Clinical trial · Interventional
Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 cm colon-J-pouch | Procedure | — | UNRESOLVED |
| side-to-end anastomosis | Procedure | — | UNRESOLVED |
| straight coloanal anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Arm I
- description
- Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
- interventionNames
- Procedure: side-to-end anastomosis
- type
- OTHER
- label
- Arm II
- description
- Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
- interventionNames
- Procedure: 5 cm colon-J-pouch
- type
- OTHER
- label
- Arm III
- description
- Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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)
References
Publications (1)
- RESULTMarti 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. PMID 30252681