
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: Klinik Hirslanden
city: Zurich
country: Switzerland
facility: City Hospital Triemli
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zuerich
Study officials:
affiliation: Kantonsspital - Abteilung Onkologie
name: Christian T. Hamel, MD
role: STUDY_CHAIR
affiliation: Kantonsspital Aarau
name: Walter R. Marti, Prof.
role: STUDY_CHAIR
affiliation: Kantonsspital Olten
name: Markus Zuber, MD
role: STUDY_CHAIR
References:
citation: Marti WR, Curti G, Wehrli H, Grieder F, Graf M, Gloor B, Zuber M, Demartines N, Fasolini F, Lerf B, Kettelhack C, Andrieu C, Bigler M, Hayoz S, Ribi K, Hamel C; Swiss Group for Clinical Cancer Research (SAKK), Section Surgery. Clinical Outcome After Rectal Replacement With Side-to-End, Colon-J-Pouch, or Straight Colorectal Anastomosis Following Total Mesorectal Excision: A Swiss Prospective, Randomized, Multicenter Trial (SAKK 40/04). Ann Surg. 2019 May;269(5):827-835. doi: 10.1097/SLA.0000000000003057.