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CompletedNCT00238381Updated May 15, 2019

Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer

A Phase 3 interventional study of 5 cm colon-J-pouch and side-to-end anastomosis in Colorectal Cancer, sponsored by Swiss Group for Clinical Cancer Research. Completed at 18 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.

Sponsored by Swiss Group for Clinical Cancer Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
336
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 336 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Swiss Group for Clinical Cancer Research is the lead sponsor of 107 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
336 participants (actual)

Study arms

  • Other
    Arm I

    Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.

    Procedure: side-to-end anastomosis

  • Other
    Arm II

    Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.

    Procedure: 5 cm colon-J-pouch

  • Other
    Arm III

    Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy

    Procedure: straight coloanal anastomosis

Interventions

  • Procedure5 cm colon-J-pouch

    5 cm colon-J-pouch with/without temporary protective ileostomy

  • Procedureside-to-end anastomosis

    side-to-end anastomosis with/without temporary protective ileostomy

  • Procedurestraight coloanal anastomosis

    straight coloanal anastomosis with/without temporary protective ileostomy

06

What researchers measure

Primary outcomes

  1. Composite evacuation score after total mesorectal excision

    Time frame: 12 months after surgery

Secondary outcomes

  1. Composite evacuation score at 6, 18, and 24 months after total mesorectal excision

    Time frame: 6, 18 and 24 months after surgery

  2. Composite incontinence score after total mesorectal excision

    Time frame: 6, 12, 18 and 24 months

  3. Quality of life after total mesorectal excision

    Time frame: 6, 12m 18 and 24 months

  4. Overall survival

    Time frame: 2 years follow-up

  5. Morbidity

    Time frame: 2 years follow-up

07

Study locations

18 sites
  • Kreiskrankenhaus Lörrach
    Lörrach, 79539, Germany
  • Kantonsspital Aarau
    Aarau, CH-5001, Switzerland
  • Zuger Kantonsspital AG
    Baar, 6340, Switzerland
  • Universitaetsspital-Basel
    Basel, CH-4031, Switzerland
  • Inselspital Bern
    Bern, CH-3010, Switzerland
  • Kantonsspital Bruderholz
    Bruderholz, CH-4101, Switzerland
  • Bezirksspital Dornach
    Dornach, CH-4143, Switzerland
  • Hopitaux Universitaires de Geneve
    Geneva, CH-1226, Switzerland
  • Hopital de La Chaux-de-Fonds
    La Chaux-de-Fonds, CH 2300, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, CH-1011, Switzerland
  • Kantonsspital Luzern
    Luzerne, CH-6000, Switzerland
  • Ospedale Beata Vergine
    Mendrisio, CH-6850, Switzerland
  • Kantonsspital Olten
    Olten, CH-4600, Switzerland
  • GZO Spital Wetzikon
    Wetzikon, 8620, Switzerland
  • Kantonsspital Winterthur
    Winterthur, CH-8400, Switzerland
  • Klinik Hirslanden
    Zurich, CH-8032, Switzerland
  • City Hospital Triemli
    Zurich, CH-8063, Switzerland
  • UniversitaetsSpital Zuerich
    Zurich, CH-8091, Switzerland
08

References and documents

Publications

  • 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. PubMed 30252681 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00238381
Lead sponsor
Swiss Group for Clinical Cancer Research
Responsible party
Sponsor
First posted
Oct 13, 2005
Start date
Jul 2005
Primary completion
May 2014
Completion
Aug 2016
Last update
May 15, 2019

Study contacts

Christian T. Hamel, MD
study chair · Kantonsspital - Abteilung Onkologie
Walter R. Marti, Prof.
study chair · Kantonsspital Aarau
Markus Zuber, MD
study chair · Kantonsspital Olten

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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